Melanotan-II — safety
Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.
§4Safety
§4.1Adverse events reported in controlled trials
Table 4. Adverse events for Melanotan-II as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.
| Event | Active, % | Comparator, % | Difference, pp | Source |
|---|---|---|---|---|
| Nausea | — | — | — | Very commonly reported; mechanistically expected |
| Facial flushing | — | — | — | Common |
| Spontaneous erection | — | — | — | Commonly reported in men |
| New and changing melanocytic naevi | — | — | — | Case reports describe eruptive naevi and changes in existing naevi, and at least one report describes melanoma diagnosed in a user. Causation is not established, but a compound that stimulates melanocyte proliferation raises the question directly and no study has answered it |
| Hyperpigmentation of existing naevi and of unexposed skin | — | — | — | Consistently reported |
| Transient blood-pressure increase | — | — | — | Expected from the melanocortin mechanism |
| Rhabdomyolysis and renal injury | — | — | — | Isolated case reports |
| Posterior reversible encephalopathy syndrome | — | — | — | An isolated case report |
| A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here. | ||||
§4.2Contraindications
- Not established — no marketing authorisation
- A personal or family history of melanoma or of atypical naevus syndrome would be an absolute contraindication on mechanistic grounds
§4.3Warnings and precautions
- Regulatory authorities in multiple jurisdictions have issued specific warnings against use of melanotan products, citing melanocytic lesion changes and the absence of any safety assessment
- The compound stimulates melanocyte proliferation; the melanoma question is mechanistically direct and unanswered
- Sold almost exclusively through unregulated channels with no quality oversight
- Frequently supplied as an injectable with no sterility assurance
§4.4What this section does not establish
Related assessments: tolerability of incretin receptor agonists · acute pancreatitis · the rodent thyroid C-cell signal.[1,2]
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Women’s Health 2016;12(3):325–337. doi:10.2217/whe-2016-0018 · PMID 27638896
- Carvalho M, Dinis-Oliveira RJ. Analytical and forensic aspects of counterfeit peptide hormones. Drug Testing and Analysis 2023;15(1):5–19. doi:10.1002/dta.3379
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