Pediatric spontaneous-reporting patterns for biologics approved or used for asthma: Analysis of the FDA adverse event...

Pediatric post-marketing evidence for biologics used for asthma remains limited and uneven across agents. We characterized pediatric spontaneous-reporting patterns for biologics approved or used for asthma in the FDA Adverse Event Reporting System.

We analyzed pediatric reports involving omalizumab, mepolizumab, benralizumab, dupilumab, and tezepelumab from 2015 through 2025. Reports were summarized by age, sex, reporting year, outcomes, and preferred terms. Serious-outcome and indication-linked classifications were performed. Disproportionality was assessed using reporting odds ratios, proportional reporting ratios, chi-square statistics, and information components. Pediatric signals were compared with adult findings and interpreted according to method agreement, report volume, and sparse-data restrictions.

We identified 5155 pediatric reports. Dupilumab accounted for 3787 reports (73.5%) and omalizumab for 1152 (22.3%). Serious outcomes were reported in 1273 reports (24.7%), with substantial variation across biologics. Dupilumab showed prominent injection-site, dermatologic, and ocular reporting, whereas omalizumab showed respiratory, asthma-related, hypersensitivity-related, and vital-sign reporting. Of 43 pediatric signals supported by at least two disproportionality criteria, 31 were also identified in adults. After restricting to terms with at least five reports, 33 signals remained for the main analysis. Narrow anaphylaxis-related domains occurred in 17 dupilumab, 113 omalizumab, 3 mepolizumab, 3 benralizumab, and no tezepelumab reports. Among dupilumab reports, 83.4% were classified as asthma-related and 15.2% as mixed indications.

Pediatric FAERS reports showed biologic-specific reporting patterns. These patterns may reflect potential drug-related events, underlying disease activity, treatment failure, indication mix, monitoring, and reporting practices. The findings are hypothesis-generating and do not establish incidence, causality, or asthma-specific safety profiles.