Differential Analysis of Neonatal Adverse Drug Events from Intrauterine and Extrauterine Exposure: Insights into Administration Routes Using the FAERS Database
Zhuqing Yang, Meng Hou, Tingting Li · Zeitschrift für Geburtshilfe und Neonatologie · 2026 · Heft 03 · S. 209-221
Bibliografische Angaben
Zusammenfassung
Abstract Objective This study aimed to systematically characterize the features and drug distribution of neonatal adverse drug reactions using data from the FAERS, with a focus on exposure-specific patterns and stratified analyses by sex and clinical outcomes. Methods Reports submitted to FAERS from the first quarter of 2004 to the fourth quarter of 2024 were utilized. Patients experienced the ADR at an age of no more than 28 days. Four quantitative disproportionality analysis methods, including ROR, PRR, BCPNN, and MGPS, were used to detect signals of adverse drug events. Results A total of 15,456 neonatal case…