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Fexofenadine Pregnancy and Breastfeeding Warnings

Brand names: Allegra, Allegra Allergy, Allegra Hives, Allegra ODT, Aller-Ease, Mucinex Allergy

Medically reviewed by Drugs.com. Last updated on Jan 10, 2025.

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

Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comment:
-The effects in the nursing infant are unknown.

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

See references

See also

References for pregnancy information

  1. (2001) "Product Information. Allegra (fexofenadine)." Hoechst Marion Roussel
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."

References for breastfeeding information

  1. (2001) "Product Information. Allegra (fexofenadine)." Hoechst Marion Roussel
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. 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.

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