Safety evaluation of cinacalcet: Signal mining and analysis of adverse events based on the FAERS database.

ABSTRACT:

Objective

This study utilized the FDA Adverse Event Reporting System (FAERS) to assess signals of adverse events (AEs) associated with cinacalcet, aiming to enhance its safe and rational clinical application.

Methods

Adverse event reports related to cinacalcet were extracted from the FAERS database from the first quarter of 2004 to the first quarter of 2025. The AE reports were categorized by Preferred Terms (PTs) and System Organ Classes (SOCs), and risk signals were analyzed using disproportionality analysis.

Results

Among 30,540 AE reports where cinacalcet was the primary suspect drug, females exhibited a higher reporting frequency than males (47.30% vs. 39.80%). The highest proportion of reports was observed in the 60-74 age group (23.85%). Most AEs predominantly

SUBMITTER: Cao J 

PROVIDER: S-EPMC12558480 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature