Azelaic acid topical Pregnancy and Breastfeeding Warnings

Brand names: Azelex, Finacea, Finevin

Medically reviewed by Drugs.com. Last updated on Aug 3, 2023.

Azelaic acid topical Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk.
-Some experts recommend: Caution is recommended.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk summary: This drug may be associated with an increase in embryotoxic effects with oral administration. There are no data available on topical use of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of embryotoxicity and impaired postnatal fetal development at maternally toxic oral doses. There are no controlled data in human pregnancy.

AU TGA pregnancy 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.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Azelaic acid topical Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-Some experts recommend: Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.
-Ointments should not be applied to the breast prior to breastfeeding; water-miscible cream or gel products should be used if necessary.

Risk to the nursing infant considered low as less than 4% is absorbed after topical application.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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