Medication-related nephrotic syndrome: a real-world study from 2004 to 2024 based on the Food and Drug Administration Adverse Event Reporting System
Abstract
Background: Nephrotic syndrome is a clinical syndrome caused by glomerular injury. Medication-related nephrotic syndrome (MRNS) has become an important focus of pharmacovigilance. However, there is currently a lack of real-world studies on MRNS in large populations.
Objectives: To systematically evaluate adverse drug events associated with MRNS using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and to identify high-risk medications and their onset characteristics.
Design: A retrospective pharmacovigilance study based on disproportionality analysis and Bayesian signal detection.
Methods: This is a retrospective pharmacovigilance study. FAERS reports from 2004 to 2024 were extracted, cleaned, and standardized to identify MRNS cases. The association between medications and MRNS was evaluated using four methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio, Multi-Item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN). In addition, medication risk classification and cumulative risk curve of medication-induced onset time were conducted.
Results: A total of 3990 MRNS cases were identified, including 1963 males (56.23%) and 1528 females (43.77%). Fifty-four medications demonstrated significant positive signals, including 26 antineoplastic medications (ramucirumab, ROR = 33.59), 7 anti-inflammatory medications (sulfasalazine, ROR = 24.74), 2 digestive system medications (famotidine, ROR =…
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