CASE FILE CF-ATO-2025
Non-Stimulant
SPECIMEN IDENTIFICATION

atomoxetine hydrochloride

CATEGORY Selective Norepinephrine Reuptake Inhibitor
TARGETS
NOREPINEPHRINE
BRAND (US) Strattera

Mechanism

Selectively inhibits the presynaptic norepinephrine Norepinephrine A neurotransmitter involved in attention, alertness, and the fight-or-flight response. Many ADHD medications increase norepinephrine activity. transporter, increasing norepinephrine Norepinephrine A neurotransmitter involved in attention, alertness, and the fight-or-flight response. Many ADHD medications increase norepinephrine activity. levels in the prefrontal cortex. Unlike stimulant Stimulant A class of drugs that increase activity in the central nervous system. Stimulants are the first-line treatment for ADHD and work by increasing dopamine and norepinephrine. s, does not significantly affect dopamine Dopamine A neurotransmitter that plays a key role in reward, motivation, and attention. ADHD medications often work by increasing dopamine levels in the brain. in the nucleus accumbens, resulting in lower abuse potential.

Chemical Structure

atomoxetine hydrochloride chemical structure
Molecular Formula C17H21NO
SMILES CC1=CC=CC=C1O[C@H](CCNC)C2=CC=CC=C2
PubChem Wikipedia

Drug Identifiers (RxNorm)

RxNorm Ingredient
atomoxetine RxCUI: 38400
Alternative Names
atomoxetine hydrochloride chemical Strattera brand atomoxetine generic
Brand Name Mappings
Strattera
358330 US
Qelbree
2536549 US
Related Drug Forms
atomoxetine 10 MG Oral Capsule SCD clinical drug atomoxetine 18 MG Oral Capsule SCD clinical drug atomoxetine 25 MG Oral Capsule SCD clinical drug atomoxetine 40 MG Oral Capsule SCD clinical drug atomoxetine 60 MG Oral Capsule SCD clinical drug atomoxetine 100 MG Oral Capsule SCD clinical drug atomoxetine 80 MG Oral Capsule SCD clinical drug atomoxetine 10 MG Oral Capsule [Strattera] SBD branded drug
Source: NLM RxNorm

Approvals by Region

Region Agency Year Ages Status
🇺🇸 US FDA 2002 6 years and older Available
🇨🇳 CN NMPA 2007 6 years and older Available
🇪🇺 EU EMA 2004 6 years and older Available
🇯🇵 JP PMDA 2009 6 years and older Available
🇬🇧 UK MHRA 2004 6 years and older Available
🇦🇺 AU TGA 2007 6 years and older Available
🇨🇦 CA Health Canada 2004 6 years and older Available

Prescribing Information

1 Indications and Usage

Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of: - Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older ADHD should be diagnosed according to DSM criteria based upon a complete history and evaluation of the patient. Atomoxetine may be used as part of a comprehensive treatment program that includes other measures (psychological, educational, social).

2 Dosage and Administration

CHILDREN AND ADOLESCENTS UP TO 70 KG: - Initial: 0.5 mg/kg/day - Target dose: Increase after minimum of 3 days to approximately 1.2 mg/kg/day - Maximum: 1.4 mg/kg/day or 100 mg/day, whichever is less - May be given as single daily dose in morning or as evenly divided doses in morning and late afternoon/early evening CHILDREN AND ADOLESCENTS OVER 70 KG AND ADULTS: - Initial: 40 mg/day - Target dose: Increase after minimum of 3 days to approximately 80 mg/day - Maximum: 100 mg/day - May be given as single daily dose in morning or as evenly divided doses HEPATIC IMPAIRMENT: - Moderate (Child-Pugh Class B): Reduce to 50% of normal dose - Severe (Child-Pugh Class C): Reduce to 25% of normal dose STRONG CYP2D6 INHIBITORS: - In patients receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine): Initiate at 0.5 mg/kg/day and only increase to usual target dose if symptoms fail to improve after 4 weeks and initial dose is well tolerated General Instructions: - May be taken with or without food - Capsules should be swallowed whole; do not open capsules - If capsule is accidentally opened, wash hands and any exposed surfaces immediately - Full therapeutic effect may take 4-6 weeks to achieve

3 Dosage Forms and Strengths

Capsules: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg Oral Solution: 4 mg/mL (available in some markets)

4 Contraindications

Atomoxetine is contraindicated in patients with: - Known hypersensitivity to atomoxetine or other constituents of the product - Use of monoamine oxidase inhibitors (MAOIs) concurrently or within 2 weeks of discontinuing atomoxetine - Narrow-angle glaucoma (increased risk of mydriasis) - Pheochromocytoma or history of pheochromocytoma - Severe cardiovascular disorders in which the condition might be expected to deteriorate if clinically significant increases in blood pressure or heart rate occur

5 Warnings and Precautions

SUICIDAL IDEATION (BLACK BOX WARNING): - Increased risk of suicidal ideation in children and adolescents with ADHD - Pooled analyses showed: atomoxetine 0.4% (5/1357 patients) vs placebo 0% (0/851 patients) - All events were suicidal ideation; no suicides occurred - Closely monitor all patients for clinical worsening, suicidality, or unusual changes in behavior, especially during initial months of therapy or dose changes - Families/caregivers should observe patient closely and communicate with prescriber SEVERE LIVER INJURY: - Postmarketing reports of severe liver injury including acute liver failure - Discontinue and do not restart if jaundice or laboratory evidence of liver injury develops - Perform liver tests at first symptom/sign of liver dysfunction SERIOUS CARDIOVASCULAR EVENTS: - Sudden death reported in patients with structural cardiac abnormalities or other serious heart problems - Avoid in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems EFFECTS ON BLOOD PRESSURE AND HEART RATE: - Can cause increased blood pressure and heart rate - Monitor blood pressure and pulse at baseline and periodically during treatment - Use caution in patients with hypertension, tachycardia, or cardiovascular disease PSYCHIATRIC EVENTS: - May cause treatment-emergent psychotic or manic symptoms in patients without prior history - Consider discontinuation if such symptoms occur EFFECTS ON URINARY SYSTEM: - Urinary hesitancy and urinary retention have been reported - Consider atomoxetine as possible cause of urinary retention PRIAPISM: - Rare reports of prolonged penile erections; seek immediate medical attention if occurs GROWTH EFFECTS: - Monitor growth during treatment; treatment interruption may be considered if growth is not as expected

