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.
An analysis of the FDA adverse event reporting system from late 2022 through 2024 identified 3,580 adverse events linked to dextromethorphan-bupropion, a drug for major depressive disorder approved in August 2022. The most common adverse events were psychiatric disorders (21.17%), nervous system disorders (20.92%), and general disorders or administration site conditions (19.75%). Obsessive rumination, though rare, showed the strongest statistical signal. Notably, 65.3% of the reported adverse event signals were not listed in the drug's official prescribing instructions, suggesting previously unrecognized risks. Clinicians should monitor for these events, especially those not mentioned in the label.