{
 "query": "lisdexamfetamine",
 "ingredient": "lisdexamfetamine",
 "slug": "lisdexamfetamine",
 "rxcui": "700810",
 "brands": [
  "Vyvanse",
  "Arynta"
 ],
 "names": [
  "lisdexamfetamine",
  "lisdexamfetamine dimesylate"
 ],
 "classes": [
  {
   "id": "N06BA",
   "name": "Centrally acting sympathomimetics"
  }
 ],
 "alternatives": [
  "amphetamine",
  "armodafinil",
  "atomoxetine",
  "dexmethylphenidate",
  "dextroamphetamine",
  "fenethylline",
  "fenozolone",
  "methamphetamine",
  "methylphenidate",
  "modafinil",
  "pemoline",
  "solriamfetol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 26
  },
  "boxed_warning": "WARNING: ABUSE, MISUSE, AND ADDICTION VYVANSE 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 VYVANSE, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing VYVANSE, 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 VYVANSE 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 Precautions (5.1) , Drug Abuse and Dependence (9.2) ] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. VYVANSE 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 VYVANSE, can result in overdose and death ( 5.1 , 9.2 , 10 ): ...",
  "indications_and_usage": "\u00ae is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1) ]. Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2) ] . VYVANSE is a central nervous system (CNS) stimulant indicated for the treatment of ( 1 ): Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older Moderate to severe binge eating disorder (BED) in adults Limitations of Use : The use of VYVANSE is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.5 , 8.4 ) VYVANSE is not indicated for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of VYVANSE for the treatment of obesity have not been established ( 5.2 ) Limitations of Use: The use of VYVANSE is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a high...",
  "contraindications": "is contraindicated in patients with: Known hypersensitivity to amphetamine products or other ingredients of VYVANSE. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports [see Adverse Reactions (6.2) ] . Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions (5.7) and Drug Interactions (7.1) ] . Known hypersensitivity to amphetamine products or other ingredients in VYVANSE ( 4 ) Use with monoamine oxidase (MAO) inhibitor, or within 14 days of the last MAO inhibitor dose ( 4 , 7.1 )",
  "warnings_and_cautions": "Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease ( 5.2 ) Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. ( 5.3 ) Psychiatric Adverse Reactions: Prior to initiating VYVANSE, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing VYVANSE. ( 5.4 ) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted. ( 5.5 ) Peripheral Vasculopathy, including Raynaud's phenomenon: Careful observation for digital changes is necessary during VYVANSE treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy. ( 5.6 ) Serotonin Syndrome: Increased risk when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during overdosage situati...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in greater detail in other sections of the labeling: Known hypersensitivity to amphetamine products or other ingredients of VYVANSE [see Contraindications (4) ] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4) and Drug Interactions (7.1) ] Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions (5.1) , and Drug Abuse and Dependence (9.2 , 9.3) ] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2) ] Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3) ] Psychiatric Adverse Reactions [see Warnings and Precautions (5.4) ] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.5) ] Peripheral Vasculopathy, including Raynaud's phenomenon [see Warnings and Precautions (5.6) ] Serotonin Syndrome [see Warnings and Precautions (5.7) ] Motor and Verbal Tics, and Worsening of Tourette's Syndrome [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence \u22655% and at a rate at least twice placebo) in pediatric patients ages 6 to 17 years, and/or adults with ADHD were anore...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance VYVANSE contains lisdexamfetamine, a prodrug of amphetamine, a Schedule II controlled substance. 9.2 Abuse VYVANSE has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1) ] . VYVANSE 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 lisdexamfetamine, a prodrug of amphetamine, may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils;...",
  "controlled_substance": "9.1 Controlled Substance VYVANSE contains lisdexamfetamine, a prodrug of amphetamine, a Schedule II controlled substance.",
  "recent_major_changes": "Indications and Usage ( 1 ) 09/2025 Warnings and Precautions ( 5.5 ) 09/2025",
  "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 VYVANSE, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2) , Overdosage (10) ] . Advise patients to store VYVANSE in a safe place, preferably locked, and instruct patients to not give VYVANSE 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 VYVANSE 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 and Precautions (5.2) ] . Increased Blood Pressure and Heart Rate Instruct patients that VYVANSE can cause elevations of their blood pressure and pulse rate and they should be monitored for such effects. Psychiatric Adverse Reactions Advise patients that VYVANSE at recommended doses may cause psychotic or manic sympt...",
  "spl_medguide": "MEDICATION GUIDE VYVANSE \u00ae (Vi \u2013 vans) (lisdexamfetamine dimesylate) capsules and chewable tablets, CII This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 04/2026 What is the most important information I should know about VYVANSE? VYVANSE may cause serious side effects, including: Abuse, misuse, and addiction. VYVANSE has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of VYVANSE, 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 VYVANSE or when it is 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 VYVANSE and will monitor you or your child during treatment. VYVANSE may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give VYVANSE to anyone else. See \" What is VYVANSE? \" for more information. Keep VYVANSE in a safe place and properly dispose of any...",
