Gabapentinoids related psychiatric disorders: an analysis based on the FAERS database from 2004 to 2023

Background Gabapentinoids, including gabapentin and pregabalin, are commonly used for neuropathic pain but have safety concerns. This study analyzed U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) data to assess risks of psychiatric disorders as adverse effects.Research design and methods Data from 2004 to 2023 were extracted for disproportionality analysis using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and the Multi-Item Gamma Poisson Shrinker (MGPS) to evaluate the association between gabapentinoids and psychiatric AEs. Kaplan-Meier and log-rank tests assessed the incidence and onset profiles, while chi-square examined mortality and hospitalization rates differences.Results Of 174,321 AE reports, 22.67% involved psychiatric disorders. Gabapentinoids increased psychiatric disorder incidence at SOC level, with events like anxiety and suicidal ideation. Differences in incidence and health outcomes between gabapentin and pregabalin were significant (p < 0.05).Conclusion There is a correlation between the use of gabapentinoids and psychiatric disorders. Further research is needed into the mechanisms and prevention strategies for these adverse effects.