ORIGINAL RESEARCH article
Front. Med.
Sec. Regulatory Science
Statin Use and the Risk of Tubulointerstitial Nephritis: A Real-World Signal Detection Analysis using FDA Adverse Event Reporting System (FAERS)
Provisionally accepted
- Jazan University College of Pharmacy, Jazan, Saudi Arabia
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Abstract Background: Statins are widely prescribed for cardiovascular risk reduction but have been linked to a range of adverse effects. Tubulointerstitial nephritis (TIN), a potentially serious renal condition, has been sporadically reported with statin use. This study aims to evaluate the association between statins and TIN using real-world pharmacovigilance data. Methods: We analyzed adverse event reports from the U.S. FDA Adverse Event Reporting System (FAERS) between 2017 and 2024. Cases of TIN associated with statins were identified using MedDRA Preferred Terms. Disproportionality analyses—including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Empirical Bayes Geometric Mean (EBGM), and Information Component (IC)—were applied to detect safety signals, stratified by pre-and post-COVID-19 periods. Results: A total of 120 TIN cases linked to statin use were identified. While no significant signal was detected prior to 2020, consistent signal emergence was noted from 2021 onwards. In 2024, all signal metrics peaked (e.g., ROR 5.77; PRR 5.75; EBGM 5.32; IC 2.41), meeting thresholds for signal detection. Most reports involved patients aged ≥60 years and over 65% resulted in hospitalization. Geographic analysis showed wide international distribution, with the majority of reports from the United States and Europe. Conclusion: This real-world analysis identifies a statistically significant disproportionality signal that indicates a possible association between statin use and TIN, particularly in older adults. Clinicians may consider TIN in patients presenting with unexplained renal dysfunction while on statins. Further research is warranted to evaluate this association and identify patient-level risk factors.
Keywords: Hydroxymethylglutaryl-CoA Reductase Inhibitors, tubulointerstitial nephritis, Pharmacovigilance, Adverse Drug Reaction Reporting Systems, Drug Surveillance, Postmarketing
Received: 27 Jul 2025; Accepted: 23 Oct 2025.
Copyright: © 2025 Yasmeen, Syed, Khardali, Almansour and Alshammari. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Thamir M Alshammari, thamer.alshammary@gmail.com
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