# Strattera ### (atomoxetine) **[Strattera](https://wiki.joshnp.com/books/drug-library/page/strattera)** (atomoxetine); not controlled
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=309de576-c318-404a-bc15-660c2b1876fb&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=309de576-c318-404a-bc15-660c2b1876fb)
--- ### **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](https://wiki.joshnp.com/link/11) the trade-off is weeks-long onset and a smaller effect size. [Qelbree](https://wiki.joshnp.com/link/36) 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](https://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