Vyleesi Side Effects

Generic name: bremelanotide

Medically reviewed by Drugs.com. Last updated on Sep 17, 2024.

Note: This document provides detailed information about Vyleesi.

Applies to bremelanotide: subcutaneous solution Side Effects associated with bremelanotide. Some dosage forms listed on this page may not apply specifically to the brand name Vyleesi.

Applies to bremelanotide: subcutaneous solution.

Precautions

It is very important that your doctor check your progress at regular visitsto make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

If your condition does not improve within 8 weeks, or if it become worse, check with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

This medicine may cause darkening of the skin on the face, gums, or breasts, especially in patients with darker skin and daily use. Talk to your doctor if you have concerns about any skin changes.

Nausea may occur after first using bremelanotide (the active ingredient contained in Vyleesi) which may last for 2 hours or more. Your doctor may give you an anti-emetic medicine for this. Check with your doctor right away if the nausea is severe or continuing.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Vyleesi

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:

Other side effects of Vyleesi

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:

For healthcare professionals

Applies to bremelanotide: subcutaneous solution.

General adverse events

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

Cardiovascular

• 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.

Gastrointestinal

• 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.

Dermatologic

• 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.

Local

• 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.

Musculoskeletal

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

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

Hepatic

• Frequency not reported: Acute hepatitis

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.

Respiratory

• Common (1% to 10%): Cough, nasal congestion
• Frequency not reported: Rhinorrhea

Rhinorrhea was reported in less than 2% of patients.

Other

• Common (1% to 10%): Fatigue

Nervous system

• Very common (10% or more): Headache (11.3%)
• Common (1% to 10%): Paraesthesia, dizziness

See also:

Frequently asked questions

• Vyleesi vs Addyi: What is the difference?

Further information

Vyleesi 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