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Prescribing medicines in pregnancy database

Search the prescribing medicines in pregnancy database.

Last updated

Our database for prescribing medicines in pregnancy is here to help doctors prescribe medicines to pregnant women. It is not for public use or a substitute for a health professional's medical advice. Doctors using this database should not consider it their sole or main resource. 

We do not give advice on using medicines in pregnancy for specific cases.

Before you use the database

We have categorised medicines in the database using the Australian categorisation system for prescribing medicines in pregnancy:

It is important to understand this categorisation system before using the database. 

The database also contains safety information about the medicine. Health professionals should consider this essential information when prescribing medicines to pregnant women. This information may differ from the published Product Information (PI) that comes with the medicine. This is because of ongoing updates to the database.

More information about medicines in pregnancy

If you would like to understand more about medicines in pregnancy, before using the database, you can see:

You can use eBusiness Services to search product and consumer medicine information documents:

  • eBusiness Services

    Search Consumer medicine information (CMI) or Product information (PI) by medicine, trade name or active ingredient

Updates to the database

We update the database when new information about a medicine used in pregnancy becomes available. You can find updates to the database by:

  • using the database search for a specific medicine (see 'Search the database' on this page)
  • visiting our news page. 

If you get no results when searching

If no results come from your search this may mean: 

  1. The medicine has no pregnancy classification. This means the therapeutic good is exempt from pregnancy categorisation.
  2. No one has registered the medicine in Australia.
  3. You may have misspelled the medicine's name. 
  4. You may have used the trade name instead of the name of the active ingredient. You can find the name of the active ingredient by looking up the trade name in the Australian Register of Therapeutic Goods (ARTG).

Search the database

By accessing the database, you acknowledge that you have read, understood, and accept the introductory information provided on the Australian categorisation system for prescribing medicines in pregnancy (see Australian categorisation system for prescribing medicines).

The current (full) database is searchable in the table below by medicine name only. You can also access the database, and use the search function, via TROVE which includes the ability to search by drug class.

Note: the TROVE search is limited to information only available up to 16 August 2022. The searchable database may be updated later to search all medicines currently in the database].

