Pharmacovigilance assessment of ropivacaine safety using FAERS data (2004-2024)

Despite widespread clinical use of the long-acting local anesthetic ropivacaine, its population-level safety remains under-explored. This study aimed to analyze and categorize adverse events (AE) associated with ropivacaine reported in the US Food and Drug Administration Adverse Event Reporting System (FAERS). We retrospectively extracted reports on adverse drug events (ADEs) from the FAERS database from the first quarter of 2004 to the fourth quarter of 2024. Using disproportionality analysis, including the reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and the empirical Bayesian geometric mean, we assessed whether there was a significant association between ropivacaine and ADEs. The Weibull shape parameter was used to test the time to onset curve. The Kaplan-Meier method was employed to evaluate the cumulative incidence. In the FAERS database, ropivacaine was identified as the primary suspect in 1463 AE reports. The adverse reactions induced by ropivacaine involved 3 system organ categories and 21 high-level group terms. At the preferred term level, 181 positive ADEs were detected. Common ADEs included complications of anesthesia, Horner's syndrome, delayed awakening after anesthesia, systemic toxicity of local anesthetics, and monoparesis. Gender differences existed in ADEs related to ropivacaine. The median time to onset of ADEs related to ropivacaine was 2 days (range: 1-3 days). Weibull shape parameter testing revealed an early failure pattern for ropivacaine-associated ADEs. This pharmacovigilance study identifies significant safety signals associated with ropivacaine, particularly neurological and cardiac events that predominantly occur within the first 72 hours after administration. The detection of potential gender-specific reporting patterns and specific high-strength signals warrants further clinical investigation. These findings provide valuable hypothesis-generating evidence from real-world data to guide targeted monitoring and inform future research on ropivacaine's safety profile.