U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C15H25N3O
Molecular Weight 263.3791
Optical Activity UNSPECIFIED
Defined Stereocenters 2 / 2
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of LISDEXAMFETAMINE

SMILES

C[C@@]([H])(Cc1ccccc1)N=C([C@]([H])(CCCCN)N)O

InChI

InChIKey=VOBHXZCDAVEXEY-JSGCOSHPSA-N
InChI=1S/C15H25N3O/c1-12(11-13-7-3-2-4-8-13)18-15(19)14(17)9-5-6-10-16/h2-4,7-8,12,14H,5-6,9-11,16-17H2,1H3,(H,18,19)/t12-,14-/m0/s1

HIDE SMILES / InChI
Molecular Formula C15H25N3O
Molecular Weight 263.3791
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 2 / 2
E/Z Centers 0
Optical Activity UNSPECIFIED

Description
Curator's Comment:: description was created based on several sources, including: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021977lbl.pdf | https://www.drugs.com/ppa/lisdexamfetamine.html | https://www.ncbi.nlm.nih.gov/pubmed/27125257

Lisdexamfetamine (LDX) is a d-amphetamine (d-AMPH) pro-drug used to treat Attention Deficit and Hyperactivity Disorder (ADHD) and Binge Eating Disorder (BED). After oral administration, lisdexamfetamine dimesylate is rapidly absorbed from the gastrointestinal tract and converted to dextroamphetamine, which is responsible for the drug’s activity. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. Most common adverse reactions in children, adolescents and/or adults with ADHD were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting. Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents decrease amphetamine blood levels, while alkalinizing agents increase amphetamine blood levels. Needs to adjust Lisdexamfetamine dosage accordingly.

CNS Activity

Originator

New River Pharmaceuticals
2
Curator's Comment:: New River Pharmaceuticals was bought by Shire Pharmaceuticals

Approval Year

2007
178
Targets

Targets

Primary TargetPharmacologyConditionPotency
Modulator
780
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Approved
8043
VYVANSE

Approved Use

VYVANSE® is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14.1)

Launch Date

1.17218882E12
Primary
Approved
8043
VYVANSE

Approved Use

VYVANSE® is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14.1)

Launch Date

1.17218882E12
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
47.9 ng/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/18021493/
70 mg 1 times / day multiple, oral
dose: 70 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
LISDEXAMFETAMINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
60.7 ng × h/mL
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/18021493/
70 mg 1 times / day multiple, oral
dose: 70 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
LISDEXAMFETAMINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
12 h
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/18021493/
70 mg 1 times / day multiple, oral
dose: 70 mg
route of administration: Oral
experiment type: MULTIPLE
co-administered:
LISDEXAMFETAMINE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: FASTED
Doses