Name Category Safety statement Classification 1 Classification 2 Classification 3
abacavir B3 Antimicrobials Antiviral agents
abacavir / dolutegravir / lamivudine B3 Antimicrobials Antiviral agents
abacavir / lamivudine / zidovudine B3 Antimicrobials Antiviral agents
abacavir/ lamivudine B3 Antimicrobials Antiviral agents
abaloparatide B3 Abaloparatide is contraindicated during pregnancy. Endocrine System Agents affecting calcium and bone metabolism
abatacept C Allergy and Immune System Immunomodifiers
abciximab C All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
abemaciclib D Based on results from animal studies and its mechanism of action, abemaciclib may harm the foetus. Antineoplastic Agents
abiraterone D Antiandrogens carry the potential for feminisation of the male fetus at or after 8 weeks post conception and exposure should be avoided during pregnancy. Endocrine System Antiandrogens
abrocitinib D Abrocitinib is contraindicated in pregnancy due to concerns for potential teratogenicity. Animal studies with abrocitinib revealed decreased postnatal survival and effects on skeletal development. Allergy and Immune System Immunomodifiers
acalabrutinib C Based on findings in animals, acalabrutinib may cause fetal harm. Antineoplastic Agents Tyrosine kinase inhibitors
acamprosate B2 Detoxifying Agents, Antidotes
acarbose B3 Endocrine System Hypoglycaemic agents
acetazolamide B3 Cardiovascular System Diuretics Carbonic anhydrase inhibitor
acetazolamide (ophthalmic) B3 Ophthalmic Drugs
acetylcholine B2 Ophthalmic Drugs
acetylcysteine B2 Respiratory System
acetylcysteine (inhaled) B2 Respiratory System Expectorants and mucolytics
acetylcysteine (intravenous) B2 Detoxifying Agents, Antidotes
aciclovir B3 Antimicrobials Antiviral agents
aciclovir (topical) B3 Drugs used in Dermatology Topical antiviral
acitretin X This drug is teratogenic at doses within the therapeutic range. The drug is stored in the body for several months after cessation. Because of the long half-life of this drug and storage in fat, patients are advised not to conceive until two years after cessation of treatment because of risk of birth defects. Should pregnancy occur during treatment with this drug, there is a high risk of birth defects. Drugs used in Dermatology Systemic
aclidinium bromide B3 Respiratory System Inhalational agents Bronchospasm relaxants
aclidinium bromide / eformoterol fumarate B3 Respiratory System Inhalational agents
actinomycin D (dactinomycin) D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antibiotic cytotoxic agents
adalimumab C Adalimumab crosses the placental barrier. Due to its inhibition of TNFalpha, adalimumab administered during pregnancy could affect immune response in the in utero-exposed newborn and infant. Allergy and Immune System Immunomodifiers
adapalene D There have been isolated reports of birth defects in babies born to women using this drug. Because of the potential risk of adverse effects on fetal development, adapalene should not be used by women who are pregnant or who plan to become pregnant during treatment. Drugs used in Dermatology Topical
adefovir B3 Antimicrobials Antiviral agents
adenosine B2 Cardiovascular System Antiarrhythmics
adrenaline (epinephrine) A Cardiovascular System Adrenergic stimulants
afamelanotide B1 Drugs Used in Dermatology Systemic
afatinib C This drug inhibits EGFR. EGFR plays an important role in embryofetal development. Antineoplastic Agents Tyrosine kinase inhibitors
aflibercept D Ophthalmic Drugs
agalsidase alfa B2 Metabolism Agents used for the treatment of metabolic disorders
agalsidase beta B2 Metabolism Agents used for the treatment of metabolic disorders
agomelatine B1 Central Nervous System Antidepressants
alatrofloxacin B3 Antimicrobials Antibiotics Quinolones
albendazole D In animal studies albendazole is teratogenic in several species. Until human data are available, it must be suspected of being teratogenic. Antimicrobials Anthelmintics
albutrepenonacog alfa B2 Cardiovascular System Haemostatic agents
alcuronium B2 Drugs Used in Anaesthesia Neuromuscular blocking agents
aldesleukin C Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
alectinib D Alectinib caused embryofetal lethality in rats and rabbits, visceral and skeletal anomalies in rats, and visceral malformation and skeletal variations in rabbits. Antineoplastic Agents Tyrosine kinase inhibitors
alefacept C Allergy and Immune System Immunomodifiers
alemtuzumab B2 Antineoplastic Agents Monoclonal antibodies
alendronate B3 Endocrine System Agents affecting calcium and bone metabolism Bisphosphonates
alfentanil C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
alfuzosin B2 Genitourinary System Prostate hyperplasia
alginates/antacids A Alimentary System Hyperacidity, reflux, ulcers
alglucerase B3 Metabolism Agents used for the treatment of metabolic disorders
alglucosidase alfa B1 Metabolism Agents used for the treatment of metabolic disorders
alimemazine C When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the infant. Allergy and Immune System Antihistamines
alirocumab B1 Cardiovascular System Hypolipidaemic agents
aliskiren D When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin II receptor antagonists and renin inhibitors
allergen pollen extract of 5 grasses B2 Allergy and Immune System
allopurinol B2 Musculoskeletal System Agents used in gout and hyperuricaemia
alogliptin / metformin C It is important to achieve strict normoglycaemia during pregnancy. Endocrine System Hypoglycaemic agents
alogliptin benzoate B3 Endocrine System Hypoglycaemic agents
alpelisib D Based on animal data and its mechanism of action, alpelisib can cause fetal harm when administered to a pregnant woman. Antineoplastic Agents
alpha-1-proteinase inhibitor B2 Respiratory System
alprazolam C Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
alprenolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
alteplase B1 Cardiovascular System Fibrinolytic agents
altretamine (hexamethylmelamine) D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
amantadine B3 Central Nervous System Antiparkinson agents
ambenonium chloride B2 Drugs Used in Myasthenia Gravis
ambrisentan X Teratogenicity is a class effect of these agents, which induce multiple fetal abnormalities in animal studies. These drugs are likely to cause major birth defects if used during pregnancy. Cardiovascular System Endothelin receptor antagonist
amethocaine (tetracaine) B2 Ophthalmic Drugs
amifampridine C Animal studies to assess the potential adverse effects of amifampridine on embryofetal development have not been conducted. However, amifampridine may block potassium channels which also play a role in normal uterine smooth muscle function during gestation and parturition. Central Nervous System
amifostine B3 Antineoplastic Agents Non-cytotoxic supportive therapy
amikacin D There is evidence of selective uptake of aminoglycosides by the fetal kidney resulting in damage (probably reversible) to immature nephrons. Eighth cranial nerve damage has also been reported following in utero exposure to some of the aminoglycosides. Because of their chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the fetus. It should also be noted that therapeutic blood concentrations in the mother do not equate with safety for the fetus. Antimicrobials Antibiotics Aminoglycosides
amiloride C Potassium sparing diuretics may cause an electrolyte disturbance in the fetus. Cardiovascular System Diuretics Potassium sparing diuretics
aminocaproic acid B3 Cardiovascular System Haemostatic agents
aminoglutethimide D There have been reports of pseudohermaphrodism with use of this drug in pregnancy. Antineoplastic Agents Hormonal antineoplastic agents
aminoglutethimide D There have been reports of pseudohermaphrodism with use of this drug in pregnancy. Endocrine System Hormonal agents
aminolevulinic acid HCl C Diagnostic Agents
amiodarone C Because of the long half-life of amiodarone and its major metabolite, and the potential to cause abnormal thyroid function and bradycardia in the fetus, its use is probably best avoided in the three months before and throughout the duration of pregnancy. When exposure of the fetus is unavoidable, thyroid function (including TSH) should be assessed promptly in the newborn infant. Cardiovascular System Antiarrhythmics
amisulpride C There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity. While in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Amisulpride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Central Nervous System Antipsychotic drugs
amitriptyline C Withdrawal symptoms in newborn infants have been reported with prolonged maternal use of tricyclic antidepressants. Central Nervous System Antidepressants Tricyclic antidepressants
amivantamab D IgG1 is known to cross the placent. Therefore, amivantamab has the potential to be transmitted from a pregnant patient to the developing fetus. Administration of other EGFR or MET inhibitor molecules to pregnant animals has resulted in an increased incidence of impairment of embryo-fetal development, embryolethality and abortion. Antineoplastic Agents Monoclonal antibodies
amlodipine C Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. Cardiovascular System Antihypertensives Calcium channel blockers
amlodipine / atorvastatin D Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. Cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, these drugs may cause fetal harm when administered to a pregnant woman. The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System
amlodipine / hydrochlorothiazide /valsartan D Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System
amlodipine / olmesartan medoxomil D Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives
amlodipine / olmesartan medoxomil / hydrochlorothiazide D Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System
amlodipine / telmisartan D Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives
amlodipine / valsartan D Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives
ammonium chloride A Respiratory System Expectorants and mucolytics
amobarbital C Barbiturates can give rise to hypotension, respiratory depression and hypothermia in the newborn infant. Continuous treatment during pregnancy and administration during labour should be avoided. Central Nervous System Hypnotics and sedatives Barbiturates
amorolfine B3 Drugs used in Dermatology Topical antifungals, antiseptics (see also antifungal agents)
amoxicillin A Antimicrobials Antibiotics Penicillins
amphotericin B3 Antimicrobials Antifungal agents (see also topical antifungals)
amphotericin B (liposomal) B3 Antimicrobials Antifungal agents (see also topical antifungals)
ampicillin A Antimicrobials Antibiotics Penicillins
amprenavir B3 Antimicrobials Antiviral agents
amsacrine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
amylobarbitone (amobarbital) C Barbiturates can give rise to hypotension, respiratory depression and hypothermia in the newborn infant. Continuous treatment during pregnancy and administration during labour should be avoided. Central Nervous System Hypnotics and sedatives Barbiturates
anacaulase-bcdb B1 Drugs Used in Dermatology Topical
Anacaulase-bcdb B2 Endocrine System Ovulation inducers Gonadotrophins
anagrelide B3 Antineoplastic Agents
anakinra B1 Allergy and Immune System Immunomodifiers
anastrozole C This drug disrupts oestrogen dependant metabolism and may result in abortion. Antineoplastic Agents Hormonal antineoplastic agents
ancestim B2 Blood and Haemopoietic System Haemopoietic agents
andexanet alfa B2 Detoxifying Agents, Antidotes
anecortave B1 Ophthalmic Drugs
anidulafungin B3 Antimicrobials Antifungal agents (see also topical antifungals)
anifrolumab C A higher risk of certain viral infections could theoretically occur in (human) infants exposed to anifrolumab during the later stage of the gestational period. Allergy and Immune System Immunomodifiers
anistreplase C Cardiovascular System Fibrinolytic agents
antithrombin III C Cardiovascular System Haemostatic agents
anti-thymocyte immunoglobulin C Allergy and Immune System Immunomodifiers
apadamtase alfa / cinaxadamtase alfa B1 Cardiovascular System Anticoagulants and thrombolytic agents
apalutamide D Based on its mechanism of action, it may cause fetal harm when administered during pregnancy. Antineoplastic Agents Hormonal antineoplastic agents
apixaban C All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
apomorphine B3 Central Nervous System Antiparkinson agents
apraclonidine B3 Ophthalmic Drugs
apremilast B3 Allergy and Immune System Immunomodifiers
aprepitant B1 Antineoplastic Agents Non-cytotoxic supportive therapy
aprotinin B1 Cardiovascular System Haemostatic agents
argipressin B2 Endocrine System Antidiuretics
aripiprazole C There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity. While in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Aripiprazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Central Nervous System Antipsychotic drugs
armodafinil D This drug is embryotoxic and fetotoxic when administered to pregnant rats and rabbits. Central Nervous System CNS stimulants
arsenic trioxide X In hamsters, rats and mice, parenteral administration of arsenite during the period of organogenesis produced fetal malformations, including neural tube, eye, facial, genitourinary and skeletal defects. Arsenite treatment of mice during gestation has also produced a widespread tumourigenic response in offspring. Antineoplastic Agents
artemether with lumefantine D Artemisinins are known to be embryotoxic in animals, causing cardiovascular and skeletal malformations. Based on evidence from animal studies, artemether is suspected to cause serious birth defects when administered during the first trimester of pregnancy. Antimicrobials Antimalarials
articaine B3 Drugs Used in Anaesthesia Local anaesthetics
articaine / adrenaline B3 Drugs Used in Anaesthesia Local anaesthetics
asciminib hydrochloride D Asciminib may cause fetal harm when administered to a pregnant woman. In treated pregnant rats and rabbits, administration of asciminib during organogenesis induced embryotoxicity, fetotoxicity and teratogenicity. Antineoplastic Agents Tyrosine kinase inhibitors
asenapine C There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity. While in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Asenapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Central Nervous System Antipsychotic drugs
asfotase alfa (rch) C There is a potential effect on embryofetal and neonate bone development with the production of antibodies against asfotase alfa. Metabolism Agents used for the treatment of metabolic disorders
asparaginase D Cytotoxicity from asparaginase activity poses a risk for spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
aspirin C Aspirin inhibits prostaglandin synthesis. When given late in pregnancy, it may cause premature closure of the fetal ductus arteriosus, delay labour and birth. Aspirin increases the bleeding time both in the newborn infant and in the mother because of its antiplatelet effects. Products containing aspirin should be avoided in the last trimester. Low-dose aspirin (100mg/day) does not affect bleeding time. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents)
aspirin / dipyridamole C Aspirin inhibits prostaglandin synthesis. When given late in pregnancy, it may cause premature closure of the fetal ductus arteriosus, delay labour and birth. Aspirin increases the bleeding time both in the newborn infant and in the mother because of its antiplatelet effects. Products containing aspirin should be avoided in the last trimester. Low-dose aspirin (100mg/day) does not affect bleeding time. Cardiovascular System Vasodilators
asunaprevir B1 Antimicrobials Antiviral agents
atazanavir B2 Antimicrobials Antiviral agents
atazanavir / cobicistat B2 Antimicrobials Antiviral agents
atenolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
atezolizumab D PD-1/PD-L1 is involved in fetomaternal tolerance. Administration during pregnancy may cause fetal harm, including abortion or stillbirth. Antineoplastic Agents Monoclonal antibodies
atogepant B3 Central Nervous System
atomoxetine B3 Central Nervous System CNS stimulants
atorvastatin D Cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, these drugs may cause fetal harm when administered to a pregnant woman. The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System Hypolipidaemic agents
atorvastatin / ezetimibe D Cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, these drugs may cause fetal harm when administered to a pregnant woman. The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System Hypolipidaemic agents
atovaquone B2 Antimicrobials Antibiotics
atracurium C There have been no demonstrated adverse effects in the fetus or the newborn infant. Drugs Used in Anaesthesia Neuromuscular blocking agents
atropine A Alimentary System Antispasmodics
atropine A Cholinergic and Anticholinergic Agents
atropine methonitrate B2 Cholinergic and Anticholinergic Agents
auranofin B3 Musculoskeletal System Antirheumatoid agents
aurothioglucose B2 Musculoskeletal System Antirheumatoid agents
avacopan D Oral administration of avacopan to pregnant hamsters during the period of organogenesis caused an increased incidence of skeletal variations in the absence of maternal toxicity, while in rabbits an increase in the number of abortions was observed at subclinical maternal exposures. Allergy and Immune System Immunomodifiers
avalglucosidase alfa B1 Metabolism Agents used for the treatment of metabolic disorders
avatrombopag maleate B3 Blood and Haemopoietic System
avelumab D PD-1/PD-L1 is involved in fetomaternal tolerance. Administration during pregnancy may cause fetal harm, including abortion or stillbirth. Antineoplastic Agents Monoclonal antibodies
axatilimab D Based on its mechanism of action, axatilimab may cause malformations and embryofetal loss when administered to pregnant women. Allergy and Immune System Immunomodifiers
axicabtagene ciloleucel C Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopaenia. Antineoplastic Agents
axitinib D Angiogenesis plays a key role in embryo-fetal development.VEGF receptor inhibitors inhibit angiogenesis and may cause fetal harm when administered to pregnant women. Antineoplastic Agents Tyrosine kinase inhibitors
azacitidine X Azacitidine must not be used during pregnancy. There are no adequate data on the use of azacitidine in pregnant women. Studies in animals have shown reproductive toxicity including teratogenic effects at relatively low doses. Azacitidine also had adverse effects on embryofetal development following treatment of male rats. Antineoplastic Agents Antimetabolites
azatadine B2 Allergy and Immune System Antihistamines
azathioprine D This drug has been associated with a slightly increased risk of fetal malformations, neonatal immunosuppression and bone marrow suppression in the infant. Allergy and Immune System Immunomodifiers
azelaic acid B1 Drugs used in Dermatology Topical
azelastine B3 Allergy and Immune System Antihistamines
azelastine hydrochloride / fluticasone propionate B3 Allergy and Immune System
azithromycin B1 Antimicrobials Antibiotics Macrolide antibiotics
azlocillin B3 Antimicrobials Antibiotics Penicillins
aztreonam B1 Antimicrobials Antibiotics
baclofen B3 Musculoskeletal System Muscle relaxants
baloxavir B3 Antimicrobials antiviral agents
balsalazide C Non-steroidal anti-inflammatory drugs inhibit prostaglandin synthesis and, when given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with non-steroidal anti-inflammatory drugs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Alimentary System Antidiarrhoeals
baricitinib D Based on the mechanism of action, baricitinib is suspected to affect early embryonic development when administered during pregnancy. Baricitinib has been shown to cause embryofetal lethality and fetal malformations in pregnant rats or rabbits. Allergy and Immune System Immunomodifiers
basiliximab D This drug has potentially hazardous pharmacological effects based on its immunosuppressive action. Allergy and Immune System Immunomodifiers
BCG (Mycobacterium bovis) B2 Vaccines Live attenuated vaccines
becaplermin B2 Drugs used in Dermatology Topical
beclometasone B3 The benefits of asthma control outweigh any potential for an adverse pregnancy outcome. Endocrine System Corticosteroids Inhalation/intranasal
beclomethasone B3 The benefits of asthma control outweigh any potential for an adverse pregnancy outcome. Respiratory System Inhalational agents Preventative aerosols and inhalations
belantamab mafodotin D Based on its mechanism of action, belantamab mafodotin may cause embryofetal harm (embryotoxicity and teratogenicity) when administered to a pregnant woman. Antineoplastic Agents Monoclonal antibodies
belatacept C Allergy and Immune System Immunomodifiers
belimumab C IgG antibodies are known to cross the placental barrier. This drug has the potential to affect embryofetal survival due to its pharmacological action. Allergy and Immune System Immunomodifiers
belladonna B2 Cholinergic and Anticholinergic Agents
belumosudil D Studies in animals indicate a risk of malformations and embryofetal lethality with use of belumosudil during pregnancy. Allergy and Immune System Immunomodifiers
belzutifan D Based on findings in animal studies, belzutifan may cause fetal harm, including fetal loss - administration of belzutifan to pregnant rats during organogenesis caused embryo-fetal lethality, reduced fetal body weight and fetal skeletal abnormalities. Antineoplastic Agents
bendamustine hydrochloride D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Alkylating agents
bendrofluazide C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
benralizumab B1 Allergy and Immune System Immunomodifiers
benserazide B3 Central Nervous System Antiparkinson agents
benserazide / levodopa B3 Central Nervous System Antiparkinson agents
benzathine penicillin A Antimicrobials Antibiotics Penicillins
benzatropine B2 Central Nervous System Antiparkinson agents
benzhexol (trihexyphenidyl) B1 Central Nervous System Antiparkinson agents
benzoyl peroxide / adapalene D There have been isolated reports of birth defects in babies born to women using this drug. Because of the potential risk of adverse effects on fetal development, adapalene should not be used by women who are pregnant or who plan to become pregnant during treatment.
benzoyl peroxide / clindamycin A Antimicrobials Topical antimicrobials
benzydamine (topical oropharyngeal) B2 Mouth Preparations
benzyl benzoate B2 Drugs used in Dermatology Topical antiparasitics
benzylpenicillin A Antimicrobials Antibiotics Penicillins
betahistine B2 Cardiovascular System Vasodilators
betamethasone acetate / betamethasone C Endocrine System Corticosteroids
betamethasone dipropionate B3 Endocrine System Corticosteroids
betamethasone dipropionate / calcipotriol B3 Drugs Used in Dermatology Topical
betamethasone valerate B3 Endocrine System Corticosteroids
betaxolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
betaxolol (ophthalmic) C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Ophthalmic Drugs
bethanechol B2 This drug has a potent excitatory effect on smooth muscle and should be avoided during pregnancy. Cholinergic and Anticholinergic Agents
bethanechol B2 Bethanechol has a potent excitatory effect on smooth muscle and should be avoided during pregnancy. Genitourinary System Bladder function disorders
bevacizumab D IgG antibodies are known to cross the placental barrier, and this drug may inhibit angiogenesis in the fetus. Angiogenesis has been shown to be critically important to fetal development. Antineoplastic Agents Monoclonal antibodies
bevantolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
bezlotoxumab B2 Allergy and Immune System Immunomodifiers
bicalutamide D Oral administration of this drug to rats in late gestation and during lactation caused feminisation of the male offspring. Antineoplastic Agents Hormonal antineoplastic agents
bictegravir/emtricitabine/tenofovir alafenamide B3 Antimicrobials Antiviral agents
bifonazole B3 Drugs used in Dermatology Topical antifungals, antiseptics (see also antifungal agents)
bilastine B3 Allergy and Immune System Antihistamines
bimatoprost B3 Ophthalmic Drugs
bimatoprost / timolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Ophthalmic Drugs
bimekizumab C Based on the mechanism of action of bimekizumab, the theoretical risk that use during pregnancy may affect neonatal immunity cannot be excluded. Allergy and Immune System Immunomodifiers
binimetinib D Based on results from animal studies, binimetinib may harm the foetus. Binimetinib should not be administered during pregnancy unless the benefits for the mother clearly outweigh the risks for the fetus. Antineoplastic Agents
bioallethrin B2 Drugs used in Dermatology Topical antiparasitics
biperiden B2 Central Nervous System Antiparkinson agents
birch bark dry extract B1 Drugs Used in Dermatology Topical
bisacodyl A Alimentary System Laxatives
bismuth subcitrate B2 Alimentary System Hyperacidity, reflux, ulcers
bisoprolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
bivalirudin C All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
bleomycin D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antibiotic cytotoxic agents
blinatumomab (rch) C Antineoplastic Agents Monoclonal antibodies
boceprevir B2 Antimicrobials Antiviral agents
boceprevir with ribavirin and peginterferon alfa X Although there are no pertinent human data, ribavirin has been found to be teratogenic and/or embryolethal in nearly all species in which it has been tested. Malformations of skull, palate, eye, jaw, skeleton and gastrointestinal tract were noted in animal studies. Survival of fetuses and offspring was reduced. Antimicrobials Antiviral agents
bortezomib C If sufficient placental transfer occurred, bortezomib has the potential to disrupt protein cycling in the developing fetus and, therefore, may have an adverse effect on fetal development. Antineoplastic Agents
bosentan X Teratogenicity is a class effect of these agents, which induce multiple fetal abnormalities in animal studies. These drugs are likely to cause major birth defects if used during pregnancy. Cardiovascular System Endothelin receptor antagonist
botulinum toxin type A B3 Musculoskeletal System Muscle relaxants
brentuximab vedotin D IgG antibodies are known to cross the placental barrier and this drug binds to the epidermal growth factor receptor that is involved in fetal development. Antineoplastic Agents Monoclonal antibodies
bretylium tosilate C This drug carries the potential for fetal hypoxia associated with maternal hypotension. Cardiovascular System Antiarrhythmics
brexpiprazole C Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalisation. Central Nervous System Antipsychotic drugs
brexucabtagene autoleucel C Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopaenia. Antineoplastic Agents
brigatinib D Brigatinib may cause fetal harm when administered to a pregnant woman. Studies in animals have shown reproductive toxicity. In treated pregnant rats at doses approximately equivalent to the human dose, skeletal or visceral anomalies and malformations. Antineoplastic Agents Tyrosine kinase inhibitors
brimonidine / brinzolamide B3 Ophthalmic Drugs
brimonidine / timolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Ophthalmic Drugs
brimonidine tartrate B3 Ophthalmic Drugs
brinzolamide B3 Ophthalmic Drugs
brinzolamide / timolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Ophthalmic Drugs
brivaracetam B3 Central Nervous System Anticonvulsants/antiepileptics
brolucizumab D Based on the mechanism of action, brolucizumab is regarded as potentially teratogenic and embryo/fetotoxic. Ophthalmic Drugs
bromazepam C Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
bromhexine A Respiratory System Expectorants and mucolytics
bromocriptine (injection) B2 Endocrine System Pituitary inhibitors
bromocriptine (oral) A Endocrine System Pituitary inhibitors
brompheniramine A Allergy and Immune System Antihistamines
budesonide A The benefits of asthma control outweigh any potential for an adverse pregnancy outcome. Endocrine System Corticosteroids Inhalation/intranasal
budesonide A The benefits of asthma control outweigh any potential for an adverse pregnancy outcome. Respiratory System Inhalational agents Preventative aerosols and inhalations
budesonide (systemic) B3 Alimentary System Antidiarrhoeals
bulevirtide B1 Antimicrobials Antiviral agents
bumetanide C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
bupivacaine A Drugs Used in Anaesthesia Local anaesthetics
bupivacaine / fentanyl C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal and anti-inflammatory agents)
buprenorphine C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
bupropion B2 Agents used in dependency states
burosumab B3 Endocrine System Agents affecting calcium and bone metabolism
buspirone B1 Central Nervous System Antianxiety agents
busulfan D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Alkylating agents
butoconazole B3 Antimicrobials Antifungal agents (see also topical antifungals)
cabazitaxel D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
cabergoline B1 Endocrine System Pituitary inhibitors
cabotegravir B1 Antimicrobials Antiviral agents
cabozantinib D Animal studies in rats or rabbits with cabozantinib have shown adverse effects of embryofetal lethality and and teratogenicity. Antineoplastic Agents
caffeine A Central Nervous System CNS stimulants
calcifediol B3 Vitamins
calcipotriol B1 Drugs used in Dermatology Topical
calcitonin B2 Endocrine System Agents affecting calcium and bone metabolism
calcitonin salmon B2 Endocrine System Agents affecting calcium and bone metabolism
calcitriol B3 Endocrine System Agents affecting calcium and bone metabolism
calcium carbimide A Agents used in dependency states
canagliflozin C Studies in rats have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy. Endocrine System Hypoglycaemic agents
canakinumab B3 Allergy and Immune System Immunomodifiers
candesartan cilexetil D When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin II receptor antagonists and renin inhibitors
cannabidiol B2 Central Nervous System Anticonvulsants/antiepileptics
capecitabine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
capivasertib D PI3K/AKT/mTOR signalling plays important roles in embryofetal development. Akt knockout results in a range of fetal defects in mice. Capivasertib caused an increase in early embryonic deaths, and fetal visceral abormalities in rats. Antineoplastic Agents
caplacizumab B1 Cardiovascular System Anticoagulants and thrombolytic agents
captopril D When taken during the second and third trimesters, ACE inhibitors cause a range of abnormalities including renal dysfunction and oligohydramnios. These can be associated with fetal death in utero. Although no adverse fetal effects have been linked to first trimester drug use of ACE inhibitors, the number of exposures reported is too small to determine conclusively that ACE inhibitors are safe in the first trimester. Pregnant women who are taking ACE inhibitors should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ACE inhibitors for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin converting enzyme (ACE) inhibitors
carbachol B2 Ophthalmic Drugs
carbamazepine D Spina bifida occurs in about one percent of pregnancies in which carbamazepine is used as monotherapy. Carbamazepine taken during pregnancy also has been associated with minor craniofacial defects, fingernail hypoplasia and developmental disability. Carbamazepine also can cause coagulation defects with consequent risk of haemorrhage in the fetus and the newborn infant which may be preventable by the prophylactic administration of vitamin K to the mother prior to delivery. The risk of having an abnormal child as a result of antiepileptic medication is far outweighed by the dangers to the mother and fetus of uncontrolled epilepsy. It is recommended that: • women on antiepileptic drugs (AEDs) receive prepregnancy counselling with regard to the risk of fetal abnormalities; • AEDs should be continued during pregnancy and monotherapy should be used if possible at the lowest effective dose as risk of abnormality is greater in women taking combined medication; • folic acid supplementation (5mg) should be commenced four weeks prior to and continue for twelve weeks after conception; • Specialist prenatal diagnosis including detailed mid-trimester ultrasound should be offered. Central Nervous System Anticonvulsants/antiepileptics
