Drug-Induced Acute Kidney Injury: A Real-World Pharmacovigilance Study Using the FDA Adverse Event Reporting System Database

Background: Comprehensive quantitative and comparative risk data on drug-induced acute kidney injury (AKI) remain limited. Thus, this study aimed to supplement the current data with information from the FDA Adverse Event Reporting System (FAERS) database. Methods: Based on the collected AKI-related reports in the FAERS database from 2004 to 2023, we summarized a list of reported nephrotoxic drugs, compiling counts of the most frequently reported single drugs and drug classes. A disproportionality analysis was used to evaluate the AKI risk of reported drugs, and histological and onset time analyses were conducted. Results: A total of 1456 drugs were reported as culprit drugs in the 327,561 AKI-related reports in the FAERS database, most of which were antineoplastic agents. Omeprazole was the most frequently reported single drug, followed by furosemide, pantoprazole, esomeprazole, and lansoprazole. Drugs for acid-related disorders were the most commonly reported drug class, followed by agents acting on the renin–angiotensin system, antineoplastic agents, immunosuppressants, and analgesics. In the disproportionality analysis, 1021 drugs showed different degrees of association with the occurrence of AKI, among which eight drugs (spironolactone, mycophenolic acid, enalapril, valsartan, candesartan, gentamicin, vancomycin, and nifedipine) had the largest number of positive signals, with 15 positive signals each. Drugs acting as an antineoplastic agent were the class with the largest number of positive signal drugs in most preferred term groups; however, the imbalance of risk signal distribution among drug classes reflected the subsequent risk differences in relation to AKI. In the histological analysis, tubulointerstitial injury was the most commonly reported type of histological injury. In the onset time analysis, vancomycin presented the shortest median onset time, while the median onset time for lansoprazole was the longest. Conclusions: Our study integrated quantitative and comparative AKI risk data for 1456 reported culprit drugs using the FAERS database, which can provide reference information for clinical practice.