Abstract: Objective To retrieve the signals of suspected adverse events caused by sugammadex based on the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database so as to provide reference for clinical rational drug use. Methods The signals were detected using the ROR method in the disproportionality assay analysis of FAERS data collected from January 1, 2012 to March 31, 2022. Results A total of 1 379 records of adverse events associated with sugammadex were detected, and a total of 130 suspected adverse event signals were detected based on the ROR method. Recurrence of neuromuscular blockade (n=58,ROR₀₂₅: 79.67), bronchospasm (n=123,ROR₀₂₅: 71.47), anaphylactic reactions (n=192,ROR₀₂₅: 44.47), bradycardia (n=177,ROR₀₂₅: 38.32) and anaphylactic shock (n=85,ROR₀₂₅: 35.48) had higher signal intensities. The common adverse events following the use of sugammadex in patients of different age groups varied, and the overall intensity of adverse event signals was lower in the group aged 0 to 17. Conclusion Adverse events related to sugammadex mainly involve respiratory, cardiovascular and immune systems. Among other things, allergic events and arrhythmia are strongly associated with sugammadex. Anesthesiologists should routinely monitor neuromuscular function, ECG and hemodynamics when using sugammadex.

Key words: sugammadex, FDA, FAERS, adverse event, signal mining, neuromuscular block reversal, pharmacovigilance