Skip to Content

Fexofenadine Pregnancy and Breastfeeding Warnings

Fexofenadine is also known as: Allegra, Allegra Allergy, Allegra Hives, Allegra ODT, Aller-Ease, Mucinex Allergy

Fexofenadine Pregnancy Warnings

Use is not recommended unless clearly needed. AU TGA pregnancy category: B2 US FDA pregnancy category: C

Animal models have failed to reveal evidence of teratogenicity. Decreased dose-related pup weight gain and survival occurred at 3 times the maximum recommended human dose. There are no controlled data in human pregnancy. AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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.

See references

Fexofenadine Breastfeeding Warnings

This drug is a metabolite of terfenadine; when given terfenadine, animal models expressed this drug.

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

See references

References for pregnancy information

  1. "Product Information. Allegra (fexofenadine)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Allegra (fexofenadine)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  2. 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 -]):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

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