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Amlodipine / benazepril Pregnancy and Breastfeeding Warnings

Amlodipine / benazepril is also known as: Amlobenz, Lotrel

Medically reviewed on March 12, 2018

Amlodipine / benazepril Pregnancy Warnings

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.

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.

See references

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 references

References for pregnancy information

  1. "Product Information. Lotrel (amlodipine-benazepril)." Ciba Pharmaceuticals, Summit, NJ.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Lotrel (amlodipine-benazepril)." Ciba Pharmaceuticals, Summit, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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