Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Amlexanox
Drug ID BADD_D00120
Description Amlexanox is an antiallergic drug, clinically effective for atopic diseases, especially allergic asthma and rhinitis. Amlexanox as a topical paste is a well tolerated treatment of recurrent aphthous ulcers. Recurrent aphthous ulcer (RAU) is the most prevalent oral mucosal disease in humans, estimated to affect between 5% and 50% of the general population.
Indications and Usage Used as a paste in the mouth to treat aphthous ulcers (canker sores).
Marketing Status Discontinued
ATC Code A01AD07; R03DX01
DrugBank ID DB01025
KEGG ID D01828
MeSH ID C045742
PubChem ID 2161
TTD Drug ID D0G5UB
NDC Product Code 71052-005; 73309-350; 72969-097
Synonyms amlexanox | 2-amino-7-isopropyl-5-oxo-5H-(1)benzopyrano(2,3b)pyridine-3-carboxylic acid | amoxanox | Aphthasol | CHX 3673 | AA 673 | AA-673
Chemical Information
Molecular Formula C16H14N2O4
CAS Registry Number 68302-57-8
SMILES CC(C)C1=CC2=C(C=C1)OC3=NC(=C(C=C3C2=O)C(=O)O)N
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Aphthous ulcer07.05.06.002--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Headache17.14.01.001--
Liver function test abnormal13.03.01.013--Not Available
Mouth ulceration07.05.06.004--Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Pain08.01.08.004--
Paraesthesia17.02.06.005--
Stomatitis07.05.06.005--
Oropharyngeal discomfort07.05.05.008; 22.02.05.027--Not Available
Oropharyngeal pain07.05.05.004; 22.02.05.022--
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