TRIAL RESULTS · SIDE EFFECTS
Afamelanotide side effects
ANSWER
In 4 placebo-controlled trials with posted results, the most common side effects of Afamelanotide were headache 33.8% (placebo 31.1%), nausea 25.3% (placebo 14.6%), nasopharyngitis 16.0% (placebo 15.3%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
5
with an arm on Afamelanotide, of 28 registered
Against placebo
4
placebo-controlled trials
People in those trials
225
on Afamelanotide · 219 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Afamelanotide beside placebo
Share of people with each side effect in 4 placebo-controlled trials with posted results: 225 people on Afamelanotide (all doses), 219 on placebo, same trials. Listed only when reported for at least half of the people on Afamelanotide. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
All 57 side effects reported
Every trial with posted results and an arm on Afamelanotide (n ≥ 20), all phases, by people affected. Placebo is shown where placebo-controlled trials reported the same event. Comparator arms are not counted.
| Side effect | Organ system | Afamelanotide | Placebo | Trials |
|---|---|---|---|---|
| Headache | Nervous system disorders | 32.4% (82 of 253) | 31.1% | 5 |
| Nausea | Gastrointestinal disorders | 24.1% (61 of 253) | 14.6% | 5 |
| Nasopharyngitis | Infections and infestations | 16.0% (30 of 187) | 15.3% | 3 |
| Fatigue | General disorders | 9.6% (18 of 187) | 6.6% | 3 |
| Diarrhoea | Gastrointestinal disorders | 10.2% (18 of 176) | 11.0% | 3 |
| Influenza | Infections and infestations | 10.1% (15 of 148) | 7.6% | 2 |
| Dizziness | Pregnancy, puerperium and perinatal conditions | 10.1% (14 of 138) | 3.7% | 2 |
| Back pain | Musculoskeletal and connective tissue disorders | 10.1% (14 of 139) | 8.0% | 2 |
| Implant site discolouration | General disorders | 15.1% (13 of 86) | 0.0% | 2 |
| Abdominal pain | Gastrointestinal disorders | 6.5% (12 of 186) | 5.0% | 3 |
| Pyrexia | General disorders | 7.2% (10 of 139) | 3.6% | 2 |
| Migraine | Nervous system disorders | 6.8% (10 of 148) | 7.6% | 2 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 9.2% (8 of 87) | 7.2% | 2 |
| Abdominal pain upper | Gastrointestinal disorders | 5.4% (8 of 148) | 5.5% | 2 |
| Vomiting | Gastrointestinal disorders | 8.0% (8 of 100) | 6.0% | 1 |
| Implant site haematoma | General disorders | 8.0% (8 of 100) | 8.0% | 1 |
| Implant site pain | General disorders | 8.0% (8 of 100) | 6.0% | 1 |
| Flushing | Vascular disorders | 8.0% (8 of 100) | 0.0% | 1 |
| Upper respiratory tract infection | Infections and infestations | 7.0% (7 of 100) | 6.0% | 1 |
| Haematoma | Vascular disorders | 7.0% (7 of 100) | 9.0% | 1 |
| Back Pain | Musculoskeletal and connective tissue disorders | 12.5% (6 of 48) | 13.3% | 1 |
| Oedema peripheral | General disorders | 5.0% (5 of 100) | 2.0% | 1 |
| Cough | Respiratory, thoracic and mediastinal disorders | 5.0% (5 of 100) | 9.0% | 1 |
| Sinusitis | Infections and infestations | 4.6% (4 of 87) | 7.2% | 2 |
| Pain | General disorders | 8.3% (4 of 48) | 8.9% | 1 |
| Toothache | Gastrointestinal disorders | 4.0% (4 of 100) | 7.0% | 1 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 4.0% (4 of 100) | 11.0% | 1 |
| Influenza like illness | General disorders | 14.3% (4 of 28) | - | 1 |
| Pigmentation disorder | Skin and subcutaneous tissue disorders | 7.9% (3 of 38) | 0.0% | 1 |
| Abdominal discomfort | Gastrointestinal disorders | 7.7% (3 of 39) | 5.3% | 1 |
| Dyspepsia | Gastrointestinal disorders | 6.3% (3 of 48) | 6.7% | 1 |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 6.3% (3 of 48) | 2.2% | 1 |
| Myalgia | Musculoskeletal and connective tissue disorders | 6.3% (3 of 48) | 2.2% | 1 |
| Rhinitis* | Infections and infestations | 10.7% (3 of 28) | - | 1 |
| Photosensitivity reaction* | Skin and subcutaneous tissue disorders | 10.7% (3 of 28) | - | 1 |
| Blood urine present | Investigations | 5.3% (2 of 38) | 5.6% | 1 |
| Implant Site haematoma* | General disorders | 7.1% (2 of 28) | - | 1 |
| Implant Site Pain | General disorders | 2.6% (1 of 39) | 13.2% | 1 |
| CRAMPY ABDOMINAL PAIN | Gastrointestinal disorders | 2.6% (1 of 39) | 0.0% | 1 |
| RECURRENT RECTAL BLEEDING | Gastrointestinal disorders | 2.6% (1 of 39) | 0.0% | 1 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 2.1% (1 of 48) | 0.0% | 1 |
| Melanocytic naevus | Skin and subcutaneous tissue disorders | 2.1% (1 of 48) | 0.0% | 1 |
| Dysmenorrhoea | Reproductive system and breast disorders | 1.0% (1 of 100) | 5.0% | 1 |
