DIQTA 1.0: Drug-Induced QT Prolongation Atlas

HYDROXYZINE HYDROCHLORIDE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Most-DIQT concern

Severity Score:4.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

PRECAUTIONS
QT Prolongation/Torsade de Pointes (TdP): Cases of QT prolongation and Torsade de Pointes have been reported during post-marketing use of hydroxyzine. The majority of reports occurred in patients with other risk factors for QT prolongation/TdP (pre-existing heart disease, electrolyte imbalances or concomitant arrhythmogenic drug use). Therefore, hydroxyzine should be used with caution in patients with risk factors for QT prolongation, congenital long QT syndrome, a family history of long QT syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia, as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias.
Caution is recommended during the concomitant use of drugs known to prolong the QT interval. These include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, certain antipsychotics (e.g., ziprasidone, iloperidone, clozapine, quetiapine, chlorpromazine), certain antidepressants (e.g., citalopram, fluoxetine), certain antibiotics (e.g., azithromycin, erythromycin, clarithromycin, gatifloxacin, moxifloxacin); and others (e.g., pentamidine, methadone, ondansetron, droperidol).
CONTRAINDICATIONS
Hydroxyzine is contraindicated in patients with a prolonged QT interval.
OVERDOSAGE
Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes. ECG monitoring is recommended in cases of hydroxyzine overdose.
ADVERSE REACTIONS
Cardiac System
QT prolongation, Torsade de Pointes.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

102

23990

Other ADRs

9759

38371828

Odds Ratio = 16.718

Drug Property Information

ATC Code(s):

N05BB01 - hydroxyzine hydrochloride

N05BB - Diphenylmethane derivatives
N05B - ANXIOLYTICS
N05 - PSYCHOLEPTICS
N - NERVOUS SYSTEM

Active Ingredient:HYDROXYZINE HYDROCHLORIDE

Active Ingredient UNII:76755771U3

Drugbank ID:DB00557

PubChem Compound:3658

CTD ID:D006919

PharmGKB:PA449943

CAS Number:68-88-2

Dosage Form(s):tablet, film coated

Route(s) Of Administrator:oral

Daily Dose:

75.0 mg/day N05BB01

Chemical Structure:

SMILE Code:
OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1

Reference

N/A