Atomoxetine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Atomoxetine: Specific developmental disorder
One-Sentence Summary
Atomoxetine is a selective norepinephrine reuptake inhibitor, used as a non-stimulant treatment for attention deficit hyperactivity disorder (ADHD). The TxGNN model predicts it may be useful for specific developmental disorder, but no study in the data compiled for this report tests atomoxetine in this condition itself, so the evidence level is L5. The related literature (14 publications, no registered clinical trials) addresses ADHD, including ADHD in children with autism, rather than the predicted disease.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Specific developmental disorder |
| TxGNN Prediction Score | 1.0000 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs on record: at least 19; dormant: 1) |
| Number of DINs | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Atomoxetine is known as a selective norepinephrine reuptake inhibitor, which is how it is used in ADHD, and this mechanism could in principle be relevant to neurodevelopmental conditions.
ADHD often co-occurs with learning disabilities and autism spectrum conditions. The literature shows that atomoxetine can improve ADHD symptoms in these groups, for example a meta-analysis of three placebo-controlled trials in 241 children with autism. However, this reflects its effect on ADHD symptoms, not a distinct effect on the developmental disorder itself. The very high score most likely reflects the close network relationship between this condition and ADHD. The prediction should therefore be treated as a research question, not as demonstrated efficacy.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
None of these publications studies atomoxetine in a specific developmental disorder directly. They concern ADHD and its comorbidities.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39701638 | 2025 | Network meta-analysis | The Lancet Psychiatry | Compares drug, psychological and neurostimulation interventions for adult ADHD |
| 30653855 | 2019 | Meta-analysis | Autism Research | Three placebo-controlled trials (241 children) of atomoxetine for ADHD symptoms in autism |
| 27721971 | 2016 | Review | Therapeutic Advances in Psychopharmacology | Efficacy of atomoxetine for ADHD with common comorbidities, including pervasive developmental disorders |
| 35485452 | 2022 | Cohort | Neuropsychopharmacology Reports | Factors associated with atomoxetine efficacy in adult ADHD |
| 33012168 | 2021 | Observational | Clinical EEG and Neuroscience | Quantitative EEG in childhood ADHD and learning disabilities |
| 42675180 | 2026 | Research article | Nature Biomedical Engineering | Structural connectivity deviations in youths with ADHD predict symptom and treatment outcomes |
Canada Market Information
Atomoxetine is marketed in Canada. The records contain no indication text, dosage form or manufacturer.
| DIN | Product Name |
|---|---|
| 02318024 | APO-ATOMOXETINE |
| 02506815 | JAMP ATOMOXETINE |
| 02467755 | ATOMOXETINE |
| 02362511 | TEVA-ATOMOXETINE |
| 02471493 | AURO-ATOMOXETINE |
Safety Considerations
- Drug Interactions: 100 interactions were found in the interaction database. Those listed include a major interaction with cisapride and dolasetron, and moderate interactions with bupropion, cimetidine, clarithromycin, epinephrine, ephedrine, fenfluramine and others.
Please refer to the package insert for warnings and contraindications, which are not available in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: No study tests atomoxetine in a specific developmental disorder itself. The linked evidence concerns ADHD, so the evidence level is L5 and the high score is not supported by direct data.
To proceed, the following is needed:
- Studies or trials that directly assess atomoxetine in the specific developmental disorder, with outcomes beyond ADHD symptoms
- Mechanism of action data
- Package insert warnings and contraindications from Health Canada
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.