6 Adverse Reactions

Most Common Adverse Reactions in Children and Adolescents (≥5% and greater than placebo): - Dyspepsia - Nausea - Vomiting - Fatigue - Decreased appetite - Dizziness - Mood swings Most Common Adverse Reactions in Adults (≥5% and greater than placebo): - Constipation - Dry mouth - Nausea - Decreased appetite - Dizziness - Erectile dysfunction - Urinary hesitation/retention - Dysmenorrhea - Hot flush - Insomnia - Hyperhidrosis Other Notable Adverse Reactions: - Abdominal pain - Somnolence - Irritability - Weight loss - Increased heart rate - Increased blood pressure

7 Drug Interactions

CONTRAINDICATED: - MAO Inhibitors: Do not use during or within 2 weeks of MAOI treatment. Serious, potentially fatal reactions may occur. USE WITH CAUTION: - Strong CYP2D6 Inhibitors (paroxetine, fluoxetine, quinidine): Increase atomoxetine exposure 6-8 fold; dose adjustment required - Albuterol or other beta2-agonists: Cardiovascular effects may be potentiated; use with caution - Pressor Agents: Because of effects on norepinephrine, use caution with drugs that affect blood pressure - Antihypertensives: Effects may be diminished NO SIGNIFICANT INTERACTIONS: - Methylphenidate: No clinically significant pharmacokinetic interaction - Desipramine: Atomoxetine did not affect desipramine pharmacokinetics in CYP2D6 extensive metabolizers

8 Use in Specific Populations

PREGNANCY: - Category C. No adequate studies in pregnant women. Use only if potential benefit justifies risk to fetus. LACTATION: - Unknown if atomoxetine is excreted in human milk. Caution advised when administering to nursing women. PEDIATRIC USE: - Safety and efficacy established in patients 6 years and older - Not studied in children younger than 6 years - Long-term effects on growth should be monitored GERIATRIC USE: - Safety and efficacy in geriatric patients have not been established HEPATIC IMPAIRMENT: - Moderate impairment (Child-Pugh Class B): Reduce dose to 50% - Severe impairment (Child-Pugh Class C): Reduce dose to 25% CYP2D6 POOR METABOLIZERS: - Approximately 7% of Caucasians and 2% of African Americans are poor metabolizers - These patients have higher plasma concentrations; may need dose adjustment

9 Overdosage

SIGNS AND SYMPTOMS: - Somnolence - Agitation - Hyperactivity - Abnormal behavior - Gastrointestinal symptoms - Tachycardia - Mydriasis - Dry mouth - Prolonged QT interval - Seizures (rarely reported) TREATMENT: - No specific antidote - An airway should be established - Monitor cardiac and vital signs - Provide symptomatic and supportive care - Gastric lavage may be indicated if performed soon after ingestion - Activated charcoal may be useful to limit absorption - Due to high protein binding, dialysis is not likely to be useful

10 Clinical Pharmacology

MECHANISM OF ACTION: The precise mechanism by which atomoxetine produces its therapeutic effects in ADHD is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter. Atomoxetine has minimal affinity for other noradrenergic receptors or for other neurotransmitter transporters or receptors. PHARMACODYNAMICS: - Increases norepinephrine concentrations in the prefrontal cortex - Does not significantly affect dopamine in the nucleus accumbens (unlike stimulants), contributing to its low abuse potential - No significant affinity for dopamine transporter PHARMACOKINETICS: - Absorption: Well absorbed with bioavailability of 63% (extensive metabolizers) to 94% (poor metabolizers) - Peak plasma concentration: 1-2 hours - Distribution: Volume of distribution is 0.85 L/kg; 98% protein bound - Metabolism: Primarily by CYP2D6 to 4-hydroxyatomoxetine; also by CYP2C19 - Half-life: 5 hours (extensive metabolizers); 21 hours (poor metabolizers) - Excretion: Greater than 80% excreted in urine (mainly as 4-hydroxyatomoxetine-O-glucuronide)

11 How Supplied/Storage

STORAGE AND HANDLING: - Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) - Protect from light and moisture - Keep capsules in original container CAPSULE HANDLING: - Atomoxetine is an eye irritant - If capsule contents contact the eye, flush with water immediately and seek medical advice - Wash hands and any surfaces that contact capsule contents Not a Controlled Substance - No DEA Schedule

12 Patient Counseling Information

IMPORTANT PATIENT INFORMATION: 1. SUICIDAL THOUGHTS: Watch for worsening symptoms of depression, suicidal thoughts, or unusual changes in behavior, especially at the start of treatment or when the dose is changed. Report any concerning symptoms immediately. 2. LIVER PROBLEMS: Stop taking and call your doctor immediately if you develop itching, dark urine, yellow skin/eyes, right upper belly pain, or unexplained flu-like symptoms. 3. HEART EFFECTS: Report any chest pain, shortness of breath, or fainting. Your blood pressure and heart rate will be monitored. 4. FULL EFFECT: This medication may take 4-6 weeks to show full benefit. Do not stop taking without consulting your doctor. 5. DOSING: Take as prescribed. May be taken with or without food. Swallow capsules whole - do not open or crush. 6. MISSED DOSE: Take as soon as remembered. If almost time for next dose, skip the missed dose. Never double doses. 7. CAPSULE HANDLING: Avoid contact with eyes. Wash hands immediately if capsule contents are touched. 8. PREGNANCY/NURSING: Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. 9. GROWTH IN CHILDREN: Height and weight will be monitored during treatment. 10. DRUG INTERACTIONS: Tell your doctor about all medications you take, especially MAO inhibitors, as serious interactions can occur.

