Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Hydroxyzine
Drug ID BADD_D01111
Description Hydroxyzine is a first-generation histamine H1-receptor antagonist of the dephenylmethane and piperazine classes that exhibits sedative, anxiolytic, and antiemetic properties.[A1257,A187589] It was first developed in 1955,[A189726] and has since remained a relatively common treatment for allergic conditions such as pruritus, urticaria, dermatoses, and histamine-mediated pruritus.[L9677] The active metabolite of hydroxyzine, [cetirizine], is also available as an active ingredient in allergic medications, and is responsible for much of its hydroxyzine's antihistaminic effect.[A189753] Hydroxyzine is also used for generalized anxiety disorder, tension caused by psychoneurosis, and other conditions with manifestations of anxiety.[L9677]
Indications and Usage Hydroxyzine is indicated for the symptomatic relief of anxiety and tension associated with psychoneuroses, and as an adjunct in organic disease states in which anxiety is manifested.[L9677] It is also indicated in the treatment of histamine-mediated pruritus and pruritus due to allergic conditions such as chronic urticaria.[L9677] Canadian labeling states that hydroxyzine is also indicated in adults and children as a premedication prior to medical procedures, such as dental surgery.[L9680] It is also used in the control of nausea and vomiting, excluding nausea and vomiting of pregnancy.[L9680]
Marketing Status approved
ATC Code N05BB01
DrugBank ID DB00557
KEGG ID D08054
MeSH ID D006919
PubChem ID 3658
TTD Drug ID D0O6SX
NDC Product Code 65162-577; 65162-575; 65162-671; 52584-007; 0404-9878
UNII 30S50YM8OG
Synonyms Hydroxyzine | 2-(2-(4-((4-Chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)ethanol | Hydroxyzine Dihydrochloride | Vistaril | Hydroxyzine Pamoate | Pamoate, Hydroxyzine | Orgatrax | Durrax | Atarax | Hydroxyzine Hydrochloride
Chemical Information
Molecular Formula C21H27ClN2O2
CAS Registry Number 68-88-2
SMILES C1CN(CCN1CCOCCO)C(C2=CC=CC=C2)C3=CC=C(C=C3)Cl
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Constipation07.02.02.001--
Cough22.02.03.001--
Crying08.01.03.005; 12.02.11.001; 17.02.05.013; 19.04.02.0020.000082%-
Delirium19.13.02.0010.000093%
Depressed level of consciousness17.02.04.0020.000056%
Depression19.15.01.0010.000326%
Dermatitis23.03.04.002---
Dermatitis exfoliative10.01.01.004; 23.03.07.0010.000056%
Disorientation17.02.05.015; 19.13.01.0020.000111%-
Disturbance in attention17.03.03.001; 19.21.02.002--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Drug abuse19.07.06.0100.000371%-
Drug eruption08.01.06.015; 10.01.01.005; 23.03.05.001---
Drug hypersensitivity10.01.01.0010.006914%-
Drug ineffective08.06.01.0060.001319%-
Drug interaction08.06.03.0010.000111%-
Dry mouth07.06.01.0020.000137%
Dyspnoea02.11.05.003; 22.02.01.004--
Eczema23.03.04.0060.000037%
Epilepsy17.12.03.0020.000037%-
Erythema23.03.06.001---
Erythema multiforme10.01.03.015; 23.03.01.0030.000056%
Extrapyramidal disorder17.01.02.0070.000056%
Eyelid oedema06.04.04.004; 10.01.05.001; 23.04.01.0030.000082%-
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.0040.000037%
Feeling abnormal08.01.09.014---
Feeling hot08.01.09.009---
Generalised tonic-clonic seizure17.12.01.0020.000185%-
Hallucination19.10.04.0030.000100%
Hallucination, visual19.10.04.0070.000056%-
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