Drugs Associated with Increased Urine Oxalate Using FAERS and the VigiAccess Database

Background: To identify drugs associated with increased urinary oxalate excretion using the FDA Adverse Event Reporting System (FAERs) and VigiAccess databases, providing insights into potential medication-related risk factors for hyperoxaluria. Methods: Data from the FAERS and VigiAccess databases were analyzed for reports of adverse drug events (ADEs) related to increased urinary oxalate between January 2004 and December 2024. A total of 22,375,298 reports were retrieved from FAERS, and 46,535,254 reports were retrieved from VigiAccess. Data cleaning and standardization procedures were applied, and four statistical methods—Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM)—were used for signal detection. Results: Five drugs—topiramate, alemtuzumab, acyclovir, orlistat, and amlodipine—consistently showed positive signals for the ADE "Urine oxalate increased" across all four statistical methods in both databases. These drugs exhibited strong associations with increased urinary oxalate levels, with topiramate and orlistat showing the most significant signals. Other drugs, such as teriparatide, methylprednisolone, and rifampicin, displayed positive signals in one or more methods, but not consistently across all statistical methods. Conclusion: These findings highlight the potential role of specific drugs, including topiramate, alemtuzumab, and orlistat, in increasing urinary oxalate excretion. Clinicians should consider monitoring urinary oxalate levels in patients on these medications, particularly those at risk of kidney stones or renal impairment.