Evaluating adverse reaction signals of vancomycin in pediatric patients: A FAERS database analysis

Based on the US FDA Adverse Event Reporting System, the adverse reaction (AE) signals of vancomycin in pediatric patients were mined, and its safety characteristics and risk association were evaluated. Data from 2004 to 2024 were extracted. The AE reports (n = 20,983) with vancomycin as the primary suspected drug were screened and standardized by MedDRA (version 26.1). Multi-algorithm fusion strategies were used to detect the signal intensity, and the effects of gender, age, and weight on AE distribution were analyzed. Male, 12 to 18 years old, weight ≥45 kg; the US reported the most, and the main outcome was hospitalization. Skin and subcutaneous tissue disorders reported the most, while renal and urinary disorders have the strongest signal. Acute kidney injury is the most common, and linear immunoglobulin A disease has the highest signal intensity. Acute kidney injury is the main factor for both men and women. The <1 year-old-group has the highest risk of renal and urinary disorders. The signal of renal and urinary disorders was significant in the group <10 kg. Vancomycin is related to nephrotoxicity, skin reaction, and rare immune diseases in pediatric patients, especially in low-birth-weight infants and adolescents. Strengthening therapeutic drug monitoring and individualized medication strategies and paying attention to the influence of gender and geographical differences on AE reports is necessary. This study provides data support for optimizing the safety management of vancomycin in children; however, prospective research is necessary to verify the clinical significance of the FDA Adverse Event Reporting System signal.