ArticleTherapeutic innovation & regulatory science2023
Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010-2020: A Cross-Sectional Study.
Article in Therapeutic innovation & regulatory science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed.
- Linezolid-related Optic Nerve Disorders: Insight From a Pharmacovigilance Analysis of the US FDA Adverse Event Reporting System.Open forum infectious diseases · 2025Trial
- Differential Analysis of Neonatal Adverse Drug Events from Intrauterine and Extrauterine Exposure: Insights into Administration Routes Using the FAERS Database.Zeitschrift fur Geburtshilfe und Neonatologie · 2026Article
- A real-world investigation of drug-induced hyperglycemia and diabetes mellitus in pediatric populations using the FDA adverse event reporting system.Frontiers in medicine · 2026Article
- A Real-World Disproportionality Analysis of Avacopan in Anti-Neutrophil Cytoplasmic Antibodies Associated Vasculitis: Insights From FDA Adverse Event Reporting System.Pharmacology research & perspectives · 2025Article
- A retrospective analysis of medications associated with pityriasis rosea reported in the FDA adverse events reporting system.Archives of dermatological research · 2025Article
- Article
- Challenges of pediatric pharmacotherapy: A narrative review of pharmacokinetics, pharmacodynamics, and pharmacogenetics.European journal of clinical pharmacology · 2024Review
- Adverse drug reactions in neonates: a brief analysis of the FDA adverse event reporting system.Frontiers in pharmacology · 2024Article
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
introductionThe Food and Drug Administration Adverse Event Reporting System (FAERS) is a database of adverse event (AE) and medication error reports for drugs and therapeutic biologics. Examining trends of reported individual case safety reports (ICSRs) provides context for evaluating safety concerns.
objectiveCharacterize pediatric FAERS ICSRs and compare trends (1) to adult reports; (2) within pediatric subgroups.
methodsThis cross-sectional study examined FAERS ICSRs received between January 1, 2010, through December 31, 2020. Stratified age bands were neonates, infants, younger children, older children, adolescents, and adults. We characterized groups by patient demographic information, suspect products, AEs, and reporter type.
resultsFrom 2010 to 2020, there were 11,258,995 FAERS ICSRs; 3.1% described pediatric patients. Compared to adults, pediatric ICSRs had higher proportions of all serious outcomes except death. Within pediatric subgroups, neonates had the highest proportions of serious outcomes (96.2%) compared to infants, younger children, older children, and adolescents (79.8%, 67.9%, 59.5%, and 52.7%, respectively). Younger pediatric age groups were more likely to have weight information than older age groups but were less likely to include gender information. The most frequently reported AE was off label use for pediatrics and drug ineffective for adults. Products and AEs reported also differed among pediatric subgroups. Neonates, infants, and adolescents had entirely distinct sets of top five product-event combinations.
conclusionPediatric ICSRs represent a minority of FAERS reports but have distinctly different attributes relative to adult ICSRs. Reporting trends also vary within pediatric subgroups, which highlights the need for unique considerations for pediatric safety surveillance.
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