Drug
Setmelanotide
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Hunger | 17 | 98.3 | 104.8 | signal |
| 2 | Injection Site Nodule | 13 | 92.0 | 96.6 | signal |
| 3 | Increased Appetite | 17 | 70.3 | 75.0 | signal |
| 4 | Skin Discolouration | 35 | 59.2 | 67.9 | signal |
| 5 | Intentional Dose Omission | 15 | 42.6 | 45.1 | signal |
| 6 | Product Dose Omission In Error | 14 | 40.5 | 42.7 | signal |
| 7 | Injection Site Irritation | 5 | 30.7 | 31.3 | signal |
| 8 | Injection Site Pruritus | 22 | 25.7 | 27.9 | signal |
| 9 | Affect Lability | 3 | 24.1 | 24.4 | signal |
| 10 | Injection Site Induration | 4 | 24.0 | 24.3 | signal |
| 11 | Injection Site Urticaria | 6 | 19.2 | 19.6 | signal |
| 12 | Injection Site Bruising | 18 | 17.7 | 18.9 | signal |
| 13 | Injection Site Erythema | 21 | 13.2 | 14.2 | signal |
| 14 | Injection Site Mass | 6 | 12.6 | 12.9 | signal |
| 15 | Intentional Self-injury | 3 | 11.5 | 11.7 | signal |
| 16 | Injection Site Swelling | 11 | 11.3 | 11.7 | signal |