Finasteride Pregnancy and Breastfeeding Warnings
Brand names: Propecia, Proscar
Medically reviewed by Drugs.com. Last updated on Aug 31, 2023.
Finasteride Pregnancy Warnings
AU TGA pregnancy 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.
US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Use is contraindicated
AU TGA pregnancy category: X
US FDA pregnancy category: X
Comments:
-Finasteride is not indicated for use in females.
-Adequate methods of contraception should be encouraged.
-Finasteride is present in semen and therefore may pose a risk to the fetus. Male patients should be instructed to wear a condom during intercourse with women of childbearing potential or discontinue finasteride. The drug should be discontinued in patients wishing to conceive a child.
-Women who are or may become pregnant should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. (Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.)
Finasteride Breastfeeding Warnings
Finasteride is not indicated for use in females.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
See also
References for pregnancy information
- Product Information. Proscar (finasteride). Merck & Co., Inc. 2002;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
References for breastfeeding information
- Carlin JR, Hoglund P, Eriksson LO, Christofalo P, Gregoire SL, Taylor AM, Andersson KE. Disposition and pharmacokinetics of [14C] finasteride after oral administration in humans. Drug Metab Dispos. 1992;20:148-55.
- Product Information. Proscar (finasteride). Merck & Co., Inc. 2002;PROD.
- Cerner Multum, Inc. Australian Product Information.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
