IS PARACETAMOL AND NSAIDS SAFE FOR PEDIATRIC? A DATA-DRIVEN FAERS PHARMACOVIGILANCE STUDY
Author(s)
Lijing Yang, Bachelor1, Yingting Zeng, Bachelor2, Xiangzhen Wang, Bachelor1, Xiaoting Huang, Bachelor3, xiuhua weng, Doctor4;
1The School of Pharmacy,Fujian Medical University, Student, Fuzhou, China, 2The School of Pharmacy,Fujian Medical University, Fuzhou, China, 3The First Affiliated Hospital of Fujian Medical University, Fuzhou, China, 4Fujian Medical University Mengchao Hepatobiliary Hospital, Fuzhou, China
1The School of Pharmacy,Fujian Medical University, Student, Fuzhou, China, 2The School of Pharmacy,Fujian Medical University, Fuzhou, China, 3The First Affiliated Hospital of Fujian Medical University, Fuzhou, China, 4Fujian Medical University Mengchao Hepatobiliary Hospital, Fuzhou, China
OBJECTIVES: This study aimed to leverage the FAERS to comprehensively assess and compare the real-world safety profiles of Paracetamol and NSAIDs in individuals under 18 years old.
METHODS: A disproportionality analysis was performed on FAERS data from Q1 2014 to Q4 2024. Adverse events (AEs) for paracetamol and NSAIDs were identified. Analyses included calculating the information component for signal detection, parametric time-to-onset (TTO) analysis with goodness-of-fit testing, and subgroup analyses stratified by age, gender, weight, and specific drug.
RESULTS: Analysis of pediatric AEs revealed adolescents constituted the largest proportion, with females predominating. Hospitalization was the most common outcome (41.99%). Most AEs occurred acutely, though acetylsalicylic acid showed delayed onset. Significant signals emerged across System Organ Classes, most notably injury/poisoning, gastrointestinal, and general disorders. Critically, adolescents exhibited disproportionately high rates of psychiatric events, including suicide-related behaviors. Substantial drug-specific heterogeneity was observed, with indomethacin associated with the highest mortality.
CONCLUSIONS: This large-scale pharmacovigilance study confirms that paracetamol and NSAIDs safety in pediatrics is stratified by age and drug, necessitating precision monitoring. The findings reveal acute-onset AEs, establishing a critical 24-hour surveillance window, and identify specific vulnerabilities: infants to pharmacokinetic/toxicological events and adolescents to severe neuropsychiatric risks. These results underscore the imperative for individualized risk-benefit assessment and support the implementation of targeted surveillance protocols and intelligent pharmacovigilance frameworks in pediatric therapeutics.
METHODS: A disproportionality analysis was performed on FAERS data from Q1 2014 to Q4 2024. Adverse events (AEs) for paracetamol and NSAIDs were identified. Analyses included calculating the information component for signal detection, parametric time-to-onset (TTO) analysis with goodness-of-fit testing, and subgroup analyses stratified by age, gender, weight, and specific drug.
RESULTS: Analysis of pediatric AEs revealed adolescents constituted the largest proportion, with females predominating. Hospitalization was the most common outcome (41.99%). Most AEs occurred acutely, though acetylsalicylic acid showed delayed onset. Significant signals emerged across System Organ Classes, most notably injury/poisoning, gastrointestinal, and general disorders. Critically, adolescents exhibited disproportionately high rates of psychiatric events, including suicide-related behaviors. Substantial drug-specific heterogeneity was observed, with indomethacin associated with the highest mortality.
CONCLUSIONS: This large-scale pharmacovigilance study confirms that paracetamol and NSAIDs safety in pediatrics is stratified by age and drug, necessitating precision monitoring. The findings reveal acute-onset AEs, establishing a critical 24-hour surveillance window, and identify specific vulnerabilities: infants to pharmacokinetic/toxicological events and adolescents to severe neuropsychiatric risks. These results underscore the imperative for individualized risk-benefit assessment and support the implementation of targeted surveillance protocols and intelligent pharmacovigilance frameworks in pediatric therapeutics.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
RWD116
Topic
Real World Data & Information Systems
Topic Subcategory
Reproducibility & Replicability
Disease
SDC: Pediatrics