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ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Renal Pharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1511115
Drug-Induced Kidney Stones: A Real-World Pharmacovigilance Study Using the FDA Adverse Event Reporting System Database
Provisionally accepted- Nanchang People's Hospital, Jiangxi, China
Objective: This study aims to identify the drugs most commonly associated with kidney stonerelated adverse events using data from the FDA Adverse Event Reporting System (FAERS), providing insights for clinical reference regarding the use of these drugs.: We utilized the Medical Dictionary for Regulatory Activities (MedDRA 26.0) preferred term "nephrolithiasis" to identify drug-related adverse events (ADEs) for kidney stones reported in FAERS from Q1 2004 to Q1 2024. Reporting odds ratio (ROR) was used to quantify the signal strength of these ADEs, and new risk signals for kidney stones were compared with drug labeling information to identify any previously unreported risks. Results: Out of 21,035,995 adverse events reported in FAERS, 38,307 were associated with kidney stones. The top 5 drugs most frequently linked to kidney stone cases were adalimumab (2,636 cases), infliximab (1,266 cases), interferon beta-1a (920 cases), sodium oxybate (877 cases), and teriparatide (836 cases). Notably, certain drugs like lansoprazole (ROR 7.2, 95% CI 6.62-7.84), Xywav (ROR 7.1, 95% CI 6.03-8.35), and teduglutide (ROR 5.54, 95% CI 4.83-6.36) showed significant risk signals. Of the 50 drugs identified, 33 were not previously labeled as carrying a risk of kidney stones. Conclusion: Our analysis of FAERS data revealed new risk signals for kidney stones not indicated in the labels of 33 drugs. Close monitoring is recommended when using these medications, and further research is needed to investigate the mechanisms behind druginduced kidney stone formation. 1 设置了格式: 默认段落字体, 字体: (默认) Times New Roman, (中 文) +中文正文 (宋体), (中文) 简体中文(中国大陆) 设置了格式: 字体: (默认) Times New Roman, (中文) +中文正文 (宋体), (中文) 简体中文(中国大陆) 设置了格式: 删除线 设置了格式: 字体: (默认) Times New Roman, (中文) +中文正文 (宋体), (中文) 简体中文(中国大陆) 设置了格式: 删除线 设置了格式: 字体: (默认) Times New Roman, (中文) +中文正文 (宋体), (中文) 简体中文(中国大陆) 设置了格式: 删除线 设置了格式: 字体: (默认) Times New Roman, (中文) +中文正文 (宋体), (中文) 简体中文(中国大陆) 设置了格式: 字体: (默认) Times New Roman, (中文) Times New Roman, (中文) 简体中文(中国大陆) 设置了格式: 删除线 设置了格式: 字体: (默认) Times New Roman, (中文) Times New Roman, (中文) 简体中文(中国大陆)
Keywords: drugs1, Kidney Stones2, FAERS3, Disproportionality analysis4, pharmacovigilance5
Received: 14 Oct 2024; Accepted: 11 Mar 2025.
Copyright: © 2025 Ding, Luo and Cao. 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:
Leihua Cao, Nanchang People's Hospital, Jiangxi, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.