Skip to content
PeptideHound

Safety & side effects

Melanotan side effects and safety data

StatusMT-II not FDA approved

PeptideHound Staff · Last editorially reviewed · 24 sources

Melanotan-II is injected to darken skin, sold with no regulator behind it, and almost all of its harm record comes from people who reached a hospital. No controlled safety study of either melanotan molecule sits among the research behind this page; what exists is three supervised studies finished before 2001 and individual case reports since.

The supervised half is small and it is specific. In the 2000 crossover study, nausea and yawning were frequently reported side effects due to Melanotan II; at a dose of 0.025 mg/kg, 12.9% of subjects had severe nausea. In the 1996 pilot in three male volunteers, the 0.03 mg/kg dose produced Grade II somnolence and fatigue in one of two subjects (WHO standards), and erections were intermittently experienced for 1-5 hours after MT-II dosing, depending on the MT-II dose.

After 2001 the published record arrives one patient at a time. A 2026 systematic review of tanning agents states that unregulated melanotan I and II use has caused serious adverse effects, including rhabdomyolysis, renal infarction, and priapism, meaning muscle breaking down, a blocked artery inside a kidney, and an erection that will not subside. Case reports also run to melanoma, sudden crops of new moles, and ulcers at the injection sites. Read what that is: a count of the people who reached a clinic, with the number exposed unknown, so these are events rather than rates.

Nothing sold as Melanotan-I or Melanotan-II is an approved medicine. The FDA's enforcement records hold three Class II recalls of compounded melanotan injections, one of Melanotan I and two of Melanotan II, every one of them for a sterility failure rather than for anything about the molecule. A 2018 analytical review lists melanotan II among the image-enhancing polypeptides turning up in falsified preparations.

Evidence: Harm record is individual case reports, not a controlled safety study · 3 human studies, 30 volunteers, all finished before 2001 · 29 of those 30 were men · 1 Phase 2 trial recruiting

What are the documented side effects of Melanotan-II?

human RCT

The supervised record is short, and it is the only part of this story where somebody sat and counted.

In the 2000 crossover study of twenty men, nausea and yawning were frequently reported side effects due to Melanotan II; at a dose of 0.025 mg/kg, 12.9% of subjects had severe nausea.1 Severe there is a graded finding, not a word for feeling queasy. In the 1996 pilot, the 0.03 mg/kg dose produced Grade II somnolence and fatigue in one of two subjects (WHO standards).2 Lower down that ladder, mild nausea, not requiring antiemetic treatment, was reported at most MT-II dose levels.2

Erections came with the rest rather than apart from it. The same pilot describes spontaneous, penile erections which were intermittently experienced for 1-5 hours after MT-II dosing, depending on the MT-II dose.2

What has been reported since those studies ended?

review

The last deliberate human study of Melanotan-II was published in 2000. Everything on the harm side since has arrived one patient at a time.

A 2026 systematic review of tanning agents compresses that record into a sentence: unregulated melanotan I and II use has caused serious adverse effects, including rhabdomyolysis, renal infarction, and priapism.4 Those are muscle breaking down into the blood, a blocked artery inside a kidney, and an erection that will not subside. The review was built from 68 peer-reviewed studies.4 A 2025 history of tanning says much the same from a different direction: tanning injections, moreover, introduced a new host of health risks for twenty-first-century consumers.5

Read what a record of this shape can carry. Case reports count the people who reached a clinic. The number who injected and went home is unknown, so these are events rather than rates.

Does Melanotan-II affect the kidneys?

human case report

Readers ask about the kidneys more than anything else on this page. There is a real answer under the question, though a thin one.

A 2020 case report sets out where things stand. Its authors note that Melanotan II inducing rhabdomyolysis and renal failure have been described previously.6 That means muscle tissue breaking apart, and kidneys losing the power to filter. They then add a case of a renal infarction most likely attributed to Melanotan II.6 An infarction is the sudden loss of blood supply to part of a kidney, and the report calls it a potentially life-threatening disease.6

What caused it is not settled. The authors write that in the mechanism of renal injury with Melanotan II, thrombotic pharmacological influence and possible direct toxic effect on renal parenchyma must be considered.6 Clotting and direct damage to kidney tissue are both on the table. A single case cannot separate them.

Can an injection cause an erection that will not stop?

human case report

It can, and it has taken men to the operating theatre. Priapism is an erection that persists without stimulation and turns painful. The ischaemic kind cuts off the blood supply inside the penis.

A 2019 report describes a man who reached hospital with acute priapism after abdominal subcutaneous injection of melanotan.7 He was seen at a tertiary urology centre, which is a specialist unit.7 Doctors drained and flushed the erectile tissue, and the patient avoided requiring surgical shunting but had not yet recovered erectile function at 4-week follow-up7.

