Is Atarax (hydroxyzine) safe to use during pregnancy?

Hydroxyzine (Atarax) Should Be Avoided During Pregnancy

Hydroxyzine is contraindicated in early pregnancy according to the FDA drug label, and should be avoided throughout pregnancy when possible, particularly in the first trimester. 1

FDA Contraindication and Animal Data

• The FDA drug label explicitly states that hydroxyzine is contraindicated in early pregnancy due to animal studies showing fetal abnormalities in rats and mice at doses substantially above the human therapeutic range 1
• Clinical data in humans are inadequate to establish safety in early pregnancy, which is the basis for the contraindication 1
• This represents the strongest regulatory warning against use during pregnancy

Guideline Recommendations

• The British Journal of Dermatology guidelines recommend avoiding all antihistamines in pregnancy when possible, especially in the first trimester, though none has been proven teratogenic in humans 2
• When antihistamine treatment is absolutely necessary during pregnancy, chlorphenamine is often chosen due to its long safety record, while loratadine and cetirizine are FDA Pregnancy Category B drugs (safer alternatives) 2
• The Journal of Allergy and Clinical Immunology guidelines specifically mention hydroxyzine in the context of pregnancy safety discussions, noting limited safety data compared to other antihistamines 3

Clinical Decision Algorithm

If antihistamine therapy is required during pregnancy:

1. First-line alternatives: Use chlorphenamine (long safety record) or loratadine/cetirizine (FDA Category B) instead of hydroxyzine 2
2. Risk-benefit assessment: Weigh the benefits of treating maternal symptoms against potential fetal risks before prescribing any medication 4
3. Timing considerations: Avoid all antihistamines if possible in the first trimester when organogenesis occurs 2
4. If hydroxyzine exposure occurs: Individual risk assessment and risk management strategy must be determined 5

Important Caveats

• While hydroxyzine has not been definitively proven teratogenic in humans, the combination of FDA contraindication, animal data showing fetal abnormalities, and availability of safer alternatives makes it inappropriate for use during pregnancy 1, 2
• The safety profile of medications can change according to gestational age, with first trimester exposure carrying the highest risk for structural malformations 6, 7
• An estimated 10% or more of birth defects result from maternal drug exposure, emphasizing the importance of avoiding medications with uncertain safety profiles 6, 7