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 20, 2023.

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.

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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

Further information

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