Travel Information atomoxetine hydrochloride

Atomoxetine is NOT a controlled substance, making international travel significantly easier than with stimulants. However, carry prescription documentation for customs.

Required Documentation

  • Valid prescription Recommended but not strictly required in most countries
Maximum Supply 90 days

Region-Specific Rules

🇺🇸 US
🇯🇵 JP
GO
📦 Limit 90 days
Requirements:
  • Carry prescription copy
  • Keep in original packaging

No special permit required. Atomoxetine is available in Japan and is not a controlled substance.

🇺🇸 US
🇨🇳 CN
GO
📦 Limit 90 days
Requirements:
  • Carry prescription copy
  • Keep in original packaging

Atomoxetine is approved in China. No special import requirements for personal use.

🇺🇸 US
🇪🇺 EU
GO
📦 Limit 90 days
Requirements:
  • Carry prescription copy
  • Keep in original packaging

No special requirements for non-controlled medications. Atomoxetine is widely available in EU.

Use Region Checker Tool

Side Effects

COMMON
  • nausea 20-30%
  • decreased appetite 15-25%
  • fatigue/somnolence 10-20%
  • dry mouth 15-20%
  • headache 15-20%
  • abdominal pain 10-20%
  • vomiting 10-15%
  • constipation 10%
⚠ SERIOUS
  • suicidal ideation Black box warning; monitor closely, especially early in treatment
  • hepatotoxicity Rare but serious; discontinue if jaundice or liver damage signs
  • severe allergic reactions Angioedema, urticaria reported
  • cardiovascular effects Increased heart rate and blood pressure
  • priapism Rare; requires immediate medical attention
! Seek medical attention immediately
Show raw YAML data
ARCHIVE +
FILE: atomoxetine.yaml Last updated: 2025-12-05 
id: atomoxetine
brandNames:
  US:
    - Strattera
  CN:
    - 择思达 (Strattera)
  EU:
    - Strattera
    - Atomoxetine generics
  JP:
    - ストラテラ (Strattera)
  UK:
    - Strattera
  AU:
    - Strattera
  CA:
    - Strattera
genericName:
  en: atomoxetine hydrochloride
  zh: 盐酸托莫西汀
  ja: アトモキセチン塩酸塩
manufacturers:
  - name: Eli Lilly
    region: US
    product: Strattera
  - name: 礼来 (Eli Lilly China)
    region: CN
    product: 择思达
  - name: 日本イーライリリー
    region: JP
    product: ストラテラ
chemicalStructure:
  smiles: CC1=CC=CC=C1O[C@H](CCNC)C2=CC=CC=C2
  pubchemCid: 54841
  molecularFormula: C17H21NO
  imageUrl: https://pubchem.ncbi.nlm.nih.gov/rest/pug/compound/cid/54841/PNG
  wikipediaUrl: https://en.wikipedia.org/wiki/File:Atomoxetine_structure.svg
drugClass: non-stimulant
drugClassLabel:
  en: Non-Stimulant
  zh: 非兴奋剂
  ja: 非中枢刺激薬
category: SNRI
categoryLabel:
  en: Selective Norepinephrine Reuptake Inhibitor
  zh: 选择性去甲肾上腺素再摄取抑制剂
  ja: 選択的ノルエピネフリン再取り込み阻害薬
controlledSubstance: false
schedule:
  US: Not scheduled
  CN: Not scheduled (prescription only)
  EU: Not scheduled
  JP: Not scheduled
  UK: Not scheduled
activeIngredient:
  en: atomoxetine hydrochloride
  zh: 盐酸托莫西汀
  ja: アトモキセチン塩酸塩
mechanismOfAction:
  en: Selectively inhibits the presynaptic norepinephrine transporter, increasing norepinephrine levels in the prefrontal cortex. Unlike stimulants, does not significantly affect dopamine in the nucleus accumbens, resulting in lower abuse potential.
  zh: 选择性抑制突触前去甲肾上腺素转运体，增加前额叶皮层中去甲肾上腺素的水平。与兴奋剂不同，不会显著影响伏隔核中的多巴胺，因此滥用风险较低。
  ja: シナプス前のノルエピネフリントランスポーターを選択的に阻害し、前頭前皮質のノルエピネフリン濃度を上昇させます。刺激薬とは異なり、側坐核のドーパミンに大きな影響を与えないため、乱用の可能性が低くなります。
neurotransmittersAffected:
  - norepinephrine
forms:
  - type: capsule
    typeLabel:
      en: Capsule
      zh: 胶囊
      ja: カプセル
    releaseType: immediate
    releaseTypeLabel:
      en: Immediate Release
      zh: 速释
      ja: 即放性
    brandName: Strattera
    strengths:
      - 10mg
      - 18mg
      - 25mg
      - 40mg
      - 60mg
      - 80mg
      - 100mg
    durationHours: 24
    notes:
      en: Once or twice daily dosing; do not open capsules
      zh: 每日一次或两次给药；请勿打开胶囊
      ja: 1日1回または2回投与；カプセルを開けないでください
  - type: liquid
    typeLabel:
      en: Oral Solution
      zh: 口服溶液
      ja: 内用液
    releaseType: immediate
    releaseTypeLabel:
      en: Immediate Release
      zh: 速释
      ja: 即放性
    brandName: Strattera
    strengths:
      - 4mg/mL
    durationHours: 24
    notes:
      en: Available in US and some markets for those who can't swallow capsules
      zh: 适用于不能吞服胶囊者，在美国和部分市场有售
      ja: カプセルを飲み込めない方のために、米国および一部の市場で入手可能
onsetMinutes:
peakEffectHours: 2
durationHours: 24
sideEffects:
  common:
    - name:
        en: nausea
        zh: 恶心
        ja: 悪心
      frequency: 20-30%
    - name:
        en: decreased appetite
        zh: 食欲下降
        ja: 食欲減退
      frequency: 15-25%
    - name:
        en: fatigue/somnolence
        zh: 疲劳/嗜睡
        ja: 疲労/傾眠
      frequency: 10-20%
    - name:
        en: dry mouth
        zh: 口干
        ja: 口渇
      frequency: 15-20%
    - name:
        en: headache
        zh: 头痛
        ja: 頭痛
      frequency: 15-20%
    - name:
        en: abdominal pain