carbetocin C Genitourinary System Agents acting on the uterus
carbidopa B3 Central Nervous System Antiparkinson agents
carbidopa / entacapone / levodopa B3 Central Nervous System Antiparkinson agents
carbidopa / levodopa B3 Central Nervous System Antiparkinson agents
carbimazole D Antithyroid agents may cause congenital goitre by inhibiting thyroxine synthesis in the fetus. Endocrine System Antithyroid agents
carboplatin D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
carboprost D This drug has been found to cross the placenta and distribute to the fetus in pregnant women. Administration of prostaglandings including this drug during pregnancy stimulates the uterus and may cause inability to sustain pregnancy and irreversible fetal damage or death. Genitourinary System Agents acting on the uterus
carfilzomib C Based on its mechanism of action and findings in animals, carfilzomib can cause foetal harm when administered to a pregnant woman Antineoplastic Agents
carglumic acid B1 Blood and Haemopoietic System
cariprazine D Malformations: Dosing of cariprazine to rats caused malformations, lower pup survival, and developmental delays. Class effect: Neonates exposed to antipsychotics (including cariprazine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress or feeding disorder. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases, neonates have required intensive care unit support and prolonged hospitalisation. Consequently, newborns should be monitored carefully. Central Nervous System Antipsychotic drugs
carmustine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Alkylating agents
carvedilol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
cascara A Alimentary System Laxatives
casirivimab / imdevimab B2 Antimicrobials Antiviral agents antiviral monoclonal antibodies
caspofungin B3 Antimicrobials Antifungal agents (see also topical antifungals)
cefaclor B1 Antimicrobials Antibiotics Cephalosporins
cefalexin A Antimicrobials Antibiotics Cephalosporins
cefalotin A Antimicrobials Antibiotics Cephalosporins
cefamandole B1 Antimicrobials Antibiotics Cephalosporins
cefazolin B1 Antimicrobials Antibiotics Cephalosporins
cefepime B1 Antimicrobials Antibiotics Cephalosporins
cefodizime B2 Antimicrobials Antibiotics Cephalosporins
cefotaxime B1 Antimicrobials Antibiotics Cephalosporins
cefotetan B1 Antimicrobials Antibiotics Cephalosporins
cefoxitin B1 Antimicrobials Antibiotics Cephalosporins
cefpirome B2 Antimicrobials Antibiotics Cephalosporins
cefpodoxime B1 Antimicrobials Antibiotics Cephalosporins
ceftaroline fosamil B1 Antimicrobials Antibiotics Cephalosporins
ceftazidime B1 Antimicrobials Antibiotics Cephalosporins
ceftazidime / avibactam B3 Antimicrobials Antibiotics
ceftolozane/tazobactam B1 Antimicrobials Antibiotics
ceftriaxone B1 Antimicrobials Antibiotics Cephalosporins
cefuroxime B1 Antimicrobials Antibiotics Cephalosporins
celecoxib B3 Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
cemiplimab D PD-1/PD-L1 is involved in fetomaternal tolerance. Administration during pregnancy may cause fetal harm, including abortion or stillbirth. Antineoplastic Agents Monoclonal antibodies
ceritinib D As an ALK inhibitor, ceritinib also inhibits other members of the insulin receptor superfamily, such as InsR, IGF-1R and ROS1. Since InsR and IGF-1R play vital roles during early development including embryofetal development and postnatal growth, ceritinib is likely to adversely affect embryofetal development. Antineoplastic Agents
cerivastatin D Cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, these drugs may cause fetal harm when administered to a pregnant woman. The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System Hypolipidaemic agents
cerliponase alfa B2 Central Nervous System
certolizumab C Due to its inhibition of TNFα, certolizumab administration during pregnancy could affect normal immune responses in the new-born. Allergy and immune system Immunomodifiers
cetirizine B2 Allergy and Immune System Antihistamines
cetrorelix D There is a theoretical risk of abortion if gonadotrophin releasing hormone antagonists are used during pregnancy. Endocrine System Pituitary inhibitors
cetuximab D IgG antibodies are known to cross the placental barrier and this drug binds to the epidermal growth factor receptor that is involved in fetal development. Antineoplastic Agents Monoclonal antibodies
cetylpyridinium A Drugs used in Dermatology Topical antifungals, antiseptics (see also antifungal agents)
chenodeoxycholic acid B3 Alimentary System Cholelitholytics
chloral hydrate A Central Nervous System Hypnotics and sedatives
chlorambucil D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Alkylating agents
chloramphenicol A Antimicrobials Antibiotics
chloramphenicol (ophthalmic) A Ophthalmic Drugs
chlorcyclizine B3 Allergy and Immune System Antihistamines
chlordiazepoxide C Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
chlorhexidine A Drugs used in Dermatology Topical antifungals, antiseptics (see also antifungal agents)
chlormethiazole A Central Nervous System Hypnotics and sedatives
chlormethine B3 Pregnancy Category B3 applies only to topical use. Antineoplastic Agents Alkylating agents
chloroquine (prophylaxis) A The use of this drug in the treatment of malaria is accepted because the small risk to the fetus is outweighed by the benefits to the mother and fetus. Prophylaxis in high risk situations is also justified. Antimicrobials Antimalarials
chloroquine (treatment) D When used in high doses and for prolonged periods, chloroquine and related substances may cause neurological disturbances and interference with hearing, balance and vision in the fetus. The use of this drug in the treatment of malaria is accepted because the small risk to the fetus is outweighed by the benefits to the mother and fetus. Prophylaxis in high risk situations is also justified. Antimicrobials Antimalarials
chlorothiazide C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
chlorphenamine A Allergy and Immune System Antihistamines
chlorpromazine D When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the newborn infant. Central Nervous System Antipsychotic drugs Phenothiazines
chlorpropamide C Sulphonylureas may enter the fetal circulation and may cause neonatal hypoglycaemia. Endocrine System Hypoglycaemic agents
chlorquinaldol A Drugs used in Dermatology Topical antifungals, antiseptics (see also antifungal agents)
chlortalidone C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
cholera vaccine (killed) B2 Vaccines Inactivated vaccines
cholic acid B2 Alimentary System Cholelitholytics
choriogonadotropin alfa (rch) B3 Endocrine System Ovulation inducers Gonadotrophins
ciclesonide B3 Endocrine System Corticosteroids Inhalation/intranasal
ciclesonide B3 Respiratory System Inhalational agents Preventative aerosols and inhalations
ciclopirox B3 Antimicrobials Antifungal agents (see also topical antifungals)
ciclosporin C This drug may cause immunosuppression in the infant. Allergy and Immune System Immunomodifiers
cidofovir D This drug could be expected to cause fetal loss and birth defects. Antimicrobials Antiviral agents
cilazapril D When taken during the second and third trimesters, ACE inhibitors cause a range of abnormalities including renal dysfunction and oligohydramnios. These can be associated with fetal death in utero. Although no adverse fetal effects have been linked to first trimester drug use of ACE inhibitors, the number of exposures reported is too small to determine conclusively that ACE inhibitors are safe in the first trimester. Pregnant women who are taking ACE inhibitors should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ACE inhibitors for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin converting enzyme (ACE) inhibitors
cilostazol B3 Cardiovascular System Vasodilators
ciltacabtagene autoleucel C Based on the mechanism of action, ciltacabtagene autoleucel may cause fetal harm, including B-cell lymphocytopenia, when administered to a pregnant woman. Fetal B-cell depletion poses a risk of opportunistic infections in the neonate. Ciltacabtagene autoleucel-induced cytokine release may also pose a risk for embryofetal loss. Antineoplastic Agents
cimetidine B1 Alimentary System Hyperacidity, reflux, ulcers
cinacalcet B3 Endocrine System Agents affecting calcium and bone metabolism
cinchocaine A Drugs Used in Anaesthesia Local anaesthetics
cipaglucosidase alfa / miglustat D Studies in animals indicate a risk for cardiovascular malformations and embryofetal loss when dosed in combination with miglustat. Metabolism
ciprofloxacin B3 Antimicrobials Antibiotics Quinolones
cisapride B1 Alimentary System Hyperacidity, reflux, ulcers
cisatracurium besilate C There have been no demonstrated adverse effects in the fetus or the newborn infant. Drugs Used in Anaesthesia Neuromuscular blocking agents
cisplatin D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
citalopram C Selective serotonin reuptake inhibitors (SSRIs) have had limited use in pregnancy without a reported increase in birth defects. The use of SSRIs in the third trimester may result in a withdrawal state in the newborn infant. Central Nervous System Antidepressants Selective serotonin reuptake inhibitors (SSRIs)
cladribine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
clarithromycin B3 Antimicrobials Antibiotics Macrolide antibiotics
clascoterone D Administration of clascoterone during pregnancy in rats and rabbits produced adverse effects on development including embryolethality and fetal malformations. Drugs Used in Dermatology Topical
clavulanic acid B1 Antimicrobials Antibiotics
clemastine A Allergy and Immune System Antihistamines
clevidipine C This drug caused increases in maternal and fetal mortality and length of gestation in animals. Cardiovascular System Antihypertensives Calcium channel blockers
clindamycin A Antimicrobials Antibiotics
clindamycin A Antimicrobials Topical antimicrobials
clindamycin / tretinoin D Use of tretinoin cream formulation during the first trimester does not appear to cause birth defects. Other formulations should not be used during pregnancy. There have been isolated reports of birth defects in babies born to women using topical tretinoin in pregnancy, some similar to those reported with oral retinoids. While a retrospective cohort study on women exposed to tretinoin in the first trimester did not reveal an association with this treatment, the numbers in this study are too small to establish the safety of use in pregnancy. Drugs Used in Dermatology Topical
clioquinol A Antimicrobials
clobazam C Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
clobetasol D Clobetasol was shown to be teratogenic when given topically or subcutaneously during organogenesis in pregnant animals. Fetoxicity and fetal malformations (including skeletal abnormalities, cleft palate, cranioschisis or umbilical cord hernia) were observed in animals. Drugs Used in Dermatology Topical
clobetasol B3 Drugs Used in Dermatology Topical Shampoo
clobetasone butyrate B3 Drugs Used in Dermatology Topical
clodronate B3 Endocrine System Agents affecting calcium and bone metabolism Bisphosphonates
clofarabine D Clofarabine may cause fetal harm when administered to a pregnant woman. The drug was teratogenic in rats and rabbits. Antineoplastic Agents Antimetabolites
clofazimine C Clofazimine may cause discolouration of the skin of the baby. This is reversible but recovery may be delayed because clofazimine has an average serum half life of 70 days. Antimicrobials Antituberculotics and antileprotics
clofibrate B1 The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System Hypolipidaemic agents
clomifene B3 Endocrine System Ovulation inducers Gonadotrophins
clomipramine C Withdrawal symptoms in newborn infants have been reported with prolonged maternal use of tricyclic antidepressants. Central Nervous System Antidepressants Tricyclic antidepressants
clonazepam B3 Clonazepam is a benzodiazepine. These drugs may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with this class of drugs. Compared to conventional anticonvulsants, the extent of the risk of this drug is unknown. Central Nervous System Anticonvulsants/antiepileptics
clonazepam B3 Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
clonidine B3 Cardiovascular System Antihypertensives
clopamide C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
clopidogrel B1 All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
clopidogrel / aspirin C Aspirin inhibits prostaglandin synthesis. When given late in pregnancy, it may cause premature closure of the fetal ductus arteriosus, delay labour and birth. Aspirin increases the bleeding time both in the newborn infant and in the mother because of its antiplatelet effects. Products containing aspirin should be avoided in the last trimester. Low-dose aspirin (100mg/day) does not affect bleeding time. Cardiovascular System Anticoagulants and thrombolytic agents
clorazepate C Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
clotrimazole A Drugs used in Dermatology Topical antifungals, antiseptics (see also antifungal agents)
clotrimazole A Genitourinary System Topical vaginal medication
cloxacillin A Antimicrobials Antibiotics Penicillins
clozapine C The adverse pharmacological and toxicological effects of clozapine in adults may also occur in the fetus. Central Nervous System Antipsychotic drugs
cobicistat B1 Antimicrobials Antiviral agents
cobimetinib fumarate D Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. Antineoplastic Agents
codeine A Prolonged high-dose use of codeine prior to delivery may produce codeine withdrawal symptoms in the neonate. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
codeine A Respiratory System Antitussives
colaspase (asparaginase) D Cytotoxicity from asparaginase activity poses a risk for spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
colchicine D Cell division can be arrested by colchicine. This drug should be avoided in pregnancy. Musculoskeletal System Agents used in gout and hyperuricaemia
colestipol B2 The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System Hypolipidaemic agents
colestyramine B2 The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System Hypolipidaemic agents
colistimethate B2 Antimicrobials Antibiotics
colistin IV with colistimethate B2 Antimicrobials Antibiotics
collagenase clostridium histolyticum B1 Musculoskeletal System Muscle relaxants
concizumab D Nil Cardiovascular System Haemostatic agents
conjugated estrogens D Endocrine System Oestrogens (see also oral contraceptives)
corifollitropin alfa B3 Endocrine System Ovulation inducers Gonadotrophins
corticotrophin A Endocrine System Pituitary hormones
cortisone A Endocrine System Corticosteroids Systemic
COVID-19 Vaccine (Ad26.COV2.S) B1 Vaccines adenoviral vector vaccines
COVID-19 Vaccine (ChAdOx1-S) B1 Vaccines adenoviral vector vaccines
COVID-19 Vaccine (mRNA) B1 Vaccines mRNA vaccines
COVID-19 Vaccine (recombinant protein) B1 Vaccines Subunit vaccines Recombinant protein vaccines
crisaborole B1 Drugs Used in Dermatology Topical
crisantaspase D Cytotoxicity from asparaginase activity poses a risk for spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
crizanlizumab B1 Blood and Haemopoietic System
crizotinib D Crizotinib has pharmacological activity against c-Met and RON kinase, both of which play a role in embryofetal development Antineoplastic Agents Tyrosine kinase inhibitors
crotamiton B2 Drugs used in Dermatology Topical antiparasitics
cyclizine B3 Allergy and Immune System Antihistamines
cyclopenthiazide C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
cyclopentolate B2 Ophthalmic Drugs
cyclophosphamide D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Alkylating agents
cyproheptadine A Allergy and Immune System Antihistamines
cyproterone acetate (10 mg daily or higher PO) D Antiandrogens carry the potential for feminisation of the male fetus at or after 8 weeks post conception and should be avoided during pregnancy. Administration of high doses of cyproterone acetate during the hormone sensitive differentiation phase of the genital organs (after approximately day 45 of pregnancy) could lead to signs of feminisation in male fetuses. Endocrine System Antiandrogens
cyproterone acetate (2 mg daily PO) B3 Antiandrogens carry the potential for feminisation of the male fetus at or after 8 weeks post conception and should be avoided during pregnancy. Endocrine System Antiandrogens
cysteamine bitartrate (mercaptamine bitartrate) B3 Metabolism Agents used for the treatment of metabolic disorders
cytarabine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
dabigatran etexilate C All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
dabrafenib mesilate D This drug inhibits multiple kinases (including BRAF) that may be important during embryofetal development. Antineoplastic Agents Tyrosine kinase inhibitors
dacarbazine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Alkylating agents
daclatasvir B3 Antimicrobials Antiviral agents
daclizumab C Allergy and Immune System Immunomodifiers
dactinomycin D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antibiotic cytotoxic agents
dalfopristin with quinupristin B3 Antimicrobials Antibiotics
dalteparin C All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
damoctocog alfa pegol B2 Cardiovascular System Haemostatic agents
danaparoid C All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
danazol D If taken by the mother at or after 8 weeks post conception, danazol may cause virilisation of the female fetus. Prior to 8 weeks post conception it has no virilising effects. Danazol may not inhibit ovulation in all women. Endocrine System Pituitary inhibitors
danicopan B3 Allergy and Immune System Immunomodifiers
dantrolene B2 Musculoskeletal System Muscle relaxants
dapagliflozin D Studies in rats have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy. Endocrine System Hypoglycaemic agents
dapagliflozin / saxagliptin D Studies with dapagliflozin in rats have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy. Endocrine System Hypoglycaemic agents
dapagliflozin /metformin D Studies with dapagliflozin in rats have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy. Endocrine System Hypoglycaemic agents
dapoxetine C Selective serotonin reuptake inhibitors (SSRIs) have had limited use in pregnancy without a reported increase in birth defects. The use of SSRIs in the third trimester may result in a withdrawal state in the newborn infant. Central Nervous System Antidepressants Selective serotonin reuptake inhibitors (SSRIs)
dapsone B2 Antimicrobials Antituberculotics and antileprotics
daptomycin B1 Antimicrobials Antibiotics
daratumumab C IgG antibodies are known to cross the placental barrier. This drug has the potential to affect embryofetal survival due to its pharmacological action. Allergy and Immune System Immunomodifiers
darbepoetin alfa B3 Blood and Haemopoietic System Haemopoietic agents
darifenacin B3 Genitourinary System Prostate hyperplasia
darolutamide D Based on its mechanism of action, it may cause fetal harm when administered during pregnancy. Antineoplastic Agents Hormonal antineoplastic agents
darunavir B2 Antimicrobials Antiviral agents
dasatinib D This drug is embryotoxic in both pregnant rats and rabbits, and teratogenic when administered to pregnant animals. Antineoplastic Agents Tyrosine kinase inhibitors
datopotamab deruxtecan D Based on findings in animals and its mechanism of action, datopotamab deruxtecan may cause embryofetal harm (malformations and embryofetal loss) when administered to a pregnant woman. Antineoplastic Agents Monoclonal antibodies
daunorubicin D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antibiotic cytotoxic agents
daxibotulinumtoxinA B3 Musculoskeletal System Muscle relaxants
decitabine / cedazuridine X Decitabine / cedazuridine is contraindicated in pregnancy. Decitabine has been shown to cause malformations and embryofetal lethality in multiple laboratory animal species at dose levels well below the clinical dose. Antineoplastic Agents Antimetabolites
deferasirox C Detoxifying Agents, Antidotes
deferiprone D Reproductive studies in non iron-loaded rats and rabbits have indicated that deferiprone is embryotoxic and teratogenic. Detoxifying Agents, Antidotes
defibrotide D This drug has revealed a high rate of haemorrhagic abortion in animals. Blood and Haemopoietic System
degarelix D At very low doses (<10% clinical dose), an increase in the number of abortions, early embryo/fetal deaths and premature deliveries along with prolonged parturition were observed in animals Antineoplastic Agents Hormonal antineoplastic agents
delavirdine B3 Antimicrobials Antiviral agents
delgocitinib (dermal) B1 Allergy and Immune System Immunomodifiers
demeclocycline D Tetracyclines are safe for use during the first 18 weeks of pregnancy (16 weeks post conception) after which they cause discolouration of the baby’s teeth. Antimicrobials Antibiotics Tetracyclines
dengue tetravalent vaccine B2 This is a live attenuated vaccine, therefore is contraindicated during pregnancy. Vaccines Live attenuated vaccines
denosumab D Treatment with denosumab may impair bone growth in children with open growth plates and may inhibit eruption of dentition. Endocrine System Agents affecting calcium and bone metabolism
deoxycholic acid B1 Drugs Used in Dermatology
desferrioxamine B3 Detoxifying Agents, Antidotes
desflurane B3 All general anaesthetics carry the potential to produce central nervous system and respiratory depression in the newborn infant. In routine practice this does not appear to be a problem. However, in the compromised fetus, careful consideration should be given to this potential depression and to the selection of particular anaesthetic drugs, doses and techniques. Drugs Used in Anaesthesia General anaesthetics
desipramine C Withdrawal symptoms in newborn infants have been reported with prolonged maternal use of tricyclic antidepressants. Central Nervous System Antidepressants Tricyclic antidepressants
desirudin B3 All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
desloratadine B1 Allergy and Immune System Antihistamines
desmopressin B1 Endocrine System Antidiuretics
desogestrel with ethinylestradiol B3 Contraceptive Agents Oral contraceptives
desonide B3 Drugs used in Dermatology Topical
desvenlafaxine B2 Central Nervous System Antidepressants
deucravacitinib B1 Allergy and Immune System Immunomodifiers
deutetrabenazine B3 Central Nervous System
dexamethasone A Endocrine System Corticosteroids Systemic
dexamfetamine B3 Central Nervous System CNS stimulants
dexchlorphenamine (dexchlorpheniramine ) A Allergy and Immune System Antihistamines
dexfenfluramine B3 Weight reduction using appetite suppressant drugs is not recommended in pregnancy. Metabolism Anorectic and weight reducing agents
dexmedetomidine B1 Central Nervous System Hypnotics and sedatives
dextromethorphan A Respiratory System Antitussives
dextromoramide C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
dextropropoxyphene C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
diazepam C Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
diazoxide C This drug may cause fetal bradycardia. Hyperglycaemia has been observed in the newborn. Diazoxide is a potent relaxant of uterine smooth muscle and may inhibit uterine contraction if given during labour. Diazoxide should be used with extreme caution during pregnancy. Cardiovascular System Antihypertensives
diclofenac C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
dicloxacillin B2 Antimicrobials Antibiotics Penicillins
dicyclomine hydrochloride B1 Alimentary System Laxatives
didanosine B2 Antimicrobials Antiviral agents
dienoestrol X Endocrine System Oestrogens (see also oral contraceptives)
dienogest with ethinylestradiol B3 Contraceptive Agents Oral contraceptives
dienosliterol B1 Genitourinary System Topical vaginal medication
diethylcarbamazine B2 Antimicrobials Anthelmintics
diethylpropion B2 Weight reduction using appetite suppressant drugs is not recommended in pregnancy. Metabolism Anorectic and weight reducing agents
difelikefalin B1 Allergy and Immune System Immunomodifiers
diflunisal C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
digoxin and other cardiac glycosides A Cardiovascular System Cardiac inotropic agents
digoxin immune fab B2 Detoxifying Agents, Antidotes
digoxin-specific antibody fragment F(Ab) (Ovine) B2 Detoxifying Agents, Antidotes
dihydrocodeine A Prolonged high-dose use of codeine prior to delivery may produce codeine withdrawal symptoms in the neonate. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
dihydrocodeine A Respiratory System Antitussives
dihydroergotamine C Standard oral dose regimens for migraine headaches in the first half of pregnancy do not appear to pose hazards to the fetus. Ergotamine induces uterine contraction and may therefore cause premature parturition or hypertonic labour. Larger doses or more frequent use may jeopardise the fetus because of the potential for impeding fetal blood supply. Cardiovascular System Antimigraine preparations
dihydrotachysterol B3 Endocrine System Agents affecting calcium and bone metabolism
diltiazem C Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. Cardiovascular System Antihypertensives Calcium channel blockers
dimenhydrinate A Central Nervous System Antiemetics, antinauseants
dimethyl fumarate B1 Allergy and Immune System Immunomodifiers
dinoprost C Genitourinary System Agents acting on the uterus
dinoprostone (prostaglandin E2) C There have been instances of idiosyncratic sensitivity of the uterus resulting in fetal anoxia. Genitourinary System Agents acting on the uterus
dinutuximab beta C Based on the mechanism of action, dinutuximab beta has the potential to affect embryofetal development and cause fetal harm. Antineoplastic Agents Monoclonal antibodies
diphenhydramine A Allergy and Immune System Antihistamines
diphenhydramine A Central Nervous System Antiemetics, antinauseants
diphenoxylate C This drug is chemically related to the narcotic analgesic pethidine. Narcotic analgesics may cause respiratory depression in the newborn infant. This drug should not be given at or near term. Alimentary System Antidiarrhoeals
diphenylamine A Allergy and Immune System Antihistamines
diphenylpyraline B2 Allergy and Immune System Antihistamines
diphtheria-tetanus vaccine A Vaccines Subunit vaccines Toxoid vaccines
diphtheria-tetanus-pertussis vaccine A Vaccines Toxoid vaccines
diphtheria-tetanus-pertussis-hepatitis B- inactivated poliomyelitis-Haemophilus influenzae type b conjugate vaccine B2 Vaccines Killed vaccines
diphtheria-tetanus-pertussis-hepatitis B- inactivated poliomyelitis-Haemophilus influenzae type b vaccine B1 or B2 (depending on brand of vaccine) Vaccines Killed vaccines
diphtheria-tetanus-pertussis-inactivated poliomyelitis vaccine A Vaccines Killed vaccines
dipivefrine B2 Ophthalmic Drugs
dipyridamole B1 Cardiovascular System Vasodilators
diroximel fumarate B3 Allergy and Immune System Immunomodifiers
disopyramide B2 Cardiovascular System Antiarrhythmics
disulfiram B2 Agents used in dependency states
dithranol B2 Drugs used in Dermatology Topical
dobutamine B2 Cardiovascular System Adrenergic stimulants
docetaxel D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
docusate sodium A Alimentary System Laxatives
dofetilide D This drug has been shown to cause fetal deths and abnormalities when administered to animals during gestation. Cardiovascular System Antiarrhythmics
dolasetron B1 Central Nervous System Antiemetics, antinauseants
dolutegravir B1 Antimicrobials Antiviral agents
dolutegravir / abacavir / lamivudine B3 Antimicrobials Antiviral agents
domperidone B2 Central Nervous System Antiemetics, antinauseants
donepezil B3 Cholinergic and Anticholinergic Agents
donidalorsen B1 Cardiovascular System
dopamine B3 Cardiovascular System Adrenergic stimulants
doravirine B1 Antimicrobials Antiviral agents
doripenem B2 Antimicrobials Antibiotics
dornase alfa B1 Respiratory System
dorzolamide B3 Ophthalmic Drugs
dorzolamide / timolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Ophthalmic Drugs
dostarlimab D PD-1/PD-L1 is involved in fetomaternal tolerance. Administration during pregnancy may cause fetal harm, including abortion or stillbirth. Antineoplastic Agents Monoclonal antibodies
dosulepin C Withdrawal symptoms in newborn infants have been reported with prolonged maternal use of tricyclic antidepressants. Central Nervous System Antidepressants Tricyclic antidepressants
dothiepin (dosulepin) C Withdrawal symptoms in newborn infants have been reported with prolonged maternal use of tricyclic antidepressants. Central Nervous System Antidepressants Tricyclic antidepressants
doxazosin B3 Cardiovascular System Antihypertensives
doxepin C Withdrawal symptoms in newborn infants have been reported with prolonged maternal use of tricyclic antidepressants. Central Nervous System Antidepressants Tricyclic antidepressants
doxorubicin D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antibiotic cytotoxic agents
doxycycline D Tetracyclines are safe for use during the first 18 weeks of pregnancy (16 weeks post conception) after which they cause discolouration of the baby’s teeth. Antimicrobials Antibiotics Tetracyclines
doxycycline (antimalarial) D Tetracyclines are safe for use during the first 18 weeks of pregnancy (16 weeks post conception) after which they cause discolouration of the baby’s teeth. The use of this drug in the treatment of malaria is accepted because the small risk to the fetus is outweighed by the benefits to the mother and fetus. Prophylaxis in high risk situations is also justified. Antimicrobials Antimalarials
doxylamine A Allergy and Immune System Antihistamines
dronedarone D Cardiovascular System Antiarrhythmics
droperidol C When given in high doses during late pregnancy, butyrophenones may cause prolonged neurological disturbances in the newborn infant. Central Nervous System Antipsychotic drugs Butyrophenones
drospirenone with ethinylestradiol B3 Contraceptive Agents Oral contraceptives
drotrecogin alfa C Cardiovascular System Haemostatic agents
dulaglutide B3 Endocrine System Hypoglycaemic agents
duloxetine B3 Selective serotonin reuptake inhibitors (SSRIs) have had limited use in pregnancy without a reported increase in birth defects. The use of SSRIs in the third trimester may result in a withdrawal state in the newborn infant. Central Nervous System Antidepressants Selective serotonin reuptake inhibitors (SSRIs)
dupilumab B1 Allergy and Immune System Immunomodifiers
durvalumab D PD-1/PD-L1 is involved in fetomaternal tolerance. Administration during pregnancy may cause fetal harm, including abortion or stillbirth. Antineoplastic Agents Monoclonal antibodies
dutasteride X Dutasteride may cause abnormalities of the external genitalia of a male fetus. Genitourinary System Prostate hyperplasia
dydrogesterone with estradiol B3 Endocrine System Progestogens (see also oral contraceptives)
econazole A Drugs used in Dermatology Topical antifungals, antiseptics (see also antifungal agents)
econazole A Genitourinary System Topical vaginal medication
ecothiopate B2 Ophthalmic Drugs
eculizumab B2 Allergy and Immune System Immunomodifiers
edaravone B3 Central Nervous System
efalizumab C Allergy and Immune System Immunomodifiers
efanesoctocog alfa B2 Cardiovascular System Haemostatic agents
efavirenz D This drug may cause fetal harm when administered during the first trimester to a pregnant woman. It crossed the placenta and was teratogenic (anencephaly, unilateral anophthalmia, microophthalmia and/or cleft palate) in cynomolgus monkeys. Antimicrobials Antiviral agents
efgartigimod alfa C Neonatal passive immunity may be affected with use in pregnancy, caused by interruption of placental transfer of maternal antibodies to the developing fetus and owing to the pharmacological action of the drug. Drugs Used in Myasthenia Gravis
eflornithine B3 Drugs used in Dermatology Topical
eformoterol (formoterol) B3 Respiratory System Inhalational agents Bronchospasm relaxants
efraloctocog alfa (rhu) C Cardiovascular System Haemostatic agents
eftrenonacog alfa (rhu) C Cardiovascular System Haemostatic agents
elafibranor D Studies in animals indicate strong potential for malformations and embryofetal loss with use in pregnancy. Alimentary System
elbasvir / grazoprevir B1 Antimicrobials Antiviral agents
eletriptan B1 Cardiovascular System Antimigraine preparations
eliglustat B3 Metabolism Agents used for the treatment of metabolic disorders
elinzanetant B3 Central Nervous System
elosulfase alfa (rch) B3 Metabolism Agents used for the treatment of metabolic disorders
