Safety assessment of S-1: Real-world adverse event analysis from the FAERS database

Abstract

Abstract Background The aim of this study was to gather information on adverse drug events (ADEs) associated with S1 from the US Food and Drug Administration Adverse Event Reporting System (FAERS) to evaluate its safety and provide a reference for drug use. Methods We searched the raw data of the FAERS database from its establishment to the third quarter of 2023 to screen ADE reports involving S-1. Signal detection indicators, including ROR, PRR, BCPNN, and MGPS, were used to perform statistical analysis and systematic classification of adverse drug events (ADEs) based on corresponding threshold conditions. Results A total of 186,085,022 REAC reports, and 2,011 PT signals induced by S1 as the PS were obtained. Among them, there were 856 adverse event reports of S1 as the PS. In addition, the average age of patients was 65 years and 6 months. Through screening analysis, a total of 126 PT signals involving 18 SOSCs were identified. Mainly involved in vascular disorders, general disorders, and administration site conditions such as skin and subcutaneous tissue disorders. PT with high occurrence frequency includes papules/rash/pruritus; we also found hypertension with an ROR of 95% CI 90-77121-1156 and uterine cancer with an ROR of 95% CI 90-7292-2817. Conclusions Mining and analysis of real-world adverse event data of S1 is helpful in finding potential risk signs or symptoms of adverse drug reactions, suggesting that clinical attention should be paid not only to the adverse reactions mentioned in the drug instructions but also to new suspected adverse reactions and clinical standardized medication to ensure patient medication safety.