{
 "query": "atomoxetine",
 "ingredient": "atomoxetine",
 "slug": "atomoxetine",
 "rxcui": "38400",
 "brands": [
  "Strattera",
  "Atoncy"
 ],
 "names": [
  "atomoxetine",
  "atomoxetine hydrochloride"
 ],
 "classes": [
  {
   "id": "N06BA",
   "name": "Centrally acting sympathomimetics"
  }
 ],
 "alternatives": [
  "amphetamine",
  "armodafinil",
  "dexmethylphenidate",
  "dextroamphetamine",
  "fenethylline",
  "fenozolone",
  "lisdexamfetamine",
  "methamphetamine",
  "methylphenidate",
  "modafinil",
  "pemoline",
  "solriamfetol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 47
  },
  "boxed_warning": "WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER All STRATTERA-treated pediatric patients 6 years of age or older should be monitored and observed closely for suicidal thoughts and behavior, clinical worsening, or unusual changes in behavior, especially during the initial months of therapy or at times of dosage changes. Families and caregivers should be advised of the need for close observation and communication with the health care provider. Consider stopping STRATTERA in patients who experience emergent suicidal thoughts and behavior [see Warnings and Precautions ( 5.1 )]. STRATTERA increased the risk of suicidal ideation in pediatric patients aged 6 years of age and older with attention-deficit/hyperactivity disorder (ADHD) in short-term studies. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER See full prescribing information for complete boxed warning. All STRATTERA-treated pediatric patients 6 years of age or older should be monitored and observed closely for suicidal thoughts and behavior, clinical worsening, or unusual changes in behavior, especially during the initial months of therapy or at time...",
  "indications_and_usage": "is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD. STRATTERA \u00ae is a selective norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older. ( 1 )",
  "contraindications": "is contraindicated in patients: With known hypersensitivity reaction to atomoxetine or other constituents of STRATTERA. Hypersensitivity reactions included anaphylaxis, angioneurotic edema, urticaria, and rash [see Warnings and Precautions ( 5.8 )] . Taking, or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) [see Drug Interactions ( 7 )] . With narrow angle glaucoma. In clinical trials, STRATTERA use was associated with an increased risk of mydriasis. With pheochromocytoma or a history of pheochromocytoma. Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received STRATTERA. With severe cardiac or vascular disorders whose condition would be expected to deteriorate if they had a clinically important increase in blood pressure or heart rate (e.g., 15 to 20 mm Hg in blood pressure or 20 beats per minute in heart rate) [see Warnings and Precautions ( 5.4 )] . Contraindicated in patients ( 4 ): With known hypersensitivity to atomoxetine or other constituents of STRATTERA Taking or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) With narrow a...",
  "warnings_and_cautions": "Severe Liver Injury: STRATTERA should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. ( 5.2 ) Serious Cardiovascular Reactions: Prior to STRATTERA treatment, patients should have a careful history and physical exam to assess for presence of cardiovascular (CV) disease. STRATTERA generally should not be used in pediatric patients with known serious cardiac abnormalities, cardiomyopathy, serious arrhythmias. Consideration should be given to not using STRATTERA in adults with clinically significant cardiac abnormalities. Patients who develop symptoms suggestive of cardiac disease during STRATTERA treatment should stop STRATTERA and undergo a prompt cardiac evaluation. ( 5.3 ) Increase in Blood Pressure and Heart Rate: Heart rate and blood pressure should be measured at baseline, following STRATTERA dosage increase, and periodically while on therapy. ( 5.4 ) New Psychotic or Manic Symptoms and Activation of Mania: If psychotic or manic symptoms occur, consider discontinuing STRATTERA. ( 5.5 ) Aggressive Behavior or Hostility: Monitor for the appearance or worsening of aggressive behavior or hostility. ( 5.7 ) Effects on Urine Outflow:...",
  "warnings": "",
