| Side effect | Placebo (n = 620) | Bremelanotide 1.75 mg (n = 627) | ||
|---|---|---|---|---|
| n | % | n | % | |
| Nausea | 8 | 1.3 | 251 | 40.0 |
| Flushing | 2 | 0.3 | 127 | 20.3 |
| Headache | 12 | 1.9 | 71 | 11.3 |
| Injection site reaction | 3 | 0.5 | 34 | 5.4 |
| Vomiting | 1 | 0.2 | 30 | 4.8 |
| Cough | 8 | 1.3 | 21 | 3.3 |
| Fatigue | 3 | 0.5 | 20 | 3.2 |
| Injection site erythema | 1 | 0.2 | 18 | 2.9 |
| Hot flush | 1 | 0.2 | 17 | 2.7 |
| Paresthesia | 0 | 0.0 | 16 | 2.6 |
| Dizziness | 3 | 0.5 | 14 | 2.2 |
| Injection site pruritus | 1 | 0.2 | 13 | 2.1 |
| Abdominal pain | 4 | 0.6 | 12 | 1.9 |
| Myalgia | 1 | 0.2 | 11 | 1.8 |
| Summary: Side effects of bremelanotide with a ≥1% incidence in a combined analysis of two phase 3, double-blind, placebo controlled-clinical trials evaluating safety and efficacy at a daily dosage of 1.75 mg. Nausea was very common and occurred after a median time of 30 minutes for a median duration of 2.4 hours. "Across both studies, seven patients who received bremelanotide reported 10 treatment-emergent serious adverse events, and three patients who received placebo reported four treatment-emergent serious adverse events." Most side effects were reported to be transient and were "mild or moderate in intensity". Bremelanotide had a "favourable" safety profile. Sources: | ||||
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