ArticleBMC pharmacology & toxicology2020
Characteristics of pediatric adverse drug reaction reports in the Japanese Adverse Drug Event Report Database.
Article in BMC pharmacology & toxicology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed, 11 citations in OpenAlex.
- Safety profiles of calcineurin inhibitor-related infections in the pediatric population: a real-world pharmacovigilance analysis.European journal of pediatrics · 2026Article
- Strengthening pharmacovigilance through patient reporting: a scoping review of awareness, barriers, and facilitators.Journal of pharmaceutical policy and practice · 2026Review
- Trends in Anti-Influenza Drug Prescription and Adverse Drug Reaction Reporting After the Lifting of Oseltamivir Prescribing Restrictions in Pediatric Outpatients: An Ecological Study Using the MDV AnalyzerDrugs - real world outcomes · 2024Article
- Characteristics of adverse drug reactions due to nonsteroidal anti-inflammatory drugs: a cross-sectional study.Nagoya journal of medical science · 2023Article
- Itraconazole Contaminated with Rilmazafone in Japan: A Retrospective Analysis Using the Japanese Adverse Drug Event Report Database.Drugs - real world outcomes · 2022Article
- Adverse Drug Reaction Reports Regarding Abnormal Behavior After Oseltamivir Use in Children as Reported by Consumers or Healthcare Professionals.Patient preference and adherence · 2021Article
- Evaluation of Adverse Drug Reactions in Paediatric Patients: A Retrospective Study in Turkish Hospital.Frontiers in pharmacology · 2021Article
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Authors and funding
8 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundThere are no reports on investigations of the characteristics of adverse drug reaction (ADR) reports for pediatric patients in the Japanese Adverse Drug Event Report database (JADER) and the utility of database for drug safety surveillance in these patients.
methodWe aimed to evaluate ADR reports for pediatric patients in the JADER. We used spontaneous ADR reports included in the JADER since April 1, 2004, to December 31, 2017, which was downloaded in April 2018. In a total of 504,407 ADR reports, the number of spontaneous reports was 386,400 (76.6%), in which 37,534 (7.4%) were unknown age reports. After extraction of 27,800 ADR reports for children aged < 10 and 10-19 years, we excepted for ADR reports associated with a vaccine (n = 6355) and no-suspected drug reports (n = 86). A total of 21,359 (4.2%) reports were finally included in this analysis.
resultsMore than half of the ADR reports were for children aged < 10 years. Approximately 30% of ADR reports had multiple suspected drugs, which did not differ by age. The percentages of fatal outcomes of ADRs among patients aged < 10 and 10-19 years were 4.7 and 3.9%, respectively. The most frequently reported drug, reaction, and drug-reaction pair were oseltamivir, abnormal behavior, and oseltamivir and abnormal behavior, respectively.
conclusionWe clarified the characteristics of ADR reports for Japanese children by using the JADER. ADR report databases, especially those for pediatric patients, are valuable pharmacovigilance tools in Japan and other countries. Therefore, a proper understanding of the characteristics of the ADR reports in the JADER is important. Additionally, potential signals for ADRs in pediatric patients should be monitored continuously and carefully.
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