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Fertility/Pregnancy: Eplerenone has not been studied in pregnant women. Animal studies did not indicate direct or indirect adverse effects with respect to pregnancy, embryofetal development, parturition or post-natal development (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). Caution should be exercised when prescribing eplerenone to pregnant women.
Lactation: It is unknown if eplerenone is excreted in human breast milk after oral administration. However, preclinical data show that eplerenone and/or metabolites are present in rat breast milk and that rat pups exposed by this route developed normally. Because many drugs are excreted in human milk and because of the unknown potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