elotuzumab C Based on its pharmacology, maternal treatment with elotuzumab may have effects on fetal immune cells and maternal tolerance. Antineoplastic Agents Monoclonal antibodies
elranatamab C Based on the mechanism of action, elranatamab may cause fetal harm, including B-cell lymphocytopenia, when administered to a pregnant woman. Fetal B-cell depletion poses a risk of opportunistic infections in the neonate. Elranatamab-induced cytokine release may also pose a risk for embryofetal loss. Antineoplastic Agents Monoclonal antibodies
eltrombopag B3 Blood and Haemopoietic System Haemopoietic agents
elvitegravir B2 Antimicrobials Antiviral agents
elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide B3 Antimicrobials Antiviral agents
emetine A Respiratory System Expectorants and mucolytics
emicizumab B2 Cardiovascular System Haemostatic agents
empagliflozin D Studies in rats have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy. Endocrine System Hypoglycaemic agents
empagliflozin / linagliptin D Studies with empagliflozin in rats have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy. Endocrine System Hypoglycaemic agents
empagliflozin / metformin D Studies with empagliflozin in rats have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy. Endocrine System Hypoglycaemic agents
emtricitabine B1 Antimicrobials Antiviral agents
emtricitabine / ripilvirine / tenofovir alafenamide B3 Antimicrobials Antiviral agents
emtricitabine / tenofovir alafenamide B3 Antimicrobials Antiviral agents
emtricitabine / tenofovir disoproxil fumarate B3 Antimicrobials Antiviral agents
emtricitabine / tenofovir disoproxil fumarate / rilpivirine B3 Antimicrobials Antiviral agents
emtricitabine / tenofovir disoproxil maleate B3 Antimicrobials Antiviral agents
enalapril D When taken during the second and third trimesters, ACE inhibitors cause a range of abnormalities including renal dysfunction and oligohydramnios. These can be associated with fetal death in utero. Although no adverse fetal effects have been linked to first trimester drug use of ACE inhibitors, the number of exposures reported is too small to determine conclusively that ACE inhibitors are safe in the first trimester. Pregnant women who are taking ACE inhibitors should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ACE inhibitors for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin converting enzyme (ACE) inhibitors
enasidenib D Enasidenib can cause embryofetal harm when administered to a pregnant woman based on adverse findings in animal studies. Antineoplastic Agents
encorafenib D Based on results from animal studies, encorafenib may harm the fetus. Encorafenib should not be administered during pregnancy unless the benefits for the mother outweigh the risks for the fetus. If encorafenib is used during pregnancy or if the patient becomes pregnant while taking encorafenib, the patient should be informed of the potential hazard to the fetus. Antineoplastic Agents
enflurane A All general anaesthetics carry the potential to produce central nervous system and respiratory depression in the newborn infant. In routine practice this does not appear to be a problem. However, in the compromised fetus, careful consideration should be given to this potential depression and to the selection of particular anaesthetic drugs, doses and techniques. Drugs Used in Anaesthesia General anaesthetics
enfortumab vedotin D Based on its mechanism of action and findings in animals, enfortumab vedotin can cause fetal harm. Antineoplastic Agents
enfuvirtide B2 Antimicrobials Antiviral agents
enoxacin B3 Antimicrobials Antibiotics Quinolones
enoxaparin C All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
entacapone B3 Central Nervous System Antiparkinson agents
entecavir B3 Antimicrobials Antiviral agents
entrectinib D Based on its mechanism of action and findings in animal studies, entrectinib may cause fetal malformations. Antineoplastic Agents Tyrosine kinase inhibitors
enzalutamide X Teratogenicity (cleft palate, cervical rib and decreased anogenital distance) and embryofetal lethality were seen in a mouse embryofetal development study. Antineoplastic Agents Hormonal antineoplastic agents
epcoritamab C Based on the mechanism of action, epcoritamab may cause fetal harm, including B-cell lymphocytopenia, when administered to a pregnant woman. Fetal B-cell depletion poses a risk of opportunistic infections in the neonate. Epcoritamab-induced cytokine release may also pose a risk for embryofetal loss. Antineoplastic Agents Monoclonal antibodies
ephedrine A Cardiovascular System Adrenergic stimulants
ephedrine A Respiratory System Inhalational agents Bronchospasm relaxants
epirubicin D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antibiotic cytotoxic agents
eplerenone B3 Cardiovascular System Diuretics
eplontersen D Treatment with eplontersen reduces serum levels of vitamin A, which has an increased risk of fetal malformation. Cardiovascular System
epoetin alfa B3 Blood and Haemopoietic System Haemopoietic agents
epoetin beta (rch) B3 Blood and Haemopoietic System Haemopoietic agents
epoetin lambda (rch) B3 Blood and Haemopoietic System Haemopoietic agents
epoprostenol B1 Cardiovascular System Vasodilators
eprosartan D When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin II receptor antagonists and renin inhibitors
eptacog alfa (activated Factor VII - rch) B1 Cardiovascular System Haemostatic agents
eptifibatide C All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
eptinezumab B1 Central Nervous System
eptotermin alfa D Altering the normal levels of bone morphogenic proteins, including this protein in the embryo may alter the normal course of action of these agents, and possibly result in fetal malformation. Musculoskeletal System Osteogenic agents
erenumab B1 Cardiovascular System Antimigraine preparations
ergometrine C This drug induces uterine contraction and may cause premature or hypertonic labour. Products containing ergometrine should be avoided during pregnancy. Genitourinary System Agents acting on the uterus
ergotamine C Standard oral dose regimens for migraine headaches in the first half of pregnancy do not appear to pose hazards to the fetus. Ergotamine induces uterine contraction and may therefore cause premature parturition or hypertonic labour. Larger doses or more frequent use may jeopardise the fetus because of the potential for impeding fetal blood supply. Cardiovascular System Antimigraine preparations
eribulin D Eribulin is embryotoxic, fetotoxic and teratogenic in rats at less than the recommended human dose based on body surface area. Antineoplastic Agents
erlotinib C This drug inhibits EGFR. EGFR plays an important role in embryofetal development. Antineoplastic Agents Tyrosine kinase inhibitors
ertapenem B3 Antimicrobials Antibiotics
ertugliflozin pyroglutamic acid D Based on results from animal studies, ertugliflozin may affect renal development and maturation. Use in during pregnancy is not recommended. Endocrine System Hypoglycaemic agents
ertugliflozin pyroglutamic acid; Metformin hydrochloride D Based on results from animal studies, ertugliflozin may affect renal development and maturation. No animal embryofetal development studies have been performed with ertugliflozin and metformin in combination. Use in pregnancy is not recommended. Endocrine System Hypoglycaemic agents
ertugliflozin pyroglutamic acid; sitagliptin phosphate monohydrate D Based on results from animal studies, ertugliflozin may affect renal development and maturation. No animal embryofetal development studies have been performed with ertugliflozin and sitagliptin in combination. Use in pregnancy is not recommended. Endocrine System Hypoglycaemic agents
erythromycin A Antimicrobials Antibiotics Macrolide antibiotics
erythropoietin B3 Blood and Haemopoietic System Haemopoietic agents
escitalopram C Selective serotonin reuptake inhibitors (SSRIs) have had limited use in pregnancy without a reported increase in birth defects. The use of SSRIs in the third trimester may result in a withdrawal state in the newborn infant. Central Nervous System Antidepressants Selective serotonin reuptake inhibitors (SSRIs)
esketamine B3 Central Nervous System Antidepressants
eslicarbazepine acetate D Embyrofetal effects have been observed in animals including increases in pre-and post-implantation loss, decreases in fetal weight, an increased incidence of major and minor malformations and variations, at subclinical doses. Effects include minor and major rib abnormalities, cleft palate, missing thoracic neural arches and offset or hemicentric thoracic centra in mice, pelvic cavitation of the kidney, missing caudal vertebra, ossification delays and ridged palate. Central Nervous System Anticonvulsants/antiepileptics
esmolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
esomeprazole B3 Alimentary System Hyperacidity, reflux, ulcers
estetrol (as monohydrate) B3 Endocrine System Oestrogens (see also oral contraceptives)
estradiol B3 Endocrine System Oestrogens (see also oral contraceptives)
estramustine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Alkylating agents
estriol B1 Endocrine System Oestrogens (see also oral contraceptives)
estropipate B1 Endocrine System Oestrogens (see also oral contraceptives)
etacrynic acid C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
etanercept D Etanercept crosses the placenta and has been detected in the serum of infants born to female patients treated with etanercept. Infants may be at increased risk of infection. Allergy and Immune System Immunomodifiers
ethambutol A Antimicrobials Antituberculotics and antileprotics
ethinylestradiol B3 Endocrine System Oestrogens (see also oral contraceptives)
ethosuximide D Compared to conventional anticonvulsants, the extent of the risk of this drug is unknown. Central Nervous System Anticonvulsants/antiepileptics
etidocaine B1 Drugs Used in Anaesthesia Local anaesthetics
etidronate disodium B3 Endocrine System Agents affecting calcium and bone metabolism
etonogestrel B3 Contraceptive Agents
etoposide D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
etoricoxib C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
etranacogene dezaparvovec B2 Cardiovascular System Haemostatic agents
etrasimod arginine D Administration of etrasimod during pregnancy in rats and rabbits produced adverse effects on development, including embryolethality, fetal malformations and an increased number of stillbirths. Allergy and Immune System Immunomodifiers
etravirine B1 Antimicrobials Antiviral agents
etretinate X This drug is teratogenic at doses within the therapeutic range. The drug is stored in the body for several months after cessation. Because of the long half-life of this drug and storage in fat, patients are advised not to conceive until two years after cessation of treatment because of risk of birth defects. Should pregnancy occur during treatment with this drug, there is a high risk of birth defects. Drugs used in Dermatology Systemic
everolimus C Allergy and Immune System Immunomodifiers
evolocumab (rch) B1 Cardiovascular System Hypolipidaemic agents
exemestane C Exemestane disrupts oestrogen dependent metabolism and may result in abortion. Antineoplastic Agents Hormonal antineoplastic agents
exenatide C Endocrine System Hypoglycaemic agents
ezetimibe B3 The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System Hypolipidaemic agents
factor IX (human) C The safe use of this drug during pregnancy has not been established in controlled clinical trials. Cardiovascular System Haemostatic agents
factor IX (r CHO) B2 Cardiovascular System Haemostatic agents
famciclovir B1 Antimicrobials Antiviral agents
famotidine B1 Alimentary System Hyperacidity, reflux, ulcers
fampridine C Central Nervous System
faricimab D Based on the mechanism of action of faricimab (VEGF and Ang-2 inhibition), there is a potential risk to female reproductive capacity, and to embryo-fetal development. VEGF inhibition has been shown to cause malformations, embryofetal resorption and decreased fetal weight. No dedicated studies addressing the effects of Ang-2 inhibition on pregnancy are available. Based on nonclinical information Ang-2 inhibition may lead to effects comparable to VEGF inhibition. Systemic exposures after ocular administration of faricimab is very low. Ophthalmic Drugs
febuxostat B1 Musculoskeletal System Agents used in gout and hyperuricaemia
fedratinib D Fedratinib was shown to cause embryofetal lethality in animals at exposure levels well below that of patients. Antineoplastic Agents Tyrosine kinase inhibitors
felodipine C Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. Cardiovascular System Antihypertensives Calcium channel blockers
fenfluramine D Studies in animals indicate a risk for embryofetal loss and malformations with use during pregnancy. Central Nervous System Anticonvulsants/antiepileptics
fenfluramine B2 Weight reduction using appetite suppressant drugs is not recommended in pregnancy. Metabolism Anorectic and weight reducing agents
fenofibrate B3 The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System Hypolipidaemic agents
fenoterol A Cardiovascular System Adrenergic stimulants
fenoterol A Respiratory System Inhalational agents Bronchospasm relaxants
fentanyl C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
fentanyl / ropivacaine C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal and anti-inflammatory agents)
ferric carboxymaltose B3 Blood and Haemopoietic System
ferucarbotran B1 Diagnostic Agents Radiographic agents
fexofenadine B2 Allergy and Immune System Antihistamines
fezolinetant B3 Central Nervous System
fibrin B2 Cardiovascular System Haemostatic agents
fibrinogen B2 Cardiovascular System Haemostatic agents
fibrinogen / thrombin B2 Cardiovascular System Haemostatic agents
fibronectin B2 Cardiovascular System Haemostatic agents
fidaxomicin B1 Antimicrobials Antibiotics
filgrastim B3 Blood and Haemopoietic System Haemopoietic agents
finasteride X Finasteride may cause abnormalities of the external genitalia of a male fetus. Drugs used in Dermatology Topical
finasteride X Finasteride may cause abnormalities of the external genitalia of a male fetus. Genitourinary System Prostate hyperplasia
finerenone D Adverse effects on embryofetal development, including teratogenicity, were observed with finerenone in rats. Metabolism Agents used for the treatment of metabolic disorders
fingolimod D This drug causes cardiovascular malformations in rats, and post-implantation loss and/or abortion in rats and rabbits. Allergy and Immune System Immunomodifiers
flecainide B3 Cardiovascular System Antiarrhythmics
fleroxacin B3 Antimicrobials Antibiotics Quinolones
flucloxacillin B1 Antimicrobials Antibiotics Penicillins
fluconazole D Effective contraceptive measures should be considered in women of child-bearing potential and should continue throughout the treatment period and for approximately 1 week (5 to 6 half-lives) after the final dose. There have been reports of spontaneous abortion and congenital abnormalities in infants whose mothers were treated with 150 mg of fluconazole as a single or repeated dose in the first trimester. Repeated doses of fluconazole (400-800mg daily) have been associated with a consistent pattern of birth defects similar to those seen in animal studies. Antimicrobials Antifungal agents (see also topical antifungals)
flucytosine B3 Antimicrobials Antifungal agents (see also topical antifungals)
fludarabine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antibiotic cytotoxic agents
fludrocortisone (systemic) C Endocrine System Corticosteroids Systemic
fludrocortisone (topical) A Endocrine System Corticosteroids Topical
flumazenil B3 Detoxifying Agents, Antidotes
flumetasone A Endocrine System Corticosteroids Topical
flunisolide B3 The benefits of asthma control outweigh any potential for an adverse pregnancy outcome. Endocrine System Corticosteroids Inhalation/intranasal
flunitrazepam C Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
fluocinolone A Endocrine System Corticosteroids Topical
fluocortolone A Endocrine System Corticosteroids Topical
fluorescein sodium (systemic) B2 Ophthalmic Drugs
fluorometholone B3 Ophthalmic Drugs
fluorouracil D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
fluoxetine C Selective serotonin reuptake inhibitors (SSRIs) have had limited use in pregnancy without a reported increase in birth defects. The use of SSRIs in the third trimester may result in a withdrawal state in the newborn infant. Central Nervous System Antidepressants Selective serotonin reuptake inhibitors (SSRIs)
fluoxymesterone D Anabolic steroids and other substances with androgenic effects may have a virilising effect on the female fetus and should be avoided during pregnancy. Endocrine System Androgens and anabolic steroids
flupenthixol C When given in high doses during late pregnancy, related compounds have caused prolonged neurological disturbances in the newborn infant. Central Nervous System Antipsychotic drugs
fluphenazine C When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the newborn infant. Central Nervous System Antipsychotic drugs Phenothiazines
flurazepam C Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
flurbiprofen C The safety of this product for use in human pregnancy has not been established. Reproductive studies in rats showed that flurbiprofen had a significant effect on parturition at doses of >0.4 mg/kg/day. Additionally, flurbiprofen was considered embryolethal at doses > 4.0 mg/kg/day. Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system of rats (closure of the ductus arteriosus), the use of flurbiprofen eye drops during late pregnancy should be avoided. Flurbiprofen should only be used in pregnancy when the potential benefit to the patient outweighs the potential risk to the fetus. Ophthalmic Drugs
fluticasone furoate B3 The benefits of asthma control outweigh any potential for an adverse pregnancy outcome. Endocrine System Corticosteroids Inhalation/intranasal
fluticasone furoate / vilanterol trifenatate B3 Respiratory System Inhalational agents Preventative aerosols and inhalations
fluticasone propionate B3 The benefits of asthma control outweigh any potential for an adverse pregnancy outcome. Respiratory System Inhalational agents Preventative aerosols and inhalations
fluticasone propionate / eformoterol fumarate B3 Respiratory System Inhalational agents
fluticasone propionate / salmeterol xinafoate B3 Respiratory System Inhalational agents
fluvastatin D Cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, these drugs may cause fetal harm when administered to a pregnant woman. The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System Hypolipidaemic agents
fluvoxamine C Selective serotonin reuptake inhibitors (SSRIs) have had limited use in pregnancy without a reported increase in birth defects. The use of SSRIs in the third trimester may result in a withdrawal state in the newborn infant. Central Nervous System Antidepressants Selective serotonin reuptake inhibitors (SSRIs)
folic acid A Blood and Haemopoietic System
folinic acid (leucovorin) A Blood and Haemopoietic System
follicle stimulating hormone (recombinant human) B3 Endocrine System Ovulation inducers Gonadotrophins
follitropin alfa D Endocrine System Pituitary hormones
follitropin beta B2 Endocrine System Pituitary hormones
follitropin delta D Endocrine System Pituitary hormones
fomepizole B2 Detoxifying Agents, Antidotes
fomivirsen B2 Antimicrobials Antiviral agents
fondaparinux C All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
formoterol B3 Respiratory System Inhalational agents Bronchospasm relaxants
fosamprenavir B3 Antimicrobials Antiviral agents
fosaprepitant B2 Antineoplastic Agents Non-cytotoxic supportive therapy
foscarnet B3 Antimicrobials Antiviral agents
fosfomycin trometamol B2 Antimicrobials Antibiotics
fosinopril D When taken during the second and third trimesters, ACE inhibitors cause a range of abnormalities including renal dysfunction and oligohydramnios. These can be associated with fetal death in utero. Although no adverse fetal effects have been linked to first trimester drug use of ACE inhibitors, the number of exposures reported is too small to determine conclusively that ACE inhibitors are safe in the first trimester. Pregnant women who are taking ACE inhibitors should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ACE inhibitors for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin converting enzyme (ACE) inhibitors
foslevodopa / foscarbidopa B3 Central Nervous System Antiparkinson agents
fostemsavir B3 Antimicrobials Antiviral agents
fotemustine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Alkylating agents
framycetin D There is evidence of selective uptake of aminoglycosides by the fetal kidney resulting in damage (probably reversible) to immature nephrons. Eighth cranial nerve damage has also been reported following in utero exposure to some of the aminoglycosides. Because of their chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the fetus. It should also be noted that therapeutic blood concentrations in the mother do not equate with safety for the fetus. Antimicrobials Antibiotics Aminoglycosides
fremanezumab B1 Central Nervous System
fruquintinib D Studies in animals indicate strong potential for malformations and embryofetal loss with use in pregnancy. Antineoplastic Agents Tyrosine kinase inhibitors
frusemide (furosemide) C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
fulvestrant D This drug is teratogenic in rats. It may cause fetal harm when administered to a pregnant woman. Antineoplastic Agents Hormonal antineoplastic agents
furosemide C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
fusidic acid C This drug may cause kernicterus in babies during the first month of life by displacing bilirubin from plasma albumin. Fusidic acid should be avoided if possible during the last month of pregnancy. Antimicrobials Antibiotics
futibatinib D Studies in animals indicate strong potential for malformations and embryofetal loss with use in pregnancy. Antineoplastic Agents Tyrosine kinase inhibitors
FVIII inhibitor bypassing fraction B2 Cardiovascular System Haemostatic agents
gabapentin D Compared to conventional anticonvulsants, the extent of the risk of this drug is unknown. Central Nervous System Anticonvulsants/antiepileptics
gadobenate B3 Diagnostic Agents Radiographic agents
gadobutrol B3 Diagnostic Agents
gadodiamide B3 Diagnostic Agents Radiographic agents
gadofosveset B3 Diagnostic Agents Radiographic agents
gadopentetate dimeglumine B2 Diagnostic Agents Radiographic agents
gadoteridol B3 Diagnostic Agents Radiographic agents
gadoversetamide B3 Diagnostic Agents Radiographic agents
gadoxetate B3 Diagnostic Agents Radiographic agents
galactose with palmitic acid B2 Diagnostic Agents Radiographic agents
galantamine B1 Cholinergic and Anticholinergic Agents
galcanezumab B1 Central Nervous System
gallamine C There have been no demonstrated adverse effects in the fetus or the newborn infant. Drugs Used in Anaesthesia Neuromuscular blocking agents
galsulfase B3 Metabolism Agents used for the treatment of metabolic disorders
ganciclovir D Ganciclovir has been shown to be teratogenic and embryotoxic in animals. Antimicrobials Antiviral agents
ganirelix D There is a theoretical risk of abortion if gonadotrophin releasing hormone antagonists are used during pregnancy. Endocrine System Pituitary inhibitors
garadacimab B1 Blood and Haemopoietic System
gatifloxacin B3 Antimicrobials Antibiotics Quinolones
gefitinib C This drug inhibits EGFR. EGFR plays an important role in embryofetal development. Antineoplastic Agents Tyrosine kinase inhibitors
gemcitabine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
gemeprost B3 Genitourinary System Agents acting on the uterus
gemfibrozil B3 The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System Hypolipidaemic agents
gemtuzumab ozogamicin D Gemtuzumab ozogamicin may cause embryofetal lethality and malformations based on findings in anmials Antineoplastic Agents Monoclonal antibodies
gentamicin D There is evidence of selective uptake of aminoglycosides by the fetal kidney resulting in damage (probably reversible) to immature nephrons. Eighth cranial nerve damage has also been reported following in utero exposure to some of the aminoglycosides. Because of their chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the fetus. It should also be noted that therapeutic blood concentrations in the mother do not equate with safety for the fetus. Antimicrobials Antibiotics Aminoglycosides
gestoden B3 If taken by the mother at or after 8 weeks post conception, these drugs can cause virilisation of the female fetus. This is a dose-dependent effect. Prior to 8 weeks post conception, they have no virilising effects. Endocrine System Progestogens (see also oral contraceptives)
gestrinone D This drug may interfere with pregnancy and in animal tests caused masculinisation of female fetuses. Gestrinone may not inhibit ovulation in all women. Endocrine System Pituitary inhibitors
gilteritinib  D Studies in animals indicate strong potential for malformations and embryofetal loss with use in pregnancy. Antineoplastic Agents Tyrosine kinase inhibitors
givosiran B3 Alimentary System
glatiramer B1 Allergy and Immune System Immunomodifiers
glecaprevir / pibrentasvir B1 Antimicrobials Antiviral agents
glibenclamide C Sulphonylureas may enter the fetal circulation and may cause neonatal hypoglycaemia. Endocrine System Hypoglycaemic agents
glibenclamide / metformin C Sulphonylureas may enter the fetal circulation and may cause neonatal hypoglycaemia. Endocrine System Hypoglycaemic agents
gliclazide C Sulphonylureas may enter the fetal circulation and may cause neonatal hypoglycaemia. Endocrine System Hypoglycaemic agents
glimepiride C Sulphonylureas may enter the fetal circulation and may cause neonatal hypoglycaemia. Endocrine System Hypoglycaemic agents
glipizide C Sulphonylureas may enter the fetal circulation and may cause neonatal hypoglycaemia. Endocrine System Hypoglycaemic agents
glofitamab C Based on its mechanism of action, glofitamab is likely to cause fetal B-cell depletion when administered to a pregnant woman, posing a risk of opportunistic infections in the neonate. Glofitamab-induced cytokine release may also pose a risk for embryofetal loss. Antineoplastic Agents Monoclonal antibodies
glucagon B3 Detoxifying Agents, Antidotes
glyceryl trinitrate B2 Cardiovascular System Antiangina agents
glyceryl trinitrate B2 Cardiovascular System Vasodilators
glycopyrronium bromide B2 Alimentary System Antispasmodics
glycopyrronium bromide B2 Cholinergic and Anticholinergic Agents
glycopyrronium bromide B3 Respiratory System Inhalational agents Bronchospasm relaxants
glycopyrronium bromide / formoterol fumarate B3 Respiratory System Inhalational agents
golimumab C IgG antibodies are known to cross the placental barrier. This drug has the potential to affect embryofetal survival due to its pharmacological action. Allergy and immune System Immunomodifiers
gonadotrophin - human chorionic A Endocrine System Ovulation inducers Gonadotrophins
gonadotrophin - human menopausal C Endocrine System Ovulation inducers Gonadotrophins
goserelin D There is a theoretical risk of abortion or fetal abnormality if GnRH agonists are used during pregnancy. Antineoplastic Agents Hormonal antineoplastic agents
goserelin D There is a theoretical risk of abortion or fetal abnormality if GnRH agonists are used during pregnancy. Endocrine System Pituitary hormones
granisetron B1 Central Nervous System Antiemetics, antinauseants
griseofulvin D Antimicrobials Antifungal agents (see also topical antifungals)
guaifenesin A Respiratory System Expectorants and mucolytics
guanethidine A Cardiovascular System Antihypertensives
guanfacine hydrochloride B3 Central Nervous System
guselkumab B1 Allergy and Immune System Immunomodifiers
Haemophilus influenzae type b conjugate vaccine B2 Vaccines Subunit vaccines Polysaccharide conjugate vaccines
Haemophilus influenzae type b-meningococcal group C conjugate vaccine B2 Vaccines Subunit vaccines Polysaccharide conjugate vaccines
halcinonide A Endocrine System Corticosteroids Topical
haloperidol C When given in high doses during late pregnancy, butyrophenones may cause prolonged neurological disturbances in the newborn infant. Central Nervous System Antipsychotic drugs Butyrophenones
halothane A All general anaesthetics carry the potential to produce central nervous system and respiratory depression in the newborn infant. In routine practice this does not appear to be a problem. However, in the compromised fetus, careful consideration should be given to this potential depression and to the selection of particular anaesthetic drugs, doses and techniques. Drugs Used in Anaesthesia General anaesthetics
heparin C All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
hepatitis A vaccine B2 Vaccines Inactivated vaccines
hepatitis B vaccine B2 Vaccines Subunit vaccines Recombinant protein vaccines
homatropine B2 Ophthalmic Drugs
house dust mite allergen extract B2 Allergy and Immune System
human papillomavirus vaccine B2 Vaccines Subunit vaccines Recombinant protein vaccines
hydralazine C Following intravenous administration, hydralazine has been associated with fetal distress and fetal arrhythmia in the last trimester of pregnancy. Cardiovascular System Antihypertensives
hydrochlorothiazide C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
hydrocortisone A Endocrine System Corticosteroids Systemic
hydromorphone C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
hydroxycarbamide D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
hydroxychloroquine D When used in high doses and for prolonged periods, chloroquine and related substances may cause neurological disturbances and interference with hearing, balance and vision in the fetus. Musculoskeletal System Antirheumatoid agents
hydroxychloroquine (antimalarial) D When used in high doses and for prolonged periods, chloroquine and related substances may cause neurological disturbances and interference with hearing, balance and vision in the fetus. The use of this drug in the treatment of malaria is accepted because the small risk to the fetus is outweighed by the benefits to the mother and fetus. Prophylaxis in high risk situations is also justified. Antimicrobials Antimalarials
hydroxyprogesterone D If taken by the mother at or after 8 weeks post conception, these drugs can cause virilisation of the female fetus. This is a dose-dependent effect. Prior to 8 weeks post conception, they have no virilising effects. Endocrine System Progestogens (see also oral contraceptives)
hydroxyurea (hydroxycarbamide) D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
hydroxyzine A Allergy and Immune System Antihistamines
hyoscine B2 Central Nervous System Antiemetics, antinauseants
hyoscine B2 Cholinergic and Anticholinergic Agents
hyoscine hydrobromide B2 Central Nervous System Antiemetics, antinauseants
hyoscine methobromide A Cholinergic and Anticholinergic Agents
hyoscine-N-butylbromide B2 Alimentary System Antispasmodics
hyoscine-N-butylbromide B2 Cholinergic and Anticholinergic Agents
hyoscyamine B2 Alimentary System Antidiarrhoeals
hyoscyamine B2 Cholinergic and Anticholinergic Agents
ibandronate B3 Endocrine System Agents affecting calcium and bone metabolism Bisphosphonates
ibrutinib D This drug is embryotoxic in both pregnant rats and rabbits, and teratogenic when administered to pregnant animals. Antineoplastic Agents Tyrosine kinase inhibitors
ibuprofen C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
ibutilide B3 Cardiovascular System Antiarrhythmics
icatibant C Cardiovascular System
idarubicin D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antibiotic cytotoxic agents
idarucizumab B2 Cardiovascular System
idelalisib D This drug is embryotoxic in both pregnant rats and rabbits, and teratogenic when administered to pregnant animals. Antineoplastic Agents
idoxuridine (ophthalmic) B3 Ophthalmic Drugs
idoxuridine (topical) B1 Drugs used in Dermatology Topical antiviral
idursulfase B2 Metabolism Agents used for the treatment of metabolic disorders
ifosfamide D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Alkylating agents
iloprost B3 Cardiovascular System Vasodilators
imatinib D This drug is embryotoxic in both pregnant rats and rabbits, and teratogenic when administered to pregnant animals. Antineoplastic Agents Tyrosine kinase inhibitors
imiglucerase B2 Metabolism Agents used for the treatment of metabolic disorders