        zh: 腹痛
        ja: 腹痛
      frequency: 10-20%
    - name:
        en: vomiting
        zh: 呕吐
        ja: 嘔吐
      frequency: 10-15%
    - name:
        en: constipation
        zh: 便秘
        ja: 便秘
      frequency: 10%
  uncommon:
    - name:
        en: dizziness
        zh: 头晕
        ja: めまい
      frequency: 5-10%
    - name:
        en: mood swings
        zh: 情绪波动
        ja: 気分変動
      frequency: 5%
    - name:
        en: insomnia
        zh: 失眠
        ja: 不眠
      frequency: 5%
    - name:
        en: erectile dysfunction (adults)
        zh: 勃起功能障碍（成人）
        ja: 勃起不全（成人）
      frequency: 5-10%
    - name:
        en: urinary retention
        zh: 尿潴留
        ja: 尿閉
      frequency: 5%
  serious:
    - name:
        en: suicidal ideation
        zh: 自杀意念
        ja: 自殺念慮
      notes:
        en: Black box warning; monitor closely, especially early in treatment
        zh: 黑框警告；需密切监测，尤其是治疗初期
        ja: ブラックボックス警告；特に治療初期は注意深くモニタリングが必要
    - name:
        en: hepatotoxicity
        zh: 肝毒性
        ja: 肝毒性
      notes:
        en: Rare but serious; discontinue if jaundice or liver damage signs
        zh: 罕见但严重；如出现黄疸或肝损伤迹象应停药
        ja: まれだが重篤；黄疸や肝障害の兆候があれば中止
    - name:
        en: severe allergic reactions
        zh: 严重过敏反应
        ja: 重度アレルギー反応
      notes:
        en: Angioedema, urticaria reported
        zh: 有血管性水肿、荨麻疹报告
        ja: 血管性浮腫、蕁麻疹の報告あり
    - name:
        en: cardiovascular effects
        zh: 心血管影响
        ja: 心血管への影響
      notes:
        en: Increased heart rate and blood pressure
        zh: 心率和血压升高
        ja: 心拍数と血圧の上昇
    - name:
        en: priapism
        zh: 阴茎异常勃起
        ja: 持続勃起症
      notes:
        en: Rare; requires immediate medical attention
        zh: 罕见；需立即就医
        ja: まれ；直ちに医療処置が必要
contraindications:
  en:
    - Hypersensitivity to atomoxetine
    - MAO inhibitor use within 14 days
    - Narrow-angle glaucoma
    - Pheochromocytoma
    - Severe cardiovascular disorders
  zh:
    - 对托莫西汀过敏
    - 14天内使用过MAO抑制剂
    - 窄角型青光眼
    - 嗜铬细胞瘤
    - 严重心血管疾病
  ja:
    - アトモキセチンに対する過敏症
    - 14日以内のMAO阻害剤使用
    - 閉塞隅角緑内障
    - 褐色細胞腫
    - 重度の心血管疾患
drugInteractions:
  - drug:
      en: MAO inhibitors
      zh: MAO抑制剂
      ja: MAO阻害剤
    severity: major
    effect:
      en: Serious, potentially fatal reactions
      zh: 严重的、可能致命的反应
      ja: 重篤で致命的な可能性のある反応
  - drug:
      en: CYP2D6 inhibitors (fluoxetine, paroxetine)
      zh: CYP2D6抑制剂（氟西汀、帕罗西汀）
      ja: CYP2D6阻害剤（フルオキセチン、パロキセチン）
    severity: moderate
    effect:
      en: Increased atomoxetine levels
      zh: 托莫西汀血药浓度升高
      ja: アトモキセチン濃度の上昇
  - drug:
      en: Albuterol (salbutamol)
      zh: 沙丁胺醇
      ja: サルブタモール
    severity: moderate
    effect:
      en: Enhanced cardiovascular effects
      zh: 心血管作用增强
      ja: 心血管作用の増強
  - drug:
      en: Antihypertensives
      zh: 降压药
      ja: 降圧薬
    severity: moderate
    effect:
      en: May reduce effectiveness
      zh: 可能降低疗效
      ja: 効果を低下させる可能性
blackBoxWarnings:
  en:
    - Increased risk of suicidal ideation in children and adolescents; monitor closely
  zh:
    - 儿童和青少年自杀意念风险增加；需密切监测
  ja:
    - 小児および青年における自殺念慮のリスク増加；注意深くモニタリングが必要
pregnancyCategory: C
foodInteractions:
  en: Can be taken with or without food; food may reduce GI side effects
  zh: 可随餐或空腹服用；进食可减少胃肠道副作用
  ja: 食事の有無にかかわらず服用可能；食事により消化器系副作用が軽減される可能性
typicalDosing:
  children:
    startingDose: 0.5mg/kg/day
    maxDose: 1.4mg/kg/day or 100mg/day
    notes:
      en: Increase to target of 1.2mg/kg/day after 1 week; full effect takes 4-6 weeks
      zh: 1周后增加至目标剂量1.2mg/kg/天；完全起效需4-6周
      ja: 1週間後に1.2mg/kg/日の目標用量に増量；完全な効果発現には4〜6週間
  adults:
    startingDose: 40mg/day
    maxDose: 100mg/day
    notes:
      en: Target dose 80mg/day; can be once daily or divided
      zh: 目标剂量80mg/天；可每日一次或分次服用
      ja: 目標用量80mg/日；1日1回または分割投与可能
costEstimate:
  US:
    brand: $350-400/month
    generic: $50-150/month
  CN:
    brand: ¥400-800/month
    generic: ¥200-400/month
storageRequirements:
  en: Room temperature (25°C), protect from moisture
  zh: 室温保存（25°C），避免潮湿
  ja: 室温（25°C）で保存、湿気を避ける
approvals:
  - region: US
    agency: FDA
    year: 2002
    approvedAges:
      en: 6 years and older
      zh: 6岁及以上
      ja: 6歳以上
    indications:
      en:
        - ADHD
      zh:
        - 注意缺陷多动障碍
      ja:
        - ADHD
    available: true
    notes:
      en: First non-stimulant approved for ADHD
      zh: 首个获批用于ADHD的非兴奋剂药物
      ja: ADHDに承認された最初の非刺激薬
  - region: CN
    agency: NMPA
    year: 2007
    approvedAges:
      en: 6 years and older
      zh: 6岁及以上
      ja: 6歳以上
    indications:
      en:
        - ADHD
      zh:
        - 注意缺陷多动障碍
      ja:
        - ADHD
    available: true
    notes:
      en: Brand capsules discontinued Jan 2024; oral solution and domestic generics available
      zh: 品牌胶囊2024年1月停产；口服溶液和国产仿制药可用
