Prescribing medicines in pregnancy database
The Australian categorisation system for prescribing medicines in pregnancy.
Our database search is temporarily unavailable. The full database is provided as a searchable table below. You can also access the database, including the search function, via TROVE.
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.
What does the Australian categorisation system take into account?
Most medicines cross the placenta. The categorisation system has taken into account the known harmful effects of medicines on the developing baby, including the potential to cause:
- birth defects
- unwanted pharmacological effects around the time of birth, which may or may not be reversible
- problems in later life
The categorisation system does not take into account the rare circumstance of an idiosyncratic reaction in the neonate to a medicine that crosses the placenta.
Situations for which the pregnancy category may not be valid
The pregnancy categorisation system only applies to recommended therapeutic doses in women. It cannot be assumed that the classifications assigned to individual medicines are valid in situations such as:
- Overdose
- Occupational exposure
- Other situations in which the recommended therapeutic dose has been exceeded
Why do some products have more than one pregnancy category?
While some medicines are genuinely teratogenic, and carry a category X, for most medicines the risk of developing birth defects is also dependent on:
- Systemic exposure of the mother
- Exposure of the fetus, which may be affected by:
- Dose
- Route of administration
- Dosing regimen
Thus, a low dose, limited topical application of a medicine for a particular indication may have a less restrictive category (such as A) compared to a more restrictive category for the same medicine given long-term or at higher doses orally for a different indication.
The Australian categorisation system is not hierarchical
The Australian categorisation system differs from the US FDA categorisation. The categorisation of medicines for use in pregnancy does not follow a hierarchical structure.
- Human data are lacking or inadequate for drugs in the B1, B2 and B3 categories
- Subcategorisation of the B category is based on animal data
- The allocation of a B category does not imply greater safety than a C category
- Medicines in category D are not absolutely contraindicated during pregnancy (e.g.anticonvulsants)
Due to legal considerations in Australia, sponsor companies have, in some cases, applied a more restrictive category than can be justified on the basis of the available data.
For pharmaceutical products containing two or more active ingredients, the categorisation of the combination is based on the active ingredient with the most restrictive pregnancy categorisation.
Definitions of the Australian categories for prescribing medicines in pregnancy
Category A
Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
Category B1
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have not shown evidence of an increased occurrence of fetal damage.
Category B2
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
Category B3
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
Category 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.
Category 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.
Category X
Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.
By accessing the database, you acknowledge that you have read, understood and accept the introductory information above and the basis on which this information is provided.
This database is intended to provide information to health professionals planning the medical management of pregnant patients or patients intending to become pregnant. It is not presented as medical advice to health professionals or the public.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. Any decision about taking a medicine during pregnancy should:
- involve a health professional and the patient
- take into account:
- all available information on the medicine
- the specific circumstances
This database must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
The database does not include all therapeutic goods, because certain types of therapeutic good are usually exempt from pregnancy categorisation. Those that are included have been categorised using the Australian categorisation system for prescribing medicines in pregnancy. In addition to the category, the safety statement for each medicine or medicine class should be considered integral information about the medicine.
In some cases there may be discrepancies between the published Product Information and the information in this database due to the process of ongoing revision.
The pregnancy category and safety statement for some medicines that are no longer registered for use in Australia are presented in this database for information only. Likewise, the pregnancy category for medicines registered for use in men only is also presented for information purposes only.
Database search
Our database search is temporarily unavailable. The full database is provided as a searchable table below. You can also access the database, including the search function, via TROVE.
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.
| Drug 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) | B2 | - | 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 | - |
| 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 | Cytotoxic agents can produce 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 | - |
| 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 | - |
| 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 | - |
| 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:
|
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 | - |
| 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 |
| 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 | 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 | Cytotoxic agents can produce 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 | - |
| 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 | - |
| 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 | - |
| 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 | 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 | - |
| 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 | - |
| 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 inju-ry 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) | - |
| 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 | - |
| 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 | B3 | 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 | - |
| gatifloxacin | B3 | - | Antimicrobials | Antibiotics | Quinolones |
| gefitinib | C | This drug inhibits EGFR. EGFR plays an important role in embryofetal development. | Antineoplastic Agents | Tyrosine kinase inhibitors | - |
| gelatin - succinylated | B3 | - | Cardiovascular System | - | - |
| 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 | - |
| 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 | - |
| 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 | - |
| inactivated influenza vaccine (pandemic) | B2 | - | Vaccines | Inactivated vaccines | - |
| inactivated influenza vaccine (pre-pandemic) | B2 | - | Vaccines | Inactivated vaccines | - |
| inactivated influenza vaccine (seasonal), split, trivalent or quadrivalent | A | - | Vaccines | Inactivated vaccines | - |
| inactivated influenza vaccine (seasonal), surface antigen, trivalent or quadrivalent | B1 or B2 (depending on brand of vaccine) | - | Vaccines | Inactivated vaccines | - |
| 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 | - |
| 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 (seasonal; recombinant) | 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 |
| 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 | - |
| 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:
|
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 | - | - |
| 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 | - | - |
| 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 | 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 | - |
| 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) chloride | 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 pro-duce 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:
|
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:
|
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 | B2 | - | 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 | - |
| 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 | - |
| 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 | - |
| 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 bl-ockers 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 | - |
| 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 | - | - |
| 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:
|
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 | Anti-sychotic drugs | - |
| palonosetron | B1 | - | Central Nervous System | Antiemetics, antinauseants | - |
| pamidronate | B3 | - | Endocrine System | Agents affecting calcium and bone metabolism | Bis-phosphonates |
| 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 | Pegaspargase is a modified version of the enzyme asparaginase. Animal studies in rats or rabbits with native L-asparaginase have shown adverse effects of embryofetal lethality and fetal malformations. Due to teratogenicity also shown in animal studies with L-asparaginase, pegaspargase should not be used during pregnancy. | 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:
|
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:
|
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:
|
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 | - |
| 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:
|
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 | Deco-ngestants | - |
| 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 | - |
| 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 | - |
| 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 | - | - |
| 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 | - | - |
| 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 | - |
| 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 | - |
| 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 | - |
| 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 in-dications. 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 | - | - |
| 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 | - | - |
| 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 pregna-ncy. 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 | - |