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Spironolactone Pregnancy and Breastfeeding Warnings

Spironolactone is also known as: Aldactone, CaroSpir

Medically reviewed on Dec 28, 2017

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: C

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Aldactone (spironolactone)." Searle, Skokie, IL.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Aldactone (spironolactone)." Searle, Skokie, IL.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

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

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