The most commonly reported side effects of omaveloxolone include fatigue, nausea, and hepatic enzyme increased, based on 1,400 FDA adverse event reports from 2005 to 2025.
Percentages show how often each reaction appears relative to total reports for omaveloxolone.
These are voluntary reports and do not establish that omaveloxolone caused these reactions.
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Other drugs that appear in adverse event reports alongside omaveloxolone. 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.
38.9% of omaveloxolone adverse event reports involve female patients and 41.9% involve male patients. The largest age group is adult at 84%. These figures reflect who reports side effects, not underlying risk.
Sex
Age group
Conditions and purposes for which patients were taking omaveloxolone when the adverse event was reported.
Omaveloxolone is sold under the brand name Skyclarys.
An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.
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