Template:Side effects of bremelanotide in phase 3 clinical trials

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Side effects of bremelanotide in phase 3 clinical trials
Side effect	Placebo (n = 620)		Bremelanotide 1.75 mg (n = 627)
Side effect	n	%	n	%
Nausea	8	1.3	251	40.0
FlushingTooltip Flushing_(physiology)	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: ^[1]

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