imipenem with cilastatin B3 Antimicrobials Antibiotics
imipramine C Withdrawal symptoms in newborn infants have been reported with prolonged maternal use of tricyclic antidepressants. Central Nervous System Antidepressants Tricyclic antidepressants
imiquimod B1 Drugs used in Dermatology Topical antiviral
imlifidase B2 Allergy and Immune System
inavolisib D Based on animal studies and its pharmacological activity, inavolisib is expected to cause fetal harm (including teratogenicity and miscarriage) when administered to a pregnant woman. Antineoplastic Agents
inclisiran B1 Cardiovascular System Hypolipidaemic agents
incobotulinumtoxinA B3 Musculoskeletal System Muscle relaxants
indacaterol B3 Respiratory System Inhalational agents Bronchospasm relaxants
indacaterol maleate / glycopyrronium bromide B3 Respiratory System Inhalational agents
indacaterol/glycopyrronium B3 Respiratory System Inhalational agents Bronchospasm relaxants
indapamide C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
indigo carmine B2 Genitourinary System
indinavir B3 Antimicrobials Antiviral agents
indocyanine green B2 Diagnostic Agents Radiographic agents
indometacin C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
inebilizumab C Depletion of B cells in newborns may be expected following exposure during pregnancy due to the pharmacological activity of inebilizumab. Antineoplastic Agents Monoclonal antibodies
infigratinib D This drug is embryotoxic and fetotoxic in both pregnant rats and rabbits, and teratogenic when administered to pregnant animals. Antineoplastic Agents
infliximab C Infliximab crosses the placenta. Infliximab has been detected in the serum of infants up to six months following birth. After in utero exposure to infliximab, infants may be at increased risk of infection. Allergy and Immune System Immunomodifiers
influenza vaccine, inactivated (pandemic) B2 Vaccines Inactivated vaccines
influenza vaccine, inactivated (prepandemic) B2 Vaccines Inactivated vaccines
influenza vaccine, inactivated (seasonal) A or B2 (depending on brand of vaccine) Vaccines Inactivated vaccines
influenza vaccine, recombinant (seasonal) B1 Vaccines Subunit vaccines Recombinant protein vaccines
ingenol B3 Drugs used in Dermatology Topical
Inotuzumab ozogamicin D IgG antibodies are known to cross the placental barrier. This drug has the potential to affect embryofetal survival due to its pharmacological action. Antineoplastic Agents Monoclonal antibodies
insulin aspart A Endocrine System Hypoglycaemic agents Insulins
insulin aspart / insulin degludec A Endocrine System Hypoglycaemic agents Insulins
insulin detemir A Endocrine System Hypoglycaemic agents Insulins
insulin glargine B3 Endocrine System Hypoglycaemic agents Insulins
insulin glulisine B3 Endocrine System Hypoglycaemic agents Insulins
insulin icodec B3 Endocrine System Hypoglycaemic agents Insulins
insulin lispro A Endocrine System Hypoglycaemic agents Insulins
interferon alpha-2a B3 Allergy and Immune System Immunomodifiers
interferon alpha-2b B3 Allergy and Immune System Immunomodifiers
interferon beta-1a D Interferon beta-1a has abortifacient activity in monkeys. Allergy and Immune System Immunomodifiers
interferon beta-1b D This drug has abortifacient activity in monkeys. Spontaneous abortions have been reported in subjects with multiple sclerosis in controlled clinical trials. Allergy and Immune System Immunomodifiers
interferon gamma-1b B3 Allergy and Immune System Immunomodifiers
iodixanol B1 Diagnostic Agents Radiographic agents
iodoform with bismuth subnitrate D Sufficient iodine may be absorbed to affect fetal thyroid development and function. Drugs used in Dermatology Topical antifungals, antiseptics (see also antifungal agents)
iomeprol B3 Diagnostic Agents Radiographic agents
iopromide B2 Diagnostic Agents Radiographic agents
ioversol B1 Diagnostic Agents Radiographic agents
ipecacuanha A Respiratory System Expectorants and mucolytics
ipilimumab C IgG antibodies are known to cross the placental barrier. This drug may affect embryofetal survival due to its pharmacological action. Antineoplastic Agents Monoclonal antibodies
ipratropium bromide B1 Respiratory System Inhalational agents Bronchospasm relaxants
iptacopan B1 Blood and Haemopoietic System
irbesartan D When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin II receptor antagonists and renin inhibitors
irinotecan D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
irinotecan (nanoliposomal as sucrosofate) D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
iron [as ferric derisomaltose] (parenteral) B3 Blood and Haemopoietic System
iron polymaltose (oral) A Blood and Haemopoietic System
iron polymaltose (parenteral) A Blood and Haemopoietic System
iron sucrose (parenteral) B3 Blood and Haemopoietic System
isatuximab C Antineoplastic Agents Monoclonal antibodies
isavuconazole D Isavuconazole must not be used during pregnancy except in patients with severe or potentially life-threatening fungal infections, in whom isavuconazole may be used if the anticipated benefits outweigh the possible risks to the fetus. Isavuconazonium was associated with increases in the incidences of rudimentary cervical ribs in rats and rabbits at doses equivalent to about one fifth and one tenth of the clinical exposures. In rats, increases in the incidences of zygomatic arch fusion and supernumerary ribs/rudimentary supernumerary ribs were also noted at doses equivalent to one fifth the clinical dose. The potential risk for humans is unknown. Antimicrobials Antifungal
isoconazole B2 Genitourinary System Topical vaginal medication
isoflurane B3 All general anaesthetics carry the potential to produce central nervous system and respiratory depression in the newborn infant. In routine practice this does not appear to be a problem. However, in the compromised fetus, careful consideration should be given to this potential depression and to the selection of particular anaesthetic drugs, doses and techniques. Drugs Used in Anaesthesia General anaesthetics
isoniazid A Antimicrobials Antituberculotics and antileprotics
isoprenaline A Cardiovascular System Adrenergic stimulants
isoprenaline A Respiratory System Inhalational agents Bronchospasm relaxants
isosorbide dinitrate B1 Cardiovascular System Antiangina agents
isosorbide dinitrate B1 Cardiovascular System Vasodilators
isosorbide mononitrate B2 Cardiovascular System Antiangina agents
isotretinoin (systemic) X Isotretinoin is teratogenic and must not be used by women who are pregnant or who may possibly become pregnant while undergoing treatment and for one month after isotretinoin has stopped. Should pregnancy occur during treatment with this drug, there is a high risk of birth defects. (Refer to current Product Information). Drugs used in Dermatology Systemic
isotretinoin (topical) D Isotretinoin is known to be teratogenic when administered orally in human beings. It is associated with major birth defects and with a small risk of spontaneous abortion. Drugs used in Dermatology Topical
isoxsuprine C Maternal isoxsuprine administration for prevention of premature labour has been associated with tachycardia, hypoglycaemia, hypocalcaemia, ileus and hypotension in the neonate. Cardiovascular System Vasodilators
isradipine C Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. Cardiovascular System Antihypertensives Calcium channel blockers
itraconazole B3 Antimicrobials Antifungal agents (see also topical antifungals)
ivabradine D Animal studies have shown that this drug is embryotoxic and teratogenic (cardiac defects in rats and ectrodactyly in rabbits). Increased post-natal mortality and enlarged hearts were seen in rat pups from dams treated with this drug. Cardiovascular System Antiangina agents
ivacaftor B3 Respiratory System Inhalational agents
ivacaftor / tezacaftor / elexacaftor B3 Respiratory System Inhalational agents
ivermectin B3 Antimicrobials Anthelmintics
ivosidenib D Antineoplastic Agents
ixazomib C If sufficient placental transfer occurred, ixazomib has the potential to disrupt protein cycling in the developing fetus and, therefore, may have an adverse effect on fetal development. Antineoplastic Agents
ixekizumab C The mechanism of action of ixekizumab suggests a theoretical risk that its use during pregnancy may affect neonatal immunity. Allergy and Immune System Immunomodifiers
Japanese encephalitis vaccine (inactivated) B1 Vaccines Inactivated vaccines
Japanese encephalitis vaccine (live, attenuated) B2 Currently available live virus vaccines have not caused teratogenic effects in humans. The ATAGI publication, “The Australian Immunisation Handbook”, should be consulted for more comprehensive information. Vaccines Live attenuated vaccines
kanamycin D There is evidence of selective uptake of aminoglycosides by the fetal kidney resulting in damage (probably reversible) to immature nephrons. Eighth cranial nerve damage has also been reported following in utero exposure to some of the aminoglycosides. Because of their chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the fetus. It should also be noted that therapeutic blood concentrations in the mother do not equate with safety for the fetus. Antimicrobials Antibiotics Aminoglycosides
ketamine B3 All general anaesthetics carry the potential to produce central nervous system and respiratory depression in the newborn infant. In routine practice this does not appear to be a problem. However, in the compromised fetus, careful consideration should be given to this potential depression and to the selection of particular anaesthetic drugs, doses and techniques. Drugs Used in Anaesthesia General anaesthetics
ketoconazole B3 Antimicrobials Antifungal agents (see also topical antifungals)
ketoprofen C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
ketorolac C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
ketotifen B1 Ophthalmic Drugs
labetalol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
lacosamide B3 The risk of having an abnormal child as a result of antiepileptic medication is far outweighed by the dangers to the mother and fetus of uncontrolled epilepsy. It is recommended that: • women on antiepileptic drugs (AEDs) receive prepregnancy counselling with regard to the risk of fetal abnormalities; • AEDs should be continued during pregnancy and monotherapy should be used if possible at the lowest effective dose as risk of abnormality is greater in women taking combined medication; • folic acid supplementation (5mg) should be commenced four weeks prior to and continue for twelve weeks after conception; • Specialist prenatal diagnosis including detailed mid-trimester ultrasound should be offered. Central Nervous System Anticonvulsants/antiepileptics
lamivudine B3 Antimicrobials Antiviral agents
lamotrigine D Compared to conventional anticonvulsants, the extent of the risk of this drug is unknown. Central Nervous System Anticonvulsants/antiepileptics
lanadelumab B1 Cardiovascular System
landiolol C Based on the pharmacological action of Beta-adrenergic blocking agents, landiolol may cause harm including bradycardia in the fetus and newborn infant when administered to pregnant women. Cardiovascular System Beta-adrenergic blocking agents
lanreotide C This drug may cause fetal growth retardation, probably due to suppression of growth hormone. Endocrine System Pituitary hormones
lansoprazole B3 Alimentary System Hyperacidity, reflux, ulcers
lanthanum B3 Detoxifying Agents, Antidotes
lapatinib C This drug inhibits EGFR. EGFR plays an important role in embryofetal development. Antineoplastic Agents Tyrosine kinase inhibitors
laronidase B2 Metabolism Agents used for the treatment of metabolic disorders
larotrectinib D Based on its mechanism of action and findings in animal studies, larotrectinib may cause fetal malformations. Antineoplastic Agents Tyrosine kinase inhibitors
latanoprost B3 Ophthalmic Drugs
latanoprost / timolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Ophthalmic Drugs
lauromacrogol B3 Cardiovascular System
lazertinib D Based on its mechanism of action and animal studies, lazertinib may cause malformations and embryofetal loss when administered to a pregnant woman. Antineoplastic Agents Tyrosine kinase inhibitors
lebrikizumab B1 Drugs Used in Dermatology Systemic
ledipasvir B1 Antimicrobials Antiviral agents
ledipasvir / sofosbuvir B1 Antimicrobials Antiviral agents
ledipasvir / sofosbuvir with ribavirin X Although there are no pertinent human data, ribavirin has been found to be teratogenic and/or embryolethal in nearly all species in which it has been tested. Malformations of skull, palate, eye, jaw, skeleton and gastrointestinal tract were noted in animal studies. Survival of fetuses and offspring was reduced. Antimicrobials Antiviral agents
leflunomide X This drug may cause fetal harm in humans. This drug must not be given to pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with this drug and for a certain period of time thereafter. Pregnancy must be excluded before the start of treatment with this drug. Allergy and Immune System Immunomodifiers
lemborexant B3 Central Nervous System Hypnotics and sedatives
lemborexant B3 Central Nervous System
lenacapavir sodium B1 Antimicrobials Antiviral agents
lenalidomide X This drug is structurally related to thalidomide. Thalidomide is a known human teratogen that causes severe life threatening human birth defects. If lenalidomide is taken during pregnancy, it may cause birth defects or death to an unborn baby. Women should be advised to avoid pregnancy while taking lenalidomide and for four weeks after stopping the drug. Allergy and Immune System Immunomodifiers
leniolisib D Based on findings in animals, leniolisib may cause fetal harm when administered to a pregnant woman. Malformations were demonstrated with leniolisib in rats and rabbits. Antineoplastic Agents
lenograstim B3 Blood and Haemopoietic System Haemopoietic agents
lenvatinib D Angiogenesis plays a key role in embryo-fetal development. VEGF receptor inhibitors inhibit angiogenesis and can cause fetal harm when administered to pregnant women. Antineoplastic Agents Tyrosine kinase inhibitors
lepirudin B3 All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
lercanidipine C Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. Cardiovascular System Antihypertensives Calcium channel blockers
lesinurad B1 Musculoskeletal System Agents used in gout and hyperuricaemia
letermovir B3 Antimicrobials Antiviral agents
letibotulinumtoxinA B3 Musculoskeletal System Muscle relaxants
letrozole D This drug disrupts oestrogen dependant metabolism and is associated with fetal malformation and mortality in animals. Antineoplastic Agents Hormonal antineoplastic agents
leuprorelin D There is a theoretical risk of abortion or fetal abnormality if GnRH agonists are used during pregnancy. Antineoplastic Agents Hormonal antineoplastic agents
levamisole B3 Allergy and Immune System Immunomodifiers
levetiracetam B3 Compared to conventional anticonvulsants, the extent of the risk of this drug is unknown. Central Nervous System Anticonvulsants/antiepileptics
levobunolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
levobunolol (ophthalmic) C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Ophthalmic Drugs
levobupivacaine B3 Drugs Used in Anaesthesia Local anaesthetics
levocabastine B3 Inadvertent short term exposure during the first trimester is unlikely to cause a hazard to the fetus, but it has been shown to be teratogenic in two species of animals and until human data are available, it should be suspected of being teratogenic. Allergy and Immune System Antihistamines
levocabastine (ophthalmic) B3 Ophthalmic Drugs
levocetirizine B2 Allergy and Immune System Antihistamines
levodopa B3 Central Nervous System Antiparkinson agents
levonorgestrel D Contraceptive Agents Emergency contraceptives
levonorgestrel B3 Contraceptive Agents Oral contraceptives
levonorgestrel / ethinyloestradiol B3 Contraceptive Agents Oral contraceptives
lidocaine A Cardiovascular System Antiarrhythmics
lidocaine A Drugs Used in Anaesthesia Local anaesthetics
lifitegrast B1 Ophthalmic Drugs
lignocaine (lidocaine) A Cardiovascular System Antiarrhythmics
lignocaine (lidocaine) A Drugs Used in Anaesthesia Local anaesthetics
linaclotide B3 Alimentary System Laxatives
linagliptin B3 Endocrine System Hypoglycaemic agents
linagliptin / metformin C It is important to achieve strict normoglycaemia during pregnancy. Endocrine System Hypoglycaemic agents
lincomycin A Antimicrobials Antibiotics
lindane B3 Lindane penetrates human skin and has been reported to cause signs of CNS irritation. Because of this toxic potential it is preferable, whenever possible, to use other medications during pregnancy. Drugs used in Dermatology Topical antiparasitics
linezolid B3 Antimicrobials Antibiotics
linzagolix D Linzagolix is contraindicated in pregnancy. Embryofetal lethality was demonstrated in rats and rabbits. Endocrine System Pituitary inhibitors
liothyronine A Endocrine System Thyroid hormones
lipegfilgrastim B3 Blood and Haemopoietic System Haemopoietic agents
liraglutide (rys) B3 Endocrine System Hypoglycaemic agents
lisdexamfetamine dimesilate B3 Central Nervous System CNS stimulants
lisinopril D When taken during the second and third trimesters, ACE inhibitors cause a range of abnormalities including renal dysfunction and oligohydramnios. These can be associated with fetal death in utero. Although no adverse fetal effects have been linked to first trimester drug use of ACE inhibitors, the number of exposures reported is too small to determine conclusively that ACE inhibitors are safe in the first trimester. Pregnant women who are taking ACE inhibitors should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ACE inhibitors for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin converting enzyme (ACE) inhibitors
lithium salts D The risk of birth defects may be increased when lithium is used during the first trimester. Second trimester detailed ultrasound examination and fetal echocardiography should be considered for women who have been treated with lithium during the first trimester of pregnancy. The newborn may show signs of lithium toxicity. Central Nervous System Antipsychotic drugs
lixisenatide with insulin glargine B3 Endocrine System Hypoglycaemic agents
lodoxamide trometamol B1 Ophthalmic Drugs
lomustine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Alkylating agents
lonapegsomatropin B2 Endocrine System Pituitary hormones
loncastuximab tesirine D May cause embryofetal toxicity when administered during pregnancy,as it contains a genotoxic compound (SG3199) that affects actively dividing cells. Antineoplastic Agents Monoclonal antibodies
lonoctocog alfa B2 Cardiovascular System Haemostatic agents
loperamide B3 Alimentary System Antidiarrhoeals
lopinavir with ritonavir B3 Antimicrobials Antiviral agents
loracarbef B1 Antimicrobials Antibiotics Cephalosporins
loratadine B1 Allergy and Immune System Antihistamines
lorazepam C Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
lorlatinib D Based on its mechanism of action and findings in animal studies, lorlatinib may cause embryo-fetal harm (including embryolethality, abortions and malformations). Antineoplastic Agents Tyrosine kinase inhibitors
losartan D When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin II receptor antagonists and renin inhibitors
lumacaftor/ivacaftor B3 Respiratory System
lumasiran B1 Metabolism Agents used for the treatment of metabolic disorders
lumiracoxib C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
lurasidone hydrochloride B1 Central Nervous System Antipsychotic drugs
lurbinectedin D This drug is embryotoxic and fetotoxic when administered to pregnant rats. Antineoplastic Agents
luspatercept D Luspatercept is contraindicated in pregnancy. Embryofetal lethality was demonstrated in rats and rabbits. Blood and Haemopoietic System Haemopoietic systems
lutetium (177Lu) X Teratogenicity is a class effect of radioactive agents, which induce multiple fetal abnormalities. Radioactive drugs are likely to cause major birth defects if used during pregnancy. Antineoplastic Agents
lutropin alfa B3 Endocrine System Pituitary hormones
lypressin B2 Endocrine System Antidiuretics
macitentan X Teratogenicity is a class effect of these agents, which induce multiple fetal abnormalities in animal studies. These drugs are likely to cause major birth defects if used during pregnancy. Cardiovascular System Endothelin receptor antagonist
macrogol B1 Alimentary System Laxatives
malathion B2 Drugs used in Dermatology Topical antiparasitics
mannitol B2 Cardiovascular System
maraviroc B1 Antimicrobials Antiviral agents
maribavir D Maribavir has been shown to reduce embryo-fetal survival and delay offspring development in rats. Antimicrobials Antiviral agents
marstacimab D Based on its mechanism of action, marstacimab may cause embryofetal loss when administered to a pregnant woman. Cardiovascular System Haemostatic agents
mavacamten D Based on animal studies, mavacamten may cause malformations and embryofetal loss when administered to a pregnant woman. Cardiovascular System
mazindol B3 Weight reduction using appetite suppressant drugs is not recommended in pregnancy. Metabolism Anorectic and weight reducing agents
measles-mumps-rubella vaccine B2 Women of child bearing age should be tested for rubella antibodies prior to pregnancy. All seronegative women, provided they are not pregnant, should be offered rubella vaccine. Those administering the vaccine should be careful to instruct women to whom it is given that they should not become pregnant for at least two full menstrual cycles because rubella vaccine can cause fetal infection. However, to date, there have not been any rubella-like birth defects in the live born infants (about 400) of seronegative mothers vaccinated during or just before pregnancy. Based on this experience, rubella vaccination during pregnancy need not be the reason to recommend interruption of pregnancy. Vaccines Live attenuated vaccines
measles-mumps-rubella-varicella vaccine B2 Women of child bearing age should be tested for rubella antibodies prior to pregnancy. All seronegative women, provided they are not pregnant, should be offered rubella vaccine. Those administering the vaccine should be careful to instruct women to whom it is given that they should not become pregnant for at least two full menstrual cycles because rubella vaccine can cause fetal infection. However, to date, there have not been any rubella-like birth defects in the live born infants (about 400) of seronegative mothers vaccinated during or just before pregnancy. Based on this experience, rubella vaccination during pregnancy need not be the reason to recommend interruption of pregnancy. Vaccines Live attenuated vaccines
mebendazole B3 Antimicrobials Anthelmintics
mebeverine B2 Alimentary System Antispasmodics
mecasermin B3 Endocrine System Hormonal agents
medroxyprogesterone (IM contraceptive dose) A Contraceptive Agents
medroxyprogesterone (oral & SC high dose) D If taken by the mother at or after 8 weeks post conception, these drugs can cause virilisation of the female fetus. This is a dose-dependent effect. Prior to 8 weeks post conception, they have no virilising effects. Endocrine System Progestogens (see also oral contraceptives)
medroxyprogesterone (oral and IM high dose) D May cause virilisation of fetus if taken at or after 8 weeks post conception. Antineoplastic Agents Hormonal antineoplastic agents
mefenamic acid C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
mefloquine B3 The use of this drug in the treatment of malaria is accepted because the small risk to the fetus is outweighed by the benefits to the mother and fetus. Prophylaxis in high risk situations is also justified. Antimicrobials Antimalarials
mefruside C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
megestrol D If taken by the mother at or after 8 weeks post conception, these drugs can cause virilisation of the female fetus. This is a dose-dependent effect. Prior to 8 weeks post conception, they have no virilising effects. Endocrine System Progestogens (see also oral contraceptives)
melatonin B3 Central Nervous System Hypnotics and sedatives
meloxicam C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
melphalan D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Alkylating agents
memantine B2 Central Nervous System
meningococcal group B vaccine B1 Vaccines Subunit vaccines Polysaccharide conjugate vaccines
meningococcal group C conjugate vaccine B2 Vaccines Subunit vaccines Polysaccharide conjugate vaccines
meningococcal serogroups A, C, W-135 and Y polysaccharide or conjugate vaccine B1 or B2 depending on brand Vaccines Subunit vaccines Polysaccharide conjugate vaccines
mepivacaine A Drugs Used in Anaesthesia Local anaesthetics
mepolizumab B1 Respiratory System
meprobamate C This drug may cause hypotension, respiratory depression and hypothermia in the newborn infant. Central Nervous System Hypnotics and sedatives
mercaptamine bitartrate B3 Metabolism Agents used for the treatment of metabolic disorders
mercaptopurine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
meropenem B2 Antimicrobials Antibiotics
mesalazine C Non-steroidal anti-inflammatory drugs inhibit prostaglandin synthesis and, when given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with non-steroidal anti-inflammatory drugs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Alimentary System Antidiarrhoeals
mesna B1 Antineoplastic Agents Non-cytotoxic supportive therapy
mesterolone X Anabolic steroids and other substances with androgenic effects may have a virilising effect on the female fetus and should be avoided during pregnancy. This drug is for use in male patients only. In animal studies, it inhibits spermatogenesis. Endocrine System Androgens and anabolic steroids
mestranol B3 Endocrine System Oestrogens (see also oral contraceptives)
metaraminol C This drug may cause fetal hypoxia by constricting the uterine vessels thereby limiting placental perfusion. Cardiovascular System Adrenergic stimulants
metformin C It is important to achieve strict normoglycaemia during pregnancy. Endocrine System Hypoglycaemic agents
methacycline D Tetracyclines are safe for use during the first 18 weeks of pregnancy (16 weeks post conception) after which they cause discolouration of the baby’s teeth. Antimicrobials Antibiotics Tetracyclines
methadone C Narcotic analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this drug. Agents used in dependency states
methadone C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
methdilazine B2 Allergy and Immune System Antihistamines
methenamine A Genitourinary System Urinary antiseptics
methenolone D Anabolic steroids and other substances with androgenic effects may have a virilising effect on the female fetus and should be avoided during pregnancy. Endocrine System Androgens and anabolic steroids
methocarbamol B2 Musculoskeletal System Muscle relaxants
methohexitone B2 All general anaesthetics carry the potential to produce central nervous system and respiratory depression in the newborn infant. In routine practice this does not appear to be a problem. However, in the compromised fetus, careful consideration should be given to this potential depression and to the selection of particular anaesthetic drugs, doses and techniques. Drugs Used in Anaesthesia General anaesthetics
methotrexate D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
methoxsalen B2 Drugs used in Dermatology Topical
methoxsalen (ECP extracorporeal photopheresis) D When given to rats during organogenesis, methoxsalen caused significant fetal toxicity (not for direct injection into patients; only for extracorporeal photopheresis of leukocyte enriched blood in a photoactivation bag ) Allergy and Immune System
methoxy polyethylene glycol-epoetin beta B3 Blood and Haemopoietic System Haemopoietic agents
methoxyflurane C All general anaesthetics carry the potential to produce central nervous system and respiratory depression in the newborn infant. In routine practice this does not appear to be a problem. However, in the compromised fetus, careful consideration should be given to this potential depression and to the selection of particular anaesthetic drugs, doses and techniques. Drugs Used in Anaesthesia General anaesthetics
methsuximide D Compared to conventional anticonvulsants, the extent of the risk of this drug is unknown. Central Nervous System Anticonvulsants/antiepileptics
methyclothiazide C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
methyl aminolevulinate B2 Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
methyldopa A Cardiovascular System Antihypertensives
methylene blue D There have been reports of haemolytic anaemia and hyperbilirubinaemia in neonates exposed to methylene blue in the amniotic cavity. Blood and Haemopoietic System
methylnaltrexone B1 Central Nervous System
methylphenidate D Dosing in rabbits produced teratogenic effects at doses approximately 5 fold that in humans receiving the maximal recommended dose. Dosing to rats from early pregnancy until weaning reduced offspring weight and marginal alterations in neuromotor performance in offspring at doses approximately 3-6 fold the maximum recommended clinical dose on a mg/m2 basis. Dosing to juvenile male and female rats from weaning through mating, pregnancy and lactation until offspring weaning, was associated with reduced body weight gain and motor activity in males as well as reduced offspring weight and postnatal survival - at doses 1 to 3 fold that expected in adults or children given the maximum recommended clinical dose. The safety of methylphenidate for use during human pregnancy has not been established. Cases of fetal cardiac malformations have been identified in large observational studies. Methylphenidate should not be prescribed for pregnant women unless, in opinion of the physician, the potential benefits outweigh the possible risks Central Nervous System CNS stimulants
methylphenobarbital D The use in pregnancy of primidone, phenobarbitone or methylphenobarbitone has been associated with minor craniofacial defects, fingernail hypoplasia and developmental disability. Their use in pregnancy alone, or in combination with other anticonvulsants, can cause coagulation defects in the newborn infant which may be preventable by the prophylactic administration of vitamin K to the mother prior to delivery. The risk of having an abnormal child as a result of antiepileptic medication is far outweighed by the dangers to the mother and fetus of uncontrolled epilepsy. It is recommended that: • women on antiepileptic drugs (AEDs) receive prepregnancy counselling with regard to the risk of fetal abnormalities; • AEDs should be continued during pregnancy and monotherapy should be used if possible at the lowest effective dose as risk of abnormality is greater in women taking combined medication; • folic acid supplementation (5mg) should be commenced four weeks prior to and continue for twelve weeks after conception; • Specialist prenatal diagnosis including detailed mid-trimester ultrasound should be offered. Central Nervous System Anticonvulsants/antiepileptics
methylphenobarbitone (methylphenobarbital) D The use in pregnancy of primidone, phenobarbitone or methylphenobarbitone has been associated with minor craniofacial defects, fingernail hypoplasia and developmental disability. Their use in pregnancy alone, or in combination with other anticonvulsants, can cause coagulation defects in the newborn infant which may be preventable by the prophylactic administration of vitamin K to the mother prior to delivery. The risk of having an abnormal child as a result of antiepileptic medication is far outweighed by the dangers to the mother and fetus of uncontrolled epilepsy. It is recommended that: • women on antiepileptic drugs (AEDs) receive prepregnancy counselling with regard to the risk of fetal abnormalities; • AEDs should be continued during pregnancy and monotherapy should be used if possible at the lowest effective dose as risk of abnormality is greater in women taking combined medication; • folic acid supplementation (5mg) should be commenced four weeks prior to and continue for twelve weeks after conception; • Specialist prenatal diagnosis including detailed mid-trimester ultrasound should be offered. Central Nervous System Anticonvulsants/antiepileptics
methylprednisolone A Endocrine System Corticosteroids Systemic
methylprednisolone aceponate C Endocrine System Corticosteroids Topical
methyltestosterone D Anabolic steroids and other substances with androgenic effects may have a virilising effect on the female fetus and should be avoided during pregnancy. Endocrine System Androgens and anabolic steroids
