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

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.

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Publication Details

Journal
Journal of CardioRenal Medicine
Published
2025-09-25
DOI
https://doi.org/10.3390/jcrm1010003
Primary Topic
Atrial Fibrillation Management and Outcomes
Type
article
Field-Weighted Citation Impact
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article

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

Dragana Stanojević, Nikola Jovanovic, Predrag Jancic, Claudiu Mihai Ciuciureanu et al.
Journal of CardioRenal Medicine
Atrial Fibrillation Management and Outcomes
article

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

Dragana Stanojević, Nikola Jovanovic, Predrag Jancic, Claudiu Mihai Ciuciureanu, Stefan Milutinovic
article en

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.

Journal of CardioRenal MedicineVol. 1(1)
Florida State University (US), Tulane University (US), University of Nis (RS), Jacobi Medical Center (US), The Wright Center for Graduate Medical Education (US)
Openalex Percentile: Top 60%
Atrial Fibrillation Management and Outcomes
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