ObjectiveThis study aimed to characterize the adverse reactions related to medication errors (MEs) in pediatric population reported in the US Food and Drug Administration Adverse Event Reporting System (FAERS), and to identify the signals for different drug MEs. MethodsData from pediatric MEs reports in the FAERS from January 1, 2004, to December 1, 2022, were collected. MEs reports were categorized by patient age groups, MEs, and anatomical therapeutic chemical classification system. Disproportionality analyses were performed. ResultsA total of 16 515 MEs reports were retrieved. Psychostimulants and immunosuppressants were the most frequently reported drugs. Administration errors (72.4%) were most frequent, followed by prescription errors (7.1%) and storage errors (3.9%). In infants (1 year), ibuprofen and paracetamol were the most frequently reported, and MEs signals were found for dose and administration errors. In children (2-11 years), methylphenidate and somatropin recombinant were the most frequently reported, and MEs signals were found for dose omission and prescription errors. In adolescents (12-18 years), somatropin recombinant and adalimumab were the most frequently reported, and MEs signals were found for dose errors. ConclusionThis study systematically analyzed pediatric MEs reported in the FAERS database, identifying age-specific high-risk drugs and common error types, and noting that some high-frequency reports may be influenced by reporting mechanisms. Combined with domestic monitoring data and clinical practice experience, the findings highlight the need for age-targeted prescription review, pharmacist involvement, and medication education to reduce pediatric MEs and improve medication safety.