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Marketing Status approved; investigational; withdrawn
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
UNII BRL1C2459K
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
*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)
Aphthous ulcer07.05.06.002--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Headache17.14.01.001--
Liver function test abnormal13.03.04.030--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--
Paraesthesia23.03.03.094; 17.02.06.005--
Stomatitis07.05.06.005--
Oropharyngeal discomfort22.12.03.015; 07.05.05.008--Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
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