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Hydroxyzine Pregnancy and Breastfeeding Warnings

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

Hydroxyzine Pregnancy Warnings

Use is contraindicated.

US FDA pregnancy category: Not Assigned.

Risk Summary: There are limited data available on use of this drug in early pregnancy to inform of a drug-related risk.

Comments:
-Some authorities state that use is contraindicated during early pregnancy.
-This drug crosses the placental barrier, which may lead to higher fetal than maternal concentrations.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Reports in neonates exposed during late pregnancy and/or labor and delivery included central nervous system (CNS) depression, clonic movements, extrapyramidal symptoms, hypotension, movement disorders, neonatal hypoxic conditions, and/or urinary retention.

Animal studies have revealed evidence of fetal abnormalities at doses substantially above the human therapeutic range. There are no controlled data in human pregnancy.

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

Use is not recommended, and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes (cetirizine [main metabolite]); Unknown (parent drug)
Excreted into animal milk: No data (parent drug)

Comments:
-Some authorities state that use is contraindicated.
-This drug may be excreted into breast milk.
-Serious side effects have been reported in breastfed newborns/infants.
-Some experts state that healthcare providers should consider switching treatment to alternative agents (e.g., desloratadine, fexofenadine, loratadine), especially in breastfed newborn or preterm infants.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Atarax (hydroxyzine)" Pfizer US Pharmaceuticals, New York, NY.
  3. "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.
  2. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  3. 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 -]):
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. "Product Information. Atarax (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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