Doses

DosePopulationAdverse events​
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 13 - 17
n = 233
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 13 - 17
Sex: M+F
Population Size: 233
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Disc. AE: Irritability, Decreased appetite...
AEs leading to
discontinuation/dose reduction:
Irritability (1.3%)
Decreased appetite (0.86%)
Insomnia (0.86%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
Disc. AE: Delirium, Tachycardia...
AEs leading to
discontinuation/dose reduction:
Delirium (acute)
Tachycardia
Hypertension
Tachypnea
Creatine kinase increased (mild)
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Disc. AE: Insomnia, Tachycardia...
AEs leading to
discontinuation/dose reduction:
Insomnia (2%)
Tachycardia (1%)
Irritability (1%)
Hypertension (1%)
Headache (1%)
Anxiety (1%)
Dyspnea (1%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 6 - 12
n = 218
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 6 - 12
Sex: M+F
Population Size: 218
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Disc. AE: Ventricular hypertrophy, Tic...
AEs leading to
discontinuation/dose reduction:
Ventricular hypertrophy (1%)
Tic (1%)
Vomiting (1%)
Psychomotor hyperactivity (1%)
Insomnia (1%)
Rash (1%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
Other AEs: Decreased appetite, Insomnia...
Other AEs:
Decreased appetite (below serious, 29 patients)
Insomnia (below serious, 7 patients)
Weight decreased (below serious, 3 patients)
Irritability (below serious, 6 patients)
Fatigue (below serious, 4 patients)
Nasopharyngitis (below serious, 2 patients)
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
20 mg single, oral
Dose: 20 mg
Route: oral
Route: single
Dose: 20 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Other AEs: Nausea...
Other AEs:
Nausea (below serious, 1 patient)
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
50 mg single, oral
Dose: 50 mg
Route: oral
Route: single
Dose: 50 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Other AEs: Headache, Nausea...
Other AEs:
Headache (below serious, 4 patients)
Nausea (below serious, 1 patient)
Vomiting (below serious, 2 patients)
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
70 mg single, oral
Dose: 70 mg
Route: oral
Route: single
Dose: 70 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Other AEs: Headache, Nausea...
Other AEs:
Headache (below serious, 2 patients)
Nausea (below serious, 2 patients)
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Other AEs: Diarrhea, Dry mouth...
Other AEs:
Diarrhea (below serious, 6 patients)
Dry mouth (below serious, 25 patients)
Fatigue (below serious, 6 patients)
Feeling jittery (below serious, 10 patients)
Irritability (below serious, 8 patients)
Upper respiratory tract infection (below serious, 5 patients)
Heart rate increased (below serious, 4 patients)
Weight decreased (below serious, 8 patients)
Anorexia (below serious, 4 patients)
Decreased appetite (below serious, 26 patients)
Headache (below serious, 20 patients)
Initial insomnia (below serious, 8 patients)
Insomnia (below serious, 10 patients)
Libido decreased (below serious, 4 patients)
Hyperhidrosis (below serious, 5 patients)
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Disc. AE: Abuse, Dependence...
AEs leading to
discontinuation/dose reduction:
Abuse
Dependence
Cardiovascular disorder (NOS) (grade 3-5)
Stroke (serious)
Myocardial infarction (serious)
Blood pressure increased
Heart rate increased
Psychiatric symptom NOS
Psychotic symptom
Manic symptom
Growth suppression
Vascular disorders
Raynaud's phenomenon
Serotonin syndrome
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Other AEs: Decreased appetite, Dry mouth...
Other AEs:
Decreased appetite (below serious, 8 patients)
Dry mouth (below serious, 7 patients)
Insomnia (below serious, 10 patients)
Irritability (below serious, 3 patients)
Diaphoresis (below serious, 2 patients)
Libido decreased (below serious, 2 patients)
Tinnitus (below serious, 2 patients)
Muscle tension (below serious, 4 patients)
Tachycardia (below serious, 3 patients)
Paresthesia (below serious, 2 patients)
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
AEs

