Hydrochlorothiazide / spironolactone Pregnancy and Breastfeeding Warnings

Brand names: Aldactazide

Medically reviewed by Drugs.com. Last updated on Feb 26, 2024.

Hydrochlorothiazide / spironolactone Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

Animal studies with hydrochlorothiazide have failed to reveal evidence of teratogenicity. Animal studies with spironolactone have revealed evidence of teratogenicity. There are no controlled data in human pregnancy.

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.

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Hydrochlorothiazide / spironolactone Breastfeeding Warnings

Use is not recommended and 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 (hydrochlorothiazide); Data not available (spironolactone, but canrenone which is a major and active metabolite of spironolactone, is excreted into human milk)
Excreted into animal milk: Data not available (spironolactone)

Spironolactone has been found to be tumorigenic in rats.

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Further information

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