pharmacopeia
GET
/api/v1/drug/lisdexamfetamine

Boxed warning

ABUSE, MISUSE, AND ADDICTION Lisdexamfetamine dimesylate 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 lisdexamfetamine dimesylate, 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 lisdexamfetamine dimesylate, 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 lisdexamfetamine dimesylate 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. Lisdexamfetamine dimesylate has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction.

2D structure
(2S)-2,6-diamino-N-[(2S)-1-phenylpropan-2-yl]hexanamide
SMILES C[C@@H](CC1=CC=CC=C1)NC(=O)[C@H](CCCCN)N
InChIKey VOBHXZCDAVEXEY-JSGCOSHPSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Monoamine Oxidase Inhibitors.

Monoamine Oxidase

Indications

Sourced from openFDA
  • Lisdexamfetamine dimesylate capsules are 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) ] . Limitations of Use: Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [see Use in Specific Populations (8.4) ] .ICD-10: F90.9

Contraindications

Sourced from openFDA
  • Lisdexamfetamine dimesylate is contraindicated in patients with: Known hypersensitivity to amphetamine products or other ingredients of Lisdexamfetamine dimesylate capsules. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in post-marketing reports [see Adverse Reactions (6.2) ] .contraindicated

Dosage & administration

Sourced from openFDA

Indicated Population Initial Dose Titration Schedule Recommended Dose Maximum Dose ADHD (Adults and pediatric patients 6 years and older) ( 2.2 ) 30 mg every morning 10 mg or 20 mg weekly 30 mg to 70 mg per day 70 mg per day BED (Adults) ( 2.3 ) 30 mg every morning 20 mg weekly 50 mg to 70 mg per day 70 mg per day Prior to treatment, assess for presence of cardiac disease. ( 2.4 ) Severe renal impairment: Maximum dose is 50 mg/day. ( 2.5 ) End stage renal disease (ESRD): Maximum dose is 30 mg/day. ( 2.5 ) 2.1 Pre-treatment Screening Prior to treating patients with lisdexamfetamine dimesylate capsules, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ] . the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating lisdexamfetamine dimesylate capsules [see Warnings and Precautions (5.8) ] . 2.2 General Administration Information Take lisdexamfetamine dimesylate capsules orally in the morning with or without food; avoid afternoon doses because of the potential for insomnia. Lisdexamfetamine dimesylate capsules may be administered in one of the following ways: Information for lisdexamfetamine dimesylate capsules: Swallow lisdexamfetamine dimesylate capsules whole, or Open capsules, empty and mix the entire contents with yogurt, water, or orange juice. If the contents of the capsule include any compacted powder, a spoon may be used to break apart the powder.

Warnings & precautions

Sourced from openFDA

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 lisdexamfetamine dimesylate capsules, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing lisdexamfetamine dimesylate capsules. ( 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 lisdexamfetamine dimesylate capsules 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 situations. If it occurs, discontinue lisdexamfetamine dimesylate capsules and initiate supportive treatment.

Adverse reactions

Sourced from openFDA

The following adverse reactions are discussed in greater detail in other sections of the labeling: Known hypersensitivity to amphetamine products or other ingredients of lisdexamfetamine dimesylate capsules [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 ≥ 5% and at a rate at least twice placebo) in pediatric patients ages 6 to 17 years, and/or adults with ADHD were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting ( 6.1 ) Most common adverse reactions (incidence ≥ 5% and at a rate at least twice placebo) in adults with BED were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxie…

Use in specific populations

Sourced from openFDA

Pregnancy: May cause fetal harm. (8.1) Lactation: Breastfeeding not recommended. (8.2) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and researchprograms/pregnancyregistry/adhd-medications/. Risk Summary The limited available data from published literature and post-marketing reports on use of lisdexamfetamine dimesylate in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers dependent on amphetamines [see Clinical Considerations] . In animal reproduction studies, lisdexamfetamine dimesylate (a prodrug of d-amphetamine) had no effects on embryo-fetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis. Pre- and postnatal studies were not conducted with lisdexamfetamine dimesylate.