  "adverse_reactions": "Most common adverse reactions (\u22655% and at least twice the incidence of placebo patients): Pediatric Clinical Studies: Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. ( 6.1 ) Adult Clinical Studies: Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. ( 6.1 ) Patients should be instructed to use caution when driving a car or operating hazardous machinery (because of somnolence) until they are reasonably certain that their performance is not affected by STRATTERA. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. STRATTERA was administered to 5,382 pediatric patients 6 years of age and older in clinical ADHD studies (Studies 1, 2, 3, 4, and 5) [see Clinical Studies ( 14.1 )] and 1,007 adults in clin...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance STRATTERA contains atomoxetine which is not a controlled substance. 9.2 Abuse In a randomized, double-blind, placebo-controlled, abuse-potential study in adults that compared effects of STRATTERA and placebo, STRATTERA was not associated with stimulant or euphoriant properties. Clinical study data in over 2,000 adults and pediatric patients with ADHD and over 1,200 adults with depression (STRATTERA is not indicated for the treatment of depression) showed only isolated incidents of inappropriate STRATTERA self-administration. Drug discrimination studies in rats and monkeys showed inconsistent stimulus generalization between atomoxetine and cocaine. 9.3 Dependence After STRATTERA discontinuation, there was no evidence of symptom rebound or adverse reactions suggesting a STRATTERA-discontinuation or withdrawal syndrome.",
  "controlled_substance": "9.1 Controlled Substance STRATTERA contains atomoxetine which is not a controlled substance.",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Suicide Risk Patients, their families, and their caregivers should be alerted about the need to monitor patients daily for the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, depression, and suicidal ideation, especially early during STRATTERA treatment and when the dosage is adjusted. Such symptoms should be reported to the patient's health care provider immediately [see Warnings and Precautions ( 5.1 )] . Severe Liver Injury Patients initiating STRATTERA should be cautioned that severe liver injury may develop. Patients should be instructed to contact their healthcare provider immediately should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained \u201cflu-like\u201d symptoms [see Warnings and Precautions ( 5.2 )] . Serious Cardiovascular Reactions Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during STRATTERA treatment should stop S...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 06/2026 STR-0002-MG-20260629 MEDICATION GUIDE STRATTERA\u00ae (Stra-TAIR-a) (atomoxetine) capsules for oral use What is the most important information I should know about STRATTERA? STRATTERA can cause serious side effects, including: Suicidal thoughts and actions in children 6 years of age and older. STRATTERA can increase the risk of suicidal thoughts and actions in children ages 6 and older with attention deficit hyperactivity disorder (ADHD), especially within the first few months of treatment or when the dose is changed. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to, and tell your healthcare provider right away about, any changes, especially sudden changes, in mood, behavior, actions, thoughts, or feelings, or suicidal thoughts or actions. This is very important when STRATTERA is started or when the dose is changed. Keep all follow-up visits with the healthcare provider as scheduled. Tell your healthcare provider about symptoms between visits as needed, especially if you have concerns. Tell your healthcare provider right away if any of the follow...",
  "clinical_studies": "14.1 ADHD Studies in Pediatric Patients 6 Years of Age and Older Acute Studies in Pediatric Patients 6 Years of Age and Older with ADHD: The effectiveness of STRATTERA in the treatment of ADHD was established in four randomized, double-blind, placebo-controlled studies of pediatric patients 6 to 18 years of age (Studies 1, 2, 3, and 4). In these studies, approximately one-third of the patients met DSM-IV criteria for inattentive subtype and two-thirds met criteria for both inattentive and hyperactive/impulsive subtypes. In these studies, signs and symptoms of ADHD were evaluated with the investigator administered and scored ADHD Rating Scale-IV-Parent Version (ADHDRS) total score including hyperactive/impulsive and inattentive subscales by comparing the mean change from baseline to endpoint in the STRATTERA and placebo groups using an intent-to-treat (ITT) analysis (the primary endpoint). Each item on the ADHDRS maps directly to one symptom criterion for ADHD in the DSM-IV. In Study 1, an 8-week randomized, double-blind, placebo-controlled, dose-response, acute treatment study, pediatric patients 8 to 18 years of age (N=297) received either a fixed dosage of STRATTERA (0.25, 0.6, o...",
