Real-world study of adverse events associated with sodium zirconium cyclosilicate based on FDA adverse event reporting system and VigiAccess database.

ABSTRACT: The aim of this study was to investigate frequencies, types, and signals of adverse drug events (ADEs) associated with sodium zirconium cyclosilicate (SZC) used for the treatment of hyperkalemia, in order to inform clinicians of possible safety concerns linked with SZC in real-life usage. ADE reports associated with SZC were collected from both the FAERS and VigiAccess databases. Data extraction from FAERS was performed using OpenVigil 2.1, covering reports from the first quarter of 2004 through the third quarter of 2024. The VigiAccess database was retrieved for reports up to February 5, 2025. The ADEs were standardized and classified by using the preferred term (PT) and the system organ class (SOC) of the Medical Dictionary for Regulatory Activities (MedDRA) (Version 27.0). The reporting

SUBMITTER: Jia X 

PROVIDER: S-EPMC12513601 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature