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Vyvanse (Lisdexamfetamine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Vyvanse (Lisdexamfetamine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (251)
Death (14)
Life Threatening Events (5)
Disability (6)

Reports by Reaction Type

Depression (29)Suicidal Ideation (26)Aggression (21)Product Quality Issue (19)Drug Effect Decreased (18)Drug Ineffective (17)Overdose (16)Psychotic Disorder (15)Anger (14)Condition Aggravated (14)Convulsion (14)Hallucination (13)

Below are a few examples of reports where side effects / adverse reactions may be related to Vyvanse (Lisdexamfetamine). For a complete list or a specific selection of reports, please use the links above.

Possible Vyvanse side effects in 24 year old female

Reported by a physician from United States on 2012-08-21

Patient: 24 year old female, weighing 62.1 kg (136.7 pounds)

Reactions: Mitral Valve Prolapse, Drug Level Increased, Drug Ineffective, Cardiac Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Vyvanse
    Dosage: unk
    Administration route: Oral
    Start date: 2011-02-22
    End date: 2011-08-01

Vyvanse
    Dosage: 60 mg, 1x/day:qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-08-01
    End date: 2011-12-25

Other drugs received by patient: Zoloft; Trazodone Hydrochloride



Possible Vyvanse side effects in male

Reported by a pharmacist from United States on 2012-08-16

Patient: male

Reactions: Product Quality Issue, Wrong Technique in Drug Usage Process, Depression, Attention Deficit / Hyperactivity Disorder, Asthenia

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: male, weighing 103.9 kg (228.5 pounds)

Reactions: Physical Assault, Suicidal Ideation, Aggression, Irritability, Anxiety, Psychotic Disorder, Disturbance in Attention, Imprisonment, Abnormal Loss of Weight, Violence-Related Symptom, Feeling Abnormal

Drug(s) suspected as cause:
Vyvanse
    Dosage: unk unk, 1x/day:qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-01-01

Vyvanse
    Dosage: 50 mg, 1x/day:qd
    Administration route: Oral
    End date: 2012-07-26

Other drugs received by patient: Fluticasone Propionate; Ventolin; Xanax



Possible Vyvanse side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: female, weighing 88.0 kg (193.6 pounds)

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in female

Reported by a physician from United States on 2012-08-02

Patient: female, weighing 72.6 kg (159.6 pounds)

Reactions: Nausea, Foetal Exposure During Pregnancy, Subchorionic Haemorrhage, Feeling Abnormal

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in 50 year old male

Reported by a physician from United States on 2012-08-01

Patient: 50 year old male, weighing 81.6 kg (179.6 pounds)

Reactions: Cerebrovascular Accident

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in 22 year old male

Reported by a physician from United States on 2012-08-01

Patient: 22 year old male, weighing 75.7 kg (166.6 pounds)

Reactions: Road Traffic Accident, Tachycardia, Unevaluable Event

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vyvanse
    Dosage: 30 mg, 1x/day:qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2012-01-01
    End date: 2012-01-01

Vyvanse
    Dosage: unk, unknown
    Administration route: Oral
    Start date: 2012-01-01



Possible Vyvanse side effects in 10 year old male

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 10 year old male, weighing 34.5 kg (75.8 pounds)

Reactions: Rash Generalised, Pruritus

Drug(s) suspected as cause:
Sertraline Hydrochloride
    Dosage: 1 tablet nightly po
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2012-07-26
    End date: 2012-07-29

Vyvanse
    Dosage: 1 capsule morning po
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2012-07-27
    End date: 2012-07-29



Possible Vyvanse side effects in 12 year old male

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: 12 year old male

Reactions: Syncope

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in female

Reported by a consumer/non-health professional from Canada on 2012-07-23

Patient: female

Reactions: Suicidal Ideation

Drug(s) suspected as cause:
Vyvanse

Other drugs received by patient: Other Plant Alkaloids and Natural Products



Possible Vyvanse side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient: male

Reactions: Oral Discomfort, Gingivitis, DRY Mouth

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in female

Reported by a physician from United States on 2012-07-19

Patient: female, weighing 49.9 kg (109.8 pounds)

Reactions: Polydipsia, Decreased Eye Contact, Obsessive-Compulsive Disorder, Psychotic Disorder, Impulsive Behaviour, Inappropriate Affect

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vyvanse

Other drugs received by patient: Ritalin; Suboxone



Possible Vyvanse side effects in female

Reported by a physician from United States on 2012-07-18

Patient: female, weighing 54.4 kg (119.7 pounds)

