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Hydroxyzine Pregnancy and Breastfeeding Warnings

Hydroxyzine is also known as: Atarax, Hyzine, Rezine, Vistaril, Vistazine

Hydroxyzine Pregnancy Warnings

UK: Contraindicated
US: Contraindicated during early pregnancy.

US FDA pregnancy category: Not Assigned

Comments: This drug crosses the placental barrier, which may lead to higher fetal than maternal concentrations.

The following effects were observed immediately or only a few hours after birth in neonates whose mothers received this drug during late pregnancy and/or labor: hypotonia, movement disorders including extrapyramidal disorders, clonic movements, central nervous system (CNS) depression, neonatal hypoxic conditions, or urinary retention. Animal studies have revealed reproductive toxicity (fetal malformations and abortions) occurring at doses substantially above the human therapeutic range. Additionally, doses of 10 mg/kg/day for 70 days reduced the concentration and viability of spermatocytes in male animals.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Hydroxyzine Breastfeeding Warnings

UK: Contraindicated
US: This drug should not be given to nursing mothers.

Excreted into human milk: Unknown

Comments: Although there are no relevant data available, it is expected that this drug may be excreted into breast milk. The effects on the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Vistaril (hydroxyzine)." Pfizer US Pharmaceuticals, New York, NY.

References for breastfeeding information

  1. "Product Information. Vistaril (hydroxyzine)." Pfizer US Pharmaceuticals, New York, NY.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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