PT-141 (Vyleesi) Safety Profile
Safety information for FDA-approved PT-141 (bremelanotide/Vyleesi) for HSDD.
Last updated: January 19, 2026
For Educational Purposes Only
This safety information is compiled from clinical trial data and regulatory documents for educational purposes. It is not a substitute for professional medical advice. Always consult your healthcare provider about medication safety, especially regarding your individual circumstances, medical history, and other medications.
Safety Overview
PT-141 (Vyleesi) is FDA-approved with established safety data from the RECONNECT Phase 3 trials.
Common Side Effects
| Side Effect | Frequency | Notes |
|---|---|---|
| Nausea | 40% | Most common; often significant |
| Flushing | 21% | Expected from mechanism |
| Injection site reaction | 13% | Pain, redness |
| Headache | 11% | Usually mild |
Serious Warnings
Cardiovascular
- Transient blood pressure increases observed
- Caution in uncontrolled hypertension
- Caution in cardiovascular disease
Focal Hyperpigmentation
- Darkening of face, gums, or breasts possible
- May not resolve after stopping
Drug Interaction
- Do not use with naltrexone (antagonizes effects)
Who Should NOT Use
- Uncontrolled hypertension
- Cardiovascular disease
- Concurrent naltrexone use
- Known hypersensitivity
Usage Limitations
- Maximum 1 dose per 24 hours
- Maximum 8 doses per month
- Not for daily use
Special Populations
- Only approved for premenopausal women
- Not studied in men for this indication
- Not recommended in severe hepatic impairment
This is for educational purposes. PT-141 is a prescription medication for specific indications.
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Important: Safety information evolves as post-marketing data accumulates. This page reflects data available as of the last update date. Check official FDA and EMA resources for the most current safety information. This content is not intended to diagnose, treat, cure, or prevent any disease.