      ja: ブランドカプセルは2024年1月に販売終了；経口液と国内ジェネリックが利用可能
  - region: EU
    agency: EMA
    year: 2004
    approvedAges:
      en: 6 years and older
      zh: 6岁及以上
      ja: 6歳以上
    indications:
      en:
        - ADHD
      zh:
        - 注意缺陷多动障碍
      ja:
        - ADHD
    available: true
    notes:
      en: Approved for children and adults
      zh: 适用于儿童和成人
      ja: 小児および成人に承認
  - region: JP
    agency: PMDA
    year: 2009
    approvedAges:
      en: 6 years and older
      zh: 6岁及以上
      ja: 6歳以上
    indications:
      en:
        - ADHD
      zh:
        - 注意缺陷多动障碍
      ja:
        - ADHD
    available: true
    notes:
      en: No registration requirement (unlike stimulants)
      zh: 无需登记（与兴奋剂不同）
      ja: 登録要件なし（刺激薬とは異なる）
  - region: UK
    agency: MHRA
    year: 2004
    approvedAges:
      en: 6 years and older
      zh: 6岁及以上
      ja: 6歳以上
    indications:
      en:
        - ADHD
      zh:
        - 注意缺陷多动障碍
      ja:
        - ADHD
    available: true
    notes:
      en: ""
      zh: ""
      ja: ""
  - region: AU
    agency: TGA
    year: 2007
    approvedAges:
      en: 6 years and older
      zh: 6岁及以上
      ja: 6歳以上
    indications:
      en:
        - ADHD
      zh:
        - 注意缺陷多动障碍
      ja:
        - ADHD
    available: true
    notes:
      en: ""
      zh: ""
      ja: ""
  - region: CA
    agency: Health Canada
    year: 2004
    approvedAges:
      en: 6 years and older
      zh: 6岁及以上
      ja: 6歳以上
    indications:
      en:
        - ADHD
      zh:
        - 注意缺陷多动障碍
      ja:
        - ADHD
    available: true
    notes:
      en: ""
      zh: ""
      ja: ""
specialConsiderations:
  cardiacRisk:
    en: Can increase heart rate and blood pressure; use caution in cardiovascular disease
    zh: 可升高心率和血压；心血管疾病患者需谨慎使用
    ja: 心拍数と血圧を上昇させる可能性；心血管疾患には注意
  abuseRisk:
    en: No abuse potential; not a controlled substance
    zh: 无滥用风险；非管制药物
    ja: 乱用の可能性なし；規制物質ではない
  withdrawalNotes:
    en: No withdrawal symptoms; can be stopped without tapering
    zh: 无戒断症状；可直接停药无需减量
    ja: 離脱症状なし；漸減なしで中止可能
  monitoringRequired:
    en: Blood pressure, heart rate, liver function if symptoms; mood/suicidality in youth
    zh: 血压、心率；如有症状监测肝功能；青少年需监测情绪/自杀倾向
    ja: 血圧、心拍数、症状があれば肝機能；若年者では気分/自殺傾向
travelRules:
  generalAdvice:
    en: Atomoxetine is NOT a controlled substance, making international travel significantly easier than with stimulants. However, carry prescription documentation for customs.
    zh: 托莫西汀不是管制药物，国际旅行比兴奋剂容易得多。但仍建议携带处方文件以备海关检查。
    ja: アトモキセチンは規制物質ではないため、刺激薬よりも国際旅行がかなり容易です。ただし、税関用に処方書類を携帯してください。
  requiredDocumentation:
    - type: prescription
      typeLabel:
        en: Valid prescription
        zh: 有效处方
        ja: 有効な処方箋
      notes:
        en: Recommended but not strictly required in most countries
        zh: 建议携带但大多数国家不严格要求
        ja: 推奨されるが、ほとんどの国では厳密には必要ない
  maxPersonalSupply:
    default: 90 days
  crossBorderRules:
    - fromRegion: US
      toRegion: JP
      status: allowed
      statusLabel:
        en: Allowed
        zh: 允许
        ja: 許可
      requirements:
        en:
          - Carry prescription copy
          - Keep in original packaging
        zh:
          - 携带处方副本
          - 保持原包装
        ja:
          - 処方箋のコピーを携帯
          - 元のパッケージを維持
      maxSupply: 90 days
      notes:
        en: No special permit required. Atomoxetine is available in Japan and is not a controlled substance.
        zh: 无需特别许可。托莫西汀在日本可用且不是管制药物。
        ja: 特別な許可は不要です。アトモキセチンは日本で入手可能で、規制物質ではありません。
    - fromRegion: US
      toRegion: CN
      status: allowed
      statusLabel:
        en: Allowed
        zh: 允许
        ja: 許可
      requirements:
        en:
          - Carry prescription copy
          - Keep in original packaging
        zh:
          - 携带处方副本
          - 保持原包装
        ja:
          - 処方箋のコピーを携帯
          - 元のパッケージを維持
      maxSupply: 90 days
      notes:
        en: Atomoxetine is approved in China. No special import requirements for personal use.
        zh: 托莫西汀在中国已获批。个人使用无特殊进口要求。
        ja: アトモキセチンは中国で承認されています。個人使用に特別な輸入要件はありません。
    - fromRegion: US
      toRegion: EU
      status: allowed
      statusLabel:
        en: Allowed
        zh: 允许
        ja: 許可
      requirements:
        en:
          - Carry prescription copy
          - Keep in original packaging
        zh:
          - 携带处方副本
          - 保持原包装
        ja:
          - 処方箋のコピーを携帯
          - 元のパッケージを維持
      maxSupply: 90 days
      notes:
        en: No special requirements for non-controlled medications. Atomoxetine is widely available in EU.
        zh: 非管制药物无特殊要求。托莫西汀在欧盟广泛可用。
        ja: 非規制薬物には特別な要件はありません。アトモキセチンはEUで広く入手可能です。
rxnormData:
  ingredientRxcui: "38400"
  ingredientName: atomoxetine
  rxcuiMappings:
    - rxcui: "38400"
      name: atomoxetine
      tty: IN
      description: Base ingredient
    - rxcui: "358330"
      name: Strattera
      tty: BN
