OBJECTIVES: To identify suspected drugs associated with kidney injury in children by analyzing data from the FDA Adverse Event Reporting System.

METHODS: We extracted and analyzed reports on drugs associated with kidney injury in children in FAERS from the first quarter of 2004 to the third quarter of 2022 using OpenVigil 2.1. Descriptive analysis was performed to characterize the features of children with drug-associated kidney injury. Disproportionality analysis was conducted to evaluate the association between drugs and kidney injury in children. Meanwhile, comparisons were performed with drug specifications to identify drugs with a potential risk of kidney injury in children that were not on the list.

RESULTS: A total of 6347 children (28433 reports) had drug-associated kidney injury in FAERS. We identified 270 drugs associated with kidney injury in children. Of these， ibuprofen (644 cases, x2=1152.94, PRR=3.71) was associated with most cases of kidney injury in children. Among the 30 most frequently reported drugs, the top five drugs with the highest PRRs were gentamicin (157 cases, x²=1602.77, PRR=12.28), piperacillin (129 cases, x²=1003.24, PRR=9.77), amlodipine (271 cases, x²= 1861.46, PRR=8.98), vancomycin (295 cases, x²=1998.64, PRR=8.91), and ceftriaxone (251 cases, x²=1494.02, PRR=8.00). According to drug specifications, 21 drugs (70.00%) were classified as known nephrotoxins, and 9 drugs (30.00%) as potential nephrotoxins.

CONCLUSIONS: Approximately a third of drugs associated with kidney injury in children are not recognized as nephrotoxin in the drug specifications. It is important to note that the potential nephrotoxic drugs should be paid more attention to and closely monitored in future clinical practice. In addition, further research is needed to determine the risk of these potential nephrotoxic drugs in children, to provide references for preventing and treating drug-associated kidney injury in children.