OpenClaim

Bremelanotide Side Effects

The most commonly reported side effects of bremelanotide include nausea, headache, and vomiting, based on 799 FDA adverse event reports from 2019 to 2025. 19.6% of reports found the drug to be ineffective.

Bremelanotide side effects

Percentages show how often each reaction appears relative to total reports for bremelanotide.

1
Nausea42.7%341
2
Drug Ineffective19.6%157
3
Headache14.4%115
4
Vomiting11.8%94
5
Off Label Use7.8%62
6
Flushing7.6%61
7
Illness6.6%53
8
Adverse Drug Reaction4.8%38
9
Dizziness4.5%36
10
Cough3.9%31
11
Fatigue3.8%30
12
Feeling Abnormal3.5%28
13
Malaise3.1%25
14
Erythema2.9%23
15
Pain2.5%20

These are voluntary reports and do not establish that bremelanotide caused these reactions.

Report severity

3.1%Serious25 reports
0.8%Hospitalizations6 reports
0.1%Fatal1 reports

Seriousness is determined by the reporter, not by OpenClaim.

Bremelanotide drug interactions

Other drugs that appear in adverse event reports alongside bremelanotide. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Prasterone0.5%4
2
Risankizumab-rzaa0.1%1
3
Tirzepatide0.1%1
4
Mifepristone0.1%1
5
Clarithromycin0.1%1
6
Flibanserin0.1%1
7
Brexpiprazole0.1%1

Taken alongside

1
Bupropion4.6%37
2
Levothyroxine-sodium3.9%31
3
Progesterone2.9%23
4
Estradiol2.6%21
5
Amphetamine2.6%21
6
Dextroamphetamine2.6%21
7
Semaglutide2.3%18
8
Escitalopram-oxalate1.8%14
9
Gabapentin1.6%13
10
Sertraline-hydrochloride1.6%13
11
Lisdexamfetamine-dimesylate1.6%13
12
Tirzepatide1.6%13
13
Lamotrigine1.5%12
14
Testosterone1.4%11
15
Rosuvastatin1.4%11

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports bremelanotide side effects

86.5% of bremelanotide adverse event reports involve female patients and 4.9% involve male patients. The largest age group is adult at 94%. These figures reflect who reports side effects, not underlying risk.

Sex

Female86.5%
Male4.9%
Unknown8.6%

Age group

< 20.2%
2–110.0%
12–170.0%
18–6493.8%
65+5.9%

What is bremelanotide used for

Conditions and purposes for which patients were taking bremelanotide when the adverse event was reported.

Erectile DysfunctionErectile DysfunctionFemale Sexual Arousal DisorderHormone Level AbnormalHormone TherapyLibido DecreasedLoss Of LibidoLibido DecreasedLibido DisorderLibido IncreasedLoss Of LibidoMenopauseObesityOff Label UseOrgasm Abnormal

Showing 15 of 22 indications

Bremelanotide brand names and reporting trend

Bremelanotide is sold under the brand name Vyleesi (autoinjector).

Brand names

Vyleesi (autoinjector)3

Quarterly reports (20192025)

20192020202220242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking bremelanotide with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.