Adverse Event Profiles of Acetaminophen and Ibuprofen in Infants: A Food and Drug Administration Adverse Event Reporting System Database Retrospective Cohort Study

CONCLUSION: Through a systematic analysis of the FAERS database, this study highlights significant safety differences between acetaminophen and ibuprofen. The findings offer direct guidance for clinicians in selecting safer antipyretic medications, supporting optimized fever management practices and minimizing drug-related AEs in infants.