Abstract
PURPOSE: Antibiotic-related drug eruption is a common cutaneous adverse reaction in pediatric populations. However, its incidence and risk factor remain unclear. This study investigated the incidence of drug eruptions in pediatrics and its association with antibiotic exposure to identify potential risk factors. METHODS: Using the Health Insurance Review and Assessment Service-Pediatric Patient Sample database (2009-2019), we conducted a retrospective nationwide cohort study involving 6,699,010 pediatric patients. Drug eruptions were identified based on administrative claims data using the International Classification of Diseases, 10th Revision codes L27.0 and L27.1. The incidence was compared between antibiotic-exposed and unexposed groups. RESULTS: We analyzed 4,107,522 patients in the antibiotic-exposed group and 2,591,488 patients in the antibiotic-unexposed group. The overall incidence of drug eruptions was 10.84 per 10,000 person-years, with higher rates in the antibiotic-exposed group than in the antibiotic-unexposed group (14.59 vs. 4.89 per 10,000 person-years, Log rank P < 0.001). Any exposure to antibiotics significantly increased drug eruption risk (adjusted hazard ratio, 2.86; 95% confidence interval, 2.27-3.60). The risk of drug eruption was higher among pediatric patients who used multiple antibiotics than in those with single antibiotic use. The association remained consistent across age groups and was robust in sensitivity analyses, including extended follow-ups and inpatient-only outcomes. CONCLUSIONS: Antibiotic exposure increases the risk of drug eruption in pediatric populations, particularly with multiple antibiotic use. Careful consideration is needed when prescribing antibiotics to children, especially in combination therapy.