Isosorbide dinitrate Pregnancy and Breastfeeding Warnings
Brand names: Dilatrate-SR, ISDN, IsoDitrate, Isochron, Isordil, Isordil Tembids, Isordil Titradose, Sorbitrate
Medically reviewed by Drugs.com. Last updated on Jul 27, 2023.
Isosorbide dinitrate Pregnancy Warnings
Use is not recommended unless clearly needed.
AU TGA pregnancy category: B1
US FDA pregnancy category: C
Animal studies have revealed evidence of embryotoxicity. There are no controlled data in human pregnancy.
AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.
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.
Isosorbide dinitrate Breastfeeding Warnings
Caution is recommended.
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
- (2002) "Product Information. Isordil (isosorbide dinitrate)." Wyeth-Ayerst Laboratories
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
References for breastfeeding information
- (2002) "Product Information. Isordil (isosorbide dinitrate)." Wyeth-Ayerst Laboratories
- 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.