{
 "query": "dextroamphetamine",
 "ingredient": "dextroamphetamine",
 "slug": "dextroamphetamine",
 "rxcui": "3288",
 "brands": [
  "Zenzedi",
  "Xelstrym",
  "Dexedrine",
  "ProCentra"
 ],
 "names": [
  "dextroamphetamine",
  "dextroamphetamine saccharate",
  "dextroamphetamine sulfate"
 ],
 "classes": [
  {
   "id": "N06BA",
   "name": "Centrally acting sympathomimetics"
  }
 ],
 "alternatives": [
  "amphetamine",
  "armodafinil",
  "atomoxetine",
  "dexmethylphenidate",
  "fenethylline",
  "fenozolone",
  "lisdexamfetamine",
  "methamphetamine",
  "methylphenidate",
  "modafinil",
  "pemoline",
  "solriamfetol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 73,
   "TRANSDERMAL": 1
  },
  "boxed_warning": "WARNING: ABUSE, MISUSE, AND ADDICTION Dextroamphetamine sulfate has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including dextroamphetamine sulfate, can result in overdose and death (see OVERDOSAGE ), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing dextroamphetamine sulfate, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout dextroamphetamine sulfate treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction (see WARNINGS and DRUG ABUSE and DEPENDENCE ).",
  "indications_and_usage": "INDICATIONS AND USAGE Dextroamphetamine sulfate tablets, USP are indicated for: Narcolepsy. Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.",
  "contraindications": "CONTRAINDICATIONS Known hypersensitivity to amphetamine products. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Abuse, Misuse, and Addiction Dextroamphetamine sulfate has a high potential for abuse and misuse. The use of dextroamphetamine sulfate exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Amphetamine sulfate can be diverted for non-medical use into illicit channels or distribution (see DRUG ABUSE and DEPENDENCE ). Misuse and abuse of CNS stimulants, including dextroamphetamine sulfate, can result in overdose and death (see OVERDOSAGE ), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing dextroamphetamine sulfate, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store amphetamine sulfate in a safe place, preferably locked, and instruct patients to not give dextroamphetamine sulfate to anyone else. Throughout dextroamphetamine sulfate treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. Ri...",
  "adverse_reactions": "ADVERSE REACTIONS Cardiovascular Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and verbal tics and Tourette's syndrome. Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia, and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects. Allergic Urticaria. Endocrine Impotence, changes in libido, frequent or prolonged erections. Musculoskeletal Rhabdomyolysis.",
  "drug_abuse_and_dependence": "DRUG ABUSE AND DEPENDENCE Dextroamphetamine sulfate tablets are a Schedule II controlled substance. Abuse Dextroamphetamine sulfate has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see WARNINGS ). Dextroamphetamine sulfate can be diverted for non-medical use into illicit channels or distribution. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Misuse and abuse of amphetamines may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decr...",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Advise the patient to read the FDA-approved patient labeling (Medication Guide). Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of dextroamphetamine sulfate, which can lead to overdose and death, and proper disposal of any unused drug (see WARNINGS , DRUG ABUSE AND DEPENDENCE , and OVERDOSAGE ). Advise patients to store dextroamphetamine sulfate in a safe place, preferably locked, and instruct patients to not give dextroamphetamine sulfate to anyone else. Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with dextroamphetamine sulfate use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease (see WARNINGS ). Increased Blood Pressure and Heart Rate Advise patients that dextroamphetamine sulfate can elevate blood pressure and heart rate (see WARNINGS ). Psychiatric Adverse Reactions Advise patients that dextroamphetamine sulfate, at recommended doses, ca...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration. MEDICATION GUIDE Dextroamphetamine Sulfate Tablets, USP CII (dex\" troe am fet\u00b4 a meen sul\u00b4 fate) What is the most important information I should know about dextroamphetamine sulfate tablets? Dextroamphetamine sulfate tablets may cause serious side effects, including: Abuse, misuse, and addiction. Dextroamphetamine sulfate tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of dextroamphetamine sulfate tablets, other-amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of dextroamphetamine sulfate tablets or when they are used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child's risk for abuse, misuse, and addiction before starting treatment with dextroamphetamine sulfate tablets and will monitor you or your child during treatment. Dextroamphetamine sulfate tablets may lead to physical dependence after prolonged use, even if taken as directed by you...",
