Setmelanotide Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 5, 2023.

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.

General

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

Cardiovascular

• Common (1% to 10%): Hot flush^[Ref]

Dermatologic

• 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]

Endocrine

• Very common (10% or more): Spontaneous penile erection (23%)
• Common (1% to 10%): Disturbance in sexual arousal (female)^[Ref]

Gastrointestinal

• 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]

Abdominal pain includes upper abdominal pain.^[Ref]

Genitourinary

• 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]

Local

• Very common (10% or more): Injection site reaction (96%)
• Uncommon (0.1% to 1%): Chest pain^[Ref]

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

Musculoskeletal

• 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]

Ocular

• 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]

Oncologic

• Common (1% to 10%): Melanocytic naevus
• Uncommon (0.1% to 1%): Dysplastic naevus, eye nevis^[Ref]

Other

• 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]

Psychiatric

• Very common (10% or more): Depression (26%), insomnia (15%), suicidal ideation (11%)
• Uncommon (0.1% to 1%): Depressed mood, sleep disorder, nightmare^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory tract infection (26%)
• Uncommon (0.1% to 1%): Yawning, cough, rhinorrhea^[Ref]

Further information

Setmelanotide side effects can vary depending on the individual. 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.

Medical Disclaimer