  "brand_name": "Strattera",
  "manufacturer": "Eli Lilly and Company",
  "application_number": "NDA021411",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260630",
  "set_id": "309de576-c318-404a-bc15-660c2b1876fb",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 14103,
  "serious": 7214,
  "death": 2023,
  "hospitalization": 3146,
  "primary_suspect": 14040,
  "top_reactions": [
   [
    "Drug Ineffective",
    1849
   ],
   [
    "Off Label Use",
    1662
   ],
   [
    "Nausea",
    1329
   ],
   [
    "Fatigue",
    1219
   ],
   [
    "Vomiting",
    1144
   ],
   [
    "Headache",
    1136
   ],
   [
    "Dizziness",
    1053
   ],
   [
    "Pain",
    1041
   ],
   [
    "Abdominal Pain Upper",
    999
   ],
   [
    "Depression",
    994
   ],
   [
    "Condition Aggravated",
    965
   ],
   [
    "Insomnia",
    923
   ],
   [
    "Confusional State",
    898
   ],
   [
    "Hypoaesthesia",
    896
   ],
   [
    "Abdominal Discomfort",
    866
   ]
  ],
  "by_year": {
   "2019": 667,
   "2020": 616,
   "2021": 579,
   "2022": 615,
   "2023": 810,
   "2024": 1252,
   "2025": 1800,
   "2026": 677
  },
  "by_year_primary": {
   "2019": 666,
   "2020": 616,
   "2021": 575,
   "2022": 599,
   "2023": 788,
   "2024": 1240,
   "2025": 1796,
   "2026": 674
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260430",
   "reason": "Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.",
   "firm": "Safecor Health, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250129",
   "reason": "CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250129",
   "reason": "CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250129",
   "reason": "CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250129",
   "reason": "CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250129",
   "reason": "CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250129",
   "reason": "CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250129",
   "reason": "CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 13,
  "nda": 2,
  "anda": 9,
  "first_approval": "20021126",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 29,
  "labeling_recent": 2,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "APOTEX",
   "AUROBINDO PHARMA",
   "DR REDDYS",
   "GLENMARK PHARMS LTD",
   "HETERO LABS LTD V",
   "LILLY",
   "MAP77"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/26/2002"
 },
 "trials": {
  "total": 224,
  "completed": 170,
  "terminated": 16,
  "with_results": 82,
  "industry": 103,
  "phase3": 41,
  "results_share": 0.4823529411764706,
  "terminated_share": 0.07142857142857142
 },
 "pubmed": {
  "rct": 222,
  "meta": 43,
  "recent_rct": 27,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "atomoxetine",
   "Strattera",
   "Atoncy"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 327499,
  "beneficiaries": 66144,
  "spend": 33905335.01,
  "by_brand": [
   {
    "brand": "Atomoxetine HCl",
    "claims": 325761,
    "per_claim": 99.900938418,
    "is_generic": true
   },
   {
    "brand": "Strattera",
    "claims": 1738,
    "per_claim": 783.37480437,
    "is_generic": false
   }
  ],
  "per_claim": 103.52805660475299
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3710,
  "fills": 327499,
  "per_million": 11328.278864973634,
  "ratio": 4.091182532101295,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 53,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "11,328 FDA reports naming it as the suspect drug per million Medicare fills, 4.1x the median drug on this site (-12)",
    "Death appears in 1.6x the FAERS average share of reports (within the margin this measure deserves)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 57,
   "letter": "D",
   "why": [
    "222 randomized trials and 43 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 48% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 84,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 8 Class II, 0 Class III (-12)",
    "2 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (9 applications)",
    "12 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 70,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are nausea, fatigue. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over amphetamine, armodafinil, dexmethylphenidate? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}