methysergide C Standard oral dose regimens for migraine headaches in the first half of pregnancy do not appear to pose hazards to the fetus. Ergotamine induces uterine contraction and may therefore cause premature parturition or hypertonic labour. Larger doses or more frequent use may jeopardise the fetus because of the potential for impeding fetal blood supply. Cardiovascular System Antimigraine preparations
metoclopramide A Central Nervous System Antiemetics, antinauseants
metolazone C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
metoprolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
metronidazole B2 Antimicrobials Antibiotics
metyrapone B3 Diagnostic Agents Pituitary-adrenal response test
mexiletine B1 Cardiovascular System Antiarrhythmics
mezlocillin B1 Antimicrobials Antibiotics Penicillins
mianserin B2 Central Nervous System Antidepressants Tetracyclic antidepressants
micafungin B3 Antimicrobials Antibiotics
miconazole A Drugs used in Dermatology Topical antifungals, antiseptics (see also antifungal agents)
miconazole A Genitourinary System Topical vaginal medication
midazolam C Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
midodrine hydrochloride C This drug has demonstrated embryofetal harm and lethality in animals. Cardiovascular System
midostaurin D This drug is embryotoxic and embryolethal in pregnant animals. Antineoplastic Agents Tyrosine kinase inhibitors
migalastat hydrochloride B3 Alimentary System
miglitol B3 Endocrine System Hypoglycaemic agents
miglustat D This drug might be expected to cross the placenta and has shown to be embryotoxic in rats and rabbits. Metabolism Agents used for the treatment of metabolic disorders
milnacipran B3 Central Nervous System Antidepressants
milrinone B3 Cardiovascular System Cardiac inotropic agents
minocycline D Tetracyclines are safe for use during the first 18 weeks of pregnancy (16 weeks post conception) after which they cause discolouration of the baby’s teeth. Antimicrobials Antibiotics Tetracyclines
minoxidil C This drug has been associated with hypertrichosis in the newborn infant following exposure in utero. Cardiovascular System Antihypertensives
mirabegron B3 Genitourinary System Bladder function disorders
mirikizumab B1 Allergy and Immune System Immunomodifiers
mirtazapine B3 Central Nervous System Antidepressants
misoprostol X This drug can produce serious birth defects. It also can cause miscarriage that could lead to potentially dangerous bleeding. Alimentary System Hyperacidity, reflux, ulcers
mitomycin D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antibiotic cytotoxic agents
mitozantrone D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antibiotic cytotoxic agents
mivacurium B2 Drugs Used in Anaesthesia Neuromuscular blocking agents
mobocertinib succinate D Based on its mechanism of action and data from animal studies (embryo-fetal death and decreased fetal weight in pregnant rats treated during the period of organogenesis), mobocertinib can cause fetal harm when administered during pregnancy. Antineoplastic Agents
moclobemide B3 Central Nervous System Antidepressants
modafinil D This drug is embryotoxic and fetotoxic when administered to pregnant rats and rabbits. It also decreased viability in the offspring when administered to pregnant rats. Central Nervous System CNS stimulants
mogamulizumab C There are no data from the use in pregnant women. In pregnant cynomolgus monkeys, mogamulizumab did not cause malformations, embryofetal lethality or growth retardation. However, mogamulizumab was shown to cross the placental barrier, and this resulted in pharmacological activity in the foetuses, evident as a decrease in CCR4-expressing lymphocytes. Mogamulizumab is not recommended during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus. Antineoplastic Agents Monoclonal antibodies
molgramostim B3 Blood and Haemopoietic System Haemopoietic agents
molnupiravir D Based on animal data, molnupiravir may cause fetal harm when administered to pregnant women. Antimicrobials Antiviral agents
momelotinib D Momelotinib is contraindicated in pregnancy. Malformations, embryofetal lethality and other adverse effects were observed with momelotinib in animals at clinically relevant exposure levels. Antineoplastic Agents Tyrosine kinase inhibitors
mometasone B3 Endocrine System Corticosteroids Topical
montelukast B1 Respiratory System
moroctocog alfa (factor VIII - rch) B2 Cardiovascular System Haemostatic agents
morphine C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
moxifloxacin B3 Antimicrobials Antibiotics Quinolones
moxonidine B3 Cardiovascular System Antihypertensives
multicomponent meningococcal group B vaccine (recombinant, adsorbed) B1 Vaccines Subunit vaccines Polysaccharide conjugate vaccines
mupirocin B1 Antimicrobials Antibiotics
mustine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Alkylating agents
mycophenolate mofetil D It inhibits nucleic acid synthesis and may cause fetal malformations/death. Congenital malformations, including ear malformations i.e. abnormally formed or absent external/middle ear, have been reported in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants during pregnancy. Allergy and Immune System Immunomodifiers
mycophenolic acid D It inhibits nucleic acid synthesis and may cause fetal malformations/death. Congenital malformations, including ear malformations i.e. abnormally formed or absent external/middle ear, have been reported in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants during pregnancy. Allergy and Immune System Immunomodifiers
nabiximols B2 Central Nervous System
nabumetone C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
nadroparin C All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
nafarelin D There is a theoretical risk of abortion or fetal abnormality if GnRH agonists are used during pregnancy. Endocrine System Pituitary hormones
nalidixic acid A Antimicrobials Antibiotics
naloxone B1 Detoxifying Agents, Antidotes
naltrexone B3 Agents used in dependency states
nandrolone D Anabolic steroids and other substances with androgenic effects may have a virilising effect on the female fetus and should be avoided during pregnancy. Endocrine System Androgens and anabolic steroids
naproxen C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
naratriptan B3 Cardiovascular System Antimigraine preparations
natalizumab C Allergy and Immune System Immunomodifiers
nateglinide C Sulphonylureas may enter the fetal circulation and may cause neonatal hypoglycaemia. Endocrine System Hypoglycaemic agents
nebivolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
nedocromil B1 Respiratory System Inhalational agents Preventative aerosols and inhalations
nefazodone B3 Central Nervous System Antidepressants
nelarabine D Animal data indicate that exposure during pregnancy will likely lead to malformations of the fetus. Antineoplastic Agents Antimetabolites
nelfinavir B2 Antimicrobials Antiviral agents
nemolizumab B1 Allergy and Immune System Immunomodifiers
neomycin D There is evidence of selective uptake of aminoglycosides by the fetal kidney resulting in damage (probably reversible) to immature nephrons. Eighth cranial nerve damage has also been reported following in utero exposure to some of the aminoglycosides. Because of their chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the fetus. It should also be noted that therapeutic blood concentrations in the mother do not equate with safety for the fetus. Antimicrobials Antibiotics Aminoglycosides
neostigmine B2 Drugs Used in Myasthenia Gravis
nepafenac C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
neratinib D Studies in animals have shown embryofetal lethality and fetal morphological anomalies. Antineoplastic Agents
neratinib maleate D Studies in animals have shown embryofetal lethality and fetal abnormalities. The potential risk for humans is unknown. Neratinib is not recommended during pregnancy. If neratinib is used during pregnancy, or if the patient becomes pregnant while taking neratinib, the patient should be informed of the potential hazard to the fetus. Antineoplastic Agents
netilmicin D There is evidence of selective uptake of aminoglycosides by the fetal kidney resulting in damage (probably reversible) to immature nephrons. Eighth cranial nerve damage has also been reported following in utero exposure to some of the aminoglycosides. Because of their chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the fetus. It should also be noted that therapeutic blood concentrations in the mother do not equate with safety for the fetus. Antimicrobials Antibiotics Aminoglycosides
netupitant / palonosetron D In animals there were findings of reduced fetal weight and fetal abnormalities of the limbs, paws and ribs. There was also cleft palate and eye abnormalities in animals. Central Nervous System Antiemetics, antinauseants
nevirapine B3 Antimicrobials Antiviral agents
nicardipine C Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. Cardiovascular System Antihypertensives Calcium channel blockers
nicorandil B3 Cardiovascular System Antiangina agents
nicotine D The harmful effects of cigarette smoking on maternal and fetal health are clearly established. The specific effects of nicotine therapy on fetal development are unknown. Short-term exposure during the first trimester is unlikely to cause a hazard to the fetus. Agents used in dependency states
nicotinic acid B2 The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System Hypolipidaemic agents
nicotinic acid B2 Cardiovascular System Vasodilators
nicotinic acid B2 Vitamins
nicotinyl alcohol B1 Cardiovascular System Vasodilators
nifedipine C Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. Acute pulmonary oedema has been observed when calcium channel blockers, among others nifedipine (primarily in IR formulation), have been used as a tocolytic agent during pregnancy, especially in cases of multiple pregnancy (twins or more), with the intravenous route and/or concomitant use of beta-2 agonists. Cardiovascular System Antihypertensives Calcium channel blockers
nilotinib D This drug is embryotoxic and embryolethal in pregnant animals. Antineoplastic Agents Tyrosine kinase inhibitors
nimodipine C Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. Cardiovascular System Antihypertensives Calcium channel blockers
nintedanib esilate D Angiogenesis plays a key role in embryo-fetal development. It is teratogenic in pregnant animals. VEGF receptor inhibitors inhibit angiogenesis and can cause fetal harm when administered to pregnant women. Antineoplastic Agents Tyrosine kinase inhibitors
niraparib D Based on its mechanism of action, niraparib could cause embryonic or fetal harm, including embryo-lethal and teratogenic effects Antineoplastic Agents
nirmatrelvir B3 Antimicrobials Antiviral agents
nirsevimab B2 Antimicrobials Antiviral agents
nisoldipine C Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. Cardiovascular System Antihypertensives Calcium channel blockers
nitisinone B3 Metabolism Agents used for the treatment of metabolic disorders
nitrazepam C Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
nitric oxide B2 Cardiovascular System Vasodilators
nitrofurantoin (short term therapy) A Caution should be exercised when administering nitrofurantoin at term because of the possibility of producing haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency and due to immature enzyme systems in the early neonatal period. Antimicrobials Antibiotics
nitrous oxide A All general anaesthetics carry the potential to produce central nervous system and respiratory depression in the newborn infant. In routine practice this does not appear to be a problem. However, in the compromised fetus, careful consideration should be given to this potential depression and to the selection of particular anaesthetic drugs, doses and techniques. Drugs Used in Anaesthesia General anaesthetics
nivolumab D PD-1/PD-L1 is involved in fetomaternal tolerance. Administration during pregnancy may cause fetal harm, including abortion or stillbirth. Antineoplastic Agents Monoclonal antibodies
nizatidine B3 Alimentary System Hyperacidity, reflux, ulcers
nomegestrol with estradiol B3 Contraceptive Agents
nonacog alfa (rch) B2 Cardiovascular System Haemostatic agents
nonacog gamma (rch) B2 Cardiovascular System Haemostatic agents
nonoxinol 9 A Contraceptive Agents Vaginal spermicides
norelgestromin with ethinylestradiol B3 Contraceptive Agents
norethisterone D If taken by the mother at or after 8 weeks post conception, these drugs can cause virilisation of the female fetus. This is a dose-dependent effect. Prior to 8 weeks post conception, they have no virilising effects. Endocrine System Progestogens (see also oral contraceptives)
norfloxacin B3 Antimicrobials Antibiotics Quinolones
nortriptyline C Withdrawal symptoms in newborn infants have been reported with prolonged maternal use of tricyclic antidepressants. Central Nervous System Antidepressants Tricyclic antidepressants
nusinersen B1 Musculoskeletal System
nystatin A Antimicrobials Antifungal agents (see also topical antifungals)
nystatin A Genitourinary System Topical vaginal medication
obeticholic acid B1 Alimentary System
obinutuzumab C IgG antibodies are known to cross the placental barrier. This drug may affect embryofetal survival due to its pharmacological action. Antineoplastic Agents Monoclonal antibodies
ocrelizumab C IgG antibodies are known to cross the placental barrier. This drug has the potential to affect embryofetal survival due to its pharmacological action. Allergy and Immune System Immunomodifiers
ocriplasmin B2 Ophthalmic Drugs
octocog alfa (factor VIII - rch) B2 Cardiovascular System Haemostatic agents
octoxinol A Contraceptive Agents Vaginal spermicides
octreotide C This drug may cause fetal growth retardation, probably due to suppression of growth hormone. Endocrine System Pituitary hormones
odevixibat D Based on findings from animal studies, odevixibat may cause cardiac malformations when a fetus is exposed during pregnancy. Alimentary System
oestrone B1 Endocrine System Oestrogens (see also oral contraceptives)
ofatumumab (rmc) C IgG antibodies are known to cross the placental barrier. This drug has the potential to affect embryofetal survival due to its pharmacological action. Antineoplastic Agents Monoclonal antibodies
ofloxacin B3 Antimicrobials Antibiotics Quinolones
olanzapine C Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. Central Nervous System Antipsychotic drugs
olaparib D Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. Antineoplastic Agents
olipudase alfa D An increased incidence of a malformation (exencephaly) was observed when pregnant mice (but not rabbits) were treated with olipudase alfa. The relevance of this observation for humans is unknown. Olipudase alfa is not recommended during pregnancy and in women of childbearing potential not using effective contraception, unless the potential benefits to the mother outweigh the potential risks, including those to the fetus. Metabolism
olmesartan D When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin II receptor antagonists and renin inhibitors
olodaterol (olodaterol hydrochloride) B3 Respiratory System Inhalational agents Bronchospasm relaxants
olodaterol / tiotropium bromide B3 Respiratory System Inhalational agents
olopatadine B1 Ophthalmic Drugs
olsalazine C Non-steroidal anti-inflammatory drugs inhibit prostaglandin synthesis and, when given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with non-steroidal anti-inflammatory drugs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Alimentary System Antidiarrhoeals
omalizumab B1 Respiratory System
omega-3-acid ethyl esters 90 B1 Cardiovascular System Hypolipidaemic agents
omeprazole B3 Alimentary System Hyperacidity, reflux, ulcers
onasemnogene abeparvovec B2 Musculoskeletal System
ondansetron B1 Central Nervous System Antiemetics, antinauseants
opicapone B2 Central Nervous System Antiparkinson agents
opium alkaloids and derivatives A Respiratory System Antitussives
oral contraceptives, combined B3 Accumulated evidence reports that inadvertent exposure to these agents in early pregnancy has not been associated with an increased risk of birth defects. Contraceptive Agents Oral contraceptives
orciprenaline A Cardiovascular System Adrenergic stimulants
orciprenaline A Respiratory System Inhalational agents Bronchospasm relaxants
orelabrutinib C Based on its mechanism of action (immunosuppression), orelabrutinib may cause fetal harm when administered to pregnant women. Antineoplastic Agents Tyrosine kinase inhibitors
orlistat B1 Weight reduction using appetite suppressant drugs is not recommended in pregnancy. Metabolism Anorectic and weight reducing agents
ornipressin B3 Cardiovascular System Haemostatic agents
orphenadrine B2 Musculoskeletal System Muscle relaxants
oseltamivir B1 Antimicrobials Antiviral agents
osilodrostat D High doses of osilodrostat administered to pregnant rats during organogenesis increased embryonic and fetal deaths, decreased fetal weights and malformations. Endocrine System Corticosteroids
osimertinib D This drug inhibits EGFR. EGFR plays an important role in embryofetal development. Antineoplastic Agents Tyrosine kinase inhibitors
oxaliplatin D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
oxandrolone D Anabolic steroids and other substances with androgenic effects may have a virilising effect on the female fetus and should be avoided during pregnancy. Endocrine System Androgens and anabolic steroids
oxazepam C Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
oxcarbazepine D This drug and its active metabolite (10-monohydroxy derivative, MHD) cross the human placenta. Oxcarbazepine is (structurally) closely related to carbamazepine, which is considered to be teratogenic in humans. This drug is teratogenic in rats. The risk of having an abnormal child as a result of antiepileptic medication is far outweighed by the dangers to the mother and fetus of uncontrolled epilepsy. It is recommended that: • women on antiepileptic drugs (AEDs) receive prepregnancy counselling with regard to the risk of fetal abnormalities; • AEDs should be continued during pregnancy and monotherapy should be used if possible at the lowest effective dose as risk of abnormality is greater in women taking combined medication; • folic acid supplementation (5mg) should be commenced four weeks prior to and continue for twelve weeks after conception; • Specialist prenatal diagnosis including detailed mid-trimester ultrasound should be offered. Central Nervous System Anticonvulsants/antiepileptics
oxpentifylline (pentoxifylline) B1 Cardiovascular System
oxprenolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
oxybuprocaine D Ophthalmic Drugs
oxybutynin B1 Genitourinary System Bladder function disorders
oxycodone C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
oxycodone / naloxone C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal and anti-inflammatory agents) Opioid analgesics
oxymetholone D Anabolic steroids and other substances with androgenic effects may have a virilising effect on the female fetus and should be avoided during pregnancy. Endocrine System Androgens and anabolic steroids
oxyquinoline sulfate A Drugs used in Dermatology Topical antifungals, antiseptics (see also antifungal agents)
oxytetracycline D Tetracyclines are safe for use during the first 18 weeks of pregnancy (16 weeks post conception) after which they cause discolouration of the baby’s teeth. Antimicrobials Antibiotics Tetracyclines
oxytocin A There have been instances of idiosyncratic sensitivity of the uterus resulting in fetal anoxia. Genitourinary System Agents acting on the uterus
ozanimod D This drug causes cardiovascular malformations, and post-implantation loss in rats and rabbits, consistent with its pharmacological mechanism of action. Allergy and Immune System
paclitaxel D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
palbociclib D Based on findings in animals and mechanism of action, palbociclib can cause fetal harm when administered to a pregnant woman. Antineoplastic Agents
palifermin B3 Antineoplastic Agents Non-cytotoxic supportive therapy
paliperidone C Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. Central Nervous System Antipsychotic drugs
palonosetron B1 Central Nervous System Antiemetics, antinauseants
palopegteriparatide B3 Endocrine System Agents affecting calcium and bone metabolism
palovarotene X Palovarotene is contraindicated in pregnancy due to the potential of severe and life-threatening birth defects. Palovarotene was shown to produce fetal malformations typical of retinoids (e.g., cleft palate, malformed skull bone, shortening of the long bones) at subclinical exposure levels in rats. Musculoskeletal System
pamidronate B3 Endocrine System Agents affecting calcium and bone metabolism Bisphosphonates
pancuronium B2 Drugs Used in Anaesthesia Neuromuscular blocking agents
panitumumab C IgG antibodies are known to cross the placental barrier. This drug may affect embryofetal survival due to its pharmacological action. Antineoplastic Agents Monoclonal antibodies
panobinostat D Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. Antineoplastic Agents
pantoprazole B3 Alimentary System Hyperacidity, reflux, ulcers
papaveretum C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
papaverine B3 Cardiovascular System Vasodilators
papaverine B3 Cholinergic and Anticholinergic Agents
paracetamol A Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents)
paracetomol / tramadol C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal and anti-inflammatory agents)
paraldehyde D This drug readily diffuses across the placenta and has been known to cause respiratory depression in neonates. Central Nervous System Hypnotics and sedatives
parecoxib C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
paricalcitol C Endocrine System Agents affecting calcium and bone metabolism
paritaprevir / ritonavir / ombitasvir B3 Antimicrobials Antiviral agents
paritaprevir / ritonavir / ombitasvir with ribavirin X Although there are no pertinent human data, ribavirin has been found to be teratogenic and/or embryolethal in nearly all species in which it has been tested. Malformations of skull, palate, eye, jaw, skeleton and gastrointestinal tract were noted in animal studies. Survival of fetuses and offspring was reduced. Antimicrobials Antiviral agents
paritaprevir/ritonavir/ombitasvir/dasabuvir B3 Antimicrobials Antiviral agents
paritaprevir/ritonavir/ombitasvir/dasabuvir/ribavirin X Although there are no pertinent human data, ribavirin has been found to be teratogenic and/or embryolethal in nearly all species in which it has been tested. Malformations of skull, palate, eye, jaw, skeleton and gastrointestinal tract were noted in animal studies. Survival of fetuses and offspring was reduced. Antimicrobials Antiviral agents
paroxetine D Selective serotonin reuptake inhibitors (SSRIs) have had limited use in pregnancy without a reported increase in birth defects. The use of SSRIs in the third trimester may result in a withdrawal state in the newborn infant. Central Nervous System Antidepressants Selective serotonin reuptake inhibitors (SSRIs)
pasireotide diaspartate B3 Endocrine System Pituitary hormones
pasireotide embonate B3 Endocrine System Pituitary hormones
patiromer (as sorbitex calcium) B1 Cardiovascular System
patisiran D Patisiran administered to pregnant rabbits during the period of organogenesis resulted in embryofetal mortality and reduced fetal body weight at doses. Cardiovascular System
pazopanib D Angiogenesis plays a key role in embryo-fetal development. It is teratogenic in pregnant animals. VEGF receptor inhibitors inhibit angiogenesis and can cause fetal harm when administered to pregnant women. Antineoplastic Agents Tyrosine kinase inhibitors
pegaspargase D Cytotoxicity from asparaginase activity poses a risk for spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
pegcetacoplan B3 Allergy and Immune System
pegfilgrastim B3 Blood and Haemopoietic System Haemopoietic agents
peginterferon alfa-2a B3 Allergy and Immune System Immunomodifiers
peginterferon alfa-2b B3 Allergy and Immune System Immunomodifiers
peginterferon beta-1a (rch) D Peginterferon beta-1a has not been tested for reproductive toxicity in pregnant animals. Non-pegylated interferon beta-1a has shown no evidence of teratogenicity in pregnant animals, but has abortifacient activity in monkeys. Allergy and Immune System Immunomodifiers
pegunigalsidase alfa B3 Metabolism Agents used for the treatment of metabolic disorders
pegvaliase D Animal studies have shown maternal reproductive toxicity that may have been associated with decreased blood phenylalanine concentrations below normal levels. Embryofetal lethality, lower fetal weights and multiple fetal malformations and/or variations were seen when administered to pregnant rabbits at maternotoxic doses. Maternal blood phenylalanine levels must be strictly controlled during pregnancy. Metabolism
pegvisomant B3 Endocrine System Pituitary inhibitors
pembrolizumab D PD-1/PD-L1 is involved in fetomaternal tolerance. Administration during pregnancy may cause fetal harm, including abortion or stillbirth. Antineoplastic Agents Monoclonal antibodies
pemetrexed D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
pemigatinib D Based on its mechanism of action and data from animal studies, P pemigatinib can cause reproductive toxicity (post-implantation loss, malformations and reduced fetal weight) when administered during pregnancy. Antineoplastic Agents
penciclovir B1 Drugs used in Dermatology Topical antiviral
penicillamine D Penicillamine can cause cutis laxa in the human fetus. Detoxifying Agents, Antidotes
penicillamine D This drug can cause cutis laxa in the human fetus. Musculoskeletal System Antirheumatoid agents
pentamidine B3 Antimicrobials Antibiotics
pentastarch B3 Cardiovascular System
pentazocine C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
pentobarbitone C Barbiturates can give rise to hypotension, respiratory depression and hypothermia in the newborn infant. Continuous treatment during pregnancy and administration during labour should be avoided. Central Nervous System Hypnotics and sedatives Barbiturates
pentosan polysulfate sodium B1 Genitourinary System Bladder function disorders
pentoxifylline B1 Cardiovascular System
peramivir B3 Antimicrobials Antiviral agents
perampanel hemisesquihydrate B3 Central Nervous System Anticonvulsants/antiepileptics
perflutren B3 Diagnostic Agents Radiographic agents
pergolide C Studies in rodents have shown no evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Central Nervous System Antiparkinson agents
perhexiline B2 Cardiovascular System Antiangina agents
periciazine C When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the newborn infant. Central Nervous System Antipsychotic drugs Phenothiazines
perindopril D When taken during the second and third trimesters, ACE inhibitors cause a range of abnormalities including renal dysfunction and oligohydramnios. These can be associated with fetal death in utero. Although no adverse fetal effects have been linked to first trimester drug use of ACE inhibitors, the number of exposures reported is too small to determine conclusively that ACE inhibitors are safe in the first trimester. Pregnant women who are taking ACE inhibitors should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ACE inhibitors for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin converting enzyme (ACE) inhibitors
permethrin B2 Drugs used in Dermatology Topical antiparasitics
perphenazine C When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the newborn infant. Central Nervous System Antipsychotic drugs Phenothiazines
pertuzumab D IgG antibodies are known to cross the placental barrier. This drug has the potential to affect embryofetal survival due to its pharmacological action. Antineoplastic Agents Monoclonal antibodies
pethidine C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
phenelzine B3 Central Nervous System Antidepressants Monoamine oxidase inhibitors
phenindione D This drug can cause birth defects when used in the first trimester of pregnancy. Use of phenindione should also be avoided during the third trimester of pregnancy as delivery during phenindione therapy may lead to excessive bleeding in the infant or the mother. All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
pheniramine A Allergy and Immune System Antihistamines
phenobarbital D Refer to the relevant texts in the Product Information of individual antiepileptics for more information regarding the suitability for use in pregnancy. Phenobarbital therapy in pregnant women with epilepsy presents a risk to the fetus in terms of major and minor congenital defects including congenital craniofacial and cardiac defects digital abnormalities and less commonly cleft lip and palate. Haemorrhage at birth and addiction are also at risk. Prophylactic treatment with vitamin K1 for the mother before delivery (as well as the neonate) is recommended and the neonate should be monitored for signs of bleeding. Adverse effects on neurobehavioral development have also been reported. Studies investigating neurodevelopmental effects of prenatally administered phenobarbital were mostly small in numbers, however significant negative effects on neurodevelopment and IQ were found following in utero and postnatal exposure. It is recommended that: • women on antiepileptic drugs (AEDs) receive prepregnancy counselling with regard to the risk of congenital malformations and adverse developmental outcomes; • AEDs should be continued during pregnancy at the lowest effective dose and monotherapy should be considered if appropriate; • Adequate folic acid supplementation should be discussed as part of pre-pregnancy and pregnancy counselling; • specialist prenatal diagnosis including detailed mid-trimester ultrasound should be considered. Central Nervous System Anticonvulsants/antiepileptics
phenobarbitone (phenobarbital) D Refer to the relevant texts in the Product Information of individual antiepileptics for more information regarding the suitability for use in pregnancy. Phenobarbital therapy in pregnant women with epilepsy presents a risk to the fetus in terms of major and minor congenital defects including congenital craniofacial and cardiac defects digital abnormalities and less commonly cleft lip and palate. Haemorrhage at birth and addiction are also at risk. Prophylactic treatment with vitamin K1 for the mother before delivery (as well as the neonate) is recommended and the neonate should be monitored for signs of bleeding. Adverse effects on neurobehavioral development have also been reported. Studies investigating neurodevelopmental effects of prenatally administered phenobarbital were mostly small in numbers, however significant negative effects on neurodevelopment and IQ were found following in utero and postnatal exposure. It is recommended that: • women on antiepileptic drugs (AEDs) receive prepregnancy counselling with regard to the risk of congenital malformations and adverse developmental outcomes; • AEDs should be continued during pregnancy at the lowest effective dose and monotherapy should be considered if appropriate; • Adequate folic acid supplementation should be discussed as part of pre-pregnancy and pregnancy counselling; • specialist prenatal diagnosis including detailed mid-trimester ultrasound should be considered. Central Nervous System Anticonvulsants/antiepileptics
phenolphthalein B2 Alimentary System Laxatives
phenoperidine C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
phenoxybenzamine B2 This drug is known to be mutagenic and carcinogenic in rodents. Cardiovascular System Vasodilators
phenoxymethylpenicillin A Antimicrobials Antibiotics Penicillins
phensuximide D Compared to conventional anticonvulsants, the extent of the risk of this drug is unknown. Central Nervous System Anticonvulsants/antiepileptics
phentermine B2 Weight reduction using appetite suppressant drugs is not recommended in pregnancy. Metabolism Anorectic and weight reducing agents
phentolamine B1 Cardiovascular System Vasodilators
phenylbutazone C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
phenylephrine B2 Cardiovascular System Adrenergic stimulants
phenylephrine B2 Respiratory System Decongestants
phenylpropanolamine B2 Cardiovascular System Adrenergic stimulants
phenylpropanolamine B2 Respiratory System Decongestants
