FAERS-based pharmacovigilance study of sevoflurane-associated adverse events: A 20-year comprehensive analysis.

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.