Is Hydroxyzine (Vistaril) safe during pregnancy?
What the FDA-approved label for Hydroxyzine (Vistaril) actually states in its Pregnancy Risk Summary — not a secondhand verdict. The decision is one to make with your prescriber.
What the label’s pregnancy summary says
The label states hydroxyzine is contraindicated in early pregnancy. It notes that in animal studies (mouse, rat, rabbit) hydroxyzine induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range, and that human data are inadequate to establish safety in early pregnancy — so until such data exist, it is contraindicated early in pregnancy. Anyone who is or may become pregnant should discuss this with their prescriber.
Frequently asked questions
Is Hydroxyzine safe to take during pregnancy?
The label flags a real concern for Hydroxyzine — see the summary above. This is not a drug to start or continue in pregnancy on your own; it needs a prescriber weighing the specific risks against the reason you would take it. The one universal rule: do not start or stop a medication in pregnancy without medical advice — an untreated condition can carry its own risk to a pregnancy.
What does the FDA label say about Hydroxyzine in pregnancy?
The summary above is transcribed from the label's Pregnancy Risk Summary (§8.1). Since 2015 FDA labels replaced the old A/B/C/D/X letter categories with a narrative that describes what human and animal data actually show, which is what you are reading here — not a single letter grade.
Is Hydroxyzine safe while breastfeeding?
That is a separate question the label answers in a different section (§8.2, Lactation), and it does not always match the pregnancy verdict. This page covers pregnancy only. For breastfeeding, ask your prescriber or pharmacist, or check the NIH LactMed database, which summarizes the drug-in-breast-milk evidence.
More guides for Hydroxyzine
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The pregnancy information is transcribed from the drug’s FDA-approved label (§8.1) and mirrors what the label states — “insufficient data” is never rounded up to “safe.” This is general reference information, not medical advice. Whether to take any medication in pregnancy is a decision for you and your prescriber; do not start or stop a drug on your own, because an untreated condition can also carry risk.