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Vyvanse

Last reviewed on RxList: 8/14/2017
Vyvanse Side Effects Center

Last reviewed on RxList 08/14/2017

Vyvanse (lisdexamfetamine dimesylate) is a central nervous system stimulant used to treat attention deficit hyperactivity disorder (ADHD) and moderate to severe binge eating disorder. Common side effects of Vyvanse include

  • anorexia,
  • anxiety,
  • decreased appetite,
  • weight loss,
  • diarrhea,
  • dizziness,
  • dry mouth,
  • irritability,
  • sleep problems (insomnia),
  • nausea,
  • abdominal or stomach pain,
  • vomiting,
  • increased heart rate,
  • constipation,
  • jittery feeling,
  • mild skin rash,
  • an unpleasant taste in your mouth,
  • headache,
  • nervousness,
  • sweating, and
  • restlessness.
Tell your doctor if you have serious side effects of Vyvanse including:
  • blurred vision,
  • fast/pounding/irregular heartbeat,
  • mental/mood/behavior changes (such as agitation, aggression, mood swings, depression, hallucinations, abnormal thoughts or behavior, suicidal thoughts or attempts),
  • uncontrolled movements,
  • muscle twitching or shaking,
  • numbness/pain/skin color change/sensitivity to temperature in the fingers or toes,
  • outbursts of words or sounds,
  • a change in sexual ability or interest,
  • swelling ankles or feet,
  • extreme tiredness,
  • rapid or unexplained weight loss, or
  • frequent or prolonged erections (in males).

The recommended dose of Vyvanse is 30 mg once daily in the morning. The maximum recommended dose is 70 mg/day. Vyvanse may interact with ammonium chloride, ascorbic acid (vitamin C), K-Phos, blood pressure medications, diuretics (water pills), antihistamines, chlorpromazine, ethosuximide, lithium, methenamine, phenytoin, phenobarbital, pain medication, or antidepressants. Tell your doctor all medications and supplements you use. During pregnancy, Vyvanse should be taken only if prescribed. This medication passes into breast milk and could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug. Withdrawal symptoms may occur if you suddenly stop using this medication.

Our Vyvanse (lisdexamfetamine dimesylate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Vyvanse Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeats;
  • decreased blood pressure (feeling light-headed, fainting);
  • tremor, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, seizure).

Less serious side effects may include:

  • loss of appetite, weight loss;
  • sleep problems (insomnia);
  • nausea, vomiting, stomach pain;
  • feeling irritable;
  • mild skin rash; or
  • dry mouth or an unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vyvanse (Lisdexamfetamine Dimesylate)

Vyvanse Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Attention Deficit Hyperactivity Disorder

The safety data in this section is based on data from the 4-week parallel-group controlled clinical studies of VYVANSE in pediatric and adult patients with ADHD [see Clinical Studies].

Adverse Reactions Associated with Discontinuation of Treatment in ADHD Clinical Trials

In the controlled trial in patients ages 6 to 12 years (Study 1), 8% (18/218) of VYVANSE-treated patients discontinued due to adverse reactions compared to 0% (0/72) of placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice rate of placebo) were ECG voltage criteria for ventricular hypertrophy, tic, vomiting, psychomotor hyperactivity, insomnia, decreased appetite and rash [2 instances for each adverse reaction, i.e., 2/218 (1%)]. Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included abdominal pain upper, dry mouth, weight decreased, dizziness, somnolence, logorrhea, chest pain, anger and hypertension.

In the controlled trial in patients ages 13 to 17 years (Study 4), 3% (7/233) of VYVANSE-treated patients discontinued due to adverse reactions compared to 1% (1/77) of placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice rate of placebo) were decreased appetite (2/233; 1%) and insomnia (2/233; 1%). Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included irritability, dermatillomania, mood swings, and dyspnea.

In the controlled adult trial (Study 7), 6% (21/358) of VYVANSE-treated patients discontinued due to adverse reactions compared to 2% (1/62) of placebo-treated patients. 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.

Adverse Reactions Occurring at an Incidence of ≥5% or More Among VYVANSE Treated Patients with ADHD in Clinical Trials

The most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) reported in children, adolescents, and/or adults were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting.

Adverse Reactions Occurring at an Incidence of 2% or More Among VYVANSE Treated Patients with ADHD in Clinical Trials

Adverse reactions reported in the controlled trials in pediatric patients ages 6 to 12 years (Study 1), adolescent patients ages 13 to 17 years (Study 4), and adult patients (Study 7) treated with VYVANSE or placebo are presented in Tables 1, 2, and 3 below.

Table 1: Adverse Reactions Reported by 2% or More of Children (Ages 6 to 12 Years) with ADHD Taking VYVANSE and at least Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 1)

  VYVANSE
(n=218)
Placebo
(n=72)
Decreased Appetite 39% 4%
Insomnia 22% 3%
Abdominal Pain Upper 12% 6%
Irritability 10% 0%
Vomiting 9% 4%
Weight Decreased 9% 1%
Nausea 6% 3%
Dry Mouth 5% 0%
Dizziness 5% 0%
Affect lability 3% 0%
Rash 3% 0%
Pyrexia 2% 1%
Somnolence 2% 1%
Tic 2% 0%
Anorexia 2% 0%

Table 2: Adverse Reactions Reported by 2% or More of Adolescent (Ages 13 to 17 Years) Patients with ADHD Taking VYVANSE and at least Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 4)

  VYVANSE
(n=233)
Placebo
(n=77)
Decreased Appetite 34% 3%
Insomnia 13% 4%
Weight Decreased 9% 0%
Dry Mouth 4% 1%
Palpitations 2% 1%
Anorexia 2% 0%
Tremor 2% 0%