Overdosage

Sourced from openFDA

Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of lisdexamfetamine dimesylate should be considered when treating patients with overdose. Lisdexamfetamine and d-amphetamine are not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

Approval history

Sourced from openFDA
  • Feb 23, 2007NDANDA021977Takeda Pharms Usa
  • Jan 28, 2017NDANDA208510Takeda Pharms Usa
  • Aug 25, 2023ANDAANDA202802Actavis Elizabeth
  • Aug 25, 2023ANDAANDA202827Hikma
  • Aug 25, 2023ANDAANDA202830Amneal
  • Aug 25, 2023ANDAANDA202835Mylan
  • Aug 25, 2023ANDAANDA216944Apotex
  • Jun 16, 2025NDANDA219847Azurity

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0378-6854-77)Active
    Sponsor: Mylan Pharmaceuticals Inc., a Viatris Company
    Updated
  • Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 0378-6855-77)Active
    Sponsor: Mylan Pharmaceuticals Inc., a Viatris Company
    Updated
  • Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 65162-023-09)Active
    Sponsor: Amneal Pharmaceuticals
    Updated
  • Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 0378-6856-77)Active
    Sponsor: Mylan Pharmaceuticals Inc., a Viatris Company
    Updated
  • Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 65162-024-09)Active
    Sponsor: Amneal Pharmaceuticals
    Updated
  • Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 0378-6857-77)Active
    Sponsor: Mylan Pharmaceuticals Inc., a Viatris Company
    Updated
  • Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 65162-025-09)Active
    Sponsor: Amneal Pharmaceuticals
    Updated
  • Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 0378-6858-77)Active
    Sponsor: Mylan Pharmaceuticals Inc., a Viatris Company
    Updated
  • Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 65162-026-09)Active
    Sponsor: Amneal Pharmaceuticals
    Updated
  • Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 0378-6859-77)Active
    Sponsor: Mylan Pharmaceuticals Inc., a Viatris Company
    Updated
  • Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 65162-027-09)Active
    Sponsor: Amneal Pharmaceuticals
    Updated
  • Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 0378-6860-77)Active
    Sponsor: Mylan Pharmaceuticals Inc., a Viatris Company
    Updated
  • Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 65162-028-09)Active
    Sponsor: Amneal Pharmaceuticals
    Updated

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
33,849 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective4,82914%
  2. 2Fatigue2,0876.2%
  3. 3Off Label Use2,0686.1%
  4. 4Anxiety1,8845.6%
  5. 5Headache1,7885.3%
  6. 6Nausea1,5864.7%
  7. 7Product Availability Issue1,5774.7%
  8. 8Insomnia1,5344.5%
  9. 9Depression1,3984.1%
  10. 10Feeling Abnormal1,3854.1%
  11. 11Product Use Issue1,3263.9%
  12. 12Disturbance In Attention1,2623.7%
  13. 13No Adverse Event1,1973.5%
  14. 14Product Quality Issue1,1843.5%
  15. 15Intentional Overdose1,1613.4%

Literature

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Recent PubMed references pinned to Lisdexamfetamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 126 ClinicalTrials.gov registrations naming Lisdexamfetamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Lisdexamfetamine work?
Mechanism-of-action class: Monoamine Oxidase Inhibitors.
What is Lisdexamfetamine used for?
According to FDA labeling, Lisdexamfetamine carries indications including: Lisdexamfetamine dimesylate capsules are 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) ] . Limitations of Use: Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [see Use in Specific Populations (8.4) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Lisdexamfetamine?
Lisdexamfetamine is classified as Centrally acting sympathomimetics, Central Nervous System Stimulant, Monoamine Oxidase Inhibitors, Central Nervous System Stimulation.
What are the brand names for Lisdexamfetamine?
Lisdexamfetamine is marketed under brand names including Arynta, Vyvanse.
What are the contraindications for Lisdexamfetamine?
Lisdexamfetamine labeling lists contraindications including: Lisdexamfetamine dimesylate is contraindicated in patients with: Known hypersensitivity to amphetamine products or other ingredients of Lisdexamfetamine dimesylate capsules. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in post-marketing reports [see Adverse Reactions (6.2) ] .. Always consult the full prescribing information and a clinician.
Note. Data for lisdexamfetamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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