FDA label
What is hydroxyzine used for?
The FDA-approved uses of hydroxyzine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.”
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Hydroxyzine Hydrochloride, tablet, film coated
Indications and Usage, quoted from the label by Teva Pharmaceuticals USA, Inc. (ANDA088617). Cross-references to other label sections are left out.
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus.
As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.
The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
Source: DailyMed label, set id 80309ec1-e5d5-4454-b8ce-67d7e6805e44, version 17, effective July 31, 2025. NDC 0093-5060, one of 97 listings for this product.
Hydroxyzine Pamoate, capsule
Indications and Usage, quoted from the label by Amneal Pharmaceuticals of New York LLC (ANDA040156). Cross-references to other label sections are left out.
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.
As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.
The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
Source: DailyMed label, set id bc82aaaf-30c7-4afe-a908-d138ea1268ef, version 11, effective June 11, 2026. NDC 0115-1803, one of 82 listings for this product.
Questions
What is hydroxyzine used for?
The FDA label says: “For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.”
What drug class is hydroxyzine?
FDA lists hydroxyzine in the Antihistamine established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.