Drug-related proteinuria: a vigilance analysis based on the FAERS database.

Abstract

Proteinuria is a prevalent and significant adverse response (ADR) associated with numerous pharmaceuticals, and we employed the online public FDA Adverse Event Reporting System (FAERS) database to investigate a cohort of medications that may induce this ADR. This analysis aimed to identify and assess the most prevalent and significant medicines linked to the risk of proteinuria. We examined the publicly accessible FAERS database from 2004 to 2024. Utilizing the search term "proteinuria" and classifying by generic drug name, we aggregated reports of drug-related responses or trends in proteinuria, subsequently analyzing the data through a combination of ratio-of-reported-ratio (ROR) and proportional-reported-ratio (PRR) to identify and examine twelve medications that may induce proteinuria. A total of 16,355 adverse event reports related to proteinuria were identified in the FAERS database between 2004 and 2024. Among these, 21 drugs demonstrated statistically significant associations with proteinuria based on multivariate logistic regression, with the highest signals observed for voclosporin (ROR: 63.57) and lenvatinib (ROR: 41.01). Drug classes most strongly associated included anticancer agents, immunosuppressants, and antiviral drugs. Notably, the onset of proteinuria varied significantly across drug types, with anti-inflammatory agents showing the earliest median onset (5.4 days), while digestive system drugs and antivirals exhibited delayed onset exceeding 1,000 days on average. These findings underscore the need for early and long-term renal monitoring depending on drug category. Prompt assessment of nephrotoxicity risk is essential during the initial phase of medication, hence offering a more precise foundation for drug screening and optimization.