Dextromethorphan-bupropion-associated pharmacovigilance signals based on the FAERS database: An observational study.
Medicine June 26, 2026 Ruixue Liu, Chunxiao Liu, Chunhui Li et al.
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.