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Imcivree Side Effects

Generic name: setmelanotide

Medically reviewed by Last updated on Oct 16, 2023.

Note: This document contains side effect information about setmelanotide. Some dosage forms listed on this page may not apply to the brand name Imcivree.

Applies to setmelanotide: subcutaneous solution.

Serious side effects of Imcivree

Along with its needed effects, setmelanotide (the active ingredient contained in Imcivree) 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

Other side effects of Imcivree

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

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]


Common (1% to 10%): Hot flush[Ref]


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

Common (1% to 10%): Pruritus, hyperhidrosis, skin discoloration, skin lesion

Uncommon (0.1% to 1%): Ephelides, erythema, skin striae, hair color changes, lentigo, macule, dermal cyst, dermatitis, nail disorder nail discoloration, papular rash, application site pruritus[Ref]

Skin hyperpigmentation includes pigmentation disorders.[Ref]


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

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


Abdominal pain includes upper abdominal pain.[Ref]

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

Common (1% to 10%): Dyspepsia

Uncommon (0.1% to 1%): Gingival discoloration, abdominal distention, salivary hypersecretion, flatulence, gastroesophageal reflux disease[Ref]


Common (1% to 10%): Sexual adverse reactions, erection increased, increased libido

Uncommon (0.1% to 1%): Female sexual arousal disorder, genital discomfort, female genital disorder, genital hypoesthesia, ejaculation disorder, decreased libido

Frequency not reported: Hypersensitivity of the labia[Ref]


Injection site reaction includes injection site erythema, pruritus, edema, pain, induration, bruising, hypersensitivity, hematoma, nodule, and discoloration.[Ref]

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

Uncommon (0.1% to 1%): Chest pain[Ref]


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

Common (1% to 10%): Myalgia

Uncommon (0.1% to 1%): Musculoskeletal chest pain[Ref]


Uncommon (0.1% to 1%): Scleral discoloration, ocular icterus[Ref]

Nervous system

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

Uncommon (0.1% to 1%): Somnolence, hyperesthesia, migraine, parosmia, dysgeusia, anxiety, altered mood[Ref]


Common (1% to 10%): Melanocytic naevus

Uncommon (0.1% to 1%): Dysplastic naevus, eye nevis[Ref]


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

Uncommon (0.1% to 1%): Temperature intolerance, feeling cold, feeling hot[Ref]


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

Uncommon (0.1% to 1%): Depressed mood, sleep disorder, nightmare[Ref]


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

Uncommon (0.1% to 1%): Yawning, cough, rhinorrhea[Ref]


1. (2022) "Product Information. Imcivree (setmelanotide)." Rhythm Pharmaceuticals, 2

2. (2022) "Product Information. Imcivree (setmelanotide)." Rhythm Pharmaceuticals UK Ltd

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.