Research

Hormonal

Setmelanotide treatment is associated with a high incidence of skin hyperpigmentation and injection site reactions, though these are generally mild and manageable.

Patients should expect skin darkening (hyperpigmentation) and injection site reactions as common side effects of Setmelanotide. These are generally mild, do not indicate serious harm, and do not necessarily require discontinuation of therapy, but patients should be counseled on these expected outcomes.

GoodQualifiesHIGH confidence
Hyperpigmentation was the most common adverse effect, with 131 (68.9%) patients affected. An injection site reaction occurred in 78 (41.05%)... The risk ratio for this adverse effect was 69% (95% confidence interval: 0.57, 0.80; Analysis 6; Figure 2C), showing statistical significance in terms of the increased risk of developing skin hyperpigmentation with the use of setmelanotide (p < 0.001).
Bárbara Ferraz Barbosa et al. · Journal of Personalized Medicine · 2023

Why this rating

High certainty evidence for the occurrence of side effects, though heterogeneity was present.

Source

Efficacy and Safety of Setmelanotide, a Melanocortin-4 Receptor Agonist, for Obese Patients: A Systematic Review and Meta-Analysis

Bárbara Ferraz Barbosa et al. · Journal of Personalized Medicine · 2023

DOI 10.3390/jpm13101460

Meta-analysis · 12 studiesCited 29×
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DOI resolved against Crossref · corpus check 2026-06-10

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