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Strattera

(atomoxetine)

Strattera (atomoxetine); not controlled

Full Prescribing Information DailyMed Drug Information

Summary

Strattera is a selective norepinephrine reuptake inhibitor supplied as an oral capsule, approved for ADHD in adults and in children from 6 years of age. It is dosed on a milligram-per-kilogram basis and gives continuous, all-day coverage rather than a timed stimulant effect, so it is judged over weeks and not over a school day. It is the option to reach for when a stimulant is not tolerated, when tics or anxiety coexist, or when diversion risk makes a controlled substance unattractive. Not controlled; brand and generic.

Forms & Strengths

  • Capsules: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg
  • Oral solution (separate NDA, Atoncy): 4 mg/mL

Dosing

  • Age: 6 y/o and older, and adults; not established below 6 y/o
  • Onset: weeks to clinical effect, not minutes; not a rescue or as-needed medication
  • Duration: continuous with daily dosing; no afternoon wear-off
  • Initial Dose:
    • Under 70 kg: 0.5 mg/kg/day
    • 70 kg and over, and adults: 40 mg/day
  • Titration:
    • Under 70 kg: after at least 3 days, to a target of 1.2 mg/kg/day; no added benefit above that
    • 70 kg and over, and adults: after at least 3 days, to 80 mg/day; if response is not optimal after 2 to 4 further weeks, may increase to 100 mg/day
    • CYP2D6 poor metabolizers and patients on a strong CYP2D6 inhibitor: titration interval of 4 weeks, not 3 days. Starting, target and maximum doses unchanged
  • Max Dose:
    • Under 70 kg: the lesser of 1.4 mg/kg/day or 100 mg/day
    • 70 kg and over, and adults: 100 mg/day
  • Considerations: Give once daily in the morning, or as two evenly divided doses morning and late afternoon; never more. Reduce to 50% of the usual dose in moderate hepatic impairment and 25% in severe.

Pharmacology

  • Mechanism: Selective norepinephrine reuptake inhibitor; raises synaptic NE and, indirectly, prefrontal dopamine
  • Delivery / Release: Immediate-release capsule, no modified-release component; median Tmax 1 hour, but the therapeutic action accrues over weeks.
  • Metabolism: CYP2D6 to the equipotent 4-hydroxyatomoxetine. Half-life 5.2 hours, 21.6 in poor metabolizers; bioavailability 63%, 94% in poor metabolizers. Protein binding 98%, so dialysis is useless in overdose.
  • Pharmacogenomics: CYP2D6 poor metabolizers (about 7% White, 2% Asian, 2% Black) have higher exposure and 11% discontinuation against 6%. The action is a 4-week titration interval, not a lower ceiling.
  • Class Positioning: No striatal DAT blockade, so no euphoriant properties and no schedule; against Concerta the trade-off is weeks-long onset and a smaller effect size. Qelbree titrates in fixed milligram steps, not by weight.

Indications

  • Attention-Deficit/Hyperactivity Disorder (ICD-10: F90.x): patients 6 y/o and older, and adults, as part of a total treatment program

Off-Label Uses

  • ADHD with a comorbid tic disorder (ICD-10: F90.x with F95.2): did not worsen tics in a randomized trial; non-worsening only. Postmarketing reports of new tics exist.
  • ADHD with a comorbid anxiety disorder (ICD-10: F90.x with F41.x): did not worsen anxiety in randomized trials; supported by controlled trials for non-worsening only.
  • Where the evidence does not support use:
    • Oppositional defiant disorder (ICD-10: F91.3) as a target in itself: limited data, and the drug can itself worsen aggression and hostility. [VERIFY: no graded pediatric strength-of-evidence rating located in AHRQ CER 2024]
    • ADHD in autism spectrum disorder (ICD-10: F84.0 with F90.x): limited data; no atomoxetine-specific grade for this population. (AHRQ 2024)
    • ADHD with substance use disorder (ICD-10: F90.x with F1x.x): limited data

Contraindications & Warnings

  • Boxed Warning: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
    • 0.4% (5 of 1,357) against 0% (0 of 851) on placebo; no suicides
    • Every event occurred in patients 6 to 12 and within the first month
    • Monitor closely at start and at every dose change
  • Contraindicated:
    • Hypersensitivity; anaphylaxis, angioedema, urticaria and rash reported
    • MAOI use, or within 14 days of stopping one
    • Narrow angle glaucoma; increased risk of mydriasis
    • Pheochromocytoma or a history of it
    • Severe cardiac or vascular disease that would deteriorate with a rise of 15 to 20 mm Hg or 20 bpm
  • Use with caution:
    • Structural cardiac abnormality, cardiomyopathy or serious arrhythmia; generally should not be used, sudden death reported
    • Hypertension, tachycardia, cerebrovascular disease, or predisposition to hypotension
    • Bipolar disorder or risk factors; can precipitate mania
    • Existing aggression or hostility, which the drug can worsen
    • Moderate or severe hepatic impairment; exposure rises two- and four-fold, so reduce the dose
    • Urinary retention or hesitancy, and any history of priapism
  • Screen before starting:
    • Personal and family history of bipolar disorder, mania or hypomania
    • Cardiovascular history and exam; ECG or echocardiogram only if either suggests cardiac disease
    • Heart rate, blood pressure, height and weight on a growth chart
    • Routine liver function tests are not recommended before or during treatment

Drug Interactions

  • MAOIs (phenelzine, tranylcypromine, linezolid, IV methylene blue): risk of a fatal hyperthermic reaction; contraindicated. Allow 14 days in either direction
  • Strong CYP2D6 inhibitors (fluoxetine, paroxetine, quinidine, bupropion): exposure rises. Do not lower the target dose; lengthen the titration interval to 4 weeks
  • Antihypertensives and pressor agents (dopamine, dobutamine): blood pressure moves against intent; check it more often and adjust the atomoxetine dose
  • Systemic beta-2 agonists (oral albuterol): potentiated rise in heart rate and blood pressure; check both more often