phenytoin sodium D Refer to the relevant texts in the Product Information of individual antiepileptics for more information regarding the suitability for use in pregnancy. Prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. Malformations such as orofacial clefts, cardiac defects, dysmorphic facial features, nail and digit hypoplasia, and growth abnormalities (including microcephaly) have been reported either individually or as part of a fetal Hydantoin Syndrome among children born to women with epilepsy who took phenytoin during pregnancy. Neurodevelopmental disorder has been reported among children born to women with epilepsy who used phenytoin alone or in combination with other AEDs during pregnancy. There have been several reported cases of malignancies including neuroblastoma, in children whose mothers received phenytoin during pregnancy. Neurodevelopmental disorder has been reported among children born to women with epilepsy who used phenytoin alone or in combination with other antiepileptics during pregnancy. Phenytoin can cause coagulation defects with consequent risk of haemorrhage in the fetus and the newborn infant which may be preventable by the prophylactic administration of vitamin K to the mother prior to delivery. It is recommended that: • Women on antiepileptic drugs (AEDs) receive pre-pregnancy counselling with regard to the risk of congenital malformations or adverse developmental outcomes; • AEDs should be continued during pregnancy at the lowest effective dose, and monotherapy should be used if appropriate as risk of congenital malformations or adverse developmental outcomes is greater in women taking combined medication; • Adequate folic acid supplementation should be discussed as part of pre-pregnancy and pregnancy counselling; • Specialist prenatal diagnosis including detailed mid-trimester ultrasound should be considered. Central Nervous System Anticonvulsants/antiepileptics
pholcodine A Respiratory System Antitussives
physostigmine C Musculoskeletal System Muscle relaxants
pilocarpine B3 Ophthalmic Drugs
pimecrolimus B3 Drugs used in Dermatology Topical
pimozide C Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. Central Nervous System Antipsychotic drugs
pindolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
pioglitazone B3 Endocrine System Hypoglycaemic agents
pipecuronium C There have been no demonstrated adverse effects in the fetus or the newborn infant. Drugs Used in Anaesthesia Neuromuscular blocking agents
piperacillin B1 Antimicrobials Antibiotics Penicillins
piperacillin with tazobactam B1 Antimicrobials Antibiotics Penicillins
piperazine oestrone sulfate (estropipate) B1 Endocrine System Oestrogens (see also oral contraceptives)
piperonyl butoxide B3 Drugs used in Dermatology Topical antiparasitics
pirfenidone B3 Respiratory System
piroxicam C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
pitavastatin D Cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase to decrease the synthesis Cardiovascular System Hypolipidaemic agents
pizotifen B1 Cardiovascular System Antimigraine preparations
plerixafor D This drug has been teratogenic in animals. Blood and Haemopoietic System Haemopoietic agents
plitidepsin D This drug is embryo-lethal in pregnant animals. Antineoplastic Agents
plozasiran B1 Metabolism Agents used for the treatment of metabolic disorders
pneumococcal vaccine, capsular polysaccharides B2 Vaccines Subunit vaccines Polysaccharide conjugate vaccines
pneumococcal vaccine, polysaccharides conjugate B1 Vaccines Subunit vaccines Polysaccharide conjugate vaccines
podophyllotoxin D Drugs used in Dermatology Topical Antimitotic agent
polatuzumab vedotin D Based on its mechanism of action and findings in animals, polatuzumab vedotin can cause fetal harm. Embryofetal lethality and toxicity were seen in rats at exposures less than that expected in patients receiving polatuzumab vedotin. Findings in animals included an increased incidence of post-implantation loss, and an increase in the incidence of fetal malformations including protruding tongue, malrotated hindlimbs, gastroschisis and agnathia. Females of reproductive potential should be advised to use effective contraception during treatment and for at least 9 months after the last dose. Antineoplastic Agents
poliomyelitis vaccine (injection) B2 Vaccines Inactivated vaccines
poliomyelitis vaccine (oral) A Currently available live virus vaccines have not caused teratogenic effects in humans. The ATAGI publication, “The Australian Immunisation Handbook”, should be consulted for more comprehensive information. Vaccines Live attenuated vaccines
pomalidomide X This drug may cause fetal harm in humans. This drug must not be given to pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with this drug and for a certain period of time thereafter. Pregnancy must be excluded before the start of treatment with this drug. Allergy and Immune System Immunomodifiers
ponatinib (as hydrochloride) D This drug is embryotoxic, teratogenic and caused embryolethality in pregnant animals. Antineoplastic Agents Tyrosine kinase inhibitors
ponesimod D Based on its mechanism of action and animal data (in pregnant rats and rabbits ponesimod induced embryofetal lethality and teratogenicity when given during the period of organogenesis), ponesimod can cause fetal harm when administered to a pregnant woman. Allergy and Immune System Immunomodifiers
posaconazole B3 Antimicrobials Antifungal agents (see also topical antifungals)
prabotulinumtoxinA B3 Musculoskeletal System Muscle relaxants
pralatrexate D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defect Antineoplastic Agents Antimetabolites
pralsetinib D Pralsetinib drug is teratogenic and caused embryolethality in pregnant animals. Antineoplastic Agents Tyrosine kinase inhibitors
pramipexole B3 Central Nervous System Antiparkinson agents
prasterone D Genitourinary System
prasugrel B1 All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
pravastatin D Cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, these drugs may cause fetal harm when administered to a pregnant woman. The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System Hypolipidaemic agents
praziquantel B1 Antimicrobials Anthelmintics
prazosin B2 Cardiovascular System Antihypertensives
prednisolone A Endocrine System Corticosteroids Systemic
prednisone A Endocrine System Corticosteroids Systemic
pregabalin D Data from a Nordic observational study of more than 2700 pregnancies exposed to pregabalin in the first trimester showed a higher prevalence of major congenital malformations (MCM) among the paediatric population (live or stillborn) exposed to pregabalin compared to the unexposed population (5.9% vs. 4.1%). The risk of MCM among the paediatric population exposed to pregabalin in the first trimester was slightly higher compared to unexposed population. The analyses on specific malformations showed higher risks for malformations of the nervous system, the eye, orofacial clefts, urinary malformations and genital malformations, but numbers were small and estimates imprecise. Pregabalin should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the fetus). Central Nervous System Anticonvulsants/antiepileptics
prilocaine (with or without felypressin) A Drugs Used in Anaesthesia Local anaesthetics
primaquine phosphate D Avoid use in third trimester as primaquine may cause neonatal haemolysis and methaemoglobinaemia. The use of this drug in the treatment of malaria is accepted because the small risk to the fetus is outweighed by the benefits to the mother and fetus. Prophylaxis in high risk situations is also justified. Antimicrobials Antimalarials
primidone D Refer to the relevant texts in the Product Information of individual antiepileptics for more information regarding the suitability for use in pregnancy. Primidone therapy in pregnant women with epilepsy presents a risk to the fetus due to the major and minor congenital defects including congenital craniofacial and cardiac defects, digital abnormalities and, less commonly, cleft lip and palate associated with the phenobarbital metabolites produced from primidone. Haemorrhage at birth and addiction are also a risk. Prophylactic treatment with vitamin K1 for the mother before delivery (as well as the neonate) is recommended and the neonate should be monitored for signs of bleeding It is, recommended that: • Women on antiepileptic drugs (AEDs) receive pre-pregnancy counselling with regard to the risk of congenital malformations and adverse developmental outcomes; • AEDs should be continued during pregnancy at the lowest effective dose and monotherapy should be used if appropriate; • Adequate folic acid supplementation should be discussed as part of pre-pregnancy and pregnancy counselling; • Specialist prenatal diagnosis including detailed mid-trimester ultrasound should be considered. Central Nervous System Anticonvulsants/antiepileptics
probenecid B2 Musculoskeletal System Agents used in gout and hyperuricaemia
probucol B1 Cardiovascular System Hypolipidaemic agents
procainamide B2 Cardiovascular System Antiarrhythmics
procaine benzylpenicillin A Antimicrobials Antibiotics Penicillins
procaine hydrochloride B2 Drugs Used in Anaesthesia Local anaesthetics
procaine penicillin (procaine benzylpenicillin) A Antimicrobials Antibiotics Penicillins
procarbazine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
prochlorperazine C When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the infant. Central Nervous System Antiemetics, antinauseants Phenothiazines
procyclidine A Central Nervous System Antiparkinson agents
progesterone A Endocrine System Progestogens (see also oral contraceptives)
progestogen only contraceptives B3 Accumulated evidence reports that inadvertent exposure to these agents in early pregnancy has not been associated with an increased risk of birth defects. Contraceptive Agents Oral contraceptives
proguanil B2 If given during pregnancy, folic acid supplementation should be given. Proguanil has been used extensively with no adverse pregnancy outcome. The use of this drug in the treatment of malaria is accepted because the small risk to the fetus is outweighed by the benefits to the mother and fetus. Prophylaxis in high risk situations is also justified. Antimicrobials Antimalarials
promazine C When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the newborn infant. Central Nervous System Antipsychotic drugs Phenothiazines
promethazine C When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the infant. Allergy and Immune System Antihistamines
promethazine C When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the infant. Central Nervous System Antiemetics, antinauseants Phenothiazines
propantheline B2 Alimentary System Antispasmodics
propantheline B2 Cholinergic and Anticholinergic Agents
propofol C All general anaesthetics carry the potential to produce central nervous system and respiratory depression in the newborn infant. In routine practice this does not appear to be a problem. However, in the compromised fetus, careful consideration should be given to this potential depression and to the selection of particular anaesthetic drugs, doses and techniques. Drugs Used in Anaesthesia General anaesthetics
propranolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
propylthiouracil D Antithyroid agents may cause congenital goitre by inhibiting thyroxine synthesis in the fetus. Endocrine System Antithyroid agents
protamine B2 Cardiovascular System Haemostatic agents
protein c (human) B2 Cardiovascular System Haemostatic agents
protriptyline C Withdrawal symptoms in newborn infants have been reported with prolonged maternal use of tricyclic antidepressants. Central Nervous System Antidepressants Tricyclic antidepressants
proxymetacaine B2 Ophthalmic Drugs
prucalopride B1 Alimentary System Laxatives
pseudoephedrine B2 Cardiovascular System Adrenergic stimulants
pseudoephedrine B2 Respiratory System Decongestants
pyrantel embonate B2 Antimicrobials Anthelmintics
pyrazinamide B2 Antimicrobials Antituberculotics and antileprotics
pyrethrins B2 Drugs used in Dermatology Topical antiparasitics
pyridostigmine C The maternal requirement for this drug in the context of myasthenia gravis may be absolute. Cholinergic effects in the neonate are rare. Drugs Used in Myasthenia Gravis
pyrimethamine B3 This drug may interfere with folic acid metabolism and animal experiments have shown that administration of very high doses of pyrimethamine during organ development may give rise to birth defects typical of folic acid antagonism. If pyrimethamine is given during pregnancy, folic acid supplementation should be given. The use of this drug in the treatment of malaria is accepted because the small risk to the fetus is outweighed by the benefits to the mother and fetus. Prophylaxis in high risk situations is also justified. Antimicrobials Antimalarials
Q fever vaccine B2 Vaccines Inactivated vaccines
quetiapine C Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. Central Nervous System Antipsychotic drugs
quinagolide B3 Endocrine System Pituitary inhibitors
quinapril D When taken during the second and third trimesters, ACE inhibitors cause a range of abnormalities including renal dysfunction and oligohydramnios. These can be associated with fetal death in utero. Although no adverse fetal effects have been linked to first trimester drug use of ACE inhibitors, the number of exposures reported is too small to determine conclusively that ACE inhibitors are safe in the first trimester. Pregnant women who are taking ACE inhibitors should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ACE inhibitors for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin converting enzyme (ACE) inhibitors
quinethazone C Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Diuretics Thiazides, related diuretics and loop diuretics
quinidine C This drug is structurally similar to quinine, which in high doses, has been shown to cause fetal damage. It has been used to treat fetal cardiac arrhythmia. Cardiovascular System Antiarrhythmics
quinine D At standard doses, quinine has not been associated with fetal damage. In toxic doses, quinine causes fetal damage including deafness. Its ability to induce uterine contractions also constitutes a risk of abortion. Musculoskeletal System Muscle relaxants
quinine (treatment) D In toxic doses, quinine causes fetal damage including deafness. Its ability to induce uterine contractions also constitutes a risk of abortion. Antimicrobials Antimalarials
rabeprazole B1 Alimentary System Hyperacidity, reflux, ulcers
rabies vaccine (inactivated) B2 Vaccines Inactivated vaccines
radium (223Ra) dichloride X Teratogenicity is a class effect of radioactive agents, which induce multiple fetal abnormalities. Radioactive drugs are likely to cause major birth defects if used during pregnancy. Antineoplastic Agents
raloxifene X This drug causes abnormalities of the developing reproductive system when administered to pregnant rabbits and may have a similar effect in human pregnancy. Endocrine System Agents affecting calcium and bone metabolism
raltegravir (400mg BID) A Antimicrobials Antiviral agents
raltegravir (excluding 400mg BID) B3 Antimicrobials Antiviral agents
raltitrexed D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
ramipril D When taken during the second and third trimesters, ACE inhibitors cause a range of abnormalities including renal dysfunction and oligohydramnios. These can be associated with fetal death in utero. Although no adverse fetal effects have been linked to first trimester drug use of ACE inhibitors, the number of exposures reported is too small to determine conclusively that ACE inhibitors are safe in the first trimester. Pregnant women who are taking ACE inhibitors should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ACE inhibitors for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin converting enzyme (ACE) inhibitors
ramucirumab (rmc) D IgG antibodies are known to cross the placental barrier, and this drug may inhibit angiogenesis in the fetus. Angiogenesis has been shown to be critically important to fetal development. Antineoplastic Agents Monoclonal antibodies
ranibizumab D Angiogenesis plays a key role in embryo-fetal development. Ranibizumab inhibits angiogenesis and may cause fetal harm when administered to pregnant women. Ophthalmic Drugs
ranitidine B1 Alimentary System Hyperacidity, reflux, ulcers
rasagiline B3 Central Nervous System Antiparkinson agents
rasburicase B2 Musculoskeletal System Agents used in gout and hyperuricaemia
ravulizumab B2 Blood and Haemopoietic System
reboxetine B1 Central Nervous System Antidepressants
recombinant respiratory syncytial virus pre-fusion F protein vaccine - adjuvanted with AS01 B2 Vaccines
recombinant respiratory syncytial virus pre-fusion F protein vaccine - non-adjuvanted vaccine A Vaccines
regdanvimab B2 Antimicrobials Antiviral agents antiviral monoclonal antibodies
regorafenib D Angiogenesis plays a key role in embryofetal development. VEGF receptor inhibitors inhibit angiogenesis and can cause fetal harm when administered to pregnant women Antineoplastic Agents Tyrosine kinase inhibitors
relabotulinumtoxinA B3 Musculoskeletal System Muscle relaxants
remdesivir B2 Antimicrobials Antiviral agents
remibrutinib D Studies in animals indicate potential for teratogenicity with use in pregnancy. Allergy and Immune System Immunomodifiers
remifentanil C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
repaglinide C It is important to achieve strict normoglycaemia during pregnancy. Endocrine System Hypoglycaemic agents
respiratory syncytial virus (RSV) F protein mRNA B1 Vaccines mRNA vaccines
reteplase C Cardiovascular System Fibrinolytic agents
retigabine B3 Compared to conventional anticonvulsants, the extent of the risk of this drug is unknown. Central Nervous System Anticonvulsants/antiepileptics
ribavirin X Although there are no pertinent human data, ribavirin has been found to be teratogenic and/or embryolethal in nearly all species in which it has been tested. Malformations of skull, palate, eye, jaw, skeleton and gastrointestinal tract were noted in animal studies. Survival of fetuses and offspring was reduced. Antimicrobials Antiviral agents
ribociclib D Antineoplastic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
rifabutin C Bleeding attributable to hypoprothrombinaemia has been reported in newborn infants and in mothers after the use of rifampicin during late pregnancy. If rifabutin is used during the last few weeks of pregnancy, vitamin K should be given to the mother and the newborn infant. Antimicrobials Antituberculotics and antileprotics
rifampicin C Bleeding attributable to hypoprothrombinaemia has been reported in newborn infants and in mothers after the use of rifampicin during late pregnancy. If rifampicin is used during the last few weeks of pregnancy, vitamin K should be given to the mother and the newborn infant. Antimicrobials Antituberculotics and antileprotics
rifaximin B1 Antimicrobials Antibiotics
rilpivirine B1 Antimicrobials Antiviral agents
riluzole B3 Central Nervous System
rimegepant B1 Central Nervous System
rimiterol A Cardiovascular System Adrenergic stimulants
rimiterol A Respiratory System Inhalational agents Bronchospasm relaxants
riociguat X Teratogenicity is a class effect of these agents, which induce multiple fetal abnormalities in animal studies. These drugs are likely to cause major birth defects if used during pregnancy. Cardiovascular System Antihypertensives
ripretinib D Based on its mechanism of action and findings in animal studies, ripretinib may cause fetal malformations. Antineoplastic Agents Tyrosine kinase inhibitors
risankizumab B1 Allergy and Immune System
risdiplam D Administration to pregnant animals resulted in decreased fetal body weights, increased incidences of fetal structural variations, embryofetal mortality, fetal malformations (hydrocephaly) and structural variations. The no-effect level for adverse effects on embryofetal development was associated with maternal exposure 3 times that in humans at the maximum recommended human dose. In a pre- and post-natal study in rats treated daily with risdiplam, risdiplam caused a slight delay in gestation length. Musculoskeletal System
risedronate B3 Endocrine System Agents affecting calcium and bone metabolism Bisphosphonates
risperidone C Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. Central Nervous System Antipsychotic drugs
ritlecitinib D Ritlecitinib is contraindicated in pregnancy. Malformations were demonstrated with ritlecitinib in rats and rabbits. Antineoplastic Agents Tyrosine kinase inhibitors
ritonavir B3 Antimicrobials Antiviral agents
rituximab C Antibodies of this class are known to cross the fetoplacental barrier and may cause B cell depletion and/or other unknown effects. Allergy and Immune System Immunomodifiers
rivaroxaban C All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
rivastigmine B2 Cholinergic and Anticholinergic Agents
rizatriptan B1 Cardiovascular System Antimigraine preparations
rocuronium B2 Drugs Used in Anaesthesia Neuromuscular blocking agents
rofecoxib C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
romidepsin D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
romiplostim B3 Blood and Haemopoietic System Haemopoietic agents
romosozumab B3 Musculoskeletal System Osteogenic agents
ropinirole B3 Central Nervous System Antiparkinson agents
ropivacaine B1 Drugs Used in Anaesthesia Local anaesthetics
rosiglitazone B3 Endocrine System Hypoglycaemic agents
rosiglitazone / metformin C It is important to achieve strict normoglycaemia during pregnancy. Endocrine System Hypoglycaemic agents
rosuvastatin D The physiological hyperlipidaemia of pregnancy does not require treatment. Cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, these drugs may cause fetal harm when administered to a pregnant woman. Cardiovascular System Hypolipidaemic agents
rosuvastatin / ezetimibe D Cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, these drugs may cause fetal harm when administered to a pregnant woman. The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System Hypolipidaemic agents
rotavirus vaccine B2 Currently available live virus vaccines have not caused teratogenic effects in humans. The ATAGI publication, “The Australian Immunisation Handbook”, should be consulted for more comprehensive information. Vaccines Live attenuated vaccines
rotigotine B3 Central Nervous System Antiparkinson agents
roxithromycin B1 Antimicrobials Antibiotics Macrolide antibiotics
rozanolixizumab D Increased early pregnancy loss was observed with rozanolixizumab in pregnant monkeys. Rozanolixizumab may affect immunocompetence in neonates owing to its pharmacological action. Drugs Used in Myasthenia Gravis
rufinamide B3 Central Nervous System Anticonvulsants/antiepileptics
rurioctocog alfa pegol B2 Cardiovascular System Haemostatic agents
ruxolitinib phosphate C Antineoplastic Agents
sacituzumab govitecan D Based on its mechanism of action, sacituzumab govitecan can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant person. Antineoplastic Agents Monoclonal antibodies
safinamide (as mesilate) B3
salbutamol A Cardiovascular System Adrenergic stimulants
salbutamol A Genitourinary System Agents acting on the uterus
salbutamol A Respiratory System Inhalational agents Bronchospasm relaxants
salcatonin (calcitonin salmon) B2 Endocrine System Agents affecting calcium and bone metabolism
salmeterol B3 Respiratory System Inhalational agents Bronchospasm relaxants
salmeterol B3 The benefits of asthma control outweigh any potential for an adverse pregnancy outcome. Respiratory System Inhalational agents Preventative aerosols and inhalations
samarium [153Sm] D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
saponins A Respiratory System Expectorants and mucolytics
sapropterin B1 Metabolism Agents used for the treatment of metabolic disorders
saquinavir B1 Antimicrobials Antiviral agents
satralizumab C IgG antibodies are known to cross the placental barrier. This drug has the potential to affect embryofetal survival due to its pharmacological action. Central Nervous System
saxagliptin B3 Endocrine System Hypoglycaemic agents
saxagliptin / metformin C It is important to achieve strict normoglycaemia during pregnancy. Endocrine System Hypoglycaemic agents
sebelipase alfa B1 Metabolism Agents used for the treatment of metabolic disorders
secukinumab (rch) C IgG antibodies are known to cross the placental barrier. This drug has the potential to affect embryofetal survival due to its pharmacological action. Allergy and Immune System Immunomodifiers
seladelpar B1 Alimentary System
selegiline B2 Central Nervous System Antiparkinson agents
selexipag B1 Cardiovascular System Antihypertensives
selinexor D Selinexor may cause fetal harm when administered to a pregnant woman. In pregnant rats, administration of selinexor during organogenesis resulted in reduced fetal weight, impaired ossification and increased fetal skeletal variations and malformations. Selinexor was embryolethal in rats. Antineoplastic Agents
selpercatinib D Based on data from animal reproduction studies and its mechanism of action, selpercatinib can cause fetal harm (including post-implantation loss and an increase in external malformations) when administered to a pregnant woman. Antineoplastic Agents Tyrosine kinase inhibitors
selumetinib  D Based on animal data (in pregnant mice given selumetinib during organogenesis caused a reduction in the number of live fetuses due to an increase in post-implantation loss, a reduction in fetal weights and malformations). Selumetinib may cause fetal harm when administered to a pregnant woman. Antineoplastic Agents
semaglutide D This drug is embryotoxic and fetotoxic when administered to pregnant rats and rabbits Endocrine System Hypoglycaemic agents
senna A Alimentary System Laxatives
sepiapterin B1 Metabolism Agents used for the treatment of metabolic disorders
sertindole C Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. Central Nervous System Antipsychotic drugs
sertraline C Selective serotonin reuptake inhibitors (SSRIs) have had limited use in pregnancy without a reported increase in birth defects. The use of SSRIs in the third trimester may result in a withdrawal state in the newborn infant. Central Nervous System Antidepressants Selective serotonin reuptake inhibitors (SSRIs)
sevelamer B3 Detoxifying Agents, Antidotes
sevoflurane B2 All general anaesthetics carry the potential to produce central nervous system and respiratory depression in the newborn infant. In routine practice this does not appear to be a problem. However, in the compromised fetus, careful consideration should be given to this potential depression and to the selection of particular anaesthetic drugs, doses and techniques. Drugs Used in Anaesthesia General anaesthetics
sibutramine C Weight reduction using appetite suppressant drugs is not recommended in pregnancy. Metabolism Anorectic and weight reducing agents
sildenafil citrate B1 Cardiovascular System Vasodilators
silodosin B3 Genitourinary System Prostate hyperplasia
siltuximab C Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. Antineoplastic Agents Monoclonal antibodies
simeprevir B3 Antimicrobials Antiviral agents
simeprevir with ribavirin and peginterferon alfa X Although there are no pertinent human data, ribavirin has been found to be teratogenic and/or embryolethal in nearly all species in which it has been tested. Malformations of skull, palate, eye, jaw, skeleton and gastrointestinal tract were noted in animal studies. Survival of fetuses and offspring was reduced. Antimicrobials Antiviral agents
simvastatin D Cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, these drugs may cause fetal harm when administered to a pregnant woman. The physiological hyperlipidaemia of pregnancy does not require treatment. Cardiovascular System Hypolipidaemic agents
sipavibart B2 Antimicrobials Antiviral agents
siponimod D Based on animal data and its mechanism of action siponimodcan cause fetal harm when administered to a pregnant woman. Allergy and Immune System Immunomodifiers
sirolimus C Allergy and Immune System Immunomodifiers
sitagliptin B3 Endocrine System Hypoglycaemic agents
sitagliptin / metformin C It is important to achieve strict normoglycaemia during pregnancy. Endocrine System Hypoglycaemic agents
sitaxentan X Teratogenicity is a class effect of these agents, which induce multiple fetal abnormalities in animal studies. These drugs are likely to cause major birth defects if used during pregnancy. Cardiovascular System Endothelin receptor antagonist
smallpox (Vaccinia) vaccine D Live vaccinia virus vaccines can cause fetal harm when administered to a pregnant woman Vaccines Live attenuated vaccines
sodium aurothiomalate B2 Musculoskeletal System Antirheumatoid agents
sodium cromoglycate A Respiratory System Inhalational agents Preventative aerosols and inhalations
sodium fusidate (fusidic acid) C This drug may cause kernicterus in babies during the first month of life by displacing bilirubin from plasma albumin. Fusidic acid should be avoided if possible during the last month of pregnancy. Antimicrobials Antibiotics
sodium iodide [131I] X Sodium iodide [131I] is contraindicated in pregnancy. Sodium iodide [131I can cause severe and possibly irreversible hypothyroidism in neonates. Diagnostic Agents Radiographic agents
sodium nitroprusside C Short term use for the control of hypertensive crises may be safe provided that the pH and cyanide concentrations in maternal blood are monitored. Cardiovascular System Antihypertensives
sodium phenylbutyrate B3 Metabolism Agents used for the treatment of metabolic disorders
sodium phosphate [32P] X The use of this drug is absolutely contraindicated in women who are pregnant, or breast-feeding, and in children. Diagnostic Agents
sodium salicylate C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
sodium valproate (valproic acid) D Sodium valproate is contraindicated in pregnancy. A broad range of congenital malformations can occur in babies born to women who take sodium valproate during pregnancy, and the risk of malformations increases with increasing dose of valproate. If taken in the first trimester of pregnancy, sodium valproate (valproic acid) is associated with a one to two percent risk of neural tube defects (especially spina bifida) in the exposed fetus. Sodium valproate should not be used during pregnancy and in women of child-bearing potential unless alternative treatments are ineffective or not tolerated because of the high risk of malformation and risk of developmental disorders in infants exposed to valproate before birth. Avoid use of valproate in women of child-bearing age for all non-seizure indications. For seizure indications, consider alternatives if they exist. Always use the lowest effective dose. Patients and prescribers should reconsider benefit and risk at regular treatment reviews, at puberty and urgently when a woman of child-bearing potential treated with valproate plans a pregnancy or becomes pregnant. Folic acid supplementation (5mg) should be commenced four weeks prior to and continue for twelve weeks after conception; specialist prenatal diagnosis including detailed mid-trimester ultrasound should be offered. Central Nervous System Anticonvulsants/antiepileptics
sodium zirconium cyclosilicate B1 Metabolism
sofosbuvir B1 Antimicrobials Antiviral agents
sofosbuvir / velpatasvir / voxilaprevir B1 Antimicrobials Antiviral agents
sofosbuvir / velpatasvir B1 Antimicrobials Antiviral agents
sofosbuvir / velpatasvir with ribavirin X Although there are no pertinent human data, ribavirin has been found to be teratogenic and/or embryolethal in nearly all species in which it has been tested. Malformations of skull, palate, eye, jaw, skeleton and gastrointestinal tract were noted in animal studies. Survival of fetuses and offspring was reduced. Antimicrobials Antiviral agents
sofosbuvir with peginterferon alfa and ribavirin X Although there are no pertinent human data, ribavirin has been found to be teratogenic and/or embryolethal in nearly all species in which it has been tested. Malformations of skull, palate, eye, jaw, skeleton and gastrointestinal tract were noted in animal studies. Survival of fetuses and offspring was reduced. Antimicrobials Antiviral agents
sofosbuvir with ribavirin X Although there are no pertinent human data, ribavirin has been found to be teratogenic and/or embryolethal in nearly all species in which it has been tested. Malformations of skull, palate, eye, jaw, skeleton and gastrointestinal tract were noted in animal studies. Survival of fetuses and offspring was reduced. Antimicrobials Antiviral agents
