Ethacrynic acid Pregnancy and Breastfeeding Warnings
Brand names: Edecrin, Sodium Edecrin
Medically reviewed by Drugs.com. Last updated on Jul 4, 2025.
Ethacrynic acid Pregnancy Warnings
Use is not recommended and should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned
Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.
Animal studies have revealed reduced fetal body weights. There are no controlled data in human pregnancy.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
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.
Ethacrynic acid 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: Data not available
Comments: The effects in the nursing infant are unknown.
See also
References for pregnancy information
- (2001) "Product Information. Edecrin (ethacrynic acid)." Merck & Co., Inc
- Cerner Multum, Inc. "Australian Product Information."
- (2020) "Product Information. Edecrin (ethacrynic acid)." Bausch Health US (formerly Valeant Pharmaceuticals)
References for breastfeeding information
- (2001) "Product Information. Edecrin (ethacrynic acid)." Merck & Co., Inc
- 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.