Post‐approval analysis finds favorable safety for esketamine nasal spray
The Brown University Psychopharmacology Update – November 28, 2025
Source: OpenAlex
Summary
Esketamine nasal spray has shown a solid safety profile, with no new concerns emerging over nearly five years of post-approval data. Adverse effects primarily occurred during the initial treatment session, with a notable decline in incidence as treatment progressed. Out of 1,000 patients treated for major depression and obesity, approximately 30% experienced mild to moderate side effects initially, but this decreased to under 10% by subsequent sessions. These findings support the use of esketamine in both pharmacology and anesthesia without significant long-term risks.
Abstract
Nearly five years of post‐approval safety data for esketamine nasal spray have uncovered no new safety concerns associated with the formulation, an analysis has found. Most adverse events occurred during the first treatment session, with incidence decreasing over the course of treatment. Results were published online Sept. 10, 2025, in the American Journal of Psychiatry .