Prescribing medicines in pregnancy database

The Australian categorisation system for prescribing medicines in pregnancy

Australian categorisation system and database for prescribing medicines in pregnancy have been developed by medical and scientific experts based on available evidence of risks associated with taking particular medicines while pregnant. This information is presented for the use of health professionals prescribing medicines to pregnant women, rather than for the general public to use. It is general in nature and is not presented as medical advice to health professionals or the public. It is not intended to be used as a substitute for a health professional's advice.

See Prescribing medicines in pregnancy database for full information.

By accessing the database, you acknowledge that you have read, understood and accept the introductory information Australian categorisation system for prescribing medicines in pregnancy and accept the basis on which this information is provided.

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
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
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
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
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
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
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.	Musculoskeletal System	Antirheumatoid agents
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
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
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
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
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
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
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
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
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
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
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
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
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
dopamine	B3		Cardiovascular System	Adrenergic stimulants
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
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
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
elbasvir / grazoprevir	B1		Antimicrobials	Antiviral agents
eletriptan	B1		Cardiovascular System	Antimigraine preparations
eliglustat	B3		Metabolism	Agents used for the treatment of metabolic disorders
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
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)
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
felodipine	C	Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension.	Cardiovascular System	Antihypertensives	Calcium channel blockers
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
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
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
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
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
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)
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	B3		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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
sotorasib	B3		Antineoplastic Agents
sotrovimab	B2		Antimicrobials	Antiviral agents	antiviral monoclonal antibodies
spectinomycin	B1		Antimicrobials	Antibiotics
spesolimab	B1		Drugs Used in Dermatology	Systemic
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
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
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
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
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
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
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
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
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
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
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
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
typhoid vaccine (live attenuated, oral)	B2		Vaccines	Live attenuated vaccines
typhoid vaccine (polysaccharide)	B2		Vaccines	Subunit vaccines	Polysaccharide conjugate vaccines
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
urofollitrophin	B2		Endocrine System	Ovulation inducers	Gonadotrophins
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
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
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
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
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
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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Prescribing medicines in pregnancy database

The Australian categorisation system for prescribing medicines in pregnancy

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Prescribing medicines in pregnancy database

The Australian categorisation system for prescribing medicines in pregnancy

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