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Strattera

(atomoxetine)

Full Prescribing Information DailyMed Drug Information

Forms/Strengths

  •  Capsules: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg

Dosing

  • Age: ≥ 6
  • Onset: ~ 60 min
  • Considerations: Take the first dose on awakening. Additional doses may be given at intervals of 4-6 hours. 
  • Initial Dose:
    • ≤70 kg: 0.5 mg/kg/day (1 or 2 divided doses)
    • >70 kg: 40 mg daily
  • Titration:
    • ≤70 kg: After at least 3 days at the initial dose, increase to approximately 1.2 mg/kg/day.
    • >70 kg: After at least 3 days at 40 mg/day, increase to 80 mg/day. If no improvement after 2-4 weeks, may increase up to 100 mg/day.
  • Max Dose:
    • ≤70 kg: lesser of 1.4 mg/kg/day or 100 mg/day
    • >70 kg: 100 mg/day

Quick Facts

  • Selective norepinephrine reuptake inhibitor; increases synaptic NE and indirectly boosts dopamine in the prefrontal cortex
  • Non-stimulant ADHD option; improves focus, attention, and impulse control
  • Oral capsule; weight-based, typically once-daily dosing
  • Common side effects: decreased appetite, nausea, dry mouth, fatigue, mood swings
  • Monitor for suicidal ideation in pediatric patients; consider liver function checks

Indications

  •  ADHD (ICD-10: F90.0)

Off-Label Uses

  • Coexisting Anxiety or Tic Disorders: Used off-label in patients with ADHD who may have anxiety or tic disorders, as an alternative to stimulants.
  • Oppositional Defiant Disorder (ODD): May help reduce irritability and impulsiveness when comorbid with ADHD.
  • Autism Spectrum Disorder (ASD)-associated ADHD symptoms: Sometimes considered when stimulants are not tolerated.
  • Substance Use Disorder in ADHD patients: Considered when stimulant misuse is a concern.

How to Take

  • Take once or twice daily, with the first dose in the morning; if a second dose is needed, take it in the late afternoon.
  • Can be taken with or without food; taking with food may help reduce nausea.
  • Swallow the capsule whole; do not crush, chew, or open.
  • If a dose is missed, take it as soon as possible unless it is close to the next dose—do not double up.
  • Do not abruptly stop taking; consult a healthcare provider before discontinuation. 

Side Effects

  •  Common: Somnolence, gastrointestinal symptoms, decreased appetite.
  • Serious: Increased heart rate and blood pressure, suicidal thoughts (black box warning), rare cases of hepatitis

Monitoring / Labs

  • Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
  • Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
  • Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
  • Abuse Potential: Monitor for misuse or diversion.

Education

  • When to Call the Doctor:

    • Severe mood changes, aggression, or suicidal thoughts.
    • Symptoms of liver dysfunction (yellowing of the skin/eyes, dark urine, persistent nausea).
    • Unusual bruising or bleeding.
    • Severe dizziness, fainting, or difficulty urinating.
    • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).

  • Safety Tips:

    • Monitor blood pressure and heart rate, as Strattera may cause increases.
    • Use caution in patients with a history of depression, bipolar disorder, or suicidal thoughts.
    • Avoid alcohol, as it may increase drowsiness and liver toxicity risk.
    • May cause drowsiness; use caution when driving or operating heavy machinery.
    • Tapering may be needed when discontinuing to prevent withdrawal effects.

  • Parent Tips for Pediatric Patients:

    • Monitor for behavioral changes, increased agitation, or suicidal thoughts, particularly in the first few weeks.
    • May cause drowsiness or fatigue—observe how the child responds to the medication.
    • Encourage hydration and balanced meals to minimize side effects.
    • If taken for ADHD, track progress with teachers and caregivers to assess effectiveness.

Additional Information

  • Contraindications:

    • Hypersensitivity to atomoxetine or formulation components.
    • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
    • Severe cardiovascular disease, including history of stroke or arrhythmia.
    • Narrow-angle glaucoma.

  • Pregnancy:

    • Category C; use only if benefits outweigh risks.
    • Limited human data; animal studies suggest potential fetal harm.

  • Lactation:

    • Unknown if excreted in breast milk; use with caution.

  • Drug Interactions:

    • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) may increase atomoxetine levels.
    • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
    • Albuterol and other stimulants may enhance cardiovascular side effects.
    • Antihypertensive medications may lead to excessive blood pressure lowering.

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