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Hydroxyzine and Pregnancy

Based on animal studies on pregnancy and hydroxyzine, high doses of the medication may increase the risk of birth defects and fetal death. There is also some research indicating that hydroxyzine may cause cleft palate if taken during pregnancy. Because of the lack of information, the manufacturer recommends that women avoid this drug during the first trimester.

Is Hydroxyzine Safe During Pregnancy?

For women who are pregnant, hydroxyzine (Atarax®, Vistaril®) may not be safe. This is based on limited information from the use of the medication in pregnant animals and humans.

Hydroxyzine and Pregnancy Category C

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies.
Medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
When given to pregnant animals at high doses, hydroxyzine appears to increase the risk of birth defects and fetal death. Very limited information from use in humans suggests that there may be a link between hydroxyzine use and cleft palate, but there is not enough information to know for sure if this is a true problem.
The manufacturers of hydroxyzine state that the medication should not be used during the first trimester of pregnancy due to the lack of safety information. However, some forms are approved for use before and after childbirth to cause sedation, relieve anxiety, reduce the dose of opioid pain relievers, and relieve nausea and vomiting.
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Hydroxyzine Drug Information

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