The most commonly reported side effects of amlexanox include off label use, abdominal discomfort, and insomnia, based on 22 FDA adverse event reports from 2006 to 2025.
Percentages show how often each reaction appears relative to total reports for amlexanox.
These are voluntary reports and do not establish that amlexanox caused these reactions.
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Other drugs that appear in adverse event reports alongside amlexanox. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.
Also suspected
Taken alongside
Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.
50.0% of amlexanox adverse event reports involve female patients and 36.4% involve male patients. The largest age group is adult at 69%. These figures reflect who reports side effects, not underlying risk.
Sex
Age group
Conditions and purposes for which patients were taking amlexanox when the adverse event was reported.
Amlexanox is sold under the brand name Amlexanox.
An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.
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