Adverse drug events associated with sodium zirconium cyclosilicate: A real-world pharmacovigilance study based on the FAERS database.

ABSTRACT:

Background

Sodium zirconium cyclosilicate (SZC, Lokelma) is a novel hyperkalemia therapy, but comprehensive real-world safety data are lacking. This study aimed to characterize SZC-associated adverse events (AEs) using post-marketing surveillance.

Research design and methods

AE reports for SZC/Lokelma were extracted from the FDA Adverse Event Reporting System (FAERS) (2004-2023). Four disproportionality algorithms (ROR, PRR, BCPNN, MGPS) identified safety signals. Significant system organ class (SOC) signals required ROR ≥ 2; preferred term (PT) signals met all algorithm thresholds, with false discovery rate adjustment.

Results

Among 1,564 AE reports (49% males, 29.5% females), four SOCs showed significant signals: metabolism/nutrition, renal/urinary, cardiac, and gen

SUBMITTER: Fang Y 

PROVIDER: S-EPMC12404485 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature