Analysis of age-specific adverse events with vancomycin: a real-world pharmacovigilance study based on the FAERS...

The purpose of this study was to characterize age-specific adverse drug event profiles associated with vancomycin using real-world pharmacovigilance data, thereby advancing understanding of its safety.

The Food and Drug Administration Adverse Event Reporting System (FAERS) was used to collect data between the first quarter of 2019 and the third quarter of 2024. Disproportionality analysis was performed to detect vancomycin-related adverse event reports, with the study population stratified by age group.

A total of 8,379 adverse event reports in which vancomycin was recorded as the primary suspect drug were retrieved: 981 (11.71%) in the 0-17 age group, 1,763 (21.04%) in the 18-44 age group, 2,705 (32.28%) in the 45-64 age group, and 2,930 (34.97%) in the 65 years and above group. The adverse events associated with vancomycin were involved 25 System Organ Class (SOC). "Investigations" abnormalities (e.g., electrolyte disturbances) predominated in children; "skin and subcutaneous tissue disorders" in adults; and "infections and infestations" in the elderly. Notably, high-risk preferred terms (PTs) showed non-overlapping across age strata. The strongest age-specific signals were "blood electrolytes abnormal" in 0-17 years, "spinal stroke" in 18-44 years, "myeloid maturation arrest" in 45-64 years, and "haemorrhagic occlusive retinal vasculitis" in ≥65 years. In addition, our study identified several adverse events not explicitly described in current labeling; these totaled 32 events distributed across 13 SOCs, with the majority involving cardiac or nervous system disorders.

Real-world data from the large-scale FAERS database were used to detect vancomycin-associated adverse event signals by disproportionality analysis, Age-stratified comparisons revealed marked differences in adverse event signal. This pharmacovigilance research underscored potential safety concerns of vancomycin, corroborated known risks and identified novel safety signals not listed in the current product label. These findings expanded understanding of vancomycin's safety profile and provided evidence-based guidance for clinical practice.