Post-market safety profile and suicide/self-injury risk signals of dextromethorphan/bupropion: a real-world pharmacovigilance study.
European journal of clinical pharmacology July 1, 2025 Lingjing Yuan, Jianping He, Xiangyu Li 3 citations
Data mining of the FDA Adverse Event Reporting System (FAERS) from 2022 to 2024 identified 2,451 adverse event reports listing dextromethorphan/bupropion (D/B) as the primary suspect. Psychiatric disorders (22.07%) and nervous system disorders (18.77%) were most common, mostly in adults aged 18–44 years. Median time to onset of adverse events was 2 days. Nearly 20 novel adverse events not in the label were detected, including sensation of inebriation and panic attacks. Risk signals for suicide/self-injury with D/B were significantly lower than with bupropion or esketamine, but still warrant attention. The authors recommend careful monitoring of psychiatric and nervous system disorders and further pharmacoepidemiological research on dissociative disorders.