Amlodipine / benazepril Pregnancy and Breastfeeding Warnings
Brand names: Amlobenz, Lotrel
Medically reviewed by Drugs.com. Last updated on Apr 7, 2025.
Amlodipine / benazepril Pregnancy Warnings
This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus.
US FDA pregnancy category: D
Comments: Adequate methods of contraception should be encouraged.
Animal studies with amlodipine have revealed decreased litter size, increased intrauterine deaths, and prolonged gestation and labor. Animal studies with benazepril have failed to reveal evidence of teratogenicity. In humans, use of drugs that act on the renin angiotensin system during the second and third trimesters increases fetal and neonatal morbidity and death. There are no controlled data in human pregnancy.
US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Amlodipine / benazepril 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: Yes (amlodipine, benazepril [in small amounts])
See also
References for pregnancy information
- (2001) "Product Information. Lotrel (amlodipine-benazepril)." Ciba-Geigy Pharmaceuticals
References for breastfeeding information
- (2001) "Product Information. Lotrel (amlodipine-benazepril)." Ciba-Geigy Pharmaceuticals
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.