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Bremelanotide Side Effects

Medically reviewed by Last updated on Jul 4, 2023.

Applies to bremelanotide: subcutaneous solution.

Serious side effects of Bremelanotide

Along with its needed effects, bremelanotide 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 bremelanotide:

More common

Less common


Incidence not known

Other side effects of Bremelanotide

Some side effects of bremelanotide 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

Less common


For Healthcare Professionals

Applies to bremelanotide: subcutaneous solution.


The more commonly reported adverse reactions have included nausea, flushing, injection site reactions, headache, and vomiting.[Ref]


Very common (10% or more): Flushing (20.3%)

Common (1% to 10%): Hot flush

Frequency not reported: Transient blood pressure increases, decreased heart rate

Results of ambulatory blood pressure (BP) monitoring (n=127) showed a mean increase of 1.9 mmHg in daytime systolic BP and 1.7 mmHg in daytime diastolic BP after 8 days of dosing. Increases were transient with a mean peak increase of 2.8 mmHg in systolic BP occurring between 4- and 8-hours post-dose and a mean peak increase in diastolic blood pressure of 2.7 mmHg occurring at 0 to 4 hours post-dose. A mean transient decrease in heart rate of 0.5 beats per minute accompanied these transient increases in BP. At 12 to 24 hours post-dose, BP values were similar to pre-dose values.


Very common (10% or more): Nausea (40%)

Common (1% to 10%): Vomiting

Frequency not reported: Upper abdominal pain, diarrhea

In clinical trials, nausea was reported in 40% of patients (vs 1% placebo); median onset 1 hour and duration 2 hours. The incidence was highest with the first dose and declined with subsequent doses. Upper abdominal pain and diarrhea were reported in less than 2% of patients.


Frequency not reported: Focal skin hyperpigmentation

Focal hyperpigmentation involving face, gingiva and breasts was reported in 1% of patients who received up to 8 doses per month (placebo 0%). In another clinical study, 38% of patients developed focal hyperpigmentation after receiving this drug daily for 8 days; an additional 14% developed new focal pigmentary changes upon continuing this drug for 8 more consecutive days.


Very common (10% or more): Injection site reactions (13.2%)

Injection site reactions include injection site pain, unspecified injection site reactions, erythema, hematoma, pruritus, hemorrhage, bruising, paresthesia and hypoesthesia.


Myalgia, arthralgia, restless leg syndrome, increased creatine phosphokinase, and pain in extremity were reported in less than 2% of patients.

Frequency not reported: Myalgia, arthralgia, extremity pain, restless leg syndrome, increased creatine phosphokinase


One case of acute hepatitis has been reported in a patient receiving 10 doses of this drug over a 1-year period; serum transaminases exceeded 40 times the upper limit of normal (ULN), total bilirubin 6 x ULN, and alkaline phosphatase less than 2 x ULN. Upon discontinuation, liver tests returned to normal after 4 months.

Frequency not reported: Acute hepatitis


Common (1% to 10%): Cough, nasal congestion

Frequency not reported: Rhinorrhea

Rhinorrhea was reported in less than 2% of patients.


Common (1% to 10%): Fatigue

Nervous system

Very common (10% or more): Headache (11.3%)

Common (1% to 10%): Paraesthesia, dizziness

Frequently asked questions


1. Product Information. Vyleesi (bremelanotide). AMAG Pharmaceuticals Inc. 2019.

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.