A real-world pharmacovigilance study of modafinil events in the FDA Adverse Event Reporting System (FAERS)

This study aims to analyze adverse events (AEs) associated with modafinil based on the FAERS database to provide insights for its safety monitoring.

For quantifying signals of modafinil-related AEs, disproportionality analyses were employed, including the use of measures such as the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-Item Gamma Poisson Shrinker (MGPS) and Bayesian Confidence Propagation Neural Network (BCPNN) algorithms.

We extracted modafinil-related AE reports from the FAERS database spanning from the first quarter of 2004 to the first quarter of 2024 and conducted detailed data analysis. Out of a total of 21,035,995 case reports, 3070 were directly associated with modafinil. We identified 127 Preferred Terms (PTs) to describe these AEs, encompassing 27 organ systems. Specifically, several AEs such as stress cardiomyopathy, brain oedema, hypotonia, abortion spontaneous, premature labour, neonatal disorder, and eosinophilic myocarditis were not explicitly mentioned in the drug label, indicating potential new signals of adverse drug reactions (ADRs). The median onset time of modafinil-related AEs was 76.5 days (interquartile range [IQR] 14-392 days), with most AE cases occurring in the first month after initiation of modafinil.

Analysis of the FAERS database identified AEs associated with modafinil, particularly diseases related to pregnancy, puerperium and perinatal conditions, as well as congenital, familial and genetic disorders and cardiac disorders that were not previously documented in the drug's official labeling. These findings underscore the need for continuous post-market surveillance among healthcare professionals and heightened awareness of potential new ADR signals.