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Side effects and tolerability

Vyvanse adverse event profile1

Reported by ≥2% of Pediatric Patients in the 4-Week Clinical Study (n=290)*

Body System/
Adverse Event		 Vyvanse (n=218) Placebo (n=72)
Gastrointestinal Disorders
Abdominal pain upper 12% 6%
Vomiting 9% 4%
Nausea 6% 3%
Dry mouth 5% 0%
General Disorder and Administration Site Conditions
Pyrexia 2% 1%
Investigations
Weight decreased 9% 1%
Metabolism and Nutrition Disorders
Decreased appetite 39% 4%
Nervous System Disorders
Dizziness 5% 0%
Somnolence 2% 1%
Psychiatric Disorders
Insomnia 19% 3%
Irritability 10% 0%
Initial insomnia 4% 0%
Affect lability 3% 0%
Tic 2% 0%
Skin and Subcutaneous Tissue Disorders
Rash 3% 0%

Reported by ≥2% of Adult Patients in the 4-Week Clinical Study (n=420)*

Body System/
Adverse Event		 Vyvanse (n=358) Placebo (n=62)
Gastrointestinal Disorders
Dry Mouth 26% 3%
Diarrhea 7% 0%
Nausea 7% 0%
General Disorder and Administration Site Conditions
Feeling Jittery 4% 0%
Investigations
Blood pressure
increased		 3% 0%
Heart rate increased 2% 0%
Metabolism and Nutrition Disorders
Decreased appetite 27% 3%
Anorexia 5% 0%
Nervous System Disorders
Tremor 2% 0%
Psychiatric Disorders
Insomnia 27% 8%
Anxiety 6% 0%
Agitation 3% 0%
Restlessness 3% 0%
Respiratory Thoracic and Mediastinal Disorders
Dyspnea 2% 0%
Skin and Subcutaneous Tissue Disorders
Hyperhidrosis 3% 0%

The majority of these adverse events from these studies
were mild to moderate in severity1-3

*Tables include only those events for which the incidence in patients taking Vyvanse was greater than the incidence in patients taking placebo

Vyvanse vital signs in adults4

LS Mean Change From Baseline to End Point for Vital Signs4

Vital Signs Placebo
(n=62)		 30 mg/d Vyvanse
(n=119)		 50 mg/d Vyvanse
(n=117)		 70 mg/d Vyvanse (n=122)
Pulse (bpm) 0.0
(-2.2, 2.2)		 2.8
(1.2, 4.4)		 4.2
(2.6, 5.9)		 5.2
(3.6, 6.8)
SBP (mm Hg) -0.5
(-2.6, 1.5)		 0.8
(-0.7, 2.3)		 0.3
(-1.2, 1.8)		 1.3
(-0.2, 2.7)
DBP (mm Hg) 1.1
(-0.5, 2.7)		 0.8
(-0.4, 2.0)		 1.1
(-0.1, 2.3)		 1.6
(0.4, 2.7)

Data are least squares mean change from baseline with 95% confidence intervals (Cls)


  • Patients were excluded from the study if they had a history of hypertension, a resting sitting systolic blood pressure >139 mm Hg or diastolic blood pressure >89 mm Hg, a clinically significant ECG or laboratory abnormality at screening or baseline, a known cardiac structural abnormality, or any other condition that may affect cardiac performance. Accordingly, these results may not be generalizable to the adult population
  • In a 4-week forced-dose titration study, safety assessments, including vital sign measurements, were conducted at each weekly visit
  • In this 4-week clinical study for Vyvanse-treated patients, 3% reported an increase in blood pressure, 2% reported an increase in heart rate, and approximately 2% discontinued due to cardiovascular-related adverse events vs 0% of placebo-treated patients, respectively
  • Vyvanse is contraindicated in patients with symptomatic cardiovascular disease and moderate to severe hypertension and should not be used in patients with cardiac structure abnormalities. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses in ADHD. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events
  • Blood pressure and pulse should be monitored at appropriate intervals in patients taking Vyvanse. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure and pulse

References

  1. Vyvanse [package insert], Wayne, PA: Shire US Inc; 2008.
  2. Biederman J, Krishnan S, Zhang Y, et al. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007;29:450-463.
  3. Data on file; LDX045; Shire US Inc.
  4. Niebler G, Wilens TE, Weisler R, et al. Evaluation of cardiovascular effects with lisdexamfetamine dimesylate treatment in adults with attention-deficit/hyperactivity disorder. Presented at: Annual Meeting of the American Psychiatric Association; May 3-8, 2008; Washington, DC.
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