Jieyuan Chen, Zhaojun Wang, Songsong Mao
Background: Sevoflurane, an ether-derived inhalational anesthetic widely used for general anesthesia, requires comprehensive safety evaluation. Objectives: This study aimed to identify sevoflurane-associated adverse events and detect unexpected safety signals using data from the FDA Adverse Event Reporting System (FAERS). Methods: We analyzed FAERS data from the first quarter of 2004 through the first quarter of 2024, applying four disproportionality analysis algorithms (ROR, PRR, BCPNN, MGPS) to reports designating sevoflurane as the “primary suspect” drug. Results: Among 1,649 reports, we identified 27 significant preferred terms affecting four major organ systems. Notable unexpected safety signals included cardiac arrest, anesthesia awareness, delayed recovery, pulmonary alveolar hemorrhage, anaphylactic shock and seizures. Conclusion: These findings provide critical insights into sevoflurane’s real-world safety profile, particularly revealing severe yet underrecognized risks that can inform enhanced clinical monitoring and safer anesthetic practice. However, it should be acknowledged that disproportionality analysis is a hypothesis-generating or refinement approach, and further confirmatory studies are warranted to establish causal relationships.
Adverse events
FDA adverse event reporting system
Pharmacovigilance
Sevoflurane