INDICATION AND LIMITATION OF USE

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

This site is intended for US healthcare professionals only.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
Full Safety Information Below

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

IMPORTANT SAFETY INFORMATION    This site is intended for US healthcare professionals only.

WARNING: ABUSE AND DEPENDENCE

  • | CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
Full Safety Information Below

Adverse Reactions

Adverse reactions reported by ≥2% of adult patients taking Vyvanse and at least twice the incidence in patients taking placebo in Study 303, the 4-week, parallel-group, pivotal clinical study (n=420).¹

Adverse Reactions in ≥2% of adult patients taking Vyvanse¹

Adverse reactions Vyvanse (n=358) Placebo (n=62)
Decreased Appetite27% 2%
Insomnia27% 8%
Dry Mouth26% 3%
Diarrhea7% 0%
Nausea7% 0%
Anxiety6% 0%
Anorexia5% 0%
Feeling Jittery4% 0%
Agitation3% 0%
Increased Blood Pressure3% 0%
Hyperhidrosis3% 0%
Restlessness3% 0%
Decreased Weight3% 0%
Dyspnea2% 0%
Increased Heart Rate2% 0%
Tremor2% 0%
Palpitations2% 0%

Discontinuation rates

In this controlled adult trial, 6% (21/358) of Vyvanse-treated patients discontinued treatment due to an adverse reaction compared to 2% (1/62) of placebo-treated patients.¹

The most frequently reported adverse reactions (1% or more and twice rate of placebo) were insomnia (8/358; 2%), tachycardia (3/358; 1%), irritability (2/358; 1%), hypertension (4/358; 1%), headache (2/358; 1%), anxiety (2/358; 1%), and dyspnea (3/358; 1%). Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included palpitations, diarrhea, nausea, decreased appetite, dizziness, agitation, depression, paranoia and restlessness.1

In the adult population, erectile dysfunction was observed in 2.6% of males who took Vyvanse and 0% who took placebo; decreased libido was observed in 1.4% of subjects who took Vyvanse and 0% who took placebo.¹


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