Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cetirizine hydrochloride
Drug ID BADD_D00418
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 S01GX12; R06AE07
DrugBank ID DB00341
KEGG ID D00664
MeSH ID D017332
PubChem ID 55182
TTD Drug ID D0DK8V
NDC Product Code 73581-202; 82501-1574; 59651-628; 65498-790; 65862-444; 65862-446; 11822-2102; 25000-219; 0113-7002; 37808-671; 41163-197; 50580-721; 58602-444; 0363-3393; 68016-294; 69842-237; 70010-163; 72476-623; 0781-1684; 81522-000; 10888-8121; 17314-737; 61281-4250; 65862-445; 30142-458; 36800-458; 40032-652; 47335-343; 47335-344; 49483-682; 50090-4288; 50580-778; 50580-790; 51655-194; 51672-2106; 51672-2148; 52904-961; 55910-934; 57344-194; 58602-860; 60760-886; 62207-764; 63187-932; 0363-4101; 63868-132; 63940-043; 63981-458; 0378-3635; 68210-4219; 68210-4230; 68998-194; 69729-139; 69842-911; 70518-0182; 71141-133; 71205-093; 71205-700; 71205-705; 71610-093; 72288-980; 80539-002; 10202-715; 58175-0370; 59651-027; 66639-355; 11822-0457; 11822-1002; 45802-974; 49035-458; 49348-934; 50090-5220; 50090-5510; 50580-753; 51991-837; 54838-552; 54838-571; 55319-939; 58602-422; 58602-424; 58602-838; 0363-0471; 63868-665; 63868-865; 67296-1085; 68016-023; 68196-502; 68210-0119; 68210-4112; 69848-006; 70677-0149; 70934-986; 71141-194; 71205-435; 53943-194; 53943-519; 54838-559; 56062-111; 56062-939; 58602-446; 58602-862; 63187-110; 0363-2102; 0363-4025; 63629-4914; 0363-9602; 66424-564; 67091-494; 67296-1484; 68001-436; 68196-102; 69230-316; 70000-0380; 70677-0075; 71335-1090; 72476-764; 80267-844; 10888-8116; 17314-705; 10135-762; 61474-4307; 65498-753; 21130-098; 30142-058; 49035-106; 49035-276; 49483-692; 50090-4741; 50580-726; 55154-5399; 55910-710; 58602-447; 58602-812; 58602-813; 58602-861; 59556-894; 59779-884; 68788-7585; 70692-139; 71610-048; 0615-8240; 80159-101; 65862-447; 21130-090; 24385-998; 25000-220; 45802-626; 50580-791; 51672-2102; 51672-4070; 54257-270; 54838-572; 55910-458; 57483-250; 58602-028; 58602-030; 58602-445; 58602-823; 61919-538; 63187-436; 0378-3637; 67751-192; 68016-939; 69206-990; 70518-1652; 70752-104; 0781-5283; 80267-401; 81522-194; 0904-6717; 52493-046; 53104-7528; 53747-013; 59651-098; 62207-001; 16714-799; 0113-9458; 37808-106; 37808-583; 41520-781; 50580-779; 51079-597; 55289-995; 58602-806; 58602-808; 58602-856; 58602-863; 0363-0495; 68016-165; 68094-004; 68788-0790; 69256-458; 70934-199; 70985-002; 72036-194; 0781-1683; 59651-097; 65498-792; 11673-502; 11822-2106; 21130-712; 36800-448; 37808-102; 41163-458; 41250-618; 46122-101; 50580-752; 51660-066; 55111-351; 55154-8081; 55319-104; 0363-0068; 61919-429; 0363-3311; 63629-2521; 63941-939; 64024-475; 68210-4159; 68788-8204; 68998-939; 69842-234; 70752-103; 70985-001; 71141-294; 71309-005; 71335-0300; 72559-003; 79481-0981; 10888-8120; 10202-939; 62579-726; 71796-013; 11673-705; 11822-0458; 30142-172; 41250-458; 45802-919; 50090-6538; 50269-019; 51660-939; 51672-2097; 55315-007; 55315-354; 56062-102; 56062-106; 59779-458; 63941-194; 68016-106; 68210-1190; 68210-4136; 68391-500; 70518-2731; 71205-164; 72288-007; 72476-194; 0781-5284; 10695-143; 54469-0003; 65498-791; 11822-0980; 16571-402; 36800-180; 40032-653; 41226-692; 41520-715; 46122-020; 46994-658; 50580-730; 51655-842; 53329-652; 55681-302; 55910-699; 58602-716; 62011-0285; 0363-2106; 64024-499; 66715-6950; 69842-961; 70000-0186; 70720-100; 71205-207; 72288-411; 80267-409; 28877-1227; 59651-028; 65015-627; 11822-4228; 16571-401; 30142-169; 0113-0981; 50269-014; 50580-782; 50594-006; 55111-699; 55301-076
UNII 64O047KTOA
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 C21H27Cl3N2O3
CAS Registry Number 83881-52-1
SMILES C1CN(CCN1CCOCC(=O)O)C(C2=CC=CC=C2)C3=CC=C(C=C3)Cl.Cl.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)
Vaginal discharge21.08.02.002--
Vaginal infection11.01.10.002; 21.14.02.002--
Vertigo04.04.01.003; 17.02.12.002--
Visual field defect06.02.07.003; 17.17.01.001---
Vomiting07.01.07.003--
Weight increased13.15.01.006--
Xerophthalmia06.06.03.008; 14.12.03.002---
Acute generalised exanthematous pustulosis10.01.01.034; 11.07.01.018; 12.03.01.005; 23.03.10.002---
Affect lability19.04.01.001---
Transaminases increased13.03.04.036---
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.005--
Decreased appetite08.01.09.028; 14.03.01.005--
Uterine hyperstimulation18.07.02.008; 21.07.03.006---
Skin mass23.07.04.014---
Depersonalisation/derealisation disorder19.14.01.004---
Heavy menstrual bleeding21.01.03.005---
Intermenstrual bleeding21.01.01.015---
The 6th Page    First    Pre   6    Total 6 Pages