pharmacopeia
GET
/api/v1/drug/hydroxyzine
2D structure
2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol
SMILES C1CN(CCN1CCOCCO)C(C2=CC=CC=C2)C3=CC=C(C=C3)Cl
InChIKey ZQDWXGKKHFNSQK-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Histamine H1 Receptor Antagonists; Histamine Receptor Antagonists.

Histamine H1 ReceptorHistamine Receptor

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses. For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus: adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses. As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg for adults and 0.6 mg/kg of body weight in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all potent medication, the dosage should be adjusted according to the patient's response to therapy.

Warnings & precautions

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

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.

Overdosage

Sourced from openFDA

The most common manifestation of hydroxyzine overdosage is hypersedation. Other reported signs and symptoms were convulsions, stupor, nausea and vomiting. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and levarterenol or metaraminol. Do not use epinephrine as hydroxyzine counteracts its pressor action. Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes. ECG monitoring is recommended in cases of hydroxyzine overdose. There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.

Approval history

Sourced from openFDA
  • Aug 27, 1981ANDAANDA087408Am Regent
  • Dec 14, 1981ANDAANDA087479Sandoz
  • Dec 14, 1981ANDAANDA086183Sandoz
  • Apr 12, 1982ANDAANDA087294Chartwell Rx
  • Dec 20, 1982ANDAANDA087871Aurobindo Pharma Ltd
  • Jun 15, 1984ANDAANDA088487Barr Labs
  • Jun 15, 1984ANDAANDA088488Barr Labs
  • Jun 15, 1984ANDAANDA088496Barr

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
49,205 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective3,3606.8%
  2. 2Pruritus3,2126.5%
  3. 3Nausea2,9306.0%
  4. 4Fatigue2,8645.8%
  5. 5Completed Suicide2,5315.1%
  6. 6Toxicity To Various Agents2,5215.1%
  7. 7Off Label Use2,4925.1%
  8. 8Pain2,4294.9%
  9. 9Headache2,3584.8%
  10. 10Rash2,1814.4%
  11. 11Diarrhoea2,0584.2%
  12. 12Anxiety2,0194.1%
  13. 13Dyspnoea1,9974.1%
  14. 14Vomiting1,8313.7%
  15. 15Dizziness1,7203.5%

Literature

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Recent PubMed references pinned to Hydroxyzine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 126 ClinicalTrials.gov registrations naming Hydroxyzine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Hydroxyzine work?
Mechanism-of-action classes: Histamine H1 Receptor Antagonists; Histamine Receptor Antagonists.
What is Hydroxyzine used for?
According to FDA labeling, Hydroxyzine carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Hydroxyzine?
Hydroxyzine is classified as Diphenylmethane derivatives, Antihistamine, Histamine H1 Receptor Antagonists, Histamine Receptor Antagonists, Decreased Histamine Activity.
What are the brand names for Hydroxyzine?
Hydroxyzine is marketed under brand names including Vistaril.
What are the contraindications for Hydroxyzine?
Hydroxyzine labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for hydroxyzine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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