Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bepotastine
Drug ID BADD_D00252
Description Bepotastine is a non-sedating, selective antagonist of the histamine 1 (H1) receptor. Bepotastine was approved in Japan for use in the treatment of allergic rhinitis and uriticaria/puritus in July 2000 and January 2002, respectively, and is marketed by Tanabe Seiyaku Co., Ltd. under the brand name Talion. It is available in oral and opthalmic dosage forms in Japan. The opthalmic solution is FDA approved since Sept 8, 2009 and is under the brand name Bepreve.
Indications and Usage For the symptomatic treatment of itchy eyes (caused by IgE-induced mast cell degranulation) due to allergic conjunctivitis.
Marketing Status approved
ATC Code Not Available
DrugBank ID DB04890
KEGG ID D09705
MeSH ID C108476
PubChem ID 164522
TTD Drug ID D0U5VZ
NDC Product Code 42672-0100
UNII HYD2U48IAS
Synonyms bepotastine | betotastine | (S)-4-(4-((4-chlorophenyl)(2-pyridil)methoxy)piperidino)butylic acid monobenzenesulfonate | betotastine besilate | TAU 284 | TAU-284
Chemical Information
Molecular Formula C21H25ClN2O3
CAS Registry Number 125602-71-3
SMILES C1CN(CCC1OC(C2=CC=C(C=C2)Cl)C3=CC=CC=N3)CCCC(=O)O
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)
Dermatitis23.03.04.002---
Dysgeusia07.14.03.001; 17.02.07.003--
Eye irritation06.04.05.003---
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.007---
Nasopharyngitis11.01.13.002; 22.07.03.002---
Pruritus23.03.12.001--
Rash23.03.13.001---
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