A 2021 report describes a patient presenting with acute ischemic priapism after subcutaneous injection of melanotan II.8 Draining did not work that time, so the man then underwent operative management with penoscrotal decompression, which is surgery8. Its authors note that priapism after melanotan II injection has only been reported in the literature twice before.8 That measures how small the published record is rather than how often this happens.

Does Melanotan use cause skin cancer?

human pilot / early trial

Cases exist and causation has not been established. The distance between those two statements is the whole of what anyone knows.

A 2012 case report states that there have been reports of dysplastic naevi and melanoma associated with the use of melanotropic peptides.11 Its authors add a case of melanotan-associated melanoma in situ.11 A 2011 letter in a British skin journal is titled Melanotan-associated melanoma.12 A 2014 report describes a case where the melanocyte stimulation of MT-II in combination with the use of sun tanning beds coincided with cutaneous melanoma.13

Look at the verb in that last one, because coincided is as far as the authors could go. The question is also harder to close than it sounds. Melanotan darkens the whole skin, and in that patient her skin was universally intensely pigmented.13 That is the background a new mole then has to be spotted against.

Do new moles appear after Melanotan injections?

human case report

This is the best-documented skin effect in the published record. It is documented from two directions at once.

A 2022 case report states that previous research showed that Melanotan supports the development of new pigmented and dysplastic naevi.9 A dysplastic mole is one odd enough that a skin doctor wants a closer look. A 2019 review gathered every published report of sudden crops of new moles. It selected 93 articles, representing 179 patients with EMN, which is the short name for them.14 Among the suspected causes it groups immunosuppressive agents, chemotherapy or melanotan (41%) into one category.14

That review is also where the limit of this evidence is set out plainly. Overall, 16% of the cases had at least one histologically confirmed dysplastic nevus.14 Five cases of associated melanoma were reported.14 But the nature of the data precluded assessment of risk of malignant transformation.14 New moles are documented; what becomes of them has not been measured, rather than measured and found quiet.

What does a sunbed add to the picture?

human pilot / early trial

One published case puts the two exposures together. It repays reading closely rather than as a verdict.

A 20-year-old woman with Fitzpatrick skin type II was referred to a dermatology clinic.13 That scale describes skin which burns easily and tans poorly. Three months prior to the excision the patient had conducted a 3- to 4-week course of self-injections with MT-II, intending an augmentation of sunbed tanning.13 The melanocytic lesion was excised, and histology confirmed the diagnosis of melanoma.13

Both exposures arrived together, which is how they are usually combined and also why one case cannot take them apart. A 2014 review of tanning sets the background in a line: high-risk tanning behaviors have become increasingly popular and the incidence of melanoma has risen more rapidly than any other cancer.16 What each one contributes on its own is not something a report of this kind can separate.

What are the side effects of Melanotan-I?

human pilot / early trial

Melanotan-I is the other molecule, and its record is smaller and shaped differently. The one human study was built to measure pigment rather than harm.

Seven normal volunteers (six males and one female) were given 10 daily subcutaneous injections across two weeks.3 All of them had skin that tans rather than burns.3 The paper is written around skin colour, light readings and small skin samples. It carries no table of adverse events.

The harm signal for Melanotan-I comes out of skin clinics instead. A 2015 review states that Melanotan I leads to the activation of dysplastic nevi.15 It adds that case reports address activation of dysplastic naevi by melanotan I.15 Its conclusion names the molecule without hedging: Melanotan I and bleaching creams, which may possibly contain mercury, are dangerous.15 The FDA has also recalled a compounded Melanotan I 200mcg/mL vial, for Lack of Assurance of Sterility.21

What happens at the injection site itself?

human case report

Two case reports describe damage that showed up where the needle went in. One of them is very recent.

A 2025 report describes a 65-year-old woman who reported utilising Melanotan and subsequently developing ulcerated wounds at the injection sites on her abdomen.10 Four wounds were noted with an erythematous edge corresponding to the injection sites of melanotan.10 An erythematous edge is a red, inflamed border. The diagnosis was pyoderma gangrenosum, a rare neutrophilic dermatosis that presents as a rapidly enlarging ulcer.10 The patient's wounds healed with classic cribriform scars after several months of care.10

The other report is about a nail. A 2013 letter is titled Melanotan-associated transverse melanonychia, which is a dark band running across the nail.18 Both are single cases, and a single case shows that something can happen without telling you how often it does.

What does an acute reaction look like?

human case report

One published case follows a man from the injection to the emergency department inside two hours. It is the closest thing to an overdose report anywhere in this record.

