Real-world safety profile of finerenone in patients with type 2 diabetes and chronic kidney disease: a multi-database pharmacovigilance analysis of the FAERS and JADER systems

Abstract

Finerenone, a novel nonsteroidal mineralocorticoid receptor antagonist, has been shown to lower the risk of renal and cardiovascular events in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD). However, real-world safety data beyond clinical trials remain limited, particularly regarding the spectrum and timing of adverse events (AEs) in routine clinical practice. Disproportionality analyses (Reporting Odds Ratio and Proportional Reporting Ratio) were performed on finerenone-associated AE reports from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, Q3 2021-Q1 2025) and the Japanese Adverse Drug Event Report (JADER) database, following data deduplication and the Medical Dictionary for Regulatory Activities (MedDRA, version 27.1) standardization. The time-to-onset (TTO) of AEs was also analyzed. A total of 1,545 (FAERS) and 210 (JADER) reports with finerenone as the primary suspect were identified. Consistent with its known profile, hyperkalemia, increased blood creatinine, decreased glomerular filtration rate (GFR), and renal impairment generated significant signals in both databases. Notably, the analysis revealed several potential new signals that have not been emphasized in the drug label, including increased urine albumin/creatinine ratio (UACR), abnormal hepatic function, penile gangrene, and dizziness. The median TTO for AEs was 36 days (FAERS) and 51 days (JADER), with a substantial proportion (45.16% in FAERS, 60.18% in JADER) occurring within the first two months of treatment. This bilateral pharmacovigilance analysis confirms known risks of finerenone and identifies several potential new AE signals in patients with T2DM-CKD. The TTO analysis underscores the need for enhanced monitoring during the initial two months of therapy. This study generates actionable evidence to optimize risk management strategies and inform safer clinical use of finerenone in this high-risk population.