Characterizing Fenofibrate-Related Renal and Urinary Adverse Events: A Comprehensive Analysis of FDA Adverse Event Reporting System Database.

Abstract

Purpose: To investigate whether fenofibrate use is associated with an increased risk of renal and urinary adverse events based on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods: This retrospective pharmacovigilance study utilized data from the FAERS between January 1st, 2019, and December 31st, 2023. Reports listing fenofibrate as the primary suspect drug were extracted, and renal and urinary adverse events were identified based on preferred terms (PTs) in the MedDRA dictionary. Disproportionality analysis was conducted using four standard algorithms-reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS)-to detect safety signals. The PTs exhibiting positive signals were clinically prioritized, and bivariate logistic regression analysis was performed to identify demographic risk factors associated with serious clinical outcomes.

Findings: Between 1 January 2019 and 31 December 2023, a total of 2,810 adverse event reports related to fenofibrate were identified, of which 443 (15.77%) were classified as renal and urinary adverse events. The mean age of affected patients was 57.89 years, with a higher proportion of males (n = 183, 27.94%). Signal detection showed a significant association between fenofibrate and renal and urinary adverse events: ROR = 2.23 (95% CI:2.07-2.41), PRR = 2.18 (χ² = 428.29), IC = 1.12 (IC₀₂₅ = 1.01), EBGM = 2.18 (EBGM05 = 2.04). Adverse events reported with high frequency included acute kidney injury (n = 149, 22.29%), haematuria (n = 88, 13.44%), and urinary tract disorder (n = 82, 12.52%), with acute kidney injury and anuria identified as key clinical priority events. Bivariate logistic regression analysis demonstrated that individuals aged above 65 years had a significantly higher likelihood of experiencing serious clinical outcomes (OR = 2.046, 95% CI: 1.579-3.665; P < 0.001), males have a lower risk (OR = 0.656, 95% CI: 0.444-0.968, P = 0.034).

Implications: This study suggests a possible significant association between fenofibrate and renal and urinary adverse events. Safety monitoring and individualized risk assessment of patients using fenofibrate should be enhanced to reduce the risk of potential adverse outcomes.