Table 3: Adverse Reactions Reported by 2% or More of Adult Patients with ADHD Taking VYVANSE and at least Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 7)

  VYVANSE
(n=358)
Placebo
(n=62)
Decreased Appetite 27% 2%
Insomnia 27% 8%
Dry Mouth 26% 3%
Diarrhea 7% 0%
Nausea 7% 0%
Anxiety 6% 0%
Anorexia 5% 0%
Feeling Jittery 4% 0%
Agitation 3% 0%
Increased Blood Pressure 3% 0%
Hyperhidrosis 3% 0%
Restlessness 3% 0%
Decreased Weight 3% 0%
Dyspnea 2% 0%
Increased Heart Rate 2% 0%
Tremor 2% 0%
Palpitations 2% 0%

In addition, in the adult population erectile dysfunction was observed in 2.6% of males on VYVANSE and 0% on placebo; decreased libido was observed in 1.4% of subjects on VYVANSE and 0% on placebo.

Weight Loss and Slowing Growth Rate in Pediatric Patients with ADHD

In a controlled trial of VYVANSE in children ages 6 to 12 years (Study 1), mean weight loss from baseline after 4 weeks of therapy was -0.9, -1.9, and -2.5 pounds, respectively, for patients receiving 30 mg, 50 mg, and 70 mg of VYVANSE, compared to a 1 pound weight gain for patients receiving placebo. Higher doses were associated with greater weight loss with 4 weeks of treatment. Careful follow-up for weight in children ages 6 to 12 years who received VYVANSE over 12 months suggests that consistently medicated children (i.e. treatment for 7 days per week throughout the year) have a slowing in growth rate, measured by body weight as demonstrated by an age-and sex-normalized mean change from baseline in percentile, of -13.4 over 1 year (average percentiles at baseline and 12 months were 60.9 and 47.2, respectively). In a 4-week controlled trial of VYVANSE in adolescents ages 13 to 17 years, mean weight loss from baseline to endpoint was -2.7, -4.3, and -4.8 lbs., respectively, for patients receiving 30 mg, 50 mg, and 70 mg of VYVANSE, compared to a 2.0 pound weight gain for patients receiving placebo.

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e. treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. In a controlled trial of amphetamine (d-to l-enantiomer ratio of 3:1) in adolescents, mean weight change from baseline within the initial 4 weeks of therapy was -1.1 pounds and -2.8 pounds, respectively, for patients receiving 10 mg and 20 mg of amphetamine. Higher doses were associated with greater weight loss within the initial 4 weeks of treatment [see WARNINGS AND PRECAUTIONS].

Weight Loss in Adults with ADHD

In the controlled adult trial (Study 7), mean weight loss after 4 weeks of therapy was 2.8 pounds, 3.1 pounds, and 4.3 pounds, for patients receiving final doses of 30 mg, 50 mg, and 70 mg of VYVANSE, respectively, compared to a mean weight gain of 0.5 pounds for patients receiving placebo.

Binge Eating Disorder

The safety data in this section is based on data from two 12 week parallel group, flexible-dose, placebo-controlled studies in adults with BED [see Clinical Studies]. Patients with cardiovascular risk factors other than obesity and smoking were excluded.

Adverse Reactions Associated with Discontinuation of Treatment in BED Clinical Trials

In controlled trials of patients ages 18 to 55 years, 5.1% (19/373) of VYVANSE-treated patients discontinued due to adverse reactions compared to 2.4% (9/372) of placebo-treated patients. No single adverse reaction led to discontinuation in 1% or more of VYVANSE-treated patients. Less commonly reported adverse reactions (less than 1% or less than twice rate of placebo) included increased heart rate, headache, abdominal pain upper, dyspnea, rash, insomnia, irritability, feeling jittery and anxiety.

The most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) reported in adults were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.

Adverse reactions reported in the pooled controlled trials in adult patients (Study 11 and 12) treated with VYVANSE or placebo are presented in Table 4 below.

Table 4: Adverse Reactions Reported by 2% or More of Adult Patients with BED Taking VYVANSE and at least Twice the Incidence in Patients Taking Placebo in 12-Week Clinical Trials (Study 11 and 12)

  VYVANSE
(N=373)
Placebo
(N=372)
Dry Mouth 36% 7%
Insomnia1 20% 8%
Decreased Appetite 8% 2%
Increased Heart Rate2 7% 1%
Feeling Jittery 6% 1%
Constipation 6% 1%
Anxiety 5% 1%
Diarrhea 4% 2%
Decreased Weight 4% 0%
Hyperhidrosis 4% 0%
Vomiting 2% 1%
Gastroenteritis 2% 1%
Paresthesia 2% 1%
Pruritis 2% 1%
Upper Abdominal Pain 2% 0%
Energy Increased 2% 0%
Urinary Tract Infection 2% 0%
Nightmare 2% 0%
Restlessness 2% 0%
Oropharyngeal Pain 2% 0%
1 Includes all preferred terms containing the word “insomnia.”
2 Includes the preferred terms “heart rate increased” and “tachycardia.”

Postmarketing Experience

The following adverse reactions have been identified during post approval use of VYVANSE. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events are as follows: cardiomyopathy, mydriasis, diplopia, difficulties with visual accommodation, blurred vision, eosinophilic hepatitis, anaphylactic reaction, hypersensitivity, dyskinesia, dysgeusia, tics, bruxism, depression, dermatillomania, alopecia, aggression, Stevens-Johnson Syndrome, chest pain, angioedema, urticaria, seizures, libido changes, frequent or prolonged erections, constipation, and rhabdomyolysis.

Read the entire FDA prescribing information for Vyvanse (Lisdexamfetamine Dimesylate)

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