| Thrombocytopenia | Blood and lymphatic system disorders | 1.0% (1 of 100) | 0.0% | 1 |
| Cholelithiasis | Hepatobiliary disorders | 1.0% (1 of 100) | 0.0% | 1 |
| Spinal fracture | Injury, poisoning and procedural complications | 1.0% (1 of 100) | 0.0% | 1 |
| Gamma-glutamyltransferase increased | Investigations | 0.0% (0 of 38) | 8.3% | 1 |
| DIZZINESS | Nervous system disorders | 0.0% (0 of 39) | 2.6% | 1 |
| Low Pulse Rate | Cardiac disorders | 0.0% (0 of 39) | 2.6% | 1 |
| Gastroenteritis viral | Infections and infestations | 0.0% (0 of 48) | 6.7% | 1 |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.0% (0 of 48) | 2.2% | 1 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 0.0% (0 of 48) | 2.2% | 1 |
| Diverticulitis | Infections and infestations | 0.0% (0 of 100) | 1.0% | 1 |
| Tonsillitis | Infections and infestations | 0.0% (0 of 100) | 1.0% | 1 |
| Joint injury | Injury, poisoning and procedural complications | 0.0% (0 of 100) | 1.0% | 1 |
| Post procedural complication | Injury, poisoning and procedural complications | 0.0% (0 of 100) | 1.0% | 1 |
| Dyskinesia | Nervous system disorders | 0.0% (0 of 100) | 1.0% | 1 |
Source: ClinicalTrials.gov posted results, read 2026-10-03. A trial lists events above its own reporting threshold, so a rare event may be missing from some trials. Not medical advice.
FDA LABEL
What the FDA label says
SCENESSE NDA210797 · label of 2026-05-11 Regulator
The most common adverse reactions (incidence > 2%) are implant site reaction, nausea, oropharyngeal pain, cough, fatigue, dizziness, skin hyperpigmentation, somnolence, melanocytic nevus, respiratory tract infection, non-acute porphyria, and skin irritation.
QUESTIONS
Does afamelanotide cause headache?
In 4 placebo-controlled trials with posted results, 33.8% of people on afamelanotide reported headache, against 31.1% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does afamelanotide cause nausea?
In 4 placebo-controlled trials with posted results, 25.3% of people on afamelanotide reported nausea, against 14.6% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does afamelanotide cause nasopharyngitis?
In 4 placebo-controlled trials with posted results, 16.0% of people on afamelanotide reported nasopharyngitis, against 15.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does afamelanotide cause dizziness?
In 4 placebo-controlled trials with posted results, 10.1% of people on afamelanotide reported dizziness, against 3.7% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does afamelanotide cause diarrhoea?
In 4 placebo-controlled trials with posted results, 10.1% of people on afamelanotide reported diarrhoea, against 11.0% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
28 registered clinical trials of Afamelanotide
The 10 most recently updated are listed.
| NCT06388642 | Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients Status: COMPLETED · Updated 2026-07-27 |
|---|---|
| 2023-505907-21-00 | A Mechanistic Study to Evaluate Impact of Afamelanotide in Aqueous Solution on Ultraviolet Radiation-Induced DNA Damage and DNA Repair Capacity in Healthy Volunteers Status: UNKNOWN · Updated 2025-12-22 |
| NCT06109649 | A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo Status: ACTIVE_NOT_RECRUITING · Updated 2025-07-08 |
| NCT05854784 | Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP) Status: COMPLETED · Updated 2025-04-27 |
| 2023-507311-35-00 | A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients with Erythropoietic Protoporphyria (EPP). Status: UNKNOWN · Updated 2024-11-04 |
| 2022-500919-40-01 | A Phase IIa, Open Label, Proof of Concept Study to Evaluate the Safety of Aqueous Afamelanotide Solution in Patients with acute Arterial Ischaemic Stroke (AIS) who are ineligible for Intravenous Thrombolysis (IVT) or Endovascular Thrombectomy (EVT) Status: UNKNOWN · Updated 2024-10-15 |
| 2022-502207-30-01 | A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Early Parkinson's Disease Status: UNKNOWN · Updated 2024-06-17 |
| NCT04525157 | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV) Status: COMPLETED · Updated 2023-09-22 |
| NCT05370235 | A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V Status: UNKNOWN · Updated 2023-09-21 |
| 2022-502207-30-00 | A Phase IIa, Open Label Study to Evaluate the Safety of Afamelanotide in Patients with Early Parkinson's Disease Status: UNKNOWN · Updated 2023-08-07 |
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