AEs

AESignificanceDosePopulation
Decreased appetite 0.86%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 13 - 17
n = 233
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 13 - 17
Sex: M+F
Population Size: 233
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Insomnia 0.86%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 13 - 17
n = 233
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 13 - 17
Sex: M+F
Population Size: 233
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Irritability 1.3%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 13 - 17
n = 233
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 13 - 17
Sex: M+F
Population Size: 233
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Hypertension Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
Tachycardia Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
Tachypnea Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
Delirium acute
Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
Creatine kinase increased mild
Disc. AE
1200 mg single, oral
Overdose
Dose: 1200 mg
Route: oral
Route: single
Dose: 1200 mg
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
healthy, 17
n = 1
Health Status: healthy
Age Group: 17
Sex: F
Population Size: 1
Sources:
https://pubmed.ncbi.nlm.nih.gov/30730334
Page: e771
Anxiety 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Dyspnea 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Headache 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Hypertension 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Irritability 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Tachycardia 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Insomnia 2%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 18 - 55
n = 358
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 18 - 55
Sex: M+F
Population Size: 358
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Insomnia 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 6 - 12
n = 218
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 6 - 12
Sex: M+F
Population Size: 218
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Psychomotor hyperactivity 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 6 - 12
n = 218
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 6 - 12
Sex: M+F
Population Size: 218
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Rash 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 6 - 12
n = 218
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 6 - 12
Sex: M+F
Population Size: 218
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Tic 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 6 - 12
n = 218
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 6 - 12
Sex: M+F
Population Size: 218
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Ventricular hypertrophy 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 6 - 12
n = 218
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 6 - 12
Sex: M+F
Population Size: 218
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Vomiting 1%
Disc. AE
70 mg 1 times / day multiple, oral (max)
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
unhealthy, 6 - 12
n = 218
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder
Age Group: 6 - 12
Sex: M+F
Population Size: 218
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.8
Nasopharyngitis below serious, 2 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
Decreased appetite below serious, 29 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
Weight decreased below serious, 3 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
Fatigue below serious, 4 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
Irritability below serious, 6 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
Insomnia below serious, 7 patients
30 mg 1 times / day steady, oral
Dose: 30 mg, 1 times / day
Route: oral
Route: steady
Dose: 30 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
unhealthy, adolescents
n = 78
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adolescents
Population Size: 78
Sources:
https://clinicaltrials.gov/ct2/show/NCT00735371
Nausea below serious, 1 patient
20 mg single, oral
Dose: 20 mg
Route: oral
Route: single
Dose: 20 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Nausea below serious, 1 patient
50 mg single, oral
Dose: 50 mg
Route: oral
Route: single
Dose: 50 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Vomiting below serious, 2 patients
50 mg single, oral
Dose: 50 mg
Route: oral
Route: single
Dose: 50 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Headache below serious, 4 patients
50 mg single, oral
Dose: 50 mg
Route: oral
Route: single
Dose: 50 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Headache below serious, 2 patients
70 mg single, oral
Dose: 70 mg
Route: oral
Route: single
Dose: 70 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Nausea below serious, 2 patients
70 mg single, oral
Dose: 70 mg
Route: oral
Route: single
Dose: 70 mg
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
healthy, adult
n = 27
Health Status: healthy
Condition: Acute Sleep Loss
Age Group: adult
Sex: M
Population Size: 27
Sources:
https://clinicaltrials.gov/ct2/show/NCT01096680
Feeling jittery below serious, 10 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Insomnia below serious, 10 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Headache below serious, 20 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Dry mouth below serious, 25 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Decreased appetite below serious, 26 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Anorexia below serious, 4 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Heart rate increased below serious, 4 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Libido decreased below serious, 4 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Hyperhidrosis below serious, 5 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Upper respiratory tract infection below serious, 5 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Diarrhea below serious, 6 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Fatigue below serious, 6 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Initial insomnia below serious, 8 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Irritability below serious, 8 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Weight decreased below serious, 8 patients
70 mg 1 times / day steady, oral (max)
Dose: 70 mg, 1 times / day
Route: oral
Route: steady
Dose: 70 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
unhealthy, adult
n = 79
Health Status: unhealthy
Condition: Attention-Deficit/Hyperactivity Disorder
Age Group: adult
Population Size: 79
Sources:
https://clinicaltrials.gov/ct2/show/NCT01101022
Abuse Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Blood pressure increased Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Dependence Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Growth suppression Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Heart rate increased Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Manic symptom Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Psychiatric symptom NOS Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Psychotic symptom Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Raynaud's phenomenon Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Serotonin syndrome Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Vascular disorders Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Cardiovascular disorder (NOS) grade 3-5
Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Myocardial infarction serious
Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Stroke serious
Disc. AE
70 mg 1 times / day multiple, oral
Recommended
Dose: 70 mg, 1 times / day
Route: oral
Route: multiple
Dose: 70 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
unhealthy
Health Status: unhealthy
Condition: Attention Deficit Hyperactivity Disorder|Binge Eating Disorder
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf
Page: p.1
Insomnia below serious, 10 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Diaphoresis below serious, 2 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Libido decreased below serious, 2 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Paresthesia below serious, 2 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Tinnitus below serious, 2 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Irritability below serious, 3 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Tachycardia below serious, 3 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Muscle tension below serious, 4 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Dry mouth below serious, 7 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Decreased appetite below serious, 8 patients
50 mg 1 times / day steady, oral (max)
Dose: 50 mg, 1 times / day
Route: oral
Route: steady
Dose: 50 mg, 1 times / day
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
unhealthy
n = 28
Health Status: unhealthy
Condition: Major Depressive Disorder
Population Size: 28
Sources:
https://clinicaltrials.gov/ct2/show/NCT01148979
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
inhibitor
1467
inhibitor
1604
inhibitor
1702

