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Anticoagulant-Related Nephropathy: A Retrospective Analysis of the FDA Adverse Events Reporting System (FAERS) Database

Year: 2025

Type: article

Abstract: Background: Anticoagulation is the cornerstone of thromboembolic event prevention. Adversely, anticoagulants (ACs) are linked to a variety of adverse events. We aimed to assess the link between vitamin K antagonists (VKA) and direct anticoagulant (DOACs) use and acute kidney injury (AKI) using the FDA Adverse Events Reporting System (FAERS) Database. Methods: We conducted a disproportionality analysis on the adverse events (AEs) of interest in the FAERS database using the reporting odds ratio (ROR), proportional reporting ratio (PPR) with the Yates correction (x2yates), and the information component (IC). Results: A total of 20,253 cases of AKI associated with use of ACs were analyzed. Edoxaban, dabigatran and warfarin showed greater association with AKI (ROR 2,63; ROR 1,46; ROR). In cases with manifest bleeding, edoxaban, dabigatran, warfarin and rivaroxaban had a stronger statistical association with AKI. Rivaroxaban showed greater association with AKI compared to other ACs when used concomitantly with Aspirin (ROR 2,25). Conclusion: We showed increased odds of reporting AKI with use of edoxaban, dabigatran and warfarin compared to other anticoagulants. In cases with reported bleeding, AKI was more commonly reported with all five analyzed anticoagulants, except for apixaban, highlighting its favorable side-effect profile. Caution and clinical awareness are needed when prescribing ACs to vulnerable populations.

Source: Journal of CardioRenal Medicine

DOI: 10.3390/jcrm1010003

Authors: Predrag Jancic, Claudiu Ciuciureanu, Nikola Jovanovic, Stefan Milutinovic, Dragana Stanojevic