Eplerenone Pregnancy and Breastfeeding Warnings
Brand names: Inspra
Medically reviewed by Drugs.com. Last updated on Mar 8, 2024.
Eplerenone Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
Risk Summary: Insufficient data exists to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Animal studies have revealed decreased fetal weights, decreased maternal body weight, increased fetal resorptions, and increased post-implantation loss at exposures up to 32 times the human AUC for the 100 mg/day therapeutic dose. 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.
Eplerenone 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: Unknown
Excreted into animal milk: Yes
Comments: The effects in the nursing infant are unknown.
See also
References for pregnancy information
- (2002) "Product Information. Inspra (eplerenone)." Searle
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
References for breastfeeding information
- (2002) "Product Information. Inspra (eplerenone)." Searle
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- 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.