OverviewOther

Other InhibitorOther SubstrateOther Inducer
CYP1A2
1383

CYP2A6
627

CYP2B6
717

CYP2C19
1325
CYP
236
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
CYP2C19
1392
 no [Inhibition 87.3 uM]
CYP2C9
1648
 no [Inhibition 89 uM]
CYP2D6
1738
 no [Inhibition 90 uM]
CYP2B6
884
 no [Inhibition 90.8 uM]
CYP3A4
1772
 no [Inhibition 92.1 uM]
CYP2A6
659
 no [Inhibition 92.5 uM]
CYP1A2
1532
 no [Inhibition 94.2 uM]
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
CYP
236
 no
Sourcing

Sourcing

Vendor/AggregatorIDURL
1PlusChem LLC
1P00E9T8
Alfa Chemistry
ACM608137333
Angene
AGN-PC-0WH4QC
Cayman Chemical
18050
ChemMol
44007218
http://www.chemmol.com/chemmol/44007218.html
Compound Cloud
11597697
Compound Cloud
11597698
MolPort
MolPort-046-693-343
Sigma Aldrich
L-026
Sigma Aldrich
L-026|CERILLIAN
THE BioTek
bt-386638
https://www.thebiotek.com/product/others/bt-386638
Toronto Research Chemicals
KIT2550
Toronto Research Chemicals
L468880
Toronto Research Chemicals
L468885
ZINC
ZINC000011680943
http://zinc15.docking.org/substances/ZINC000011680943
iChemical
EBD10545
http://www.ichemical.com/chemicals/cas-608137-33-3
mcule
MCULE-1818516035
mcule
MCULE-7002483605
PubMed

PubMed

TitleDatePubMed
Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study.
2007 Nov 1
Multiple daily-dose pharmacokinetics of lisdexamfetamine dimesylate in healthy adult volunteers.
2008 Jan
Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder.
2008 Sep
Lisdexamfetamine dimesylate: in attention-deficit hyperactivity disorder in adults.
2009
An update on central nervous system stimulant formulations in children and adolescents with attention-deficit/hyperactivity disorder.
2009 Jun
Advances in the treatment of attention-deficit/hyperactivity disorder: a guide for pediatric neurologists.
2010 Dec
Eosinophilic hepatitis in an adolescent during lisdexamfetamine dimesylate treatment for ADHD.
2010 Jun
Absorption of lisdexamfetamine dimesylate and its enzymatic conversion to d-amphetamine.
2010 Jun 24
Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design.
2010 Jun 24
New and extended-action treatments in the management of ADHD: a critical appraisal of lisdexamfetamine in adults and children.
2010 May 25
Focus on Lisdexamfetamine: A Review of its use in Child and Adolescent Psychiatry.
2010 Nov
Use of psychostimulants in patients with dementia.
2010 Oct
Does prior exposure to stimulants in children with ADHD impact cardiovascular parameters from lisdexamfetamine dimesylate?
2010 Sep
Patents

