Spironolactone Pregnancy and Breastfeeding Warnings

Brand names: Aldactone, CaroSpir

Medically reviewed by Drugs.com. Last updated on Mar 4, 2025.

Spironolactone Pregnancy Warnings

Use is considered contraindicated; use during pregnancy requires the benefit be weighed against the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk summary: Based on the mechanism of action and findings in animals, this drug may affect sex differentiation of the male during embryogenesis. Inadequate data available on the use of this drug in pregnant women to inform a drug-related risk.

Comments: Adequate methods of contraception should be encouraged.

Animal studies have revealed an increased resorption rate, decreased live fetuses, and progestational and antiandrogenic effects. There are no controlled data in human pregnancy.

AU TGA pregnancy 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.

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.

See references

Spironolactone 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.

Excreted into human milk: Yes (as active metabolite)

According to some authorities, use of this drug appears acceptable during breastfeeding.

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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