What are the most common side effects of Vyvanse (lisdexamfetamine)?

Most Common Side Effects of Vyvanse (Lisdexamfetamine)

The most common side effects of Vyvanse include decreased appetite (27-47%), insomnia (13-27%), dry mouth (4-26%), headache, upper abdominal pain, irritability, nausea, dizziness, and weight loss, with most adverse effects being mild to moderate in intensity and dose-related. 1, 2

Side Effects by Frequency and Population

Very Common Side Effects (≥10% incidence)

• Decreased appetite/anorexia occurs in 27-47% of patients and represents the most frequent adverse effect across all age groups, with higher rates in adults (27%) compared to children (34% in ages 6-12) 1, 3
• Insomnia affects 13-27% of patients, with adult rates (27%) being higher than pediatric rates (13% in ages 6-12,13% in ages 13-17) 1, 4
• Dry mouth occurs in 4-26% of patients, predominantly affecting adults (26%) more than children (4%) 1, 2
• Headache is reported in approximately 17% of pediatric patients during dose optimization 3
• Upper abdominal pain affects 16% of children during initial treatment 3
• Irritability occurs in 16% of pediatric patients, particularly during dose optimization 3

Common Side Effects (2-10% incidence)

• Weight loss occurs in 3-9% of patients, with pediatric patients experiencing mean weight loss of 0.9-2.5 pounds after 4 weeks depending on dose (30-70 mg) 1
• Nausea affects 7% of adults 1
• Diarrhea occurs in 7% of adults 1
• Anxiety is reported in 6% of adults 1
• Dizziness affects multiple age groups 1
• Vomiting is more common in pediatric populations 1
• Affect lability occurs in 10% of children during dose optimization 3

Cardiovascular Effects

• Increased blood pressure and heart rate occur in 2-3% of patients, requiring regular monitoring as recommended by the American Heart Association 5, 1
• Palpitations affect 2% of patients 1
• Tachycardia leads to discontinuation in 1% of adults 1

Special Considerations by Age Group

Pediatric Patients (Ages 6-12)

• The most common side effects during dose optimization are decreased appetite (47%), insomnia (27%), headache (17%), irritability (16%), upper abdominal pain (16%), and affect lability (10%) 3
• These adverse events become less frequent during maintenance treatment (decreased appetite 6%, insomnia 4%, headache 5%) 3

Adolescents (Ages 13-17)

• Decreased appetite (34%) and insomnia (13%) are the most frequently reported adverse effects 1
• Discontinuation rates due to adverse effects are lower (3%) compared to other age groups 1

Adults

• The side effect profile includes higher rates of dry mouth (26%), insomnia (27%), and decreased appetite (27%) compared to pediatric populations 1
• Sexual dysfunction occurs in 2.6% of males (erectile dysfunction) and 1.4% overall (decreased libido) 1

Serious but Less Common Side Effects

Growth Suppression

• Consistently medicated pediatric patients experience slowing in growth rate with an age- and sex-normalized mean change from baseline in weight percentile of -13.4 over 12 months 1
• Height and weight should be monitored regularly during treatment 1

Peripheral Vasculopathy

• Fingers or toes may feel numb, cool, or painful, with color changes from pale to blue to red 1
• Unexplained wounds on fingers or toes require immediate medical attention 1

Serotonin Syndrome

• A potentially life-threatening condition when combined with other serotonergic medications, presenting with confusion, coordination problems, muscle stiffness, hallucinations, blood pressure changes, hyperthermia, and gastrointestinal symptoms 1

Psychiatric Effects

• New or worsening tics and Tourette's syndrome can occur 1
• Behavioral activation, agitation, and mood changes may develop, particularly in younger children 6

Discontinuation Rates

• Overall discontinuation rates due to adverse effects are 8% in children ages 6-12,3% in adolescents ages 13-17, and 6% in adults 1
• The most common reasons for discontinuation in adults include insomnia (2%), tachycardia (1%), irritability (1%), and hypertension (1%) 1

Tolerability Profile

• Most treatment-emergent adverse events are mild to moderate in intensity and transient in nature 2, 4
• The tolerability profile is consistent with other amphetamine-based stimulant medications 2, 7
• Adverse events are generally dose-related, with higher doses (70 mg) associated with greater frequency and intensity of side effects 1, 3