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)
Abdominal discomfort07.01.06.0010.000354%Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.0020.000480%
Abdominal pain lower07.01.05.0100.000063%Not Available
Abdominal pain upper07.01.05.0030.000231%
Abnormal faeces07.01.03.001--Not Available
Abortion spontaneous18.01.04.0010.000114%Not Available
Accommodation disorder06.02.04.001--Not Available
Acne23.02.01.0010.000097%Not Available
Acute hepatic failure09.01.03.0010.000071%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.000029%Not Available
Ageusia17.02.07.001; 07.14.03.0030.000029%Not Available
Aggression19.05.01.0010.000149%Not Available
Agitation17.02.05.012; 19.06.02.0010.000254%
Agranulocytosis01.02.03.0010.000029%Not Available
Alopecia23.02.02.001--
Amnesia19.20.01.001; 17.03.02.0010.000100%
Anaphylactic reaction24.06.03.006; 10.01.07.0010.000234%
Anaphylactic shock24.06.02.004; 10.01.07.0020.000106%Not Available
Anger19.04.02.0010.000106%Not Available
Angina pectoris24.04.04.002; 02.02.02.0020.000043%
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.0090.000543%Not Available
Anticholinergic syndrome17.05.01.0010.000071%Not Available
Anuria20.01.03.0020.000057%Not Available
Anxiety19.06.02.0020.000269%
Aphasia19.21.01.001; 17.02.03.0010.000043%
Aphonia22.12.03.001; 19.19.01.002; 17.02.08.009--
Application site reaction12.07.01.006; 08.02.01.006--Not Available
Arrhythmia02.03.02.0010.000157%Not Available
Arthralgia15.01.02.0010.000377%
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