What are the side effects of Setmelanotide (Imcivree)?
The most commonly reported Setmelanotide (Imcivree) side effects are skin hyperpigmentation (most common reaction, ~60% of patients; from off-target MC1R activation, reversible on stopping), injection-site reaction, nausea, vomiting, diarrhea. Most are mild and tend to be dose dependent. It is generally avoided with active depression or suicidal ideation. Human clinical evidence for Setmelanotide (Imcivree) is limited, so this reflects reported and observed effects, not a complete safety profile.
Reported Setmelanotide (Imcivree) side effects
- Skin hyperpigmentation (most common reaction, ~60% of patients; from off-target MC1R activation, reversible on stopping)
- Injection-site reaction
- Nausea, vomiting, diarrhea
- Spontaneous penile erections (males)
- Depression / suicidal ideation (Warnings and Precautions, monitor mood; not a boxed warning)
Who should avoid it
- Active depression or suicidal ideation
- Pregnancy / nursing
Bloodwork worth tracking
- Skin / mole monitoring (dermatology)
- Mental-health screening
References
- Setmelanotide for Obesity due to LEPR or POMC deficiency — Clément K et al., Lancet Diabetes Endocrinol, 2020
- Efficacy and safety of setmelanotide in patients with Bardet-Biedl syndrome and Alström syndrome: a phase 3 trial — Haqq AM et al., The Lancet Diabetes & Endocrinology, 2022
- Imcivree (setmelanotide) — Drugs@FDA approval record (ApplNo 213793) — FDA, Drugs@FDA
Pepdex is an editorial reference, not medical advice. Peptides vary in legal and approval status by country, many are research compounds without full human safety data. Talk to a qualified clinician before starting anything.
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Last updated 2026-06-06.