Skip to Content

Amlodipine Pregnancy and Breastfeeding Warnings

Amlodipine is also known as: Norvasc

Amlodipine Pregnancy Warnings

Amlodipine has been assigned to pregnancy category C by the FDA. Animal studies have revealed decreased litter size and intrauterine deaths, as well as prolonged gestation after oral doses exceeding 8 to 23 times the maximum recommended human dose. Animal studies have failed to reveal evidence of teratogenicity or fetal toxicity. There are no controlled data in human pregnancy. Amlodipine should only be given during pregnancy when benefit outweighs risk.

Rats and mice treated with amlodipine maleate in the diet for up to two years (at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg/kg/day) showed no evidence of carcinogenic effects. For the mouse, the highest dose was similar to the maximum recommended human dose of 10 mg/day (based on mg/m2). For the rat, the highest dose was about twice the maximum recommended human dose (based on mg/m2).

See references

Amlodipine Breastfeeding Warnings

Use of amlodipine is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Norvasc (amlodipine)." Pfizer US Pharmaceuticals, New York, NY.

References for breastfeeding information

  1. "Product Information. Norvasc (amlodipine)." Pfizer US Pharmaceuticals, New York, NY.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.