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Prescribing medicines in pregnancy database

3 March 2014

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

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.

Please note: you must have javascript enabled to use this search facility.

Search by name

  • Type the generic name/active ingredient of the medicine (or part of the name). The medicine will appear, with its classification and Pregnancy Category.
  • Click on the medicine to obtain the description of the category, and safety statements when applicable. For combination products, search the medicines individually.

Search by active ingredient/generic name of a medicine

Search by classification level

  • To select medicines by their pharmacological group or pharmacological action, select a classification level from the drop-down list.
  • To view all medicines, click on Display All.
  • Click on the medicine to obtain the description of the category, and safety statements when applicable. For combination products, search the medicines individually.
Medicine Classification
Level 1
Level 2
Level 3

More information

If you know the trade name of a medicine, then the name of the active ingredient can be found in the Australian Register of therapeutic Goods.

More information on using medicines in pregnancy can be found in the Product Information or Consumer Medicine Information documents.

For medicines approved after 2009, more information can be found in the Australian Public Assessment Report (AusPAR) for prescription medicines.

Print information

Search results

No Results have been found, this may mean either:

  1. the medicine lacks a pregnancy classification (Therapeutic goods exempted from pregnancy categorisation);
  2. the medicine has not been registered in Australia;
  3. the medicine name is misspelled, or you may have used the trade name instead of the name of the active ingredient.

Using the trade name, find the active ingredient of the medicine in the Australian Register of therapeutic Goods.

Find the Product Information or Consumer Medicine Information documents of many prescription medicines registered in Australia, searching for the trade name or active ingredient.

For medicines approved after 2009, more information can be found in the Australian Public Assessment Report (AusPAR) for prescription medicines.

No Results have been found.

Try selecting different values from the drop-down list, or searching by the medicine name.

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.

The Australian categorisation system for prescribing medicines in pregnancy

The 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.

Please note: you must have javascript enabled to use this search facility.

Name:
Category:
Category Description:
Classification 1:
Classification 2:
Classification 3:
Additional Information:

Active Ingredient/Generic Name

The substance in a medicine that is biologically active and which due to its pharmacological activity is responsible for producing the desired effect on the structure or function of the body.

Trade Name/Commercial Name

A name used to identify a commercial product or service. One generic medicine can have multiple commercial names.

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Content last updated: Monday, 3 March 2014

Content last reviewed: Monday, 3 March 2014

Web page last updated: Monday, 3 March 2014

URL: http://www.tga.gov.au/hp/medicines-pregnancy.htm