  "clinical_studies": "",
  "brand_name": "Dextroamphetamine Sulfate",
  "manufacturer": "Bryant Ranch Prepack",
  "application_number": "ANDA090533",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250826",
  "set_id": "54b122b0-2ec8-43c9-86e8-a3538a83c776",
  "has_boxed_warning": true,
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 7814,
  "serious": 4051,
  "death": 225,
  "hospitalization": 1220,
  "primary_suspect": 7790,
  "top_reactions": [
   [
    "Drug Ineffective",
    959
   ],
   [
    "Fatigue",
    617
   ],
   [
    "Anxiety",
    500
   ],
   [
    "Nausea",
    495
   ],
   [
    "Headache",
    447
   ],
   [
    "Depression",
    415
   ],
   [
    "Off Label Use",
    372
   ],
   [
    "Feeling Abnormal",
    340
   ],
   [
    "Insomnia",
    323
   ],
   [
    "Somnolence",
    323
   ],
   [
    "Pain",
    300
   ],
   [
    "Product Dose Omission Issue",
    298
   ],
   [
    "Dizziness",
    280
   ],
   [
    "Weight Decreased",
    259
   ],
   [
    "Condition Aggravated",
    258
   ]
  ],
  "by_year": {
   "2019": 663,
   "2020": 660,
   "2021": 483,
   "2022": 573,
   "2023": 597,
   "2024": 689,
   "2025": 558,
   "2026": 266
  },
  "by_year_primary": {
   "2019": 663,
   "2020": 660,
   "2021": 483,
   "2022": 566,
   "2023": 593,
   "2024": 680,
   "2025": 558,
   "2026": 263
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20241031",
   "reason": "Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).",
   "firm": "Noven Pharmaceuticals Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class I",
   "date": "20240104",
   "reason": "Labeling: Label Mix-up",
   "firm": "Azurity Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140501",
   "reason": "Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 41,
  "nda": 2,
  "anda": 30,
  "first_approval": "19750529",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 37,
  "labeling_recent": 8,
  "sponsors": [
   "ABLE",
   "ACTAVIS ELIZABETH",
   "ANI PHARMS",
   "AUROLIFE PHARMA LLC",
   "AVANTHI INC",
   "AZURITY",
   "BARR",
   "EPIC PHARMA LLC"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/29/1975"
 },
 "trials": {
  "total": 202,
  "completed": 147,
  "terminated": 31,
  "with_results": 96,
  "industry": 94,
  "phase3": 36,
  "results_share": 0.6530612244897959,
  "terminated_share": 0.15346534653465346
 },
 "pubmed": {
  "rct": 66,
  "meta": 0,
  "recent_rct": 5,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 507929.54,
  "records": 10825,
  "by_name": [
   [
    "Xelstrym",
    507929.54
   ]
  ],
  "names_checked": [
   "dextroamphetamine",
   "Zenzedi",
   "Xelstrym",
   "Dexedrine",
   "ProCentra"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 97310,
  "beneficiaries": 15800,
  "spend": 10377228.670000002,
  "by_brand": [
   {
    "brand": "Dextroamphetamine Sulfate",
    "claims": 57362,
    "per_claim": 82.408821694,
    "is_generic": true
   },
   {
    "brand": "Dextroamphetamine Sulfate ER",
    "claims": 38715,
    "per_claim": 120.37512308,
    "is_generic": false
   },
   {
    "brand": "Zenzedi",
    "claims": 562,
    "per_claim": 499.29211744,
    "is_generic": false
   },
   {
    "brand": "Xelstrym",
    "claims": 417,
    "per_claim": 479.4781295,
    "is_generic": false
   },
   {
    "brand": "Dexedrine",
    "claims": 254,
    "per_claim": 2004.8283465,
    "is_generic": false
   }
  ],
  "per_claim": 106.64092765388965
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 50,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death share in reports is near or below the FAERS average (0.3x)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 33,
   "letter": "F",
   "why": [
    "66 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 74,
   "letter": "C",
   "why": [
    "Recalls since 2016: 1 Class I, 1 Class II, 0 Class III across 30 generic makers (-18)",
    "8 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $507,930 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (30 applications)",
    "12 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 60,
 "grade": "D",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "This is a controlled substance. What is the plan for how long I take it and how I stop?",
  "The most-reported problems in FDA's adverse event data are fatigue, anxiety, nausea. How would we recognize and handle those?",
  "Why this one over amphetamine, armodafinil, atomoxetine? 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.)"
 ]
}