Abstract
This pharmacovigilance study analyzed 8249 adverse event reports for propofol in the general population and 1530 reports in patients aged ≥65 years using the US Food and Drug Administration Adverse Event Reporting System from Q1 2004 to Q1 2025. Employing 3 disproportionality analysis algorithms - reporting odds ratio, proportional reporting ratio, and multi-item gamma Poisson shrinker - we identified 27 and 26 system organ class signals in the general and elderly populations, respectively. Of these, 10 and 8 system organ class signals demonstrated positive disproportionality in the respective groups. Elderly patients exhibited a significantly higher proportion of cardiac disorder reports than the general population, accompanied by markedly stronger signals. Propofol infusion syndrome represented the strongest positive signal across both populations. Notably, acute right ventricular failure emerged as the most prominent cardiac preferred term signal in both groups and appears to be a distinctive adverse reaction unique to propofol. Comparative analysis with sevoflurane (n = 3620) revealed shared cardiovascular effects between the 2 agents; however, propofol demonstrated significantly elevated signals for immune system disorders and metabolic and nutritional disorders. The most frequently reported adverse events in the general population were anaphylactic shock, hypotension, and propofol infusion syndrome, whereas the elderly population most commonly reported anaphylactic shock, hypotension, and cardiac arrest. This study identified important safety signals associated with propofol use and revealed potential age-specific adverse reaction patterns. These findings are exploratory in nature and provide hypothesis-generating evidence; further research is required to confirm these risk associations.