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 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.
Marketing Status Prescription; Discontinued
ATC Code N05BB01
DrugBank ID DB00557
KEGG ID D08054
MeSH ID D006919
PubChem ID 3658
TTD Drug ID D0O6SX
NDC Product Code 65162-575; 65162-577; 63187-492; 52584-601; 52584-610; 65162-671; 0404-9878; 52584-007
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Insomnia19.02.01.002; 17.15.03.002--
Intentional self-injury19.12.01.002; 12.01.08.0360.000434%Not Available
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.000260%Not Available
Lactic acidosis14.01.01.0020.000045%Not Available
Loss of consciousness17.02.04.0040.000608%Not Available
Muscle contractions involuntary17.05.03.001; 15.05.03.008--Not Available
Muscle spasms15.05.03.004--
Nausea07.01.07.001--
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.000260%
Pain08.01.08.004--
Paraesthesia17.02.06.005--
Paranoia19.05.01.0050.000174%Not Available
Parotitis11.01.04.001; 07.06.04.0010.000045%Not Available
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pruritus23.03.12.0010.001736%
Psoriasis23.03.14.002; 10.02.01.0360.000434%Not Available
Pyrexia08.05.02.0030.000521%
Rash23.03.13.0010.000781%Not Available
Rash erythematous23.03.06.0030.000260%Not Available
Rash maculo-papular23.03.13.0040.000260%
Respiratory arrest22.02.01.0090.000136%Not Available
Respiratory depression22.02.01.010; 17.02.05.0470.000045%Not Available
Restlessness19.11.02.002; 17.02.05.0210.000260%
Rhabdomyolysis15.05.05.0020.000347%
Sedation17.02.04.0050.000260%Not Available
Seizure17.12.03.001--
Sepsis11.01.11.003--
Serotonin syndrome17.05.02.004; 15.05.04.016; 12.03.01.0410.000695%Not Available
Skin exfoliation23.03.07.0030.000174%Not Available
Skin necrosis23.03.03.0110.000174%Not Available
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