Melanotan I / Afamelanotide side effects and risks

Reported side effects

• Implant-site reaction: 26/125, 21%, vs 12/119, 10%, vehicle., mild (source)
• Nausea: 24/125, 19%, vs 17/119, 14%, vehicle., moderate (source)
• Fatigue: 7/125, 6%, vs 3/119, 3%, vehicle., moderate (source)
• Skin hyperpigmentation: 5/125, 4%, vs 0/119 vehicle., mild (source)
• New or darker moles: Melanocytic nevus: 5/125, 4%, vs 2/119, 2%, vehicle., moderate (source)
• Dizziness: 5/125, 4%, vs 4/119, 3%, vehicle., moderate (source)
• Sleepiness: 3/125, 2%, vs 1/119, 1%, vehicle., moderate (source)
• Severe allergy or anaphylaxis: Reported after marketing; a reliable rate cannot be calculated., serious (source)

Stop and get help if

• Trouble breathing, faintness, hives or swelling of the mouth or throat after an implant.: Get emergency care immediately; a clinician may need to remove the implant.
• A new, changing, irregular or bleeding mole.: Arrange prompt dermatology assessment and pause further exposure.
• Spreading redness, pus, fever or persistent bleeding at the implant site.: Get prompt medical assessment.

Who should avoid it

• pregnant: EMA advises against use during pregnancy; human safety data are limited.
• breastfeeding: No infant safety data; EMA advises against use while breastfeeding.
• tryingToConceive: EMA requires effective contraception during use and for three months afterward.
• under18: Adult-only approval. Pediatric cases and PK studies do not establish routine pediatric safety.
• melanomaOrAtypicalMoles: US Scenesse labeling calls for twice-yearly full-body skin examinations and monitoring of pigmented lesions. Severe hypersensitivity is the formal US contraindication. Other jurisdictions may differ.
• kidneyDisease: Renal impairment is an EMA contraindication; US label says its PK effect is unknown.
• liverDisease: Hepatic impairment and severe liver disease are EMA contraindications.
• heartCondition: Significant cardiovascular disease was not adequately evaluated; EMA advises monitoring after each implant.
• seizureDisorder: Significant neurological disease, including seizures, was not adequately studied.
• bleedingDisorder: Implant insertion may cause bleeding, especially with blood-thinning medicines.
• other: Prior serious allergy to afamelanotide or implant ingredients is a formal contraindication.
• other: EMA advises against use over age 70; if used, monitor after every implant.

Interactions

• Anticoagulants, aspirin and NSAIDs: May increase bruising or bleeding at implantation. Warfarin, aspirin and NSAIDs are specifically named by EMA.
• Other melanocortin agonists: No combination interaction studies. Overlapping pigment and systemic effects are a precaution.
• NB-UVB phototherapy: Studied with implants for vitiligo under supervision. This does not establish safety of sunbeds or unsupervised UV exposure.

Product quality risks

• Online products labeled melanotan I are unregulated tanning products; the approved implant's release and safety data do not validate them.
• No independent product-testing series specific to online MT-I powder was confirmed in this search.
• A COA showing peptide purity does not establish sterility, endotoxin safety or implant-equivalent release.