A 2022 Dutch report describes a 27 year old male, with no relevant medical history.9 He presented at the emergency department two hours after subcutaneous self-administration of Melanotan II.9 He suffered from sympathomimetic symptoms and was treated with lorazepam, supplemental potassium and intravenous fluid resuscitation.9 Sympathomimetic means the body acting as though flooded with adrenaline. Lorazepam is a sedative, and the potassium and the fluids say his blood chemistry had moved too.

The authors frame the setting rather than the molecule alone. They note that Melanotan II, also known as 'Barbie drugs', can be purchased over the internet and in gyms to facilitate sunless tanning.9 How much he injected is not in the report, so the amount that produced this cannot be stated.

Is the record different for men and for women?

human RCT

It is, and the reason is who was enrolled rather than anyone setting out to compare the sexes.

Every supervised exposure to Melanotan-II among the research behind this page was in men. One double-blind, placebo-controlled crossover trial gave Melanotan II to 20 men with psychogenic and organic erectile dysfunction (ED).1 The 1996 pilot was conducted in 3 normal male volunteers.2 So the counted side effects, the nausea figure included, were counted in men.

The Melanotan-I tanning study is the one that enrolled a woman: seven volunteers, six males and one female.3 The case reports since are mixed, and two of the worst skin cases are in women. One is a twenty-year-old with melanoma, the other a sixty-five-year-old with ulcers at her injection sites. That describes who has been written up rather than a difference anyone has measured.

What is known about interactions?

animal model

Very little, and what there is comes out of animal work rather than from anyone giving a combination to a person.

No study among the research behind this page gives Melanotan-II alongside another medicine, a stimulant or alcohol in a human being. What exists instead is a mechanism that points at where to look. A 2018 study found that melanotan II drops body temperature in mice through a route outside the receptors it was built for.17 The effect was preserved in mice lacking any one of melanocortin receptors 1, 3, 4, or 5, and was abolished in mice that lack mast cells.17 Melanotan II treatment increased plasma histamine levels in those mice.17

Histamine release is exactly the kind of effect that runs into other things, and it is also what an antihistamine acts on. In mice that is a finding. In a person it is a question that remains untested.

Who was left out of the three human studies?

human RCT

On most safety pages this is the most useful section, and here it comes down to how small the studies were.

Thirty people in total received either molecule under supervision. The 1996 work was a single-blind, alternating day (saline or MT-II), placebo-controlled trial conducted in 3 normal male volunteers.2 Normal there is how a phase I paper says healthy. The 2000 crossover study enrolled 20 men with psychogenic and organic ED, so every participant arrived with a diagnosis.1 The tanning study took volunteers with tanning skin types III or IV (Fitzpatrick scale), which leaves out the skin that burns worst.3

Everyone outside those descriptions is absent: older adults, anyone with kidney or heart disease, anyone taking something else, and anyone followed past three weeks. The groups in which a safety signal would surface first are the groups that were never enrolled at all.

What has the FDA done about melanotan?

registered trial

The regulatory record is specific, and narrower than people expect, so it is worth saying what it covers.

Neither molecule is an approved medicine. A 2015 review draws the line in one sentence: although afamelanotide is a prescription drug for a rare disorder in which sunlight causes pain, structurally related α-MSH derivatives are available via the internet.15 Case reports describe melanotan in the same terms, as unlicensed compounds with an unproven safety record.11

The agency's enforcement records hold three Class II recalls of compounded melanotan injections. One covers Melanotan I 200mcg/mL vials.21 One covers a Melanotan II, 10mg injection, pulled for Lack of sterility assurance.22 The third covers a Melanotan II 1 mg/mL (10 mL) Injection, withdrawn over deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.23 Each of those concerns how a batch was made rather than the molecule inside it. One Phase 2 study of Melanotan II in vitiligo is listed as RECRUITING and has reported nothing.24

What is actually inside a vial sold as melanotan?

review

Nothing in the harm record above assumes the vial held what the label said. With melanotan, that assumption has been checked.

A 2018 analytical review of falsified medicines lists melanotan II among the image-enhancing polypeptides being copied, alongside human growth hormone.19 The review reports that multiple reports have namely described the presence of the wrong active pharmaceutical ingredient (API), the wrong dosage or the absence of the API.19 In plain terms, that is the wrong substance, the wrong quantity of it, or none at all. It adds that adverse health effects have been reported in the past due to toxic contaminations and product or process related impurities.19

A 2022 skin review calls melanotan an unlicensed and untested form of α-melanocyte-stimulating hormone.20 That is the regulatory position rather than a comment on the molecule. So a case report describing harm after an injection is describing a vial as much as a compound. None of the cases in this record arrived with an analysis of what was in it.

