Dextromethorphan-bupropion-associated pharmacovigilance signals based on the FAERS database: An observational study

Area of Science:

• Pharmacovigilance
• Neuroscience
• Clinical Psychiatry

Background:

• Dextromethorphan-bupropion, an NMDA receptor antagonist, was approved for major depressive disorder in 2022.
• Understanding its adverse event profile is crucial for patient safety and effective treatment.

Purpose of the Study:

• To detect and characterize adverse events (AEs) associated with dextromethorphan-bupropion.
• To identify potential safety signals using disproportionality methods.

Main Methods:

• Analysis of FDA Adverse Event Reporting System data from Q4 2022 to Q4 2024.
• Application of disproportionality methods: Reporting Odds Ratio, Proportional Reporting Ratio, and Multi-item Gamma Poisson Shrinker.
• Quantification of AE signals for dextromethorphan-bupropion.

Main Results:

• 3580 AEs were linked to dextromethorphan-bupropion out of 4,804,129 total AEs analyzed.
• Key AE categories included psychiatric disorders (21.17%), nervous system disorders (20.92%), and general disorders/administration site conditions (19.75%).
• Obsessive rumination emerged as a low-morbidity, high-signal intensity AE; 65.3% of identified AE signals were not previously labeled.

Conclusions:

• Dextromethorphan-bupropion exhibits potential adverse event signals requiring clinical attention.
• Close monitoring for psychiatric, nervous system, and general/administration site AEs is recommended.
• Clinicians should be vigilant for unlabeled AEs to ensure safe and effective therapeutic use.