Skip to Content
Here’s what to ask a doctor about hereditary angioedema

Amlodipine Pregnancy and Breastfeeding Warnings

Amlodipine is also known as: Norvasc

Amlodipine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus (AU, US) Use is contraindicated (UK) AU TGA pregnancy category: C US FDA pregnancy category: C Comments: -Use of adequate methods of contraception should be encouraged. -If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have shown significantly decreased litter size, increased intrauterine deaths and prolongation of gestation and duration of labor when this drug was given before mating, throughout mating, and during gestation. There are no controlled data in human pregnancy. Reversible biochemical changes in the head of spermatozoa occurred in some patients treated with calcium channel blockers. There are no controlled data for this drug, but animal models have shown adverse effects on male fertility. 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 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.

See references

Amlodipine Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother (AU, US) Use is contraindicated (UK) Excreted into human milk: Yes Comments: -The effects in the nursing infant are unknown. -Infants exposed to this drug should be closely monitored.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Norvasc (amlodipine)." Pfizer US Pharmaceuticals, New York, NY.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Norvasc (amlodipine)." Pfizer US Pharmaceuticals, New York, NY.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. 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 -]):

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com 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.

Hide