Safety

Setmelanotide

Adverse-event report summary for Setmelanotide, drawn from the FDA Adverse Event Reporting System (FAERS).

Total reports
58
Reports flagged serious
53

“Serious” is FAERS’s own report-level flag (e.g. death, hospitalization, or another outcome the reporter marked as serious) and does not indicate a verified or compound-caused outcome.

Most frequently reported reactions

  1. Nausea22 reports
  2. Skin Discolouration16 reports
  3. Headache14 reports
  4. Skin Hyperpigmentation14 reports
  5. Vomiting14 reports
  6. Weight Increased14 reports
  7. Fatigue13 reports
  8. Diarrhoea11 reports
  9. Hospitalisation11 reports
  10. Hunger11 reports
  11. Illness11 reports
  12. Product Dose Omission Issue11 reports
  13. Abdominal Pain Upper9 reports
  14. Injection Site Erythema9 reports
  15. Injection Site Pain9 reports

Counts reflect the most-reported reaction terms (MedDRA preferred terms) associated with reports naming this compound. A single report can list multiple reactions, so reaction counts need not sum to the total number of reports.