Seizure-related phenomena associated with propofol: insights from the FDA Adverse Event Reporting System (FAERS)

Propofol is a widely used intravenous anesthetic, yet its potential epileptogenic effects remain underexplored in large-scale studies. This pharmacovigilance study leveraged data from the FDA Adverse Event Reporting System (FAERS) to investigate seizures associated with propofol. Disproportionality analysis, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS), was applied to FAERS data (Q1 2004-Q1 2025). Reports of propofol-related seizures were analyzed for signal strength, clinical prioritization, time to onset, and outcome severity. Stratified analyses examined the effects of demographic factors and concomitant antiepileptic drugs (AEDs). Among 19,026,509 reports, propofol was identified as the primary suspected drug in 7945 cases, with 322 seizure-related events reported. Propofol was significantly associated with disproportionate reporting of seizure-related adverse events across 14 preferred terms (PTs), with 11 signals validated by all four disproportionality methods. Time-to-onset analysis revealed a median of 0 days with an early-failure pattern. Clinical prioritization classified 13 of 14 signals as being of moderate concern. Serious outcomes occurred in 63.98% of seizure reports, including life-threatening events (15.05%) and death (6.31%). Propofol is significantly associated with disproportionate reporting of seizure-related adverse events. The early onset and high severity underscore the need for enhanced pharmacovigilance awareness in clinical settings.