Short answer: In the label's two 24-week placebo-controlled trials, the most common Vyleesi side effects were nausea (40.0% vs 1.3% on placebo), flushing (20.3% vs 0.3%), injection site reactions (13.2% vs 8.4%) and headache (11.3% vs 1.9%). Nausea was highest after the first dose. Each dose briefly raises blood pressure and lowers heart rate. Vyleesi has no boxed warning.
What Vyleesi is approved for: Vyleesi is approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD): low sexual desire that causes marked distress or relationship difficulty and is not due to another medical or mental health condition, relationship problems, or a medicine or drug. It is not for postmenopausal women or men, and not to enhance sexual performance (section 1).
Source
VYLEESI (bremelanotide injection), prescribing information and Patient Information. Cosette Pharmaceuticals. DailyMed, version published November 18, 2025. DailyMed setid f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
No. The current Vyleesi label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Vyleesi.
| Adverse reaction | Vyleesi (n = 627) % | Placebo (n = 620) % |
|---|---|---|
| Nausea | 40.0 | 1.3 |
| Flushing | 20.3 | 0.3 |
| Injection site reactions (a) | 13.2 | 8.4 |
| Headache | 11.3 | 1.9 |
| Vomiting | 4.8 | 0.2 |
| Cough | 3.3 | 1.3 |
| Fatigue | 3.2 | 0.5 |
| Hot flush | 2.7 | 0.2 |
| Paraesthesia | 2.6 | 0.0 |
| Dizziness | 2.2 | 0.5 |
| Nasal congestion | 2.1 | 0.5 |
Two identical 24-week, randomized, double-blind, placebo-controlled trials in 1,247 premenopausal women with acquired, generalized HSDD, aged 19 to 56 (mean 39). Most used Vyleesi two to three times per month and no more than once a week. (a) Includes injection site pain, unspecified injection site reactions, redness, hematoma, itching, bleeding, bruising, tingling and numbness.
Nausea usually began within one hour of a dose and lasted about two hours. It was reported in 21% of patients after the first dose and about 3% after later doses. 13% received an anti-nausea medicine, and 8% (vs none on placebo) left the trials because of nausea.
Stopping because of side effects: 18% on Vyleesi vs 2% on placebo. The most common reasons were nausea (8%), headache (2%), vomiting (1%), flushing (1%), injection site reactions (1%), flu-like symptoms (<1%) and increased blood pressure (<1%). Serious adverse reactions: 1.1% vs 0.5%.
After each dose, systolic blood pressure rose by up to 6 mmHg and diastolic by up to 3 mmHg, peaking 2 to 4 hours after the dose, with heart rate dropping by up to 5 beats per minute. Both usually returned to baseline within 12 hours.
Focal skin darkening (face, gums, breasts) was reported in 1% of patients using up to 8 doses per month vs no placebo patients. In another study, 38% developed it after 8 daily doses, and an additional 14% after 8 more consecutive days.
A single case of acute hepatitis was reported in the open-label extension, in a patient who had 10 doses over one year; liver tests returned to normal 4 months after stopping. The label says the role of Vyleesi could not be definitively excluded.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Short-term rise in blood pressure and drop in heart rate. Every dose briefly raises blood pressure and lowers heart rate. Vyleesi is not recommended for people at high risk of heart disease and must not be used with uncontrolled high blood pressure or known heart disease. Blood pressure should be well controlled before and during treatment, and no more than one dose is taken within 24 hours.
Focal hyperpigmentation (skin darkening). Darkening of patches of skin, including the face, gums and breasts, has been reported. It was more likely in people with dark skin and more frequent with daily use, and it did not clear in every patient after stopping. The label says more than 8 doses a month is not recommended and stopping is considered if it develops.
Nausea. Nausea was the most common side effect at 40% and improved for most patients with the second dose. For persistent or severe nausea, the label says to consider stopping Vyleesi, or anti-nausea treatment for those who want to continue. Taking oral ondansetron 30 minutes before a dose did not reduce nausea and is not recommended (section 6.1).
Who should not use it. People with uncontrolled high blood pressure (hypertension) or known cardiovascular disease.
Pregnancy and birth control. The label advises effective birth control while using Vyleesi and stopping it if pregnancy is suspected. A pregnancy registry tracks outcomes in women exposed during pregnancy.
From the Patient Information that comes with Vyleesi:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.