ArticleBMC pharmacology & toxicology2021
Descriptive analysis of adverse drug reaction reports in children and adolescents from Germany: frequently reported reactions and suspected drugs.
Article in BMC pharmacology & toxicology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 16 citations in OpenAlex.
- Prescribing trends and spontaneous reporting patterns of adverse drug reactions of ADHD medications in children and adolescents in germany: A retrospective analysis (2013-2022).European child & adolescent psychiatry · 2026Article
- Post-marketing safety profile of palivizumab: a 20-year pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS).Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Case Report: Qizhi Yishen Capsule-induced bone marrow granulomas and severe myelosuppression.Frontiers in allergy · 2026Article
- Vigi4Eudra-score: Evaluation of the completeness of spontaneous adverse drug reaction reports in EudraVigilance.PloS one · 2026Article
- Safety assessment for ibuprofen using disproportionality analysis: a decade of data from the Romanian national pharmacovigilance system.Frontiers in pharmacology · 2026Article
- Disproportionality analysis of methylphenidate-associated adverse events in pediatric patients using the FDA Adverse Event Reporting System: overall signals and stratification by gender and dosage form.Frontiers in psychiatry · 2026Article
- Metabolic and Endocrine ADRs of Atypical Antipsychotics (AAPs) in Paediatric Patients with Autism Spectrum Disorder (ASD): A Review of Prevalence, Risk Factors, and Implications for Clinical Monitoring.Journal of clinical medicine · 2025Review
- Therapeutic regimen of Crohn's disease: effect of Infliximab combined with mesalazine on intestinal flora and inflammatory indexes in patients.BMC gastroenterology · 2025Article
- Inefficiency Rates of Biological Immunosuppressive Induction Agents Used in Organ Transplantation: A Pharmacovigilance Study.Journal of clinical medicine · 2025Article
- Pharmacovigilance Strategies to Address Resistance to Antibiotics and Inappropriate Use-A Narrative Review.Antibiotics (Basel, Switzerland) · 2024Review
- Adverse Drug Reactions in Children: Comparison of Reports Collected in a Pharmacovigilance Project Versus Spontaneously Collected ADR Reports.Paediatric drugs · 2023Article
- Pediatric Drug Safety Surveillance: A 10-Year Analysis of Adverse Drug Reaction Reporting Data in Calabria, Southern Italy.Drug safety · 2022Review
- Analysis of pharmacovigilance databases for spontaneous reports of adverse drug reactions related to substandard and falsified medical products: A descriptive study.Frontiers in pharmacology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdverse drug reactions (ADRs) in the pediatric population may differ in types and frequencies compared to other populations. Respective studies analyzing ADR reports referring to children have already been performed for certain countries. However, differences in drug prescriptions, among others, complicate the transferability of the results from other countries to Germany or were rarely considered. Hence, the first aim of our study was to analyze the drugs and ADRs reported most frequently in ADR reports from Germany referring to children contained in the European ADR database (EudraVigilance). The second aim was to set the number of ADR reports in relation to the number of drug prescriptions. These were provided by the Research Institute for Ambulatory Health Care in Germany.
methodsFor patients aged 0-17 years 20,854 spontaneous ADR reports were received between 01/01/2000-28/2/2019. The drugs and ADRs reported most frequently were identified. Stratified analyses with regard to age, sex and drugs used "off-label" were performed. Reporting rates (number of ADR reports/number of drug prescriptions) were calculated.
resultsMethylphenidate (5.5%), ibuprofen (2.3%), and palivizumab (2.0%) were most frequently reported as suspected. If related to the number of drug prescriptions, the ranking changed (palivizumab, methylphenidate, ibuprofen). Irrespective of the applied drugs, vomiting (5.4%), urticaria (4.6%) and dyspnea (4.2%) were the ADRs reported most frequently. For children aged 0-1 year, drugs for the treatment of nervous system disorders and foetal exposure during pregnancy were most commonly reported. In contrast, methylphenidate ranked first in children older than 6 years and referred 3.5 times more often to males compared to females. If age- and sex-specific exposure was considered, more ADR reports for methylphenidate referred to children 4-6 years and females 13-17 years. Drugs for the treatment of nervous system disorders ranked first among "off-label" ADR reports.
conclusionsOur analysis underlines the importance of putting the number of ADR reports of a drug in context with its prescriptions. Additionally, differences in age- and sex-stratified analysis were observed which may be associated with age- and sex-specific diseases and, thus, drug exposure. The drugs most frequently included in "off-label" ADR reports differed from those most often used according to literature.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.