Medical Editor: John P. Cunha, DO, FACOEP
What Is Vyvanse?
Vyvanse (lisdexamfetamine dimesylate) is a central nervous system stimulant used to treat:
- attention deficit hyperactivity disorder (ADHD) and
- moderate to severe binge eating disorder
What Are Side Effects of Vyvanse?
Common side effects of Vyvanse include
- decreased appetite,
- weight loss,
- dry mouth,
- sleep problems (insomnia),
- abdominal or stomach pain,
- increased heart rate,
- jittery feeling,
- mild skin rash,
- an unpleasant taste in your mouth,
- sweating, and
- blurred vision,
- fast/pounding/irregular heartbeat,
- mental/mood/behavior changes such as:
- mood swings,
- 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)
Dosage for Vyvanse
The recommended dose of Vyvanse is 30 mg once daily in the morning. The maximum recommended dose is 70 mg/day.
What Drugs, Substances, or Supplements Interact with Vyvanse?
Vyvanse may interact with
- ammonium chloride,
- ascorbic acid (vitamin C),
- blood pressure medications,
- diuretics (water pills),
- pain medication, or
Tell your doctor all medications and supplements you use.
Vyvanse During Pregnancy and Breastfeeding
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.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- signs of heart problems--chest pain, trouble breathing, pounding heartbeats or fluttering in your chest, feeling like you might pass out;
- signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia; or
- signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Lisdexamfetamine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Common side effects may include:
- dry mouth, loss of appetite, weight loss;
- sleep problems (insomnia);
- fast heart rate, feeling jittery;
- dizziness, feeling anxious or irritable; or
- nausea, vomiting, stomach pain, diarrhea, constipation.
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.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Known hypersensitivity to amphetamine products or other ingredients of VYVANSE[see CONTRAINDICATIONS]
- Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS and DRUG INTERACTIONS]
- Drug Dependence [see BOX WARNING, WARNINGS AND PRECAUTIONS, and Drug Abuse And Dependence]
- Serious Cardiovascular Reactions [see WARNINGS AND PRECAUTIONS]
- Blood Pressure and Heart Rate Increases [see WARNINGS AND PRECAUTIONS]
- Psychiatric Adverse Reaction [ see WARNINGS AND PRECAUTIONS]
- Suppression of Growth [see WARNINGS AND PRECAUTIONS]
- Peripheral Vasculopathy, including Raynaud’s phenomenon [see WARNINGS AND PRECAUTIONS]
- Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
Clinical Trials 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 controlled parallel-group clinical studies of VYVANSE in pediatric and adult patients with ADHD [see Drug Abuse And Dependence ].
>Adverde Reaction Associated with Discontinuation of Treatment in ADHD Clinical Trials
In the controlled trial in pediatric 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 pediatric 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.
Adverde Reaction 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 pediatric patients ages 6 to 17 years, and/or adults were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting.
Adverde Reaction 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), pediatric 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 Adverde Reaction Reported by 2% or More of Pediatric Patients Ages 6 to 12 Years with ADHD Taking VYVANSE and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 1)
|Abdominal Pain Upper||12%||6%|
Table 2 Adverde Reaction Reported by 2% or More of Pediatric Patients Ages 13 to 17 Years with ADHD Taking VYVANSE and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 4)
Table 3 Adverde Reaction Reported by 2% or More of Adult Patients with ADHD Taking VYVANSE and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 7)
|Increased Blood Pressure||3%||0%|
|Increased Heart Rate||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 pediatric patients 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 pediatric patients ages 6 to 12 years who received VYVANSE over 12 months suggests that consistently medicated pediatric patients (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 pediatric patients 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 pediatric patients 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 pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated pediatric patients ages 7 to 13 years (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 pediatric patients ages 13 to 17 years, 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 Drug Abuse And Dependence]. Patients with cardiovascular risk factors other than obesity and smoking were excluded.
Adverde Reaction 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.
Adverde Reaction Occurring at an Incidence of 5% or More and At Least Twice Placebo Among VYVANSE Treated Patients with BED in Clinical Trials
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.
Adverde Reaction Occurring at an Incidence of 2% or More and At Least Twice Placebo Among VYVANSE Treated Patients with BED in Clinical Trials
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 Greater than or Equal to Twice the Incidence in Patients Taking Placebo in 12-Week Clinical Trials (Study 11 and 12)
|Increased Heart Rate2||7%||1%|
|Upper Abdominal Pain||2%||0%|
|Urinary Tract Infection||2%||0%|
|1 Includes all preferred terms containing the word “insomnia.”
