What the label lists and what reports show
Bremelanotide side effects
Bremelanotide's FDA label: “Most common adverse reactions (incidence > 4%) are nausea, flushing, injection site reactions, headache, and vomiting.” FAERS holds 1,004 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (432 reports).
- No generic listed
Check it at the source: the bremelanotide FDA label on DailyMed (effective November 13, 2025, Cosette Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of VYLEESI?VYLEESI can cause serious side effects, including: Temporary increase in blood pressure and decrease in heart rate: An increase in blood pressure and decrease in heart rate can happen shortly after you inject VYLEESI. These changes usually go away within 12 hours after your injection. Increases in blood pressure and an increased risk of heart (cardiovascular) problems can happen if you use VYLEESI more often than prescribed by your healthcare provider. See “How should I use VYLEESI?” Darkening of the skin on certain parts of the body (focal hyperpigmentation) including the face, gums (gingiva) and breast. The chance of darkening of the skin is increased in people with darker skin color. The chance of darkening of the skin is higher if VYLEESI is used every day. Darkening of the skin may not go away, even after you stop using VYLEESI. […]
Source: FDA drug label, Cosette Pharmaceuticals, Inc., effective November 13, 2025 (SPL set f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence > 4%) are nausea, flushing, injection site reactions, headache, and vomiting.
Table 1: Adverse Reactions Occurring in ≥ 2% of Patients in Randomized, Double-Blind Controlled Trials with VYLEESI in Premenopausal Women with HSDD
| 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 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail elsewhere in labeling: Transient increases in blood pressure and reductions in heart rate [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.2 ) ] Focal hyperpigmentation [see Warnings and Precautions ( 5.2 )] Nausea [see Warnings and Precautions ( 5.3 ) ] Most common adverse reactions (incidence > 4%) are nausea, flushing, injection site reactions, headache, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The efficacy and safety of VYLEESI was studied in two identical, 24-week, randomized, double-blind, placebo-controlled trials in 1247 premenopausal women with acquired, generalized HSDD. The age range was 19-56 years old with a mean age of 39 years old; 86% were White and 12% were Black. Both trials also included a 52-week open-label, uncontrolled extension phase during which 684 patients received VYLEESI [see Clinical Studies ( 14 )]. …
Source: FDA drug label, Cosette Pharmaceuticals, Inc., effective November 13, 2025 (SPL set f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,004 reports list bremelanotide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 6 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Bremelanotide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions