Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cetirizine
Drug ID BADD_D00417
Description Cetirizine, also commonly known as _Zyrtec_, is an orally active second-generation histamine H1 antagonist proven effective in the treatment of various allergic symptoms, such as sneezing, coughing, nasal congestion, hives, and other symptoms [A175051], [A175054]. One of the most common uses for this drug is for a condition called _allergic rhinitis_. The prevalence of allergic rhinitis in the United States is about 15% according to physician diagnoses, and up to 30%, according to self-reported nasal symptoms. Allergic rhinitis is associated with multiple missed or unproductive days at work and school, problems with sleep, and other difficulties with day to day activities for many individuals [A175057]. Furthermore, some antihistamine agents that are used to treat this condition cause undesirable, sedating effects [A175060]. Cetirizine is one of the first second-generation H1 antihistamines (SGAHs) formulated to selectively inhibit the H1 receptor without sedating effects [A175054].
Indications and Usage **Seasonal Allergic Rhinitis**: Indicated for the relief of symptoms associated with seasonal allergic rhinitis caused by allergens such as ragweed, grass and tree pollens in adults and children 2 years of age and above. Symptoms treated effectively include sneezing, rhinorrhea, nasal pruritus, ocular pruritus, tearing, and redness of the eyes [FDA label]. **Perennial allergic rhinitis**: This drug is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens including dust mites, animal dander, and molds in adults and children 6 months of age and older. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing [FDA label]. **Chronic urticaria**: Cetirizine is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. It markedly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus [FDA label].
Marketing Status approved
ATC Code R06AE07; S01GX12
DrugBank ID DB00341
KEGG ID D07662
MeSH ID D017332
PubChem ID 2678
TTD Drug ID D0DK8V
NDC Product Code 65162-684; 71776-024; 65162-003; 65015-888; 65162-005; 55111-853; 51824-076
UNII YO7261ME24
Synonyms Cetirizine | (2-(4-((4-Chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)acetic Acid | Cetirizine Dihydrochloride | Dihydrochloride, Cetirizine | Virlix | Zetir | Zyrtec | Reactine | Voltric | Zirtek | Cetirizin AL | Cetirizin AZU | Cetirizin Basics | Alerlisin | Cetalerg | Ceterifug | Ceti TAD | Ceti-Puren | Cetiderm | Cetidura | Cetil von ct | CetiLich | Cetirigamma | P-071 | P 071 | P071 | Cetirlan
Chemical Information
Molecular Formula C21H25ClN2O3
CAS Registry Number 83881-51-0
SMILES C1CN(CCN1CCOCC(=O)O)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)
Mass08.03.05.003--Not Available
Melaena24.07.02.013; 07.12.02.004--Not Available
Memory impairment17.03.02.003; 19.20.01.003--
Menopausal symptoms21.02.02.002--Not Available
Menstrual disorder21.01.01.004--Not Available
Mental disability26.01.01.001--Not Available
Mental impairment17.03.03.002; 19.21.02.003--Not Available
Methaemoglobinaemia01.05.01.0020.000100%
Middle insomnia19.02.01.003; 17.15.03.003--Not Available
Migraine24.03.05.003; 17.14.02.0010.000091%Not Available
Mitral valve incompetence02.07.01.0020.000029%Not Available
Mood altered19.04.02.0070.000029%Not Available
Mood swings19.04.03.001--Not Available
Mouth ulceration07.05.06.0040.000091%Not Available
Movement disorder17.01.02.010--Not Available
Mucosal inflammation08.01.06.0020.000029%Not Available
Multiple fractures15.08.02.005; 12.04.02.009--Not Available
Multiple sclerosis17.16.01.001; 10.04.10.008--Not Available
Muscle rigidity17.05.02.005; 15.05.04.001--Not Available
Muscle spasms15.05.03.004--
Muscle twitching15.05.03.005--Not Available
Muscular weakness17.05.03.005; 15.05.06.001--
Myalgia15.05.02.001--
Mydriasis17.02.11.003; 06.05.03.0040.000186%Not Available
Myelitis17.06.02.001; 11.01.03.007--
Myoclonus17.02.05.0080.000057%Not Available
Nasal congestion22.04.04.0010.000174%
Nasal dryness22.04.03.002--Not Available
Nasal polyps16.38.01.001; 22.04.03.010--Not Available
Nasal septum perforation22.04.03.0030.000029%Not Available
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