2 Includes the preferred terms “heart rate increased” and “tachycardia.”
The following adverse reactions have been identified during postapproval use of VYVANSE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always 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, rhabdomyolysis, and intestinal ischemia.
Drugs Having Clinically Important Interactions With Amphetamines
Table 5 Drugs having clinically important interactions with amphetamines.
|MAO Inhibitors (MAOI)|
|Clinical Impact||MAOI antidepressants slow amphetamine metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.|
|Intervention||Do not administer VYVANSE during or within 14 days following the administration of MAOI [see CONTRAINDICATIONS].|
|Clinical Impact||The concomitant use of VYVANSE and serotonergic drugs increases the risk of serotonin syndrome.|
|Intervention||Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during VYVANSE initiation or dosage increase. If serotonin syndrome occurs, discontinue VYVANSE and the concomitant serotonergic drug(s) [see WARNINGS AND PRECAUTIONS].|
|Clinical Impact||The concomitant use of VYVANSE and CYP2D6 inhibitors may increase the exposure of dextroamphetamine, the active metabolite of VYVANSE compared to the use of the drug alone and increase the risk of serotonin syndrome.|
|Intervention||Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during VYVANSE initiation and after a dosage increase. If serotonin syndrome occurs, discontinue VYVANSE and the CYP2D6 inhibitor [see WARNINGS AND PRECAUTIONS and OVERDOSE].|
|Clinical Impact||Urinary alkalinizing agents can increase blood levels and potentiate the action of amphetamine.|
|Intervention||Co-administration of VYVANSE and urinary alkalinizing agents should be avoided.|
|Clinical Impact||Urinary acidifying agents can lower blood levels and efficacy of amphetamines.|
|Intervention||Increase dose based on clinical response.|
|Clinical Impact||May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.|
|Intervention||Monitor frequently and adjust or use alternative therapy based on clinical response.|
Drugs Having No Clinically Important Interactions With VYVANSE
From a pharmacokinetic perspective, no dose adjustment of VYVANSE is necessary when VYVANSE is co-administered with guanfacine, venlafaxine, or omeprazole. In addition, no dose adjustment of guanfacine or venlafaxine is needed when VYVANSE is co-administered [see CLINICAL PHARMACOLOGY].
From a pharmacokinetic perspective, no dose adjustment for drugs that are substrates of CYP1A2 (e.g., theophylline, duloxetine, melatonin), CYP2D6 (e.g., atomoxetine, desipramine, venlafaxine), CYP2C19 (e.g., omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g., midazolam, pimozide, simvastatin) is necessary when VYVANSE is co-administered [see CLINICAL PHARMACOLOGY].
Drug Abuse And Dependence
VYVANSE contains lisdexamfetamine, a prodrug of amphetamine, a Schedule II controlled substance.
CNS stimulants, including VYVANSE, other amphetamine-containing products, and methylphenidate have a high potential for abuse. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Abuse is characterized by impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Both abuse and misuse may lead to addiction, and some individuals may develop addiction even when taking VYVANSE as prescribed.
Signs and symptoms of amphetamine abuse may include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been seen. Abusers of CNS stimulants may chew, snort, inject, or use other unapproved routes of administration which can result in overdose and death [see OVERDOSE ].
To reduce the abuse of CNS stimulants, including VYVANSE, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants. Monitor for signs of abuse while on therapy, and re-evaluate the need for VYVANSE use.
Studies of VYVANSE in Drug Abusers
A randomized, double-blind, placebo-control, cross-over, abuse liability study in 38 patients with a history of drug abuse was conducted with single-doses of 50, 100, or 150 mg of VYVANSE, 40 mg of immediate-release d-amphetamine sulphate (a controlled II substance), and 200 mg of diethylpropion hydrochloride (a controlled IV substance). VYVANSE 100 mg produced significantly less “Drug Liking Effects” as measured by the Drug Rating Questionnaire-Subject score, compared to d-amphetamine 40 mg; and 150 mg of VYVANSE demonstrated similar “Drug-Liking Effects” compared to 40 mg of d-amphetamine and 200 mg of diethylpropion.
Intravenous administration of 50 mg lisdexamfetamine dimesylate to individuals with a history of drug abuse produced positive subjