A real-world disproportionality analysis of dupilumab safety in children aged 0–5 years with atopic dermatitis

Dupilumab is approved for the treatment of moderate-to-severe atopic dermatitis (AD) in children as young as 6 months, but real-world safety reporting in children aged 0–5 years remains limited. We conducted a retrospective pharmacovigilance study using the US FDA Adverse Event Reporting System (FAERS) from Q1 2022 to Q3 2025 to characterize dupilumab-associated adverse events (AEs) in children aged 0–5 years with AD in which dupilumab was the primary suspect drug. Disproportionality analysis at the System Organ Class (SOC) and Preferred Term (PT) levels were performed using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and empirical Bayesian geometric mean (EBGM), following READUS-PV. Time-to-onset (TTO) was described when valid dates were available. A total of 2,798 reports were identified (median age 3 years; 57.6% male), of which 187 (6.7%) were serious. At SOC level, skin and subcutaneous tissue disorders (n = 2,609; ROR 12.92) and eye disorders (n = 463; ROR 5.63) met predefined signal criteria across all four algorithms. At PT level, high-frequency events included pruritus, dry skin, rash and eczema and medication-use issues such as incorrect dose and inappropriate schedule. High-disproportionality PTs included eyelid exfoliation, eyelid skin dryness, dry eye, ocular hyperaemia and skin-barrier–related PTs such as skin fissures and skin exfoliation. For TTO, most skin and ocular PTs occurred < 30d after initiation. In children aged 0–5 years with AD, FAERS reports suggest early-onset cutaneous and ocular adverse events after dupilumab. No SOC-level disproportionality signal was detected for infections and infestations or neoplasms, but rare risks cannot be excluded. Selected PTs nevertheless showed disproportionate reporting, supporting proactive ocular monitoring, caregiver education, and continued surveillance.