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Vyvanse (Lisdexamfetamine Dimesylate) - Side Effects and Adverse Reactions

 
 



ADVERSE EVENTS

The premarketing development program for Vyvanse included exposures in a total of 404 participants in clinical trials (348 pediatric patients and 56 healthy adult subjects). Of these, 348 pediatric patients (ages 6 to 12) were evaluated in two controlled clinical studies (one parallel-group and one crossover), one open-label extension study, and one single-dose clinical pharmacology study. The information included in this section is based on data from the 4-week parallel-group controlled clinical trial in pediatric patients with ADHD. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and listings that follow, MedRA terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed.

Adverse events associated with discontinuation of treatment: Ten percent (21/218) of Vyvanse-treated patients discontinued due to adverse events compared to 1% (1/72) who received placebo. The most frequent adverse events leading to discontinuation and considered to be drug-related (i.e., leading to discontinuation in at least 1% of Vyvanse-treated patients and at a rate at least twice that of placebo) were ECG voltage criteria for ventricular hypertrophy, tic, vomiting, psychomotor hyperactivity, insomnia, and rash (2/218 each; 1%).

Adverse events occurring in a controlled trial: Adverse events reported in a 4-week clinical trial in pediatric patients treated with Vyvanse or placebo are presented in the table below.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

The following adverse events that occurred in at least 5% of the Vyvanse patients and at a rate twice that of the placebo group (Table 1): Upper abdominal pain, decreased appetite, dizziness, dry mouth, irritability, insomnia, nausea, vomiting, and decreased weight.

Table 1 Adverse Events Reported by 2% or More of Pediatric Patients Taking Vyvanse in a 4 Week Clinical Trial
Body System Preferred Term Vyvanse (n=218) Placebo (n=72)
Gastrointestinal Disorders Abdominal Pain Upper
Dry Mouth
Nausea
Vomiting
12%
5%
6%
9%
6%
0%
3%
4%
General Disorder and Administration Site Conditions Pyrexia 2% 1%
Investigations Weight Decreased 9% 1%
Metabolism and Nutrition Decreased Appetite 39% 4%
Nervous System Disorders Dizziness
Headache
Somnolence
5%
12%
2%
0%
10%
1%
Psychiatric Disorders Affect lability
Initial Insomnia
Insomnia
Irritability
Tic
3%
4%
19%
10%
2%
0%
0%
3%
0%
0%
Skin and Subcutaneous Tissue Disorders Rash 3% 0%
Note: This table only includes those events for which the incidence in patients taking Vyvanse is greater than the incidence in patients taking placebo.

The following additional adverse reactions have been associated with the use of amphetamine, amphetamine (d to l enantiomer ratio of 3:1), or Vyvanse:

Cardiovascular: Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System: Psychotic episodes at recommended doses, overstimulation, restlessness, dizziness, euphoria, dyskinesia, dysphoria, depression, tremor, headache, exacerbation of motor and phonic tics and Tourette's syndrome, seizures, stroke.

Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation.

Allergic: Urticaria, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens Johnson Syndrome and toxic epidermal necrolysis have been reported.

Endocrine: Impotence, changes in libido.



REPORTS OF SUSPECTED VYVANSE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Vyvanse. The information is not vetted and should not be considered as verified clinical evidence.

Possible Vyvanse side effects / adverse reactions in 41 year old female

Reported by a physician from Canada on 2011-10-05

Patient: 41 year old female

Reactions: Mood Altered, Palpitations, Tachycardia, Incorrect Dose Administered, Depression, Suicidal Ideation

Suspect drug(s):
Vyvanse
    Dosage: 30 mg, 1x/day:qd
    Administration route: Oral
    Start date: 2011-07-01
    End date: 2011-08-13

Vyvanse
    Dosage: 20 mg, 1x/day:qd
    Administration route: Oral
    Indication: Attention Deficit/hyperactivity Disorder
    Start date: 2011-02-01
    End date: 2011-01-01

Vyvanse
    Dosage: unk unk, 1x/day:qd
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2011-07-01

Vyvanse
    Dosage: 30 mg, 1x/day:qd
    Administration route: Oral
    Start date: 2011-03-01
    End date: 2011-01-01

Other drugs received by patient: Desyrel; Trazodone Hydrochloride; Pristiq; Pristiq; Pristiq



Possible Vyvanse side effects / adverse reactions in 7 year old male

Reported by a physician from United States on 2011-10-06

Patient: 7 year old male weighing 30.4 kg (66.9 pounds)

Reactions: Completed Suicide, Abnormal Behaviour, Impulsive Behaviour, Aggression

Adverse event resulted in: death

Suspect drug(s):
Lexapro
    Dosage: 5 mg (5 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Anxiety
    Start date: 2009-02-03
    End date: 2009-03-18

Symbyax
    Dosage: 3mg/25mg (1 in 1 d),
    Indication: Aggression
    Start date: 2009-03-18
    End date: 2009-04-16

Symbyax
    Dosage: 3mg/25mg (1 in 1 d),
    Indication: Impulsive Behaviour
    Start date: 2009-03-18
    End date: 2009-04-16

Vyvanse
    Dosage: 30 mg (30 mg, 1 in 1 d), oral; 50 mg (50 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Affective Disorder
    Start date: 2009-03-31
    End date: 2009-04-16

Vyvanse
    Dosage: 30 mg (30 mg, 1 in 1 d), oral; 50 mg (50 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Attention Deficit/hyperactivity Disorder
    Start date: 2009-03-31
    End date: 2009-04-16

Vyvanse
    Dosage: 30 mg (30 mg, 1 in 1 d), oral; 50 mg (50 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Affective Disorder
    Start date: 2008-12-09
    End date: 2009-03-30

Vyvanse
    Dosage: 30 mg (30 mg, 1 in 1 d), oral; 50 mg (50 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Attention Deficit/hyperactivity Disorder
    Start date: 2008-12-09
    End date: 2009-03-30



Possible Vyvanse side effects / adverse reactions in 42 year old female

Reported by a consumer/non-health professional from United States on 2011-10-13

Patient: 42 year old female weighing 81.6 kg (179.6 pounds)

Reactions: Maternal Exposure During Pregnancy, Pregnancy

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Vyvanse



See index of all Vyvanse side effect reports >>

Drug label data at the top of this Page last updated: 2007-03-20

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