Potassium citrate is widely used as oral alkali therapy for the prevention of recurrent nephrolithiasis. Despite its long-standing clinical use, systematically collected real-world safety data remain limited. We performed a pharmacovigilance analysis to characterize adverse event reports associated with potassium citrate using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). FAERS reports submitted between 2014 and 2025 listing potassium citrate as the primary suspect drug were analyzed. Duplicate records were removed, and adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at both the system organ class and standardized event term levels (preferred terms, PTs). Disproportionality analyses were conducted using reporting odds ratio, proportional reporting ratio, bayesian confidence propagation neural network, and multi-item gamma poisson shrinker methods. A total of 408 unique reports were included. Most reports involved adults and were physician-reported from the United States. Disproportionality analysis identified potential safety issues (signals), defined as drug event associations reported more frequently than expected in FAERS and therefore warranting further evaluation, although not establishing causality. The strongest associations involved product-related issues, laboratory investigations, and gastrointestinal disorders. When these potential safety issues were described using standardized MedDRA event terms most reflected formulation- and administration-related problems, including tablet residue in stool, abnormal solubility, swallowing difficulty, throat irritation, and foreign body sensations. Reports of rash were infrequent. This first FAERS-based analysis of potassium citrate highlights that most reported adverse events are related to formulation and administration characteristics rather than drug toxicity. These findings support the overall tolerability of potassium citrate while underscoring the importance of adherence, patient education, and formulation-specific considerations in clinical practice. As a spontaneous reporting system, FAERS is valuable for hypothesis generation, label expansion, and post-marketing surveillance, but it is not suitable for estimating the incidence or absolute risk of adverse events.
Urolithiasis. 2026 Apr 28*** epublish ***
Rifat Burak Ergül, Ismail Taha Gürlek, Yasin Yitgin, Seyda Gül Ozcan, M Fırat Özervarlı, Serdar Turan, Samed Verep, Samet Şenel, Arda Atar, Muratcan Kiremit, Amelia Pietropaolo, M İlker Gökçe, Bhaskar Somani, Kemal Sarica, Tzevat Tefik
Department of Urology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey., Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey., Istanbul Nisantasi University, Faculty of Medicine, Istanbul, Turkey., Department of Nephrology, Cerrahpasa Faculty of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey., University of Health Sciences Taksim Training and Research Hospital, Istanbul, Turkey., Department of Urology, Private Yuzyil Gebze Hospital, Gebze, Turkey., Department of Urology, Ankara City Hospital, Ankara, Turkey., Department of Urology, Acibadem Atasehir Hospital, Istanbul, Turkey., Department of Urology, Koç University, Istanbul, Turkey., EAU Young Academic Urologists (YAU) Urolithiasis and Endourology Working Group Arnhem, Arnhem, NL-6803, The Netherlands., Department of Urology, Ankara University School of Medicine, Ankara, Turkey., Department of Urology, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Department of Urology, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital, Istanbul, Turkey., Department of Urology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey. .