Patents

08614346
2
20070042955
2
20080086016
4
JP2011529923A
30

Sample Use Guides

In Vivo Use Guide
Attention-deficit/hyperactivity disorder: Initial: 30 mg once daily in the morning; may increase in increments of 10 mg or 20 mg at weekly intervals until optimal response is obtained; maximum: 70 mg/day. Binge eating disorder: Initial: 30 mg once daily in the morning; may titrate in increments of 20 mg at weekly intervals to target dose of 50 to 70 mg once daily (maximum: 70 mg/day).
Route of Administration: Oral
In Vitro Use Guide
Incubation of lisdexamfetamine in microsomal suspensions at concentrations ranging from 0.01 to 100 M showed no concentration-dependent inhibition for any of the isoenzymes under investigation (CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A, CYP3A4).
Substance Class Chemical
Created
by admin
on Sat Jun 26 01:29:55 UTC 2021
Edited
by admin
on Sat Jun 26 01:29:55 UTC 2021
Record UNII
H645GUL8KJ
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
LISDEXAMFETAMINE
INN   MI   VANDF   WHO-DD  
INN  
Official Name English
L-LYSINE-DEXTROAMPHETAMINE
Common Name English
LISDEXAMPHETAMINE
Common Name English
LISDEXAMFETAMINE [INN]
Common Name English
LISDEXAMFETAMINE [WHO-DD]
Common Name English
HEXANAMIDE, 2,6-DIAMINO-N-((1S)-1-METHYL-2-PHENYLETHYL)-, (2S)-
Systematic Name English
(2S)-2,6-DIAMINO-N-((1S)-1-METHYL-2-PHENYLETHYL)HEXANAMIDE
Systematic Name English
LISDEXAMFETAMINE [VANDF]
Common Name English
LISDEXAMFETAMINE [MI]
Common Name English
Classification Tree Code System Code
NDF-RT N0000175739
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
NCI_THESAURUS C29728
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
NDF-RT N0000175729
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
DEA NO. 1205
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
WHO-ATC N06BA12
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
WHO-VATC QN06BA12
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
LIVERTOX 562
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
Code System Code Type Description
PUBCHEM
11597698
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
DRUG BANK
DB01255
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
NCI_THESAURUS
C75114
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
IUPHAR
7213
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
RXCUI
700810
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY RxNorm
MERCK INDEX
M6841
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY Merck Index
EVMPD
SUB32170
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
WIKIPEDIA
LISDEXAMFETAMINE
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
INN
8690
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
DRUG CENTRAL
4135
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
LACTMED
Lisdexamfetamine
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
EPA CompTox
608137-32-2
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
CAS
608137-32-2
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
ChEMBL
CHEMBL1201222
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
FDA UNII
H645GUL8KJ
Created by admin on Sat Jun 26 01:29:55 UTC 2021 , Edited by admin on Sat Jun 26 01:29:55 UTC 2021
PRIMARY
Related Record Type Details
Structure of LISDEXAMFETAMINE
EXCRETED UNCHANGED
URINE
Structure of LISDEXAMFETAMINE DIMESYLATE
SALT/SOLVATE -> PARENT
Related Record Type Details
Structure of HYDROXYAMPHETAMINE
METABOLITE -> PARENT
Structure of PHENYLACETIC ACID
METABOLITE -> PARENT
Structure of LYSINE
METABOLITE -> PARENT
Structure of DEXTROAMPHETAMINE
METABOLITE ACTIVE -> PRODRUG
Structure of PHENYLACETONE
METABOLITE -> PARENT
Structure of HIPPURIC ACID
METABOLITE -> PARENT
Structure of P-HYDROXYNOREPHEDRINE
METABOLITE -> PARENT
Related Record Type Details
Structure of LISDEXAMFETAMINE
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Biological Half-life PHARMACOKINETIC
Tmax PHARMACOKINETIC
NIH
NCATS
PRIVACY ACT
ACCESSIBILITY
DISCLAIMER
HHS VULNERABILITY DISCLOSURE
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