      description: Brand name
    - rxcui: "353103"
      name: atomoxetine hydrochloride
      tty: PIN
      description: Precise ingredient (includes salt form)
    - rxcui: "352317"
      name: atomoxetine 10 MG Oral Capsule [Strattera]
      tty: SBD
      description: Branded drug (brand + strength + form)
    - rxcui: "352318"
      name: atomoxetine 18 MG Oral Capsule [Strattera]
      tty: SBD
      description: Branded drug (brand + strength + form)
    - rxcui: "352319"
      name: atomoxetine 25 MG Oral Capsule [Strattera]
      tty: SBD
      description: Branded drug (brand + strength + form)
    - rxcui: "352320"
      name: atomoxetine 40 MG Oral Capsule [Strattera]
      tty: SBD
      description: Branded drug (brand + strength + form)
    - rxcui: "352321"
      name: atomoxetine 60 MG Oral Capsule [Strattera]
      tty: SBD
      description: Branded drug (brand + strength + form)
    - rxcui: "617945"
      name: atomoxetine 100 MG Oral Capsule [Strattera]
      tty: SBD
      description: Branded drug (brand + strength + form)
    - rxcui: "617947"
      name: atomoxetine 80 MG Oral Capsule [Strattera]
      tty: SBD
      description: Branded drug (brand + strength + form)
    - rxcui: "366499"
      name: atomoxetine Oral Capsule [Strattera]
      tty: SBDF
      description: Branded ingredient + dose form
    - rxcui: "349591"
      name: atomoxetine 10 MG Oral Capsule
      tty: SCD
      description: Clinical drug (ingredient + strength + form)
    - rxcui: "349592"
      name: atomoxetine 18 MG Oral Capsule
      tty: SCD
      description: Clinical drug (ingredient + strength + form)
    - rxcui: "349593"
      name: atomoxetine 25 MG Oral Capsule
      tty: SCD
      description: Clinical drug (ingredient + strength + form)
    - rxcui: "349594"
      name: atomoxetine 40 MG Oral Capsule
      tty: SCD
      description: Clinical drug (ingredient + strength + form)
    - rxcui: "349595"
      name: atomoxetine 60 MG Oral Capsule
      tty: SCD
      description: Clinical drug (ingredient + strength + form)
    - rxcui: "608139"
      name: atomoxetine 100 MG Oral Capsule
      tty: SCD
      description: Clinical drug (ingredient + strength + form)
    - rxcui: "608143"
      name: atomoxetine 80 MG Oral Capsule
      tty: SCD
      description: Clinical drug (ingredient + strength + form)
    - rxcui: "378308"
      name: atomoxetine Oral Capsule
      tty: SCDF
      description: Ingredient + dose form
  brandMappings:
    - brandName: Strattera
      rxcui: "358330"
      region: US
    - brandName: Qelbree
      rxcui: "2536549"
      region: US
  synonyms:
    - name: atomoxetine hydrochloride
      type: chemical
      source: RxNorm
    - name: Strattera
      type: brand
      source: RxNorm
    - name: atomoxetine
      type: generic
      source: RxNorm
  relatedDrugs:
    - rxcui: "349591"
      name: atomoxetine 10 MG Oral Capsule
      tty: SCD
      relationship: clinical_drug
    - rxcui: "349592"
      name: atomoxetine 18 MG Oral Capsule
      tty: SCD
      relationship: clinical_drug
    - rxcui: "349593"
      name: atomoxetine 25 MG Oral Capsule
      tty: SCD
      relationship: clinical_drug
    - rxcui: "349594"
      name: atomoxetine 40 MG Oral Capsule
      tty: SCD
      relationship: clinical_drug
    - rxcui: "349595"
      name: atomoxetine 60 MG Oral Capsule
      tty: SCD
      relationship: clinical_drug
    - rxcui: "608139"
      name: atomoxetine 100 MG Oral Capsule
      tty: SCD
      relationship: clinical_drug
    - rxcui: "608143"
      name: atomoxetine 80 MG Oral Capsule
      tty: SCD
      relationship: clinical_drug
    - rxcui: "352317"
      name: atomoxetine 10 MG Oral Capsule [Strattera]
      tty: SBD
      relationship: branded_drug
    - rxcui: "352318"
      name: atomoxetine 18 MG Oral Capsule [Strattera]
      tty: SBD
      relationship: branded_drug
    - rxcui: "352319"
      name: atomoxetine 25 MG Oral Capsule [Strattera]
      tty: SBD
      relationship: branded_drug
    - rxcui: "352320"
      name: atomoxetine 40 MG Oral Capsule [Strattera]
      tty: SBD
      relationship: branded_drug
    - rxcui: "352321"
      name: atomoxetine 60 MG Oral Capsule [Strattera]
      tty: SBD
      relationship: branded_drug
    - rxcui: "617945"
      name: atomoxetine 100 MG Oral Capsule [Strattera]
      tty: SBD
      relationship: branded_drug
    - rxcui: "617947"
      name: atomoxetine 80 MG Oral Capsule [Strattera]
      tty: SBD
      relationship: branded_drug
    - rxcui: "378308"
      name: atomoxetine Oral Capsule
      tty: SCDF
      relationship: drug_form
  lastUpdated: 2025-12-04
instructions:
  indicationsAndUsage:
    en: |
      Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of:
      - Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older

