Signal Mining of Drug-related Acute Kidney Injury Based on the FAERS Database
10.3870/j.issn.1004-0781.2025.09.010
- VernacularTitle:基于FAERS数据库的药物相关急性肾损伤信号挖掘
- Author:
Hao XIE
1
;
Jieru ZHOU
;
Rui DAI
;
Zhiqing XU
;
Wenjuan SUN
;
Gang CHEN
;
Bin ZHAO
;
Xiaoli DU
Author Information
1. 中国医学科学院北京协和医学院北京协和医院药剂科,北京 100730
- Publication Type:Journal Article
- Keywords:
Acute kidney injury;
Pharmacovigilance;
Signal mining;
Food and Drug Administration Adverse Event Reporting System(FAERS)
- From:
Herald of Medicine
2025;44(9):1431-1439
- CountryChina
- Language:Chinese
-
Abstract:
Objective To mine and analyze signals of acute kidney injury(AKI)related to drugs,comprehensively summarize the potential risk drugs,and provide a reference for clinically safe medication.Methods The AKI reports from January 2004 to September 2023 in the US FDA Adverse Event Reporting System(FAERS)were retrieved.Disproportionality methods were used to explore the relationship between drugs and AKI,and demographic information,time to onset,and patient outcomes were analyzed.Results Out of 1 253 drugs,159 were identified as AKI signal drugs.Among these,there were 49 antimicrobial agents(30.82%),including 35 antibiotics and 14 antiviral agents;33 antineoplastic agents(20.75%);and 25 hypotensive agents(15.72%).Drug-related AKI occurred mostly in the elderly,and the male-to-female ratio was 124∶100.The median time to onset for AKI related to antibiotics was≤8 d,with the third quartile≤21 d.Rivaroxaban and aspirin had higher proportions of death reports,with 33.03%and 31.44%respectively.Conclusions A multitude of drugs pose a risk for acute kidney injury,necessitating caution in their clinical application and the implementation of monitoring of renal function.The elderly are a high-risk group for drug-related AKI,and there are more males than females.For antibiotics,the first 21 days are the key monitoring period.For drugs that require long-term use,regular monitoring is necessary.
