Age-Specific Differences in Omalizumab-Related Adverse Drug Reaction Signals between Children and Adults: An Analysis Based on the FAERS Database

Objective： To analyze age-specific differences in post-marketing adverse drug reaction (ADR) signals of omalizumab between children (<18 years) and adults (≥18 years) using FAERS data, to inform optimized medication safety monitoring strategies. Methods： Omalizumab-related ADR reports (2003Q1–2025Q3) were extracted from FAERS and stratified by age. ADRs were coded with MedDRA. Signals were mined using four disproportionality methods (ROR, PRR, BCPNN, MGPS), with validity requiring all thresholds met. Cumulative incidence and time-to-onset (TTO) were analyzed. Results： Among 62,925 reports (4% children, 45% adults), both groups showed strong signals for respiratory/immune disorders. Children had an additional musculoskeletal signal; adults had more general disorders. At PT level, adults had broader coverage (allergic/infectious signals), while children had narrower coverage with a unique strong signal for asthmatic crisis (ROR=52.83). Children had shorter median TTO (34.4 vs 63.1 days) and faster cumulative incidence; adults had longer late-onset risk. Conclusion： Omalizumab shows significant age-specific ADR differences. Individualized monitoring strategies are needed to enhance clinical safety.