  "clinical_studies": "14.1 Attention Deficit Hyperactivity Disorder (ADHD) Pediatric Patients Ages 6 to 12 Years with ADHD A double-blind, randomized, placebo-controlled, parallel-group study (Study 1) was conducted in pediatric patients ages 6 to 12 years (N=290) who met DSM-IV criteria for ADHD (either the combined type or the hyperactive-impulsive type). Patients were randomized to receive final doses of 30 mg, 50 mg, or 70 mg of VYVANSE or placebo once daily in the morning for a total of four weeks of treatment. All patients receiving VYVANSE were initiated on 30 mg for the first week of treatment. Patients assigned to the 50 mg and 70 mg dose groups were titrated by 20 mg per week until they achieved their assigned dose. The primary efficacy outcome was change in Total Score from baseline to endpoint in investigator ratings on the ADHD Rating Scale (ADHD-RS), an 18-item questionnaire with a score range of 0-54 points that measures the core symptoms of ADHD which includes both hyperactive/impulsive and inattentive subscales. Endpoint was defined as the last post-randomization treatment week (i.e., Weeks 1 through 4) for which a valid score was obtained. All VYVANSE dose groups were superior to place...",
  "brand_name": "Vyvanse",
  "manufacturer": "Takeda Pharmaceuticals America, Inc.",
  "application_number": "NDA021977",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260430",
  "set_id": "704e4378-ca83-445c-8b45-3cfa51c1ecad",
  "has_boxed_warning": true,
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 30967,
  "serious": 13763,
  "death": 418,
  "hospitalization": 4163,
  "primary_suspect": 30871,
  "top_reactions": [
   [
    "Drug Ineffective",
    4618
   ],
   [
    "Fatigue",
    2033
   ],
   [
    "Anxiety",
    1832
   ],
   [
    "Headache",
    1699
   ],
   [
    "Off Label Use",
    1635
   ],
   [
    "Product Availability Issue",
    1602
   ],
   [
    "Nausea",
    1498
   ],
   [
    "Product Use Issue",
    1372
   ],
   [
    "Depression",
    1300
   ],
   [
    "Feeling Abnormal",
    1268
   ],
   [
    "Insomnia",
    1230
   ],
   [
    "Intentional Overdose",
    1201
   ],
   [
    "No Adverse Event",
    1157
   ],
   [
    "Intentional Self-Injury",
    1154
   ],
   [
    "Disturbance In Attention",
    1148
   ]
  ],
  "by_year": {
   "2019": 2065,
   "2020": 2135,
   "2021": 1940,
   "2022": 2574,
   "2023": 3289,
   "2024": 3568,
   "2025": 3177,
   "2026": 1529
  },
  "by_year_primary": {
   "2019": 2065,
   "2020": 2135,
   "2021": 1936,
   "2022": 2560,
   "2023": 3266,
   "2024": 3550,
   "2025": 3154,
   "2026": 1515
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20251028",
   "reason": "Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25\u00bfC, 60%RH) for Lisdexamfetamine dimesylate capsules.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20251028",
   "reason": "Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25\u00bfC, 60%RH) for Lisdexamfetamine dimesylate capsules.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20251028",
   "reason": "Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25\u00bfC, 60%RH) for Lisdexamfetamine dimesylate capsules.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20251028",
   "reason": "Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25\u00bfC, 60%RH) for Lisdexamfetamine dimesylate capsules.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20251028",
   "reason": "Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25\u00bfC, 60%RH) for Lisdexamfetamine dimesylate capsules.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20251028",
   "reason": "Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25\u00bfC, 60%RH) for Lisdexamfetamine dimesylate capsules.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20251028",
   "reason": "Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25\u00bfC, 60%RH) for Lisdexamfetamine dimesylate capsules.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250616",
   "reason": "Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25\u00bfC, 60%RH).",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20160902",
   "reason": "Presence of Foreign Tablets/Capsules",
   "firm": "Shire",
   "status": "Terminated"
  }
 ],
 "recall_total": 9,
 "drugsfda": {
  "applications": 25,
  "nda": 3,
  "anda": 22,
  "first_approval": "20070223",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 37,
  "labeling_recent": 11,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "ALKEM LABS LTD",
   "AMNEAL",
   "APOTEX",
   "ASCENT PHARMS INC",
   "AZURITY",
   "ELITE LABS INC",
   "GRANULES"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/23/2007"
 },
 "trials": {
  "total": 126,
  "completed": 94,
  "terminated": 20,
  "with_results": 76,
  "industry": 85,
  "phase3": 33,
  "results_share": 0.8085106382978723,
  "terminated_share": 0.15873015873015872
 },
 "pubmed": {
  "rct": 101,
  "meta": 13,
  "recent_rct": 16,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "lisdexamfetamine",
   "Vyvanse",
   "Arynta"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 409947,
  "beneficiaries": 87492,
  "spend": 133327795.50999999,
  "by_brand": [
   {
    "brand": "Vyvanse",
    "claims": 212410,
    "per_claim": 418.19394511,
    "is_generic": false
   },
   {
    "brand": "Lisdexamfetamine Dimesylate",
    "claims": 197537,
    "per_claim": 225.27030192,
    "is_generic": true
   }
  ],
  "per_claim": 325.23178730421245
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 8219,
  "fills": 409947,
  "per_million": 20048.93315477367,
  "ratio": 7.2406272910255955,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 40,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "20,049 FDA reports naming it as the suspect drug per million Medicare fills, 7.2x the median drug on this site (-15)",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death share in reports is near or below the FAERS average (0.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 52,
   "letter": "D",
   "why": [
    "101 randomized trials and 13 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": 81,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 8 Class II, 1 Class III across 22 generic makers (-6)",
    "11 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "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 (22 applications)",
    "12 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 64,
 "grade": "C",
 "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, headache. 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, 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.)"
 ]
}