Atomoxetine

The precise mechanism by which atomoxetine produces its therapeutic effects in Attention-Deficit/Hyperactivity Disorder (ADHD) is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter, as determined in ex vivo uptake and neurotransmitter depletion studies.

• Atomoxetine capsule is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1 ) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsule is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).ICD-10: F90.9

• • Hypersensitivity to atomoxetine or other constituents of product. ( 4.1 ) • Atomoxetine capsules use within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations.contraindicated

Initial, Target and Maximum Daily Dose ( 2.1 ) (Acute and Maintenance/Extended Treatment) Body Weight Initial Daily Dose Target Total Daily Dose Maximum Total Daily Dose Children and adolescents up to 70 kg 0.5 mg/kg 1.2 mg/kg 1.4 mg/kg Children and adolescents over 70 kg and adults 40 mg 80 mg 100 mg Dosing adjustment — Hepatic Impairment, Strong CYP2D6 Inhibitor, and in patients known to be CYP2D6 poor metabolizers (PMs). ( 2.4 , 12.3 ) 2.1 Acute Treatment Dosing of children and adolescents up to 70 kg body weight - Atomoxetine capsules should be initiated at a total daily dose of approximately 0.5 mg/kg and increased after a minimum of 3 days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day [see Clinical Studies ( 14 )]. The total daily dose in children and adolescents should not exceed 1.4 mg/kg or 100 mg, whichever is less. Dosing of children and adolescents over 70 kg body weight and adults - Atomoxetine capsules should be initiated at a total daily dose of 40 mg and increased after a minimum of 3 days to a target total daily dose of approximately 80 mg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. After 2 to 4 additional weeks, the dose may be increased to a maximum of 100 mg in patients who have not achieved an optimal response.

• Suicidal Ideation – Monitor for suicidality, clinical worsening, and unusual changes in behavior. ( 5.1 ) • Severe Liver Injury – Should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. ( 5.2 ) • Serious Cardiovascular Events – Sudden death, stroke and myocardial infarction have been reported in association with atomoxetine treatment. Patients should have a careful history and physical exam to assess for presence of cardiovascular disease. Atomoxetine generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to its noradrenergic effects. Consideration should be given to not using atomoxetine capsules in adults with clinically significant cardiac abnormalities. ( 5.3 ) • Emergent Cardiovascular Symptoms – Patients should undergo prompt cardiac evaluation. ( 5.3 ) • Effects on Blood Pressure and Heart Rate –Increase in blood pressure and heart rate; orthostasis and syncope may occur. Use with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease. ( 5.4 ) • Emergent Psychotic or Manic Symptoms – Consider discontinuing treatment if such new symptoms occur. ( 5.5 ) • Bipolar Disorder – Screen patients to avoid possible induction of a mixed/manic episode. ( 5.6 ) • Aggressive behavior or hostility should be monitored.

Most common adverse reactions (≥5% and at least twice the incidence of placebo patients) • Child and Adolescent Clinical Trials – Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. ( 6.1 ) • Adult Clinical Trials – Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Atomoxetine was administered to 5382 children or adolescent patients with ADHD and 1007 adults with ADHD in clinical studies. During the ADHD clinical trials, 1625 children and adolescent patients were treated for longer than 1 year and 2529 children and adolescent patients were treated for over 6 months. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Child and Adolescent Clinical Trials Reasons for discontinuation of treatment due to adverse reactions in child and adolescent clinical trials — In acute child and adolescent placebo-controlled trials, 3.0% (48/1613) of atomoxetine subjects and 1.4% (13/945) placebo subjects discontinued for adverse reactions.

• Hepatic Insufficiency - Increased exposure (AUC) to atomoxetine than with normal subjects in EM subjects with moderate (Child-Pugh Class B) (2-fold increase) and severe (Child-Pugh Class C) (4-fold increase). ( 8.6 ) • Renal Insufficiency - Higher systemic exposure to atomoxetine than healthy subjects for EM subjects with end stage renal disease - no difference when exposure corrected for mg/kg dose. ( 8.7 ) • Patients with Concomitant Illness - Does not worsen tics in patients with ADHD and comorbid Tourette’s Disorder. ( 8.10 ) • Patients with Concomitant Illness – Does not worsen anxiety in patients with ADHD and comorbid Anxiety Disorders. ( 8.10 ) 8.1 Pregnancy: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including atomoxetine, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/. Risk Summary Available published studies with atomoxetine use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Some animal reproduction studies of atomoxetine had adverse developmental outcomes.

