Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Fexofenadine hydrochloride
Drug ID BADD_D00894
Description Fexofenadine is an over-the-counter second-generation antihistamine used in the treatment of various allergic symptoms.[L4269] It is selective for the H1 receptor, carries little-to-no activity at off-targets, and does not cross the blood-brain barrier[L10779] - this is in contrast to previous first-generation antihistamines, such as [diphenhydramine], which readily bind to off-targets that contribute to side effects such as sedation.[A1452] Fexofenadine is the major active metabolite of [terfenadine][A1495] and is administered as a racemic mixture in which both enantiomers display approximately equivalent antihistamine activity.[L10779]
Indications and Usage In the United States, fexofenadine is indicated for the symptomatic treatment of allergic rhinitis in patients ≥2 years old and chronic idiopathic urticaria in patients ≥6 months old.[L4269] In Canada, fexofenadine carries the same indications but is approved only for patients ≥12 years old.[L10779] Fexofenadine is also available in combination with [pseudoephedrine] for the symptomatic treatment of season allergic rhinitis in patients ≥12 years old.[L10800]
Marketing Status approved; investigational
ATC Code R06AX26
DrugBank ID DB00950
KEGG ID D00671
MeSH ID C093230
PubChem ID 63002
TTD Drug ID D01KPV
NDC Product Code 53360-1109; 11673-571; 0113-0847; 36800-954; 41167-4121; 49348-968; 55111-782; 55319-917; 57483-230; 61269-527; 62207-766; 0363-0784; 63629-9463; 63868-334; 68001-440; 70000-0586; 12579-188; 17404-0019; 53360-1106; 66577-021; 0113-0571; 36800-761; 37808-392; 41167-4122; 41167-4131; 43598-809; 57483-240; 62011-0413; 83324-009; 12854-915; 46438-0637; 46438-1111; 55111-784; 65372-1167; 41163-571; 49035-784; 53943-392; 55301-847; 56062-847; 57344-292; 66715-9707; 68016-995; 72036-292; 72476-192; 68001-439; 68016-887; 69842-492; 69848-002; 70677-0074; 70677-1009; 53104-7583; 62207-002; 11822-0425; 11822-3698; 41163-292; 41167-4124; 50090-1234; 63940-768; 64679-982; 68210-0122; 68210-4090; 69842-052; 71205-739; 72036-191; 73581-103; 46438-0638; 65862-966; 37808-391; 37808-847; 55910-111; 63868-025; 63981-847; 68196-107; 68210-2210; 71335-0721; 72476-847; 73581-011; 0904-6711; 0480-7253; 12579-182; 51927-0016; 55111-023; 55111-783; 71796-015; 82348-104; 54257-702; 64679-987; 68998-292; 43598-577; 44657-0078; 21130-784; 41167-4120; 41167-4232; 46122-462; 62207-765; 68071-5191; 68391-847; 70518-2971; 70692-134; 65015-894; 65096-0103; 30142-878; 37808-571; 41167-4126; 41167-4244; 43598-936; 45802-847; 49035-366; 51672-2119; 55910-609; 0363-0783; 70000-0361; 72288-847; 0480-7252; 12579-189; 46438-0107; 51927-0044; 58175-0616; 65977-0060; 11822-0571; 36800-319; 36800-653; 36800-691; 41250-784; 51316-800; 51672-2121; 62011-0409; 62756-545; 64679-744; 67751-033; 71309-091; 71335-0483; 71610-292; 79481-0847; 80159-112; 46438-0651; 51686-0001; 10202-107; 10202-229; 62993-0809; 77777-113; 11673-617; 51660-998; 54257-170; 55910-571
UNII 2S068B75ZU
Synonyms fexofenadine | alpha-(4-(1-carboxy-1-methylethyl)phenyl)-4-hydroxydiphenylmethyl-1-piperidinebutanol | fexofenadine hydrochloride | MDL 16.455 | MDL-16455 | MDL 16455 | Allegra | Telfast | MDL 16,455A
Chemical Information
Molecular Formula C32H40ClNO4
CAS Registry Number 153439-40-8
SMILES CC(C)(C1=CC=C(C=C1)C(CCCN2CCC(CC2)C(C3=CC=CC=C3)(C4=CC=CC=C4)O)O)C(=O)O.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 discomfort07.01.06.001--Not Available
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Back pain15.03.04.005--
Chest discomfort08.01.08.019; 02.02.02.009; 22.12.02.002--Not Available
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dysmenorrhoea21.01.01.002--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Fatigue08.01.01.002--
Flushing24.03.01.002; 23.06.05.003; 08.01.03.025--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Influenza22.07.02.001; 11.05.03.001--Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Myalgia15.05.02.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Nightmare19.02.03.003--Not Available
Otitis media11.01.05.004; 04.05.01.001--
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rhinorrhoea22.12.03.021--
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