Analysis of 58 months postapproval data for esketamine nasal spray in the United States encompassing 1,486,213 outpatient treatment sessions confirms the established safety profile.
Commonly reported adverse events include sedation (34.7%), dissociation (41.0%), and increased blood pressure (0.9%), consistent with clinical trial observations.
Serious adverse events occurred in fewer than 0.2% of sessions, with suicide rates below background levels and limited cases of abuse/misuse reported.
No new safety signals emerged, supporting continued monitoring and use aligned with current product guidelines.
