# Proton Pump Inhibitors and Disproportionate Reporting of Acute Kidney Injury and Tubulointerstitial Nephritis: A FAERS Pharmacovigilance Study, 2020–2025

## TL;DR

This study finds that proton pump inhibitors are linked to disproportionate reports of kidney injuries in a U.S. adverse event database from 2020 to 2025.

## Contribution

The study provides updated pharmacovigilance evidence on PPI-related kidney injury signals using FAERS data from 2020–2025.

## Key findings

- 13,654 PPI-associated acute kidney injury reports and 2,409 tubulointerstitial nephritis reports were identified in FAERS from 2020–2025.
- Disproportionality metrics consistently showed signals for AKI and TIN with PPIs, strongest in 2020–2022.
- Hospitalization and death rates were higher in TIN reports compared to AKI reports.

## Abstract

Background/Objectives: Proton pump inhibitors (PPIs) are widely used, yet questions persist about kidney-related adverse events. We evaluated disproportional reporting of acute kidney injury (AKI) and tubulointerstitial nephritis (TIN) with PPIs in the FDA Adverse Event Reporting System (FAERS) from 2020 to 2025. Methods: FAERS reports were screened using MedDRA Preferred Terms. Report characteristics and annual counts of AKI and TIN reports were summarized. Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Empirical Bayes Geometric Mean (EBGM), and Information Content (IC) were used to assess disproportionality. Results: We identified 13,654 PPI-associated AKI reports and 2409 TIN reports in FAERS (2020–2025). Reports were predominantly from the United States, and missing age/sex information was common. Hospitalization was reported in 12.3% of AKI and 22.7% of TIN reports, and death in 9.1% and 5.0%, respectively. Across all years, disproportionality analyses using ROR, PRR, EBGM, and IC consistently met signal thresholds for both outcomes, with stronger signals in 2020–2022 and attenuation thereafter alongside declining report counts. Conclusions: FAERS data show persistent disproportional reporting of AKI and TIN with PPI use. Causality cannot be inferred, but the findings support cautious, indication-based PPI prescribing and highlight the need for robust studies to clarify renal safety.