Pharmacovigilance of esketamine nasal spray: an analysis of the FDA adverse event reporting system database.
Frontiers in pharmacology January 1, 2024 Ruixue Liu, Chunxiao Liu, Dianwei Feng et al. 5 citations
An analysis of adverse event reports from the FDA adverse event reporting system between 2019 and 2023 identified 14,606 reports in which esketamine nasal spray was the primary suspected drug. Psychiatric disorders accounted for 33.20% of the 518 distinct adverse event signals, followed by nervous system disorders (16.67%) and general disorders (14.21%). Dissociation was the most frequent and intense signal, reported 1,093 times. Uncommon but strong signals included hand-eye coordination impaired, feeling guilty, and feelings of worthlessness. Dissociative disorder, not listed in the product's summary of product characteristics, also showed a strong signal. Close clinical attention to psychiatric and nervous system adverse events is warranted.