Setmelanotide Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 27, 2024.

Applies to setmelanotide: subcutaneous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

If you have not lost weight after 12 to 16 weeks of treatment, check with your doctor.

This medicine may cause sexual function problems in men and women. Check with your doctor right away if you have an erection of the penis lasting longer than 4 hours.

This medicine may cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause skin problems (eg, hyperpigmentation). Check with your doctor right away if you have darkening of the skin or skin lesions (moles or nevi) you already have.

This medicine contains benzyl alcohol, which may cause serious reactions (eg, gasping syndrome) to newborn or premature babies. Discuss this with your doctor if you are concerned.

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:

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:

For healthcare professionals

Applies to setmelanotide: subcutaneous solution.

General adverse events

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]

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]

Ocular

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

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer