TRIAL RESULTS · SIDE EFFECTS
Bremelanotide side effects
ANSWER
In 4 placebo-controlled trials with posted results, the most common side effects of Bremelanotide were nausea 33.6% (placebo 17.7%), flushing 17.9% (placebo 9.4%), headache 10.7% (placebo 6.5%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
4
with an arm on Bremelanotide, of 10 registered
Against placebo
4
placebo-controlled trials
People in those trials
1,209
on Bremelanotide · 1,178 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Bremelanotide beside placebo
Share of people with each side effect in 4 placebo-controlled trials with posted results: 1,209 people on Bremelanotide (all doses), 1,178 on placebo, same trials. Listed only when reported for at least half of the people on Bremelanotide. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
All 81 side effects reported
Every trial with posted results and an arm on Bremelanotide (n ≥ 20), all phases, by people affected. Placebo is shown where placebo-controlled trials reported the same event. Comparator arms are not counted.
| Side effect | Organ system | Bremelanotide | Placebo | Trials |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 33.6% (396 of 1,178) | 17.7% | 3 |
| Flushing | Vascular disorders | 17.9% (211 of 1,178) | 9.4% | 3 |
| Headache | Nervous system disorders | 10.7% (126 of 1,178) | 6.5% | 3 |
| Upper respiratory tract infection | Infections and infestations | 5.8% (68 of 1,178) | 5.8% | 3 |
| Injection site pain | General disorders | 5.1% (60 of 1,178) | 5.7% | 3 |
| Sunburn | Injury, poisoning and procedural complications | 6.8% (60 of 881) | 11.3% | 2 |
| Urinary tract infection | Infections and infestations | 4.3% (51 of 1,178) | 4.2% | 3 |
| Vomiting | Gastrointestinal disorders | 4.1% (48 of 1,178) | 2.2% | 3 |
| Injection site reaction | General disorders | 4.5% (40 of 881) | 2.1% | 2 |
| Nasopharyngitis | Infections and infestations | 3.3% (39 of 1,178) | 3.4% | 3 |
| Fatigue | General disorders | 3.2% (38 of 1,178) | 2.3% | 3 |
| Sinusitis | Infections and infestations | 2.9% (34 of 1,178) | 3.8% | 3 |
| Injection site erythema | General disorders | 2.8% (33 of 1,178) | 0.5% | 3 |
| Dizziness | Nervous system disorders | 2.3% (27 of 1,178) | 1.7% | 3 |
| Cough | Respiratory, thoracic and mediastinal disorders | 3.0% (26 of 881) | 2.3% | 2 |
| Paresthesia | Nervous system disorders | 2.0% (24 of 1,178) | 0.8% | 3 |
| Injection site pruritus | General disorders | 3.1% (23 of 745) | 0.8% | 2 |
| Diarrhea | Gastrointestinal disorders | 2.4% (18 of 745) | 1.5% | 2 |
| Fungal infect, gastroenter/bronchitis, vulvo/vaginitis, follicul/pharyngitis, tooth abcess (1% each) | Infections and infestations | 6.1% (18 of 297) | 7.2% | 1 |
| Injection/vessel puncture site hematoma (1% each) | General disorders | 5.7% (17 of 297) | 1.0% | 1 |
| CPK/glu/lipase/chol/BP/triglycerides increased, iron decreased, MCV abnormal (1% each) | Investigations | 5.7% (17 of 297) | 3.1% | 1 |
| Vag hemorrh/discharge, breast tend/mass, metrorrhagia, menstru irreg, genit discomfort/order (1% ea) | Reproductive system and breast disorders | 5.4% (16 of 297) | 7.2% | 1 |
| Feeling hot/jittery, inj site reac/hemorrhage/rash, pain, chest pain (1% each) | General disorders | 4.7% (14 of 297) | 6.2% | 1 |
| Abdominal pain/discomfort, lower/upper abdominal pain, dyspepsia (1% each) | Gastrointestinal disorders | 4.0% (12 of 297) | 2.1% | 1 |
| Musculoskeletal pain/myalgia, arthralgia, muscle spasms, flank pain (1% each) | Musculoskeletal and connective tissue disorders | 4.0% (12 of 297) | 6.2% | 1 |
| Acne, pruritis, dermatitis contact, erythema, rash, urticaria (1% each) | Skin and subcutaneous tissue disorders | 4.0% (12 of 297) | 4.1% | 1 |
| Hot flush | Vascular disorders | 2.5% (11 of 433) | 1.6% | 1 |
| Migraine, sciatica, sinus headache (1% each) | Nervous system disorders | 3.4% (10 of 297) | 1.0% | 1 |
| Contusion, fall, joint sprain, procedural dizziness/pain, thermal pain (1% each) | Injury, poisoning and procedural complications | 3.4% (10 of 297) | 4.1% | 1 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 2.2% (10 of 448) | 0.9% | 1 |
| Somnolence | Nervous system disorders | 1.2% (9 of 745) | 1.1% | 2 |
| Back pain | Musculoskeletal and connective tissue disorders | 3.0% (9 of 297) | 2.1% | 1 |
| Abdominal pain upper | Gastrointestinal disorders | 2.0% (9 of 448) | 1.4% | 1 |
| Hot Flush | Vascular disorders | 2.0% (9 of 448) | 1.3% | 1 |
| Bronchitis | Infections and infestations | 2.1% (9 of 433) | 1.2% | 1 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 2.7% (8 of 297) | 0.0% | 1 |
| Cough, nasal/sinus congestion (1% each) | Respiratory, thoracic and mediastinal disorders | 2.7% (8 of 297) | 1.0% | 1 |
| Pain | General disorders | 1.8% (8 of 448) | 1.1% | 1 |
| Hematoma, hot flush (1% each) | Vascular disorders | 2.4% (7 of 297) | 1.0% | 1 |
| Insomnia, libido increased, restlessness (1% each) | Psychiatric disorders | 2.4% (7 of 297) | 1.0% | 1 |
| Influenza | Infections and infestations | 1.6% (7 of 448) | 2.3% | 1 |
| Injection site hematoma | General disorders | 1.6% (7 of 433) | 1.6% | 1 |
| Myalgia | Musculoskeletal and connective tissue disorders | 1.6% (7 of 433) | 1.4% | 1 |
| Gastroenteritis Viral | Infections and infestations | 1.3% (6 of 448) | 2.0% | 1 |
| Abdominal pain | Gastrointestinal disorders | 1.4% (6 of 433) | 1.2% | 1 |
| Fungal infection | Infections and infestations | 1.4% (6 of 433) | 1.6% | 1 |
| Hypertension | Vascular disorders | 1.7% (5 of 297) | 2.1% | 1 |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 1.7% (5 of 297) | 2.1% | 1 |
| Abdominal discomfort | Gastrointestinal disorders | 1.2% (5 of 433) | 0.4% | 1 |
| Vulvovaginal mycotic infection | Infections and infestations | 1.2% (5 of 433) | 2.2% | 1 |
| Influenza like illness | General disorders | 0.9% (4 of 433) | 0.6% | 1 |
| Blood creatine phophokinase | Investigations | 0.9% (4 of 433) | 0.8% | 1 |
| Anemia | Blood and lymphatic system disorders | 0.4% (3 of 730) | 0.3% | 2 |
| Migraine | Nervous system disorders | 0.7% (3 of 433) | 0.8% | 1 |
| Depression | Psychiatric disorders | 0.7% (3 of 433) | 0.2% | 1 |
| Hypersensitivity, seasonal allergy (1% each) | Immune system disorders | 0.7% (2 of 297) | 3.1% | 1 |
| Sinus bradycardia | Cardiac disorders | 0.7% (2 of 297) | 0.0% | 1 |
| Melanocytic nevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.7% (2 of 297) | 0.0% | 1 |
| Dermatitis contact | Skin and subcutaneous tissue disorders | 0.5% (2 of 433) | 0.8% | 1 |
| Erythema | Skin and subcutaneous tissue disorders | 0.5% (2 of 433) | 0.8% | 1 |
| Insomnia | Psychiatric disorders | 0.5% (2 of 433) | 1.4% | 1 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 0.3% (1 of 297) | 0.0% | 1 |
| Incisional hernia | Surgical and medical procedures | 0.3% (1 of 297) | 0.0% | 1 |
| Chest pain | Cardiac disorders | 0.3% (1 of 297) | 0.0% | 1 |
| Abdominal hernia obstructive | Gastrointestinal disorders | 0.2% (1 of 448) | 0.0% | 1 |
| Peritoneal hemorrhage | Gastrointestinal disorders | 0.2% (1 of 448) | 0.0% | 1 |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.2% (1 of 448) | 0.0% | 1 |
| Ovarian cyst ruptured | Reproductive system and breast disorders | 0.2% (1 of 448) | 0.0% | 1 |
| Abdominal Pain | Gastrointestinal disorders | 0.2% (1 of 433) | 0.0% | 1 |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.2% (1 of 433) | 0.2% | 1 |
| Pneumonia | Infections and infestations | 0.2% (1 of 433) | 0.0% | 1 |
| cholecystitis | Hepatobiliary disorders | 0.2% (1 of 433) | 0.0% | 1 |
| Gastrointestinal inflammation | Gastrointestinal disorders | 0.2% (1 of 433) | 0.0% | 1 |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.2% (1 of 433) | 0.0% | 1 |
| Escherichia bacteremia | Infections and infestations | 0.0% (0 of 297) | 1.0% | 1 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 0.0% (0 of 297) | 1.0% | 1 |
| Menometrorrhagia | Reproductive system and breast disorders | 0.0% (0 of 297) | 1.0% | 1 |
| Colitis | Gastrointestinal disorders | 0.0% (0 of 448) | 0.2% | 1 |
| Cerebrovascular accident | Cardiac disorders | 0.0% (0 of 448) | 0.2% | 1 |
| Endometriosis | Pregnancy, puerperium and perinatal conditions | 0.0% (0 of 448) | 0.2% | 1 |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | 0.0% (0 of 433) | 0.2% | 1 |
Source: ClinicalTrials.gov posted results, read 2026-10-03. A trial lists events above its own reporting threshold, so a rare event may be missing from some trials. Not medical advice.
FDA LABEL
What the FDA label says
Vyleesi NDA210557 · label of 2025-11-13 Regulator
Most common adverse reactions (incidence > 4%) are nausea, flushing, injection site reactions, headache, and vomiting.
QUESTIONS
Does bremelanotide cause nausea?
In 4 placebo-controlled trials with posted results, 33.6% of people on bremelanotide reported nausea, against 17.7% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does bremelanotide cause flushing?
In 4 placebo-controlled trials with posted results, 17.9% of people on bremelanotide reported flushing, against 9.4% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does bremelanotide cause headache?
In 4 placebo-controlled trials with posted results, 10.7% of people on bremelanotide reported headache, against 6.5% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does bremelanotide cause sunburn?
In 4 placebo-controlled trials with posted results, 6.8% of people on bremelanotide reported sunburn, against 11.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does bremelanotide cause upper respiratory tract infection?
In 4 placebo-controlled trials with posted results, 5.8% of people on bremelanotide reported upper respiratory tract infection, against 5.8% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
10 registered clinical trials of Bremelanotide
| NCT06867835 | Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk Status: COMPLETED · Updated 2026-01-13 |
|---|---|
| NCT06565611 | A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity Status: ACTIVE_NOT_RECRUITING · Updated 2025-03-06 |
| NCT04943068 | A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal) Status: COMPLETED · Updated 2024-11-13 |
| NCT05709444 | A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease Status: COMPLETED · Updated 2024-10-17 |
| NCT04179734 | Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder Status: COMPLETED · Updated 2024-08-09 |
| NCT03973047 | Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran Status: COMPLETED · Updated 2022-04-04 |
| NCT02333071 | 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder Status: COMPLETED · Updated 2021-04-09 |
| NCT02338960 | 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder Status: COMPLETED · Updated 2021-01-28 |
| NCT01382719 | Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder Status: COMPLETED · Updated 2014-12-18 |
| NCT00425256 | Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD) Status: COMPLETED · Updated 2011-02-23 |
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