Short answer: In the Scenesse label's three trials in adults with EPP, the most common side effects through month 6 were implant site reactions (21% vs 10% on a dummy implant), nausea (19% vs 14%), sore throat (7% vs 5%), cough and fatigue (6% each vs 3%). There is no boxed warning; the label warns about serious allergic reactions and darkening of the skin and moles.
What Scenesse is approved for: Scenesse is a melanocortin 1 receptor (MC1-R) agonist approved to increase pain-free light exposure in adults with a history of phototoxic reactions (painful reactions to light) from erythropoietic protoporphyria (EPP) (Indications and Usage).
Source
SCENESSE (afamelanotide) implant, for subcutaneous use, prescribing information. CLINUVEL. DailyMed, version published May 13, 2026. DailyMed setid 94f53286-11dd-7fbb-e053-2a95a90a7c48
No. The current Scenesse label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Scenesse.
| Adverse Reaction | SCENESSE n (%) N = 125 | Vehicle n (%) N = 119 |
|---|---|---|
| Implant site reaction | 26 (21%) | 12 (10%) |
| Nausea | 24 (19%) | 17 (14%) |
| Oropharyngeal pain | 9 (7%) | 6 (5%) |
| Cough | 8 (6%) | 4 (3%) |
| Fatigue | 7 (6%) | 3 (3%) |
| Skin hyperpigmentation | 5 (4%) | 0 (0%) |
| Dizziness | 5 (4%) | 4 (3%) |
| Melanocytic nevus | 5 (4%) | 2 (2%) |
| Respiratory tract infection | 5 (4%) | 3 (3%) |
| Somnolence | 3 (2%) | 1 (1%) |
| Non-acute porphyria | 2 (2%) | 0 (0%) |
| Skin irritation | 2 (2%) | 0 (0%) |
244 adults with EPP without significant liver involvement: 125 got Scenesse 16 mg implants every 2 months and 119 got vehicle (dummy) implants. Implant site reaction groups bruising, discoloration, redness, bleeding, thickening, irritation, a lump, pain, itching, swelling and an expelled implant. Skin hyperpigmentation includes darkened lips and a pigmentation disorder.
The most common implant site reaction on Scenesse was discoloration at the implant site, in 10%.
Reported after approval: allergic reactions, including hives, angioedema (swelling under the skin) and anaphylaxis.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Hypersensitivity. Serious allergic reactions, including anaphylaxis, have been reported since approval. If one happens, it is treated and the implant may be removed, and the person does not get Scenesse again.
Skin monitoring. Scenesse can darken the skin overall and darken existing moles and freckles. A full-body skin exam twice a year is recommended to check existing and new pigmented spots.
Sun and light protection continues. The label says sun and light protection measures are kept up during treatment to prevent EPP light reactions.
Who should not use it. People with a history of a severe allergic reaction to afamelanotide or any ingredient in Scenesse.
From the Patient Counseling Information section of the prescribing information that comes with Scenesse:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.