Administration

  • Once daily in the morning, or two evenly divided doses morning and late afternoon; no additional doses
  • With or without food; food lowers Cmax 37% and delays Tmax about 3 hours, blunting early nausea
  • Swallow the capsule whole. Do not open it; the contents are an ocular irritant
  • Splitting the dose is the usual answer to somnolence or nausea, not a dose reduction
  • For a child who cannot swallow capsules, the Atoncy oral solution is the route, under its own label
  • Missed dose: take it as soon as possible, never exceeding the daily total in 24 hours
  • No taper is required when stopping

Side Effects

  • Common (pediatric acute trials vs placebo):
    • Headache 19 vs 15%, abdominal pain 18 vs 10%, decreased appetite 16 vs 4%
    • Somnolence 11 vs 4%, vomiting 11 vs 6%, nausea 10 vs 5%, fatigue 8 vs 3%
    • Irritability 6 vs 3%, dizziness 5 vs 2%, decreased weight 3 vs 0%
  • Serious:
    • Suicidal thoughts and behavior, the boxed warning
    • Severe liver injury including failure requiring transplant; stop permanently and do not rechallenge
    • Sudden death with structural cardiac abnormality; stop and evaluate for exertional chest pain or syncope
    • Rise in blood pressure and heart rate; recheck after every dose increase
    • New psychotic or manic symptoms without prior history; consider discontinuing
    • Emergence or worsening of aggression or hostility; consider a drug cause
    • Priapism, an erection over 4 hours; ask adolescent males directly
    • Urinary retention or hesitancy
    • Growth lag over the first 9 to 12 months, then recovery; at 3 years, weight +0.5 kg and height -0.4 cm against prediction, pre-pubertal starters -2.1 kg and -1.2 cm

Monitoring & Labs

  • Cardiovascular: heart rate and blood pressure at baseline, after every dose increase, then every 3 months; act on a rise of 15 to 20 mm Hg or 20 bpm. Poor metabolizers rose 9.4 vs 5 bpm
  • Suicidality: screen at every visit for 3 months and at every dose change, then each routine visit
  • Growth: height and weight at baseline, every 3 months for a year, then every 6 months; investigate a sustained drop over one major percentile line
  • Liver: routine testing is not recommended
    • Obtain ALT, AST, bilirubin and INR at the first sign: pruritus, dark urine, jaundice, right upper quadrant tenderness, unexplained flu-like symptoms
    • Discontinue permanently for jaundice, laboratory evidence of injury, or aminotransferases above 5x the upper limit of normal. (LiverTox 2020)
  • Psychiatric: ask about new aggression, agitation and manic or psychotic symptoms at each titration visit and every 3 months
  • Genitourinary: ask about urinary hesitancy each visit and prolonged erection in males every 6 months

Discontinuation & Taper

  • No taper is needed (label 2.8); section 9.3 records no symptom rebound and no discontinuation or withdrawal syndrome
  • Discontinue permanently and do not restart in any patient with jaundice or laboratory evidence of liver injury
  • Drug holidays are not appropriate. The effect accrues over weeks of continuous exposure, so a break resets the clock rather than pausing a daily effect
  • Reevaluate the continued need for treatment periodically and document indication and response

Pregnancy & Lactation

  • Pregnancy: human data insufficient to establish a drug-associated risk. Animal findings include decreased live fetuses and skeletal variants at 3 to 5 times human exposure. Weigh treatment against untreated ADHD.
  • Lactation: no human milk data in the label; published mean milk concentration 12 mcg/L at 80 mg daily, relative infant dose 0.19%, worst case 0.65%. Two infants slept longer than usual. Monitor for sedation. (LactMed 2026)
  • Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, womensmentalhealth.org/adhd-medications

Counseling Points

  • Counsel the family on:

    • Nothing happening in the first week, with the review point set at 4 to 6 weeks at target dose
    • Giving it every day including weekends and holidays; the effect depends on continuous exposure
    • Swallowing the capsule whole and never opening it; the powder irritates the eyes
    • Moving the second dose later, or taking it with food, for nausea or sleepiness
    • Watching daily for new agitation or unusual behaviour in the first month
    • Stopping without a taper being safe, so there is no need to ration a dwindling supply

  • Advise them to call for:

    • New talk of self-harm, or any sudden mood or behaviour change, especially early
    • Yellow skin or eyes, dark urine, right-sided rib pain, itching, or flu-like illness; same-day call
    • Chest pain on exertion, fainting, or a racing heartbeat
    • New aggression, hostility, or behaviour out of character
    • An erection lasting more than 4 hours, painful or not, which is an emergency
    • Difficulty starting to urinate, or inability to urinate

References

  1. DailyMed. Strattera (atomoxetine) capsules prescribing information. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=309de576-c318-404a-bc15-660c2b1876fb
  2. LactMed. Atomoxetine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2026. https://www.ncbi.nlm.nih.gov/books/NBK501732/
  3. LiverTox. Atomoxetine. Clinical and Research Information on Drug-Induced Liver Injury, National Institute of Diabetes and Digestive and Kidney Diseases. 2020. https://www.ncbi.nlm.nih.gov/books/NBK548671/
  4. AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/
  5. FDA. National Drug Code Directory, openFDA. Queried by generic name atomoxetine. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22atomoxetine%22&limit=1000
  6. DailyMed. Atoncy (atomoxetine hydrochloride) oral solution prescribing information. Validus Pharmaceuticals LLC. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72d3d8cf-7f3b-479e-bd9f-e204d4118517
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