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Atomoxetine

Atofab, Atomoxetin Amarox, Atomoxetin Pharmathen, Atomoxetin Stada · ATC code N06BA09

Also known as: Atomoxetin, atomoksetin · Brand names: Atofab, Atomoxetin Amarox, Atomoxetin Pharmathen, Atomoxetin Stada, Agakalin, Atama, Strattera, Atominex, Attex, Fixatom, Setinox, Atoncy

Key facts
Active substance
Atomoxetine
ATC code
N06BA09
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

Atomoxetine hydrochloride increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of atomoxetine hydrochloride in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Atomoxetine hydrochloride is approved for ADHD in pediatric and adult patients. Atomoxetine hydrochloride is not approved for major depressive disorder.

Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of atomoxetine hydrochloride in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving atomoxetine hydrochloride compared to placebo. The average risk of suicidal ideation in patients receiving atomoxetine hydrochloride was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials [ see Warnings and Precautions ( 5.1 ) ].

Key facts

Atomoxetine is a non-stimulant medicine used to treat attention-deficit/hyperactivity disorder (ADHD) in children, adolescents and adults (US prescribing information).

What it is used for

  • Treatment of ADHD in children aged 6 and older, adolescents and adults

Dosing

  • Children and adolescents up to 70 kg: start at about 0.5 mg/kg/day, increase after at least 3 days to about 1.2 mg/kg/day; not to exceed 1.4 mg/kg or 100 mg, whichever is less
  • Children and adolescents over 70 kg and adults: start at 40 mg/day, increase after at least 3 days to about 80 mg/day; after 2 to 4 more weeks up to a maximum of 100 mg
  • Once in the morning or divided morning and late afternoon/early evening; with or without food, capsules swallowed whole
  • Moderate hepatic impairment (Child-Pugh B): 50% of the normal dose; severe (Child-Pugh C): 25%
  • Adjusted titration with strong CYP2D6 inhibitors or in CYP2D6 poor metabolizers (details in the full text)
  • Can be discontinued without tapering

Contraindications

  • Hypersensitivity to atomoxetine or product constituents
  • Use with an MAOI or within 2 weeks after stopping an MAOI
  • Narrow angle glaucoma
  • Pheochromocytoma or a history of it
  • Severe cardiac or vascular disorders that would deteriorate with increases in blood pressure or heart rate

Important warnings

  • Boxed warning: increased risk of suicidal ideation in children and adolescents (0.4% vs none on placebo); monitor closely for suicidality and behaviour changes
  • Severe liver injury reported postmarketing; discontinue with jaundice or laboratory evidence of liver injury
  • Serious cardiovascular events including sudden death with structural cardiac abnormalities; blood pressure and heart rate may rise
  • About 5 to 10% of patients had potentially clinically important changes in heart rate or blood pressure

Side effects

  • Children/adolescents, most common: nausea, vomiting, fatigue, decreased appetite, abdominal pain, somnolence
  • Adults, most common: constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, urinary hesitation
  • Serious: suicidal ideation, liver injury, cardiovascular events

Interactions

  • MAOIs: serious, sometimes fatal reactions; contraindicated
  • CYP2D6 inhibitors (e.g. paroxetine, fluoxetine, quinidine) markedly increase atomoxetine exposure
  • Use cautiously with antihypertensives and pressor agents (e.g. dopamine, dobutamine); systemic albuterol may potentiate heart rate and blood pressure increases

Pregnancy and breastfeeding

  • Published data are insufficient to establish a drug-associated risk of major birth defects or miscarriage; a pregnancy exposure registry exists
  • No data on presence in human milk; atomoxetine is present in animal milk