      ADHD should be diagnosed according to DSM criteria based upon a complete history and evaluation of the patient. Atomoxetine may be used as part of a comprehensive treatment program that includes other measures (psychological, educational, social).
  dosageAndAdministration:
    en: |
      CHILDREN AND ADOLESCENTS UP TO 70 KG:
      - Initial: 0.5 mg/kg/day
      - Target dose: Increase after minimum of 3 days to approximately 1.2 mg/kg/day
      - Maximum: 1.4 mg/kg/day or 100 mg/day, whichever is less
      - May be given as single daily dose in morning or as evenly divided doses in morning and late afternoon/early evening

      CHILDREN AND ADOLESCENTS OVER 70 KG AND ADULTS:
      - Initial: 40 mg/day
      - Target dose: Increase after minimum of 3 days to approximately 80 mg/day
      - Maximum: 100 mg/day
      - May be given as single daily dose in morning or as evenly divided doses

      HEPATIC IMPAIRMENT:
      - Moderate (Child-Pugh Class B): Reduce to 50% of normal dose
      - Severe (Child-Pugh Class C): Reduce to 25% of normal dose

      STRONG CYP2D6 INHIBITORS:
      - In patients receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine): Initiate at 0.5 mg/kg/day and only increase to usual target dose if symptoms fail to improve after 4 weeks and initial dose is well tolerated

      General Instructions:
      - May be taken with or without food
      - Capsules should be swallowed whole; do not open capsules
      - If capsule is accidentally opened, wash hands and any exposed surfaces immediately
      - Full therapeutic effect may take 4-6 weeks to achieve
  dosageForms:
    en: |
      Capsules: 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg
      Oral Solution: 4 mg/mL (available in some markets)
  contraindications:
    en: |
      Atomoxetine is contraindicated in patients with:
      - Known hypersensitivity to atomoxetine or other constituents of the product
      - Use of monoamine oxidase inhibitors (MAOIs) concurrently or within 2 weeks of discontinuing atomoxetine
      - Narrow-angle glaucoma (increased risk of mydriasis)
      - Pheochromocytoma or history of pheochromocytoma
      - Severe cardiovascular disorders in which the condition might be expected to deteriorate if clinically significant increases in blood pressure or heart rate occur
  warningsAndPrecautions:
    en: |
      SUICIDAL IDEATION (BLACK BOX WARNING):
      - Increased risk of suicidal ideation in children and adolescents with ADHD
      - Pooled analyses showed: atomoxetine 0.4% (5/1357 patients) vs placebo 0% (0/851 patients)
      - All events were suicidal ideation; no suicides occurred
      - Closely monitor all patients for clinical worsening, suicidality, or unusual changes in behavior, especially during initial months of therapy or dose changes
      - Families/caregivers should observe patient closely and communicate with prescriber

      SEVERE LIVER INJURY:
      - Postmarketing reports of severe liver injury including acute liver failure
      - Discontinue and do not restart if jaundice or laboratory evidence of liver injury develops
      - Perform liver tests at first symptom/sign of liver dysfunction

      SERIOUS CARDIOVASCULAR EVENTS:
      - Sudden death reported in patients with structural cardiac abnormalities or other serious heart problems
      - Avoid in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems

      EFFECTS ON BLOOD PRESSURE AND HEART RATE:
      - Can cause increased blood pressure and heart rate
      - Monitor blood pressure and pulse at baseline and periodically during treatment
      - Use caution in patients with hypertension, tachycardia, or cardiovascular disease

      PSYCHIATRIC EVENTS:
      - May cause treatment-emergent psychotic or manic symptoms in patients without prior history
      - Consider discontinuation if such symptoms occur

      EFFECTS ON URINARY SYSTEM:
      - Urinary hesitancy and urinary retention have been reported
      - Consider atomoxetine as possible cause of urinary retention

      PRIAPISM:
      - Rare reports of prolonged penile erections; seek immediate medical attention if occurs

      GROWTH EFFECTS:
      - Monitor growth during treatment; treatment interruption may be considered if growth is not as expected
  adverseReactions:
    en: |
      Most Common Adverse Reactions in Children and Adolescents (≥5% and greater than placebo):
      - Dyspepsia
      - Nausea
      - Vomiting
      - Fatigue
      - Decreased appetite
      - Dizziness
      - Mood swings

      Most Common Adverse Reactions in Adults (≥5% and greater than placebo):
      - Constipation
      - Dry mouth
      - Nausea
      - Decreased appetite
      - Dizziness
      - Erectile dysfunction
      - Urinary hesitation/retention
      - Dysmenorrhea
      - Hot flush
      - Insomnia
      - Hyperhidrosis

      Other Notable Adverse Reactions:
      - Abdominal pain
      - Somnolence
      - Irritability
      - Weight loss
      - Increased heart rate
      - Increased blood pressure
  drugInteractions:
    en: |
      CONTRAINDICATED:
      - MAO Inhibitors: Do not use during or within 2 weeks of MAOI treatment. Serious, potentially fatal reactions may occur.