What we don’t know

The gaps in the evidence matter as much as the findings.

  1. 01How often any of this happens. The harm record among the research behind this page is a set of individual case reports, and the number of people who injected melanotan is unknown.
  2. 02What melanotan does to a kidney in anyone who does not reach a hospital. The kidney record behind this page is one infarction case plus earlier reports of muscle breakdown and kidney failure.
  3. 03Whether melanotan causes melanoma or merely sits beside it. The 2019 review of sudden mole eruptions states that the nature of the data precluded assessment of risk of malignant transformation.
  4. 04What happens past two weeks. The longest deliberate human exposure among the research behind this page is ten injections across a fortnight, in seven volunteers.
  5. 05Anything about interactions. No source among the research behind this page gives melanotan alongside another medicine, a stimulant or alcohol in a person.
  6. 06What the harm record looks like in women. Of the thirty volunteers in the three human studies behind this page, one was a woman.
  7. 07What is actually in a vial. A 2018 analytical review lists melanotan II among falsified peptides, and the FDA has recalled compounded melanotan injections from three compounding pharmacies for sterility failures.
  8. 08Whether Melanotan-I and Melanotan-II carry the same risks. They are separate molecules, and no study among the research behind this page gave both to the same people.

Sources

  1. 1Melanocortin receptor agonists, penile erection, and sexual motivation: human studies with Melanotan II Int J Impot Res 2000. doi:10.1038/sj.ijir.3900582human pilot / early trial
  2. 2Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study Life Sci 1996. doi:10.1016/0024-3205(96)00160-9human pilot / early trial
  3. 3Increased eumelanin expression and tanning is induced by a superpotent melanotropin [Nle4-D-Phe7]-alpha-MSH in humans Photochem Photobiol 2000. doi:10.1562/0031-8655(2000)072<0526:ieeati>2.0.co;2human pilot / early trial
  4. 4Insights into Tanning Biology and Tanning Products J Clin Aesthet Dermatol 2026. PMID 41890775review
  5. 5Sunbeds, dihydroxyacetone (DHA) fake tan, and MelanoTan injections: A history of ‘safe’ tanning technologies 2025. PMID 40300020review
  6. 6Melanotan II: a possible cause of renal infarction: review of the literature and case report CEN Case Rep 2020. doi:10.1007/s13730-020-00447-zhuman case report
  7. 7Melanotan-induced priapism: a hard-earned tan BMJ Case Rep 2019. doi:10.1136/bcr-2018-227644human case report
  8. 8Melanotan Tanning Injection: A Rare Cause of Priapism Sex Med 2021. doi:10.1016/j.esxm.2020.100298human case report
  9. 9[The risks of tanning with the Barbie drug] Ned Tijdschr Geneeskd 2022. PMID 35736369human case report
  10. 10Pyoderma Gangrenosum Secondary to Melanotan Cureus 2025. doi:10.7759/cureus.98297human case report
  11. 11Melanotan-associated melanoma in situ Australas J Dermatol 2012. doi:10.1111/j.1440-0960.2012.00915.xprimary research
  12. 12Melanotan-associated melanoma Br J Dermatol 2011. doi:10.1111/j.1365-2133.2011.10273.xhuman case report
  13. 13Melanoma associated with the use of melanotan-II Dermatology 2014. doi:10.1159/000356389human pilot / early trial
  14. 14Eruptive Melanocytic Nevi: A Review Am J Clin Dermatol 2019. doi:10.1007/s40257-019-00444-8review
  15. 15[Undesirable pigmentation] Hautarzt 2015. doi:10.1007/s00105-015-3671-4review
  16. 16Update on tanning: More risks, fewer benefits J Am Acad Dermatol 2014. doi:10.1016/j.jaad.2013.11.004review
  17. 17Melanotan II causes hypothermia in mice by activation of mast cells and stimulation of histamine 1 receptors Am J Physiol Endocrinol Metab 2018. doi:10.1152/ajpendo.00024.2018animal model
  18. 18Melanotan-associated transverse melanonychia J Eur Acad Dermatol Venereol 2013. doi:10.1111/j.1468-3083.2011.04399.xhuman case report
  19. 19Falsification of biotechnology drugs: current dangers and/or future disasters? J Pharm Biomed Anal 2018. doi:10.1016/j.jpba.2018.08.037review
  20. 20A qualitative review of misinformation and conspiracy theories in skin cancer Clin Exp Dermatol 2022. doi:10.1111/ced.15249review
  21. 21Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made Compounding sourceregulatory action
  22. 22Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684 sourceregulatory action
  23. 23Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA sourceregulatory action
  24. 24Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo NCT07437560registered trial