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

Patient information (US) →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • AtofabG.L. Pharma Gmbh · 1 register entry
  • Atomoxetin AmaroxAmarox Pharma B.V. · 1 register entry
  • Atomoxetin PharmathenPharmathen S.A. · 1 register entry
  • Atomoxetin StadaStada Arzneimittel Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • AgakalinMedice Arzneimittel Pütter Gmbh & Co. Kg · 2 register entries
  • AtamaPharmathen S.A. · 1 register entry
  • Atomoxetin1 A Pharma Gmbh, Fairmed Healthcare Gmbh, Neuraxpharm Arzneimittel Gmbh, Ratiopharm Gmbh, Glenmark Pharmaceuticals S.R.O., Heumann Pharma Gmbh & Co. Generica Kg, Zentiva Pharma Gmbh, Accord Healthcare B.V., Amarox Pharma Gmbh, Puren Pharma Gmbh & Co. Kg, Betapharm Arzneimittel Gmbh, Aliud Pharma Gmbh · 14 register entries
  • StratteraKohlpharma Gmbh, Lilly Deutschland Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • AtominexSANOFİ SAĞLIK ÜRÜNLERİ LTD. ŞTİ. · 7 register entries
  • AttexABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 8 register entries
  • FixatomCELTİS İLAÇ SAN. VE TİC. A.Ş. · 7 register entries
  • SetinoxALİ RAİF İLAÇ SAN. A.Ş. · 9 register entries
  • StratteraLİLLY İLAÇ TİC. LTD. ŞTİ. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • AtoncyValidus Pharmaceuticals LLC · 1 register entry
  • StratteraEli Lilly and Company · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 22 more European countries
Belgium
Strattera
Bulgaria
Atofab
Croatia
Attoxem
Cyprus
Strattera
Czechia
Atofab, Atominex, Atomoxetin Actavis, Atomoxetin Glenmark, Atomoxetin Sandoz, Atomoxetin Viatris, Atomoxetine Accord, Atomoxetine Amarox, Bitinex
Denmark
Atomoxetin Amarox, Atomoxetin Glenmark, Atomoxetin Medical Valley, Atomoxetin Orion, Atomoxetin Teva, Atomoxetin Viatris, Atomoxetine "sandoz", Atomoxetine Accord, Atomoxetine Stada, Atomoxetine Teva
Estonia
Atominex
Finland
Atomoxetin Amarox, Atomoxetin Orion, Atomoxetine Accord, Atomoxetine Stada
Greece
Atama
Hungary
Atomoxetin Amarox, Bitinex, Strattera
Iceland
Atomoxetin Actavis, Atomoxetin Medical Valley, Atomoxetine
Ireland
Atomoxetine Accord, Atomoxetine Azure, Strattera
Malta
Atomoxetina Generis, Atomoxetine Aurobindo, Atomoxetine Puren
Netherlands
Atofab, Atomoxetine Accord, Atomoxetine Amarox, Atomoxetine Glenmark, Atomoxetine Hydrochloride Aurobindo, Atomoxetine Teva
Norway
Atomoxetin Orion, Atomoxetine Accord, Atomoxetine Amarox, Atomoxetine Medical Valley, Atomoxetine Sandoz, Atomoxetine Teva, Strattera
Poland
Atomoksetyna Medice, Auroxetyn, Kamaptin, Konaten
Portugal
Atomoxetina Generis, Atomoxetina Macleods, Atomoxetina Pentafarma, Atomoxetina Ratiopharm, Strattera
Romania
Atofab, Atomoxetin Accord, Atomoxetină Accord, Atomoxetină Amarox, Atomoxetină Zentiva, Bitinex, Strattera, Zenmet
Slovakia
Atofab, Atominex, Atomoxetine Actavis, Bitinex
Slovenia
Atomoksetin Accord, Strattera
Spain
Atamax, Atomoxetina Aurovitas, Atomoxetina Cinfa, Atomoxetina Macleods, Atomoxetina Tarbis, Strattera
Sweden
Atomoxetin Actavis, Atomoxetin Amarox, Atomoxetin Glenmark, Atomoxetin Medical Valley, Atomoxetin Orion, Atomoxetin Viatris, Atomoxetine Accord, Atomoxetine Sandoz, Atomoxetine Stada

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Atomoxetine (AvKARE) – Prescribing Information, 2026-01-14. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=dc7ba02c-bdbb-5136-e053-2995a90ac545
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.