The most commonly reported side effects of setmelanotide include nausea, off label use, and skin hyperpigmentation, based on 228 FDA adverse event reports from 2018 to 2025. 7.5% of reports found the drug to be ineffective.
Percentages show how often each reaction appears relative to total reports for setmelanotide.
These are voluntary reports and do not establish that setmelanotide caused these reactions.
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Other drugs that appear in adverse event reports alongside setmelanotide. 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.
42.5% of setmelanotide adverse event reports involve female patients and 24.6% involve male patients. The largest age group is adult at 46%. These figures reflect who reports side effects, not underlying risk.
Sex
Age group
Conditions and purposes for which patients were taking setmelanotide when the adverse event was reported.
Setmelanotide is sold under the brand name Imcivree.
An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.
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