An update on post-marketing safety signals of sugammadex: A retrospective pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS).

ObjectiveWith the expanding use of sugammadex, continued post-marketing surveillance remains warranted. This study aimed to characterize reporting patterns and update potential sugammadex-associated safety signals in the FDA Adverse Event Reporting System (FAERS).MethodsWe conducted a retrospective pharmacovigilance study of FAERS reports from January 2012 through September 2025 in which sugammadex was the primary suspect drug. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs) were compared with all other drugs in the OpenVigil 2.1 FAERS reference set using the proportional reporting ratio (PRR), reporting odds ratio (ROR), and chi-square statistic. Signals were hypothesis-generating and did not establish incidence, comparative risk, or causality.ResultsA total of 1,077 unique cases were included. Among 887 cases with known sex, 443 (49.9%) were male and 444 (50.1%) were female; the median age among 710 age-known cases was 51 years (interquartile range, 29-66 years). Of 501 PTs evaluated, 92 met the prespecified statistical criteria. After separating 15 medication-error/product-use terms, 2 exposure terms, and 4 procedure/management descriptors, 71 clinical adverse-reaction PTs remained. In sensitivity analyses, 59 of 92 signals and 43 of 71 clinical PTs persisted at a ≥ 5; IC025 was >0 for 80 signals and conservative BH q-value upper bounds were <0.05 for 87 signals. Prominent clinical clusters involved hypersensitivity, cardiovascular, respiratory, and neuromuscular events. Kounis syndrome, complete atrioventricular block, and hypercapnia were absent from the approved adverse-reaction list, whereas post-procedural hemorrhage was interpreted in the context of labeled coagulation warnings.ConclusionsFAERS identified patterns of disproportionate reporting for sugammadex that warrant further evaluation, particularly for hypersensitivity and selected cardiovascular, respiratory, and neuromuscular events. These findings are signals rather than estimates of incidence, comparative risk, or causality. The three PTs absent from the approved adverse-reaction list require independent confirmation, and the post-procedural hemorrhage signal should be interpreted alongside labeled coagulation warnings.