Hydroxyzine Hydrochloride Medication Guide

Conditions This Medication May Treat

Based on Bridgeway's clinical use. See the FDA "Uses" section below for approved indications.

Anxiety Disorders

Uses (FDA Indications) (FDA source)

INDICATIONS AND USAGE 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.

Warnings & Precautions (FDA source)

WARNINGS Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.

Common Side Effects (FDA source)

ADVERSE REACTIONS Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in post marketing reports. Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature. Anticholinergic : Dry mouth. Central Nervous System : Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of dose. Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. In post-marketing experience, the following additional undesirable effects have been reported: Cardiac System: QT prolongation, Torsade de Pointes. Body as a Whole: Allergic reaction. Nervous System : Headache. Psychiatric : Hallucination. Skin and Appendages : Pruritus, rash, urticaria.

Contraindications (FDA source)

CONTRAINDICATIONS Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride. Hydroxyzine is contraindicated in patients with a prolonged QT interval. Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy. Hydroxyzine is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.

Most-Reported Adverse Events (FAERS)

Of 50,845 adverse-event reports mentioning Hydroxyzine Hydrochloride submitted to the FDA, the most frequently reported reactions are:

• Drug Ineffective — 3,485 reports
• Pruritus — 3,383 reports
• Nausea — 3,067 reports
• Fatigue — 2,961 reports
• Off Label Use — 2,620 reports
• Toxicity To Various Agents — 2,567 reports
• Completed Suicide — 2,544 reports
• Pain — 2,510 reports
• Headache — 2,453 reports
• Rash — 2,274 reports

Source: FDA Adverse Event Reporting System (FAERS). These are voluntary, unverified reports from patients and providers worldwide — they do not mean the medication caused the reaction, and report counts reflect how widely a drug is used as much as its safety profile.

Recent FDA Recalls

There is 1 ongoing FDA recall involving Hydroxyzine Hydrochloride. See full medication safety feed →