Drug-induced nephrolithiasis: a real-world pharmacovigilance study of the FDA Adverse Event Reporting System

Drug-induced nephrolithiasis is a recognized complication in clinical practice. The objective of this study is to identify drugs that are significantly associated with an increased risk of inducing nephrolithiasis based on the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).

We collected adverse event reports associated with drug-induced nephrolithiasis from the first quarter of 2004 (2004 Q1) to the fourth quarter of 2023 (2023 Q4) in the FAERS database. Subsequently, we applied 4 disproportionality algorithms to evaluate the connection between drugs and nephrolithiasis.

A total of 32,788 adverse event reports related to nephrolithiasis with primary suspected drugs were identified. The 50 drugs with the highest frequency and the 40 drugs with the strongest signal were identified and counted. The most frequently occurring drug was adalimumab, while the antiretroviral drug indinavir exhibited the strongest signal intensity. The labels for many of these drugs did not mention the risk of nephrolithiasis.

This comprehensive pharmacovigilance study has revealed many drugs potentially associated with an increased risk of nephrolithiasis. Notably, vigilant surveillance for nephrolithiasis risk while using these drugs is crucial in clinical practice.