solifenacin B3 Genitourinary System Prostate hyperplasia
somapacitan B1 Endocrine System Hormonal agents
somatrogon B1 Endocrine System Hormonal agents
somatropin B2 Endocrine System Pituitary hormones
sorafenib D This drug is embryotoxic in both pregnant rats and rabbits, and teratogenic when administered to pregnant animals. Antineoplastic Agents Tyrosine kinase inhibitors
sotalol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
sotatercept D Based on animal studies, sotatercept may cause embryofetal loss or other fetal harm when administered to a pregnant woman. Cardiovascular System
sotorasib B3 Antineoplastic Agents
sotrovimab B2 Antimicrobials Antiviral agents antiviral monoclonal antibodies
spectinomycin B1 Antimicrobials Antibiotics
spesolimab B1 Drugs Used in Dermatology Systemic
spesolimab B1 Allergy and Immune System Immunomodifiers
spironolactone B3 This drug carries the potential to cause feminisation of the male fetus and should be avoided during pregnancy. Cardiovascular System Diuretics Potassium sparing diuretics
spironolactone B3 Antiandrogens carry the potential for feminisation of the male fetus at or after 8 weeks post conception and should be avoided during pregnancy. Endocrine System Antiandrogens
stavudine B3 Antimicrobials Antiviral agents
stiripentol B3 Central Nervous System
streptokinase C Only minimal amounts of streptokinase cross the placenta. Streptokinase-specific antibodies are found in fetal blood. Cardiovascular System Fibrinolytic agents
strontium ranelate B3 Endocrine System Agents affecting calcium and bone metabolism
succinylated gelatin B2 Cardiovascular System
sucralfate B1 Alimentary System Hyperacidity, reflux, ulcers
sucroferric oxyhydroxide B3 Blood and Haemopoietic System Haemopoietic system
sugammadex B2 Drugs Used in Anaesthesia Antagonists of neuromuscular blocking agents
sulesomab B2 Diagnostic Agents Radiographic agents
sulfacetamide C Ophthalmic Drugs
sulfadiazine C Sulfonamides may cause jaundice and haemolytic anaemia in the newborn. Antimicrobials Antibiotics Sulfonamides
sulfadoxine C Sulfonamides may cause jaundice and haemolytic anaemia in the newborn. Antimicrobials Antibiotics Sulfonamides
sulfamethizole C Sulfonamides may cause jaundice and haemolytic anaemia in the newborn. Antimicrobials Antibiotics Sulfonamides
sulfamethoxazole C Sulfonamides may cause jaundice and haemolytic anaemia in the newborn. Antimicrobials Antibiotics Sulfonamides
sulfasalazine A Alimentary System Antidiarrhoeals
sulfinpyrazone B2 Musculoskeletal System Agents used in gout and hyperuricaemia
sulindac C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
sulthiame D Compared to conventional anticonvulsants, the extent of the risk of this drug is unknown. Central Nervous System Anticonvulsants/antiepileptics
sumatriptan B3 Cardiovascular System Antimigraine preparations
sunitinib D This drug is embryotoxic in both pregnant rats and rabbits, and teratogenic when administered to pregnant animals. Antineoplastic Agents Tyrosine kinase inhibitors
susoctocog alfa B2 Cardiovascular System Haemostatic agents
suxamethonium A Drugs Used in Anaesthesia Neuromuscular blocking agents
tacrine C This drug may produce cholinergic effects in the fetus. Cholinergic and Anticholinergic Agents
tacrolimus C This drug may cause immunosuppression in the infant. Use of tacrolimus during pregnancy has been associated with neonatal hyperkalaemia and renal dysfunction. Allergy and Immune System Immunomodifiers
tadalafil B1 Cardiovascular System Vasodilators
tafamidis D Based on findings from animal studies, tafamidis may cause fetal harm and malformations. Cardiovascular System
tafasitamab C Tafasitamab may cause fetal B-cell depletion based on its pharmacological properties. Antineoplastic Agents Monoclonal antibodies
tafenoquine C Tafenoquine may cause foetal harm when administered to a pregnant woman if the foetus is G6PD-deficient and should not be taken in pregnancy. Tafenoquine is contraindicated in pregnancy because the G6PD status of the foetus is unknown (G6PD = glucose-6-phosphate dehydrogenase). Antimicrobials Antimalarials
tafluprost B3 Ophthalmic Drugs
talazoparib D Based on animal studies and its mechanism of action, talazoparib can cause embryofetal harm (malformations and embryofetal loss) when aministered to a pregnant woman. Antineoplastic Agents
talimogene laherparepvec (rmv) C Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. Antineoplastic Agents
talquetamab C Based on its mechanism of action, talquetamab may cause fetal harm when administered to a pregnant woman. Antineoplastic Agents Monoclonal antibodies
tamoxifen B3 Women should be advised not to become pregnant whilst taking tamoxifen and for nine months following the cessation of therapy and should use barrier or other non-hormonal contraceptive methods if sexually active. Premenopausal patients must be carefully examined before treatment to exclude pregnancy. Women should be informed of the potential risks to the foetus, should they become pregnant whilst taking tamoxifen or within nine months of cessation of therapy. Antineoplastic Agents Hormonal antineoplastic agents
tamsulosin B2 Genitourinary System Prostate hyperplasia
tapentadol C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
tasonermin D There is a theoretical risk of irreversible damage to the fetus due to possible breakdown of the fetal and/or placental vasculature. Allergy and Immune System Immunomodifiers
tazarotene D As with other retinoids, this drug may cause fetal harm when used during pregnancy. Drugs used in Dermatology Topical
tebentafusp C Based on its mechanism of action, tebentafusp may cause fetal harm when administered to a pregnant woman. Antineoplastic Agents Monoclonal antibodies
technetium [99mTc] C Diagnostic Agents
technetium [99mTc] albumin aggregated C Diagnostic Agents
technetium [99mTc] bicisate C Diagnostic Agents
teclistamab C Antineoplastic Agents Monoclonal antibodies
teduglutide B1 Endocrine System Hypoglycaemic agents
tegafur D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
tegaserod B3 Alimentary System Prokinetics
teicoplanin B3 Antimicrobials Antibiotics
telaprevir B2 Antimicrobials Antiviral agents
telbivudine B1 Antimicrobials Antiviral agents
telmisartan D When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin II receptor antagonists and renin inhibitors
telotristat ethyl (as etiprate) B3 Alimentary System Antidiarrhoeals
temazepam C Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
temozolomide D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Alkylating agents
temsirolimus D Antineoplastic Agents
tenecteplase C Cardiovascular System Fibrinolytic agents
teniposide D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
tenofovir B3 Antimicrobials Antiviral agents
tenofovir disoproxil fumarate / emtricitabine / elvitegravir / cobicistat B3 Antimicrobials Antiviral agents
tenoxicam C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
tepotinib D Studies in animals have shown teratogenicity (including malformations). Based on the mechanism of action and findings in animals, tepotinib can cause fetal harm when administered to pregnant women. Antineoplastic Agents
teprotumumab X Teprotumumab is contraindicated in pregnancy. Based on findings in animals and its mechanism of action, teprotumumab may cause fetal loss and malformations when administered to a pregnant woman. Ophthalmic Drugs
terazosin B2 Cardiovascular System Antihypertensives
terazosin B2 Genitourinary System Bladder function disorders
terbinafine B1 Antimicrobials Antifungal agents (see also topical antifungals)
terbutaline A Cardiovascular System Adrenergic stimulants
terbutaline A Respiratory System Inhalational agents Bronchospasm relaxants
terfenadine B2 Allergy and Immune System Antihistamines
teriflunomide X This drug may cause fetal harm in humans. This drug must not be given to pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with this drug and for a certain period of time thereafter. Pregnancy must be excluded before the start of treatment with this drug. Allergy and Immune System Immunomodifiers
teriparatide B3 Endocrine System Agents affecting calcium and bone metabolism
terlipressin D Cardiovascular System Haemostatic agents
testosterone D Anabolic steroids and other substances with androgenic effects may have a virilising effect on the female fetus and should be avoided during pregnancy. Endocrine System Androgens and anabolic steroids
tetrabenazine B3 Central Nervous System
tetracaine B2 Ophthalmic Drugs
tetracosactide D There have been some reports of miscarriage or fetal malformation occurring in pregnant women treated with tetracosactrin. Diagnostic Agents Pituitary-adrenal response test
tetracosactrin (tetracosactide) D There have been some reports of miscarriage or fetal malformation occurring in pregnant women treated with tetracosactrin. Diagnostic Agents Pituitary-adrenal response test
tetracycline D Tetracyclines are safe for use during the first 18 weeks of pregnancy (16 weeks post conception) after which they cause discolouration of the baby’s teeth. Antimicrobials Antibiotics Tetracyclines
tezacaftor / ivacaftor B3 Respiratory System
tezepelumab B1 Allergy and Immune System Immunomodifiers
thalidomide X Thalidomide has caused severe birth defects when taken during pregnancy. Even a single dose can cause birth defects. Thalidomide should never be used by women who are pregnant or who could become pregnant whilst taking the drug or could become pregnant within four weeks after stopping the drug. Allergy and Immune System Immunomodifiers
theophylline and derivatives A Respiratory System Inhalational agents Bronchospasm relaxants
thiabendazole B3 Antimicrobials Anthelmintics
thiethylperazine C When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the infant. Central Nervous System Antiemetics, antinauseants Phenothiazines
thiopentone A All general anaesthetics carry the potential to produce central nervous system and respiratory depression in the newborn infant. In routine practice this does not appear to be a problem. However, in the compromised fetus, careful consideration should be given to this potential depression and to the selection of particular anaesthetic drugs, doses and techniques. Drugs Used in Anaesthesia General anaesthetics
thiopropazate C When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the newborn infant. Central Nervous System Antipsychotic drugs Phenothiazines
thioridazine C When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the newborn infant. Central Nervous System Antipsychotic drugs Phenothiazines
thiotepa D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Alkylating agents
thiothixene C Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. Central Nervous System Antipsychotic drugs
thrombin B2 Cardiovascular System Haemostatic agents
thyrotrophin B2 Endocrine System Pituitary hormones
thyrotropin alfa B2 Diagnostic Agents Radiographic agents
thyroxine (levothyroxine) A Endocrine System Thyroid hormones
tiagabine B3 Compared to conventional anticonvulsants, the extent of the risk of this drug is unknown. Central Nervous System Anticonvulsants/antiepileptics
tiaprofenic acid C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
tibolone D Oral treatment with this drug during the period of organogenesis was associated with fetal malformations in rats and rabbits. Endocrine System Hormonal agents
ticagrelor B1 Cardiovascular System
ticarcillin B2 Antimicrobials Antibiotics Penicillins
ticlopidine B1 All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
tigecycline D Tetracyclines are safe for use during the first 18 weeks of pregnancy (16 weeks post conception) after which they cause discolouration of the baby’s teeth. Antimicrobials Antibiotics Tetracyclines
tildrakizumab B1 Allergy and Immune System Immunomodifiers
tilmanocept C There are no data from the use of tilmanocept in pregnant women. No reproductive toxicity studies in animals were performed, and it is not known if tilmanocept can cause fetal harm when administered to a pregnant woman. Radionuclide procedures carried out on pregnant women also involve radiation dose to the fetus. Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and fetus. Diagnostic Agents Radiographic agents
tiludronate disodium B2 Endocrine System Agents affecting calcium and bone metabolism
timolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Cardiovascular System Beta-adrenergic blocking agents
timolol (ophthalmic) C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Ophthalmic Drugs
tinidazole B3 Antimicrobials Antibiotics
tinzaparin C All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
tioguanine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
tiotropium B1 Respiratory System Inhalational agents Bronchospasm relaxants
tipranavir B3 Antimicrobials Antiviral agents
tirbanibulin D Tirbanibulin is contraindicated in pregnancy. Based on findings in animals and its mechanism of action, tirbanibulin may cause fetal loss and malformations when administered to a pregnant woman. Antineoplastic Agents
tirilazad B2 Cardiovascular System
tirofiban hydrochloride B1 Cardiovascular System Antiangina agents
tirzepatide D Endocrine System Hypoglycaemic agents
tisagenlecleucel C Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopaenia. Antineoplastic Agents
tislelizumab D PD-1/PD-L1 is involved in fetomaternal tolerance. Administration during pregnancy may cause fetal harm, including abortion or stillbirth. Antineoplastic Agents Monoclonal antibodies
tixagevimab; cilgavimab B2 Antimicrobials Antiviral agents Antiviral monoclonal antibodies
tobramycin D There is evidence of selective uptake of aminoglycosides by the fetal kidney resulting in damage (probably reversible) to immature nephrons. Eighth cranial nerve damage has also been reported following in utero exposure to some of the aminoglycosides. Because of their chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the fetus. It should also be noted that therapeutic blood concentrations in the mother do not equate with safety for the fetus. Antimicrobials Antibiotics Aminoglycosides
tocilizumab (rch) C IgG antibodies are known to cross the placental barrier. This drug has the potential to affect embryofetal survival due to its pharmacological action. Allergy and Immune System Immunomodifiers
tofacitinib (as citrate) D This drug is embryotoxic in both pregnant rats and rabbits, and teratogenic when administered to pregnant animals. Allergy and Immune System Immunomodifiers
tofersen B2 Central Nervous System
tolazamide C Sulphonylureas may enter the fetal circulation and may cause neonatal hypoglycaemia. Endocrine System Hypoglycaemic agents
tolbutamide C Sulphonylureas may enter the fetal circulation and may cause neonatal hypoglycaemia. Endocrine System Hypoglycaemic agents
tolcapone B3 Central Nervous System Antiparkinson agents
tolebrutinib B3 Allergy and Immune System Immunomodifiers
tolterodine B3 Genitourinary System Prostate hyperplasia
tolvaptan D Animal studies have shown adverse effects on embryofetal development (embryofetal death, microphthalmia, cleft palate, brachymelia and skeletal malformations), which were observed in conjunction with maternal toxicity, although a direct effect cannot be excluded. Tolvaptan should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Cardiovascular System Diuretics
topiramate D Topiramate can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk of congenital malformations. Central Nervous System Anticonvulsants/antiepileptics
topotecan D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Antimetabolites
toremifene B3 Antineoplastic Agents Hormonal antineoplastic agents
toripalimab D PD-1/PD-L1 is involved in fetomaternal tolerance. Administration during pregnancy may cause fetal harm, including abortion or stillbirth. Antineoplastic Agents Monoclonal antibodies
trabectedin D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents
tramadol C Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Analgesics and Antipyretics (see also non-steroidal anti-inflammatory agents) Opioid analgesics
trametinib dimethyl sulfoxide D This drug is embryotoxic in both pregnant rats and rabbits. Antineoplastic Agents Tyrosine kinase inhibitors
trandolapril D When taken during the second and third trimesters, ACE inhibitors cause a range of abnormalities including renal dysfunction and oligohydramnios. These can be associated with fetal death in utero. Although no adverse fetal effects have been linked to first trimester drug use of ACE inhibitors, the number of exposures reported is too small to determine conclusively that ACE inhibitors are safe in the first trimester. Pregnant women who are taking ACE inhibitors should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ACE inhibitors for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin converting enzyme (ACE) inhibitors
tranexamic acid B1 Cardiovascular System Haemostatic agents
tranylcypromine B2 Central Nervous System Antidepressants Monoamine oxidase inhibitors
trastuzumab D Antineoplastic Agents Monoclonal antibodies
trastuzumab deruxtecan D Based on findings in animals and its mechanism of action, trastuzumab deruxtecan may cause embryo-fetal harm (embryotoxicity and teratogenicity) when administered to a pregnant woman. Antineoplastic Agents Monoclonal antibodies
trastuzumab emtansine (rch) D IgG antibodies are known to cross the placental barrier, and this drug may inhibit angiogenesis in the fetus. Angiogenesis has been shown to be critically important to fetal development. Antineoplastic Agents Monoclonal antibodies
travoprost B3 Ophthalmic Drugs
travoprost / timolol C Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant. Ophthalmic Drugs
tremelimumab D IgG antibodies are known to cross the placental barrier. This drug may affect embryofetal survival due to its pharmacological action. Antineoplastic Agents Monoclonal antibodies
treosulfan D Based on the mechanism of action and genotoxic potential of treosulfan, there is a risk for fetal toxicity and teratogenicity. Antineoplastic Agents Alkylating agents
treprostinil B3 Cardiovascular System Vasodilators
tretinoin D Use of tretinoin cream formulation during the first trimester does not appear to cause birth defects. Other formulations should not be used during pregnancy. There have been isolated reports of birth defects in babies born to women using topical tretinoin in pregnancy, some similar to those reported with oral retinoids. While a retrospective cohort study on women exposed to tretinoin in the first trimester did not reveal an association with this treatment, the numbers in this study are too small to establish the safety of use in pregnancy. Drugs used in Dermatology Topical
tretinoin (oral) X This is a potent teratogen when taken systemically during early pregnancy, producing a pattern of birth defects termed retinoic acid embyropathy. The teratogenic effect is dose-dependent. Antineoplastic Agents
triamcinolone (inhaled) B3 The benefits of asthma control outweigh any potential for an adverse pregnancy outcome. Endocrine System Corticosteroids Inhalation/intranasal
triamcinolone (systemic) A Endocrine System Corticosteroids Systemic
triamcinolone (topical) A Endocrine System Corticosteroids Topical
triamcinolone acetonide (ocular) B3 Endocrine System Corticosteroids
triamterene C Potassium sparing diuretics may cause an electrolyte disturbance in the fetus. Cardiovascular System Diuretics Potassium sparing diuretics
triazolam C Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs. Central Nervous System Benzodiazepines
trientine D Trientine was teratogenic in animals possibly due to the induction of copper deficiency or zinc toxicity.Fetal brain abnormalities have been observrd. Metabolism Agents used for the treatment of metabolic disorders
trifarotene D Trifarotene is contraindicated during pregnancy or in women planning a pregnancy. If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued. Trifarotene was not teratogenic in rats and rabbits at systemic exposures corresponding to approximately 500 and 90-times, respectively, those observed in humans. However, in animal reproduction studies, oral administration of trifarotene in pregnant rats and rabbits during organogenesis was teratogenic and embryotoxic at exposures (AUC) that were >800-times those observed in humans at the maximum recommended human dose. Drugs Used in Dermatology Topical
trifluoperazine C When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the newborn infant. Central Nervous System Antipsychotic drugs Phenothiazines
trifluridine / tipiracil hydrochloride D Based on the mechanism of action, trifluridine is suspected to cause congenital malformations when administered during pregnancy. Trifluridine/tipiracil has been shown to cause embryofetal lethality and fetal malformations in pregnant rats. Antineoplastic Agents Antimetabolites
trihexyphenidyl B1 Central Nervous System Antiparkinson agents
trimeprazine (alimemazine) C When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the infant. Allergy and Immune System Antihistamines
trimethoprim B3 Antimicrobials Antibiotics
trimipramine C Withdrawal symptoms in newborn infants have been reported with prolonged maternal use of tricyclic antidepressants. Central Nervous System Antidepressants Tricyclic antidepressants
triprolidine A Allergy and Immune System Antihistamines
triptorelin D There is a theoretical risk of abortion or fetal abnormality if GnRH agonists are used during pregnancy. Antineoplastic Agents Hormonal antineoplastic agents
troglitazone B3 Endocrine System Hypoglycaemic agents
tropicamide B2 Ophthalmic Drugs
tropisetron B3 Central Nervous System Antiemetics, antinauseants
trovafloxacin B3 Antimicrobials Antibiotics Quinolones
tubocurarine C There have been no demonstrated adverse effects in the fetus or the newborn infant. Drugs Used in Anaesthesia Neuromuscular blocking agents
turoctocog alfa B2 Cardiovascular System Haemostatic agents
typhoid vaccine (live attenuated, oral) B2 Vaccines Live attenuated vaccines
typhoid vaccine (polysaccharide) B2 Vaccines Subunit vaccines Polysaccharide conjugate vaccines
ublituximab C IgG antibodies are known to cross the placental barrier. This drug has the potential to affect embryofetal survival due to its pharmacological action. Allergy and Immune System Immunomodifiers
ublituximab C Based on the pharmacological action, ublituximab has the potential to affect embryofetal survival. IgG antibodies are known to cross the placental barrier. Antineoplastic Agents Monoclonal antibodies
umeclidinium bromide B1 Respiratory System Inhalational agents Preventative aerosols and inhalations
umeclidinium bromide / fluticasone furoate / vilanterol trifenatate B3 Respiratory System Inhalational agents Preventative aerosols and inhalations
umeclidinium bromide / vilanterol trifenatate B3 Respiratory System Inhalational agents Preventative aerosols and inhalations
unoprostone isopropyl B3 Ophthalmic Drugs
upadacitinib D Based on findings in animal studies, upadacitinib may cause foetal harm when administered to a pregnant woman. Upadacitinib caused increases in foetal malformations in rats and rabbits and embryofoetal lethality and abortions in rabbits. Musculoskeletal System Antirheumatoid agents
urea [13C] B2 Diagnostic Agents Radiographic agents
urokinase B1 Cardiovascular System Fibrinolytic agents
ursodeoxycholic acid B3 Alimentary System Cholelitholytics
ustekinumab B1 Allergy and immune system Immunomodifiers
vadadustat C Blood and Haemopoietic System Haemopoietic agents
valaciclovir B3 Antimicrobials Antiviral agents
valdecoxib C Non-steroidal anti-inflammatory (NSAIDs) agents inhibit prostaglandin synthesis which may adversely affect pregnancy. Refer to the relevant texts in the Product Information of individual NSAID products for information regarding the suitability for use in pregnancy. Epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. When given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided. Musculoskeletal System Non-steroidal anti-inflammatory drugs (NSAIDS)
valganciclovir D Ganciclovir has been shown to be teratogenic and embryotoxic in animals. Antimicrobials Antiviral agents
valsartan D When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Cardiovascular System Antihypertensives Angiotensin II receptor antagonists and renin inhibitors
valsartan / hydrochlorothiazide D When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Thiazides, related diuretics and loop diuretics may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose. Cardiovascular System Antihypertensives
valsartan / sacubitril D When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant. Cardiovascular System
vancomycin B2 Antimicrobials Antibiotics
vandetanib D This drug is embryotoxic and embryolethal in pregnant animals. Antineoplastic Agents Tyrosine kinase inhibitors
vanzacaftor + tezacaftor + deutivacaftor B3 Respiratory System Inhalational agents
vardenafil B3 Cardiovascular System Vasodilators
varenicline B3 Agents used in dependency states
varicella vaccine B2 Currently available live virus vaccines have not caused teratogenic effects in humans. The ATAGI publication, “The Australian Immunisation Handbook”, should be consulted for more comprehensive information. Vaccines Live attenuated vaccines
varicella vaccine (recombinant glycoprotein) B2 Vaccines Subunit vaccines Recombinant protein vaccines
vasopressin B2 Endocrine System Antidiuretics
vecuronium C There have been no demonstrated adverse effects in the fetus or the newborn infant. Drugs Used in Anaesthesia Neuromuscular blocking agents
vedolizumab (rch) B1 Allergy and Immune System Immunomodifiers
velaglucerase alfa B2 Metabolism Agents used for the treatment of metabolic disorders
velmanase alfa D Based on animal studies, velmanase alfa may cause embryofetal malformations when administered to a pregnant woman. Metabolism Agents used for the treatment of metabolic disorders
vemurafenib D This drug inhibits multiple kinases (including BRAF) that may be important during embryofetal development. Antineoplastic Agents Tyrosine kinase inhibitors
venetoclax C Venetoclax is a Bcl-2 inhibitor. Bcl-2 plays a role in oocyte and embryonic development. Venetoclax may have effects on the fetus when administered to pregnant women. Antineoplastic Agents
venlafaxine B2 Central Nervous System Antidepressants
verapamil C Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension. Cardiovascular System Antihypertensives Calcium channel blockers
vericiguat D In rabbits, maternal toxicity was observed resulting in secondary late spontaneous abortions and resorptions. In addition, at this dose, a low incidence of malformation of the heart and major vessels was seen. While this could not be unambiguously attributed to vericiguat treatment, cardiac and major vessel abnormalities were observed following maternal administration of a structurally related compound (riociguat) to rats. Vericiguat was transferred to the fetus through the placenta in pregnant rats. Cardiovascular System
verteporfin B3 Ophthalmic Drugs
vigabatrin D Compared to conventional anticonvulsants, the extent of the risk of this drug is unknown. Central Nervous System Anticonvulsants/antiepileptics
vildagliptin B3 Endocrine System Hypoglycaemic agents
vildagliptin / metformin C It is important to achieve strict normoglycaemia during pregnancy. Endocrine System Hypoglycaemic agents
vinblastine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Vinca alkaloids
vincristine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Vinca alkaloids
vindesine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Vinca alkaloids
vinflunine D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Vinca alkaloids
vinorelbine tartrate D Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects. Antineoplastic Agents Vinca alkaloids
vismodegib X Antineoplastic Agents
vitamin A (retinol) D Excess vitamin A may cause birth defects. Women should consider their dietary intake of vitamin A before taking supplements. The Australian diet usually contains the recommended daily allowance of 2500 IU. Vitamins
vonicog alfa B2 Cardiovascular System Haemostatic agents
vorasidenib D Studies in animals indicate a risk for embryofetal loss and other adverse effects on embryofetal development with use of vorasidenib during pregnancy. Antineoplastic Agents
voretigene neparvovec B2 Ophthalmic Drugs
voriconazole B3 Antimicrobials Antifungal agents (see also topical antifungals)
vorinostat D This drug is cytotoxic and causes gallbladder malformations in rabbits Antineoplastic Agents
vortioxetine B3 Central Nervous System Antidepressants
vosoritide B2 Musculoskeletal System Osteogenic agents
vutrisiran D Treatment with vutrisiran reduces serum levels of vitamin A, which has an increased risk of fetal malformation. Cardiovascular System
warfarin D Warfarin has been associated with the development of a specific embryopathy following exposure at 6 to 9 weeks post conception. Exposure following first trimester of pregnancy can cause fetal bleeding leading to CNS damage. There is also an increased risk of spontaneous abortion and perinatal bleeding. It should not be used in the last few weeks of pregnancy. All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
ximelagatran C All anticoagulants and thrombolytic agents can produce placental haemorrhage and subsequent prematurity and fetal loss. Cardiovascular System Anticoagulants and thrombolytic agents
yellow fever vaccine (live attenuated) B2 Currently available live virus vaccines have not caused teratogenic effects in humans. The ATAGI publication, “The Australian Immunisation Handbook”, should be consulted for more comprehensive information. Vaccines Live attenuated vaccines
zafirlukast B1 Respiratory System
zalcitabine D This drug is teratogenic in two animal species. Antimicrobials Antiviral agents
zaleplon C This drug may cause respiratory depression and hypothermia in the newborn infant. Central Nervous System Hypnotics and sedatives
zanamivir B1 Antimicrobials Antiviral agents
zanubrutinib D This drug is embryotoxic in pregnant rabbits, and teratogenic when administered to pregnant rats. Antineoplastic Agents Tyrosine kinase inhibitors
zidovudine B3 Antimicrobials Antiviral agents
zilucoplan D Studies in monkeys indicated a risk of embryofetal lethality with use of zilucoplan during pregnancy. Drugs Used in Myasthenia Gravis
ziprasidone C Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. Central Nervous System Antipsychotic drugs
zoledronic acid B3 Endocrine System Agents affecting calcium and bone metabolism Bisphosphonates
zolmitriptan B3 Cardiovascular System Antimigraine preparations
zolpidem tartrate B3 Central Nervous System Hypnotics and sedatives
zonisamide D Refer to the relevant texts in the Product Information of individual antiepileptics for more information regarding the suitability for use in pregnancy. There are limited data from the use of Zonegran in pregnant women. Data from a registry study suggest a higher proportion of babies born at a low birth weight (LBW), pre-term or small for gestational age (SGA) in mothers treated with zonisamide (n=98) compared to mothers treated with lamotrigine monotherapy (n=1581). Zonisamide is teratogenic in mice, rats and dogs and embryolethal in monkeys when administered orally during the period of organogenesis. The pre-clinical studies in various animals indicated increased incidences of fetal cardiovascular malformations (ventricular septal defects, cardiomegaly, valvular and arterial anomalies), embryofetal deaths, skeletal and/or craniofacial defects, delayed behavioural development. Zonisamide must not be used in pregnancy unless clearly necessary and only if the potential benefit is considered to justify the risk to the fetus. The need for antiepileptic treatment should be reviewed in patients planning to become pregnant. If zonisamide is prescribed, careful monitoring is recommended. Specialist advice should be given to women who are likely to become pregnant in order to consider the optimal treatment during pregnancy. Central Nervous System Anticonvulsants/antiepileptics
zopiclone C This drug is likely to produce CNS depression in newborn infants when given during labour. Central Nervous System Hypnotics and sedatives
zuclopenthixol C When given in high doses during late pregnancy, related compounds have caused prolonged neurological disturbances in the newborn infant. Central Nervous System Antipsychotic drugs
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