Metabolism

Atomoxetine is well-absorbed after oral administration and is minimally affected by food. It is eliminated primarily by oxidative metabolism through the cytochrome P450 2D6 (CYP2D6) enzymatic pathway and subsequent glucuronidation.

10.1 Human Experience There is limited clinical trial experience with atomoxetine overdose. During postmarketing, there have been fatalities reported involving a mixed ingestion overdose of atomoxetine and at least one other drug. There have been no reports of death involving overdose of atomoxetine alone, including intentional overdoses at amounts up to 1400 mg. In some cases of overdose involving atomoxetine, seizures have been reported. The most commonly reported symptoms accompanying acute and chronic overdoses of atomoxetine were gastrointestinal symptoms, somnolence, dizziness, tremor, and abnormal behavior. Hyperactivity and agitation have also been reported. Signs and symptoms consistent with mild to moderate sympathetic nervous system activation (e.g., tachycardia, blood pressure increased, mydriasis, dry mouth) have also been observed. Most events were mild to moderate. Less commonly, there have been reports of QT prolongation and mental changes, including disorientation and hallucinations [see Clinical Pharmacology ( 12.2 )]. 10.2 Management of Overdose Consult with a Certified Poison Control Center for up to date guidance and advice.

• Nov 26, 2002NDANDA021411Lilly
• Sep 16, 2010ANDAANDA079017Zydus Pharms Usa Inc
• May 30, 2017ANDAANDA078983Apotex
• May 30, 2017ANDAANDA079019Glenmark Pharms Ltd
• May 30, 2017ANDAANDA079016Aurobindo Pharma
• May 30, 2017ANDAANDA079022Teva Pharms Usa
• Feb 23, 2018ANDAANDA090609Dr Reddys
• Mar 20, 2026NDANDA220320Map77

1. 1Drug Ineffective2,89411%
2. 2Nausea2,2048.3%
3. 3Fatigue2,1838.2%
4. 4Headache1,7966.8%
5. 5Vomiting1,7706.7%
6. 6Off Label Use1,7516.6%
7. 7Dizziness1,6556.2%
8. 8Insomnia1,5896.0%
9. 9Somnolence1,4505.5%
10. 10Depression1,4295.4%
11. 11Abdominal Pain Upper1,3975.3%
12. 12Feeling Abnormal1,2294.6%
13. 13Anxiety1,1924.5%
14. 14Pain1,1744.4%
15. 15Suicidal Ideation1,1694.4%

Recent PubMed references pinned to Atomoxetine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• UPLC-MS/MS method for quantifying non-stimulant ADHD medications in human breast milk and plasma: Application in a lactating patient receiving atomoxetine.
  Journal of pharmaceutical and biomedical analysis · 2026 · Aoyagi R, Furugen A, Nishimura A, et al.
  PMID 42202754DOI 10.1016/j.jpba.2026.117575
• In vitro exposure to atomoxetine hydrochloride reduces testosterone biosynthesis, induces cell death and DNA damage, as well as altering the oxidative profile and gene expression in TM3 Leydig cells.
  Toxicology and applied pharmacology · 2026 · Quadreli DH, Sakai AH, Martins SH, et al.
  PMID 41967611DOI 10.1016/j.taap.2026.117823
• In adults with ADHD, atomoxetine, methylphenidate, and CBT reduce symptom severity and the drugs are less tolerable vs. control at 12 wk.
  Annals of internal medicine · 2026 · Onady GM, ACP Journal Club Editorial Team at McMaster University
  PMID 41941734DOI 10.7326/ANNALS-26-00802-JC
• Prescription psychostimulants, atomoxetine and the risk of psychosis in adults with history of psychosis: a population-based cohort study.
  Translational psychiatry · 2026 · Bach P, Franck J, Hällgren J, et al.
  PMID 41916954DOI 10.1038/s41398-026-03998-4
• Understanding Atomoxetine Exposure Variability in Children and Adolescents With ADHD Through Population Pharmacokinetics.
  Journal of clinical pharmacology · 2026 · Tobin KV, Pritchett A, Leeder JS, et al.
  PMID 41906544DOI 10.1002/jcph.70168
• Symptomatic improvement in fibromyalgia after treatment of comorbid attention deficit hyperactivity disorder: a case report.
  Journal of medical case reports · 2026 · Chiu J, Nikirk J, Brown A, et al.
  PMID 41851804DOI 10.1186/s13256-026-05941-z
• Atomoxetine suppresses nitric oxide synthesis induced by lipopolysaccharide in BV-2 microglia cells through the modulation of STAT1 and STAT3.
  Neuroscience · 2026 · Nakatani Y, Takara R, Murata A, et al.
  PMID 41759989DOI 10.1016/j.neuroscience.2026.02.042
• [Priapism associated with atomoxetine use].
  Tijdschrift voor psychiatrie · 2025 · Vandemoortele S, Titeca K
  PMID 41466589

