Trial reportCNS drugs2015
Safety of Methylphenidate and Atomoxetine in Children with Attention-Deficit/Hyperactivity Disorder (ADHD): Data from the Italian National ADHD Registry.
Trial report in CNS drugs, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 5 of them syntheses that pooled it.
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
20 citing papers in PubMed, 5 syntheses or guidelines pooled it, 43 citations in OpenAlex.
- Occurrence of Psychosis and Bipolar Disorder in Individuals With Attention-Deficit/Hyperactivity Disorder Treated With Stimulants: A Systematic Review and Meta-Analysis.JAMA psychiatry · 2025Pooled it
- Epilepsy and attention-deficit/hyperactivity disorder in children and adolescents: An overview of etiology, prevalence, and treatment.Frontiers in human neuroscience · 2023Pooled it
- The effects of stimulant dose and dosing strategy on treatment outcomes in attention-deficit/hyperactivity disorder in children and adolescents: a meta-analysis.Molecular psychiatry · 2022Pooled it
- The Effect of Methylphenidate and Atomoxetine on Heart Rate and Systolic Blood Pressure in Young People and Adults with Attention-Deficit Hyperactivity Disorder (ADHD): Systematic Review, Meta-Analysis, and Meta-Regression.International journal of environmental research and public health · 2018Pooled it
- Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of adverse events in non-randomised studies.The Cochrane database of systematic reviews · 2018Pooled it
- Hepatic Safety Profile of Atomoxetine and Methylphenidate in Patients with ADHD: Disproportionality Analysis Using EudraVigilance Database Data.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Effect of Continuous Positive Airway Pressure (CPAP) Mode on Lung Function, Exercise Tolerance, Vital Signs, and Dyspnea After Acute SARS-CoV-2 Infection.Clinics and practice · 2025Article
- Multidimensional Comparison of Methylphenidate and Atomoxetine in the Treatment of Attention-Deficit/Hyperactivity Disorder in Children, a 12-Week, Open-Label, Head-to-Head Clinical Trial.Psychiatry investigation · 2025Article
- Psychosis with use of amphetamine drugs, methylphenidate and atomoxetine in adolescent and adults.BMJ mental health · 2024Article
- Efficacy and Safety of Methylphenidate and Atomoxetine in Medication-Naive Children with Attention-Deficit Hyperactivity Disorder in a Real-World Setting.Drugs in R&D · 2024Article
- Comparison of the real-world safety of two different long-acting methylphenidate formulations (MedikinetScandinavian journal of child and adolescent psychiatry and psychology · 2024Article
- Acute Tolerability of Methylphenidate in Treatment-Naïve Children with ADHD: An Analysis of Naturalistically Collected Data from Clinical Practice.Paediatric drugs · 2022Article
- Efficacy and Safety of Medication for Attention-Deficit Hyperactivity Disorder in Children and Adolescents with Common Comorbidities: A Systematic Review.Neurology and therapy · 2021Review
- ADHD: Reviewing the Causes and Evaluating Solutions.Journal of personalized medicine · 2021Review
- Suicidal and non-suicidal self-injurious behaviour in patients with bipolar disorder and comorbid attention deficit hyperactivity disorder after initiation of central stimulant treatment: a mirror-image study based on the LiSIE retrospective cohort.Therapeutic advances in psychopharmacology · 2020Article
- Evaluation of dietary intake in children and college students with and without attention-deficit/hyperactivity disorder.Nutritional neuroscience · 2019Article
- NURR1 deficiency is associated to ADHD-like phenotypes in mice.Translational psychiatry · 2019Article
- Hallucinations and other psychotic symptoms in response to methylphenidate in children and adolescents with attention-deficit/hyperactivity disorder: a Cochrane systematic review with meta-analysis and trial sequential analysisScandinavian journal of child and adolescent psychiatry and psychology · 2018Review
- Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity.Neuropsychiatric disease and treatment · 2017Review
- Sleep Problems in Children with Attention Deficit/Hyperactivity Disorder: Current Status of Knowledge and Appropriate Management.Current psychiatry reports · 2016Review
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 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe aim of this study was to assess the type and frequency of adverse events (AEs) in children with attention-deficit/hyperactivity disorder (ADHD) treated with methylphenidate or atomoxetine over a 5-year period in a large naturalistic study.
methodsWe draw on data from the Italian ADHD Registry, a national database for postmarketing phase IV pharmacovigilance of ADHD medications across 90 centers. AEs were defined as severe or mild as per the classification of the Italian Medicines Agency. AE frequency in the two treatment groups was compared using incidence rates per 100 person-years (IR100PY) and incidence rate ratios (IRRs). Mantel-Haenszel adjusted IRRs were calculated to control for psychiatric comorbidity.
resultsA total of 1350 and 753 participants (aged 6-18 years, mean age 10.7 ± 2.8) were treated with methylphenidate and atomoxetine, respectively, from 2007 to 2012. Ninety participants (7 %) were switched from methylphenidate to atomoxetine, and 138 (18 %) from atomoxetine to methylphenidate. Thirty-seven children treated with atomoxetine and 12 with methylphenidate had their medication withdrawn. Overall, 645 patients (26.8 %) experienced at least one mild AE (including decreased appetite and irritability, for both drugs) and 95 patients (3.9 %) experienced at least one severe AE (including severe gastrointestinal events). IR100PY were significantly higher in the atomoxetine-treated group compared with the methylphenidate-treated group for a number of mild and severe AEs and for any severe or mild AEs. After controlling for comorbidities, IRR was still significantly higher in the atomoxetine group compared with the methylphenidate group for a number of mild (decreased appetite, weight loss, abdominal pain, dyspepsia, stomach ache, irritability, mood disorder and dizziness) and severe (gastrointestinal, neuropsychiatric, and cardiovascular) AEs.
conclusionsIn this naturalistic study, methylphenidate had a better safety profile than atomoxetine.
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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.