Many Acute Kidney Injury Reports Linked to Drugs Not Recognized as Nephrotoxic


Acute kidney injury (AKI) was found to be a common reason for reporting in the Food and Drug Administration Adverse Event Reporting Database (FAERS), however, most of these reports were linked to drugs not typically recognized as nephrotoxic

A total of 7,241,385 reports were included in the analysis; 2.7% (193,996) of these reports involved AKI. The majority of AKI reports were associated with new potential nephrotoxins (64.8%), followed by possible nephrotoxins (18.6%) and known nephrotoxins (16.5%). The 20 most frequently reported new potential nephrotoxins included aprotinin, metformin, zoledronic acid, lenalidomide, dabigatran, deferasirox, adalimumab, atorvastatin, alendronate, everolimus, etanercept, digoxin, sunitinib, exenatide, bevacizumab, telaprevir, rosuvastatin, bortezomib, imatinib, and aliskiren.

Aprotinin was associated with over 7000 reports and had the highest ROR (115.70, 95% CI, 110.63-121.01), followed by sodium phosphate (ROR 55.81, 95% CI, 51.78‐60.17), furosemide (ROR 12.61, 95% CI, 11.94‐13.32), vancomycin (ROR 12.19, 95% CI, 11.45‐12.99), and metformin (ROR 10.65, 95% CI, 10.31‐11.00). Combined RORs were also calculated for the 20 most commonly reported drugs within each classification: known nephrotoxins (ROR 3.71, 95% CI, 3.66-3.76), possible nephrotoxins (ROR 2.09, 95% CI, 2.06-2.12), and new potential nephrotoxins (ROR 1.55, 95% CI, 1.53-1.57).