Melanotan 1 side effects are best documented for Scenesse, the FDA-approved 16 mg afamelanotide implant. In its trials, the most common were implant site reactions (21%), nausea (19%), sore throat (7%), cough (6%) and tiredness (6%), and the label warns about serious allergic reactions and darkening of moles and freckles.[1] Products sold online as “Melanotan 1” are not Scenesse: they are unregulated, so their contents and side effects are unknown.[11]
This guide walks through what the US and European labels list, what long-term follow-up found, and what is different about unregulated vials. For the bigger picture, see our Melanotan 1 profile, Melanotan 1 vs Melanotan 2 and the sexual health peptides hub.
Melanotan 1 and Scenesse: same peptide, different products
Melanotan 1 is the research name for afamelanotide, a lab-made copy of alpha-MSH, the hormone that tells skin cells to make the brown pigment eumelanin.[1] As Scenesse, it is approved in the US to increase pain-free light exposure in adults with erythropoietic protoporphyria (EPP), a rare inherited condition that makes light exposure painful.[1]
The approved product is a slow-release implant, about 1.7 cm long, placed under the skin above the hip bone every 2 months by a trained health professional.[1] That matters for side effects: the label’s numbers describe that implant at that dose, in people with EPP, with medical follow-up. They do not describe self-injected powders bought online.
Side effects in the Scenesse trials
The US label pools three placebo-controlled trials in 244 adults with EPP: 125 got Scenesse and 119 got a dummy (vehicle) implant. Side effects through month 6 that affected more than 2% of patients:[1]
| Side effect | Scenesse | Dummy implant |
|---|---|---|
| Implant site reaction | 21% | 10% |
| Nausea | 19% | 14% |
| Sore throat | 7% | 5% |
| Cough | 6% | 3% |
| Tiredness | 6% | 3% |
| Skin darkening | 4% | 0% |
| Dizziness | 4% | 3% |
| Moles (melanocytic nevus) | 4% | 2% |
| Respiratory infection | 4% | 3% |
| Sleepiness | 2% | 1% |
| Non-acute porphyria | 2% | 0% |
| Skin irritation | 2% | 0% |
Implant site reactions included bruising, discoloration, redness, bleeding, swelling, itching, pain and expelled implants. The most common was discoloration of the skin over the implant, in 10%.[1] Several side effects, such as nausea and dizziness, also showed up often on the dummy implant, so not all of them are caused by the drug.
In the two main phase 3 trials, adverse events were mostly mild, and serious adverse events were not thought to be related to the study drug.[3]
Serious warnings: allergic reactions and moles
The US label has two warnings:[1]
- Serious allergic reactions, including anaphylaxis, hives and swelling, have been reported since approval. Anyone who has had a severe reaction to afamelanotide should not receive it again. The implant may need to be removed.
- Darker skin, moles and freckles. Because it boosts pigment, Scenesse can darken the skin overall and darken existing moles and freckles. The label recommends a full-body skin exam twice a year to watch old and new pigmented spots.
The European label adds that people with a personal or family history of melanoma, or a history of other skin cancers, need special caution. It notes that people with EPP often spend much more time in the sun once treated, which raises their exposure to UV light.[2]
Other side effects in the European label
The European product information pools 425 patients and lists headache in about 20%, alongside nausea (about 19%) and implant site reactions (21%), mostly mild.[2] It also lists, among others:
- Common: flushing and feeling hot, dizziness, drowsiness, migraine, stomach pain, diarrhea, vomiting, back and muscle pain, tiredness, colds and darkening of freckles and moles.[2]
- Uncommon: allergic reactions including anaphylaxis, low mood or depression, trouble sleeping, palpitations, raised blood pressure, nail and lip pigmentation, and irregular or painful periods.[2]
Other practical cautions from the European label:[2]
- Driving: sleepiness, tiredness, dizziness and nausea can affect driving, especially in the first 72 hours after an implant.
- Pregnancy: it should not be used in pregnancy or while breastfeeding, and women who could become pregnant should use effective contraception during treatment and for 3 months after. The US label says there are no human pregnancy data.[1]
- Blood thinners: people taking warfarin, aspirin or NSAIDs may bruise or bleed more at the implant site.
- Older adults: it should not be used in people over 70, because data are limited.
- Liver and kidney problems: it is not to be used in people with liver or kidney impairment.
- Long-term use: clinical studies lasted no longer than 2 years, and long-term safety data are limited.
Long-term safety in real-world use
Years of European follow-up in people with EPP have been reassuring so far:
- Italy and Switzerland: 115 patients received 1,023 implants over up to 8 years. Only minor side effects attributable to the drug were recorded, mainly nausea.[4]
- Germany: in 200 patients in a required safety study, the safety profile matched the trials, including in people over 70. Several authors were paid by or received research support from Clinuvel, the maker.[5]
- Austria: in 20 patients treated in 2023, side effects were only mild and short-lived.[6]
Side effects in the early tanning studies
Before Scenesse, University of Arizona researchers gave Melanotan 1 to healthy volunteers as daily injections under the skin to produce a tan:
- 1997 study: in three men, side effects were minimal, mainly occasional stomach upset and facial flushing.[8]
- 2004 studies with UV light or sunlight: side effects were minor, mainly nausea and brief facial flushing, and no abnormal findings appeared at sun-exposed sites.[9]
- 1991 JAMA trial: 28 healthy white men received 10 injections over 12 days, and their skin darkened, peaking 1 to 3 weeks after the last dose.[7]
In a vitiligo trial that paired monthly implants with light therapy, notable adverse events were redness in both groups, plus minor infections and nausea with afamelanotide.[10]
Unregulated “Melanotan 1” products
Melanotan 1 and 2 are both sold without approval as tanning products. A 2017 dermatology review warned that how these products are made, stored and dosed is uncertain.[11]
- Mole changes: case reports link unregulated melanotan use to changes in existing moles and new atypical moles.[11]
- Melanoma: four case reports described melanomas arising from existing moles during or soon after melanotan use, though no causal link has been proven.[11]
- Regulators: the Danish Medicines Agency calls Melanotan an illegal product whose effect is undocumented and whose side effects have not been studied, and urges users to stop.[12]
Melanotan 2 is a different peptide with its own list of case-report harms; our Melanotan 1 vs Melanotan 2 comparison covers them.
Who should be especially cautious
Based on the labels, talk to a doctor before any afamelanotide treatment if you:[1][2]
- Have had a serious allergic reaction to afamelanotide
- Have many moles, or a personal or family history of melanoma or other skin cancer
- Are pregnant, breastfeeding or could become pregnant
- Take blood thinners
- Are over 70 or have liver or kidney disease
Questions to ask a clinician
- Do I have a light-sensitivity condition, such as EPP, that Scenesse is approved for?
- Who will check my skin, and how often?
- Which side effects should make me call you right away?
- If I have used an unregulated melanotan product, should my moles be checked?
This is general information, not medical advice.
