Current label evidence
Nausea is common with labeled Vyleesi and is most prominent after the first dose
The current Vyleesi prescribing information reports nausea in 40% of treated patients in pooled phase 3 trials, compared with about 1% of placebo-treated patients. Median onset was within one hour after the dose and median duration was about two hours. Nausea incidence was highest after the first dose—reported in 21% of patients—and declined to about 3% after subsequent doses. These are group-level trial findings, not a promise that an individual episode will be brief or safe to ignore.
- The label says 13% of Vyleesi-treated patients received an antiemetic and 8% discontinued the trials early because of nausea.
- Vomiting occurred in 4.8% of Vyleesi-treated patients versus 0.2% with placebo in the controlled trials.
- Persistent or severe nausea should be routed to the prescriber; worsening symptoms should not be managed by taking more peptide, changing routes, or waiting for a seller to respond.