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Afamelanotide Side Effects

The most commonly reported side effects of afamelanotide include anaphylactic reaction, type i hypersensitivity, and contraindication to medical treatment, based on 19 FDA adverse event reports from 2021 to 2025.

Afamelanotide side effects

Percentages show how often each reaction appears relative to total reports for afamelanotide.

1
Anaphylactic Reaction21.1%4
2
Type I Hypersensitivity15.8%3
3
Contraindication To Medical Treatment15.8%3
4
Multiple Organ Dysfunction Syndrome10.5%2
5
Implant Site Urticaria10.5%2
6
Implant Site Hypersensitivity10.5%2
7
Implant Site Pruritus10.5%2
8
Epilepsy5.3%1
9
Drug Hypersensitivity5.3%1
10
Hypotension5.3%1
11
Rash5.3%1
12
Death5.3%1
13
Hip Fracture5.3%1
14
Fall5.3%1
15
Cellulitis5.3%1

These are voluntary reports and do not establish that afamelanotide caused these reactions.

Report severity

78.9%Serious15 reports
42.1%Hospitalizations8 reports
15.8%Fatal3 reports

Seriousness is determined by the reporter, not by OpenClaim.

Afamelanotide drug interactions

Other drugs that appear in adverse event reports alongside afamelanotide. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Pimavanserin5.3%1
2
Anakinra5.3%1
3
Pembrolizumab5.3%1
4
Lenvatinib-mesylate5.3%1

Taken alongside

1
Cholecalciferol15.8%3
2
Prednisone10.5%2
3
Omalizumab10.5%2
4
Pantoprazole-sodium10.5%2
5
Ibuprofen10.5%2
6
Ergocalciferol10.5%2
7
Lamotrigine5.3%1
8
Carbidopa5.3%1
9
Levodopa5.3%1
10
Donepezil-hydrochloride5.3%1
11
Progesterone5.3%1
12
Magnesium-trisilicate5.3%1
13
Rasagiline-mesylate5.3%1
14
Magnesium-acetate-tetrahydrate5.3%1
15
Methocarbamol5.3%1

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports afamelanotide side effects

31.6% of afamelanotide adverse event reports involve female patients and 68.4% involve male patients. The largest age group is adult at 87%. These figures reflect who reports side effects, not underlying risk.

Sex

Female31.6%
Male68.4%
Unknown0.0%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6486.7%
65+13.3%

What is afamelanotide used for

Conditions and purposes for which patients were taking afamelanotide when the adverse event was reported.

Porphyria Non-acutePorphyria AcutePorphyria Non-acuteProduct Used For Unknown Indication

Afamelanotide brand names and reporting trend

Afamelanotide is sold under the brand name Scenesse.

Brand names

Scenesse2

Quarterly reports (20212025)

2021202220242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking afamelanotide with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.