Reactions: Pancreatitis, Gallbladder Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in 22 year old female

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient: 22 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient: male

Reactions: Myasthenia Gravis, Eyelid Ptosis

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in 26 year old female

Reported by a consumer/non-health professional from United States on 2012-07-12

Patient: 26 year old female, weighing 49.9 kg (109.8 pounds)

Reactions: Polydipsia, Hallucination, Auditory, Binge Eating, Inappropriate Affect

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in male

Reported by a physician from United States on 2012-07-10

Patient: male

Reactions: Psychotic Disorder, Overdose, Suicidal Behaviour, Drug Screen Positive, Depression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vyvanse
    Dosage: 120 mg, unknown
    Administration route: Oral
    End date: 2012-01-01

Vyvanse
    Dosage: 80 mg, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Alcohol; Diovan; Rozerem; Klonopin; Marijuana; Klonopin



Possible Vyvanse side effects in female

Reported by a physician from United States on 2012-07-06

Patient: female, weighing 63.5 kg (139.7 pounds)

Reactions: Mitral Valve Prolapse, Overdose, Sudden Death, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in 34 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05

Patient: 34 year old female, weighing 52.2 kg (114.8 pounds)

Reactions: Product Substitution Issue, Drug Ineffective

Drug(s) suspected as cause:
Adderall XR 30

Amphetamine and Dextroamphetamine Salts
    Dosage: 30 mg bid
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2012-06-01
    End date: 2012-07-01

Vyvanse



Possible Vyvanse side effects in female

Reported by a consumer/non-health professional from Canada on 2012-07-02

Patient: female

Reactions: Syncope, Drug Interaction, Serotonin Syndrome, Erythema

Drug(s) suspected as cause:
Cymbalta
    Dosage: unk, unknown
    Indication: Product Used FOR Unknown Indication

Vyvanse
    Dosage: 70 mg, unknown
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Vyvanse side effects in female

Reported by a physician from United States on 2012-07-02

Patient: female

Reactions: Bipolar Disorder

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in 44 year old male

Reported by a consumer/non-health professional from United States on 2012-06-25

Patient: 44 year old male, weighing 83.9 kg (184.6 pounds)

Reactions: Laboratory Test Interference

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in female

Reported by a pharmacist from United States on 2012-06-20

Patient: female, weighing 15.4 kg (33.9 pounds)

Reactions: Paranoia, Chills, Headache, Bruxism, Abdominal Pain Upper, Off Label Use, Overdose, Hallucinations, Mixed, Affect Lability, Neck Pain, Insomnia, Heart Rate Increased, Ear Pain, Dizziness, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in

Reported by a physician from United States on 2012-06-19

Patient:

Reactions: Hallucination, Visual, Homicidal Ideation

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: female, weighing 49.9 kg (109.8 pounds)

Reactions: Blood Pressure Increased, Product Quality Issue, Exposure To Communicable Disease, Nausea, Ovarian Cyst, Convulsion, Nephrolithiasis, Malaise, Amenorrhoea, Still's Disease Adult Onset, Abnormal Loss of Weight, Transient Ischaemic Attack, Decreased Appetite, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vyvanse
    Dosage: 50 mg, 1x/day:qd
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2011-12-01

Vyvanse
    Dosage: unk unk, unknown
    Administration route: Oral
    Start date: 2012-01-01
    End date: 2012-04-01

Vyvanse
    Dosage: 30 mg, 1x/day:qd
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder

Vyvanse
    Dosage: 50 mg, 1x/day:qd
    Administration route: Oral
    Start date: 2012-04-01



Possible Vyvanse side effects in male

Reported by a physician from United States on 2012-06-14

Patient: male

Reactions: Diabetes Mellitus, Enuresis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in 7 year old male

Reported by a physician from United States on 2012-06-14

Patient: 7 year old male

Reactions: Depressed Mood, Suicidal Ideation, Crying

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in 7 year old male

Reported by a consumer/non-health professional from United States on 2012-06-12

Patient: 7 year old male, weighing 30.4 kg (66.8 pounds)

Reactions: Homicidal Ideation, Aggression, Suicidal Ideation

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-11

Patient: male, weighing 31.7 kg (69.8 pounds)

Reactions: Product Quality Issue, Initial Insomnia, Condition Aggravated, Abnormal Behaviour, Headache, Self Injurious Behaviour, Tremor, Affective Disorder, Mood Altered, Dizziness, Nervousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vyvanse



Possible Vyvanse side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: male

Reactions: Pneumothorax

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vyvanse

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