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Setmelanotide Side Effects

Medically reviewed by Last updated on Aug 21, 2022.

Applies to setmelanotide: subcutaneous solution.

Serious side effects of Setmelanotide

Along with its needed effects, setmelanotide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking setmelanotide:

More common

  • Aggressive, angry
  • darkening of the skin or skin lesions
  • discouragement
  • feeling sad or empty
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • prolonged erection of the penis
  • reddish purple lines on the arms, face, legs, trunk, or groin
  • thoughts of killing oneself changes in behavior
  • tiredness
  • trouble concentrating
  • trouble sleeping

Other side effects of Setmelanotide

Some side effects of setmelanotide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Back pain
  • bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • body aches or pain
  • chills
  • cough
  • diarrhea
  • difficulty in breathing
  • difficulty in moving
  • dizziness
  • dry mouth
  • ear congestion
  • fever
  • hair loss, thinning of hair
  • headache
  • joint pain
  • lack or loss of strength
  • loss of voice
  • muscle pain, stiffness, or spasm
  • nausea
  • pain in the arms or legs
  • rash
  • runny or stuffy nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
  • vomiting

For Healthcare Professionals

Applies to setmelanotide: subcutaneous solution.


The most commonly reported adverse reactions have included injection site reactions, skin hyperpigmentation, nausea, headache, and diarrhea.[Ref]


Very common (10% or more): Injection site reaction (96%)


Very common (10% or more): Nausea (56%), diarrhea (37%), abdominal pain (33%), vomiting (30%), dry mouth (15%) constipation (11%)


Very common (10% or more): Spontaneous penile erection (23%)

Common (1% to 10%): Disturbance in sexual arousal (female)

Rare (0.01% to 0.1%): Hypersensitivity of the labia


Very common (10% or more): Skin hyperpigmentation (78%), dry skin (15%), alopecia (11%), rash (11%)


Very common (10% or more): Back pain (33%), arthralgia (19%), muscle spasm (11%), extremity pain (11%)


Very common (10% or more): Upper respiratory tract infection (26%)


Very common (10% or more): Fatigue (30%), vertigo (15%), chills 11%), influenza-like illness (11%)

Nervous system

Very common (10% or more): Headache (41%), asthenia (19%), dizziness (15%)


Very common (10% or more): Depression (26%), insomnia (15%), suicidal ideation (11%)


1. "Product Information. Imcivree (setmelanotide)." Rhythm Pharmaceuticals (2022):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.