The 10 most recently updated of 220 ClinicalTrials.gov registrations naming Atomoxetine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Progressive Relaxation and Psychoeducation in Patients With Hematological Malignancies
  Active not recruiting · Interventional · 75 enrolled · Necmettin Erbakan University
  NCT07251348updated 2026-05-15
• Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep Apnea
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 24 enrolled · Brigham and Women's Hospital
  NCT07577661updated 2026-05-11
• Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea
  Completed · Phase 4 · Interventional · 45 enrolled · China Medical University Hospital
  NCT06295562updated 2026-04-23
• Attention Deficit Hyperactivity Disorder
  Recruiting · Interventional · 80 enrolled · Nantes University Hospital
  NCT06232226updated 2026-04-17
• A Study of TAK-503 in Children and Teenagers With Attention Deficit Hyperactivity Disorder (ADHD)
  Completed · Phase 4 · Interventional · 396 enrolled · Shire
  NCT04085172updated 2026-04-13
• Endotype DIrected Treatment for OSA in Down Syndrome
  Recruiting · Phase 4 · Interventional · 200 enrolled · University of Arizona
  NCT07280468updated 2026-04-07
• Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome
  Active not recruiting · Phase 2 · Interventional · 36 enrolled · University of Arizona
  NCT05933603updated 2026-04-07
• Atomoxetine and DAW2022 on OSA Severity
  Recruiting · Phase 1 · Phase 2 · Interventional · 18 enrolled · Brigham and Women's Hospital
  NCT05350215updated 2026-03-03
• Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach
  Recruiting · Phase 3 · Interventional · 60 enrolled · Radboud University Medical Center
  NCT07316296updated 2026-02-27
• Atomoxetine and Executive Function in PTSD
  Not yet recruiting · Phase 4 · Interventional · 160 enrolled · VA Office of Research and Development
  NCT06573970updated 2026-02-12

CPIC-curated drug–gene pairs for Atomoxetine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• CYP2D6CPIC AClinPGx 1AFDA label: Actionable PGx
  CYP2D6 and Atomoxetine

Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

• FluoxetineSerotonin Reuptake Inhibitor80%

Frequently asked questions

How does Atomoxetine work?

The precise mechanism by which atomoxetine produces its therapeutic effects in Attention-Deficit/Hyperactivity Disorder (ADHD) is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter, as determined in ex vivo uptake and neurotransmitter depletion studies.

What is Atomoxetine used for?

According to FDA labeling, Atomoxetine carries indications including: Atomoxetine capsule is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1 ) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsule is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Atomoxetine?

Atomoxetine is classified as Centrally acting sympathomimetics, Norepinephrine Reuptake Inhibitor, Monoamine Oxidase Inhibitors, Norepinephrine Uptake Inhibitors, Increased Cerebral Cortex Norepinephrine Activity.

What are the brand names for Atomoxetine?

Atomoxetine is marketed under brand names including Atoncy, Strattera.

What are the contraindications for Atomoxetine?

Atomoxetine labeling lists contraindications including: • Hypersensitivity to atomoxetine or other constituents of product. ( 4.1 ) • Atomoxetine capsules use within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations.. Always consult the full prescribing information and a clinician.