      USE WITH CAUTION:
      - Strong CYP2D6 Inhibitors (paroxetine, fluoxetine, quinidine): Increase atomoxetine exposure 6-8 fold; dose adjustment required
      - Albuterol or other beta2-agonists: Cardiovascular effects may be potentiated; use with caution
      - Pressor Agents: Because of effects on norepinephrine, use caution with drugs that affect blood pressure
      - Antihypertensives: Effects may be diminished

      NO SIGNIFICANT INTERACTIONS:
      - Methylphenidate: No clinically significant pharmacokinetic interaction
      - Desipramine: Atomoxetine did not affect desipramine pharmacokinetics in CYP2D6 extensive metabolizers
  useInSpecificPopulations:
    en: |
      PREGNANCY:
      - Category C. No adequate studies in pregnant women. Use only if potential benefit justifies risk to fetus.

      LACTATION:
      - Unknown if atomoxetine is excreted in human milk. Caution advised when administering to nursing women.

      PEDIATRIC USE:
      - Safety and efficacy established in patients 6 years and older
      - Not studied in children younger than 6 years
      - Long-term effects on growth should be monitored

      GERIATRIC USE:
      - Safety and efficacy in geriatric patients have not been established

      HEPATIC IMPAIRMENT:
      - Moderate impairment (Child-Pugh Class B): Reduce dose to 50%
      - Severe impairment (Child-Pugh Class C): Reduce dose to 25%

      CYP2D6 POOR METABOLIZERS:
      - Approximately 7% of Caucasians and 2% of African Americans are poor metabolizers
      - These patients have higher plasma concentrations; may need dose adjustment
  overdosage:
    en: |
      SIGNS AND SYMPTOMS:
      - Somnolence
      - Agitation
      - Hyperactivity
      - Abnormal behavior
      - Gastrointestinal symptoms
      - Tachycardia
      - Mydriasis
      - Dry mouth
      - Prolonged QT interval
      - Seizures (rarely reported)

      TREATMENT:
      - No specific antidote
      - An airway should be established
      - Monitor cardiac and vital signs
      - Provide symptomatic and supportive care
      - Gastric lavage may be indicated if performed soon after ingestion
      - Activated charcoal may be useful to limit absorption
      - Due to high protein binding, dialysis is not likely to be useful
  clinicalPharmacology:
    en: |
      MECHANISM OF ACTION:
      The precise mechanism by which atomoxetine produces its therapeutic effects in ADHD is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter. Atomoxetine has minimal affinity for other noradrenergic receptors or for other neurotransmitter transporters or receptors.

      PHARMACODYNAMICS:
      - Increases norepinephrine concentrations in the prefrontal cortex
      - Does not significantly affect dopamine in the nucleus accumbens (unlike stimulants), contributing to its low abuse potential
      - No significant affinity for dopamine transporter

      PHARMACOKINETICS:
      - Absorption: Well absorbed with bioavailability of 63% (extensive metabolizers) to 94% (poor metabolizers)
      - Peak plasma concentration: 1-2 hours
      - Distribution: Volume of distribution is 0.85 L/kg; 98% protein bound
      - Metabolism: Primarily by CYP2D6 to 4-hydroxyatomoxetine; also by CYP2C19
      - Half-life: 5 hours (extensive metabolizers); 21 hours (poor metabolizers)
      - Excretion: Greater than 80% excreted in urine (mainly as 4-hydroxyatomoxetine-O-glucuronide)
  howSupplied:
    en: |
      STORAGE AND HANDLING:
      - Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
      - Protect from light and moisture
      - Keep capsules in original container

      CAPSULE HANDLING:
      - Atomoxetine is an eye irritant
      - If capsule contents contact the eye, flush with water immediately and seek medical advice
      - Wash hands and any surfaces that contact capsule contents

      Not a Controlled Substance - No DEA Schedule
  patientCounselingInfo:
    en: |
      IMPORTANT PATIENT INFORMATION:

      1. SUICIDAL THOUGHTS: Watch for worsening symptoms of depression, suicidal thoughts, or unusual changes in behavior, especially at the start of treatment or when the dose is changed. Report any concerning symptoms immediately.

      2. LIVER PROBLEMS: Stop taking and call your doctor immediately if you develop itching, dark urine, yellow skin/eyes, right upper belly pain, or unexplained flu-like symptoms.

      3. HEART EFFECTS: Report any chest pain, shortness of breath, or fainting. Your blood pressure and heart rate will be monitored.

      4. FULL EFFECT: This medication may take 4-6 weeks to show full benefit. Do not stop taking without consulting your doctor.

      5. DOSING: Take as prescribed. May be taken with or without food. Swallow capsules whole - do not open or crush.

      6. MISSED DOSE: Take as soon as remembered. If almost time for next dose, skip the missed dose. Never double doses.

      7. CAPSULE HANDLING: Avoid contact with eyes. Wash hands immediately if capsule contents are touched.

      8. PREGNANCY/NURSING: Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

      9. GROWTH IN CHILDREN: Height and weight will be monitored during treatment.

      10. DRUG INTERACTIONS: Tell your doctor about all medications you take, especially MAO inhibitors, as serious interactions can occur.
lastUpdated: 2025-12-04
sources:
  - https://www.goodrx.com/conditions/adhd/non-stimulant-adhd-meds
  - https://zhuanlan.zhihu.com/p/702636281
  - https://www.gelonghui.com/p/713050
  - https://h-navi.jp/column/article/35028853
notes:
  en: First non-stimulant ADHD medication. Good option for those who can't tolerate stimulants or have substance abuse history. Takes 4-6 weeks for full effect (not immediate like stimulants). Eli Lilly discontinued capsule supply to China in Jan 2024 but domestic generics available.
  zh: 首个非兴奋剂ADHD药物。适合不能耐受兴奋剂或有药物滥用史的患者。完全起效需4-6周（不像兴奋剂那样立即起效）。礼来于2024年1月停止向中国供应胶囊剂型，但国产仿制药可用。
  ja: 最初の非刺激性ADHD薬。刺激薬に耐えられない人や薬物乱用歴のある人に適しています。完全な効果発現には4〜6週間かかります（刺激薬のような即効性はありません）。イーライリリーは2024年1月に中国へのカプセル供給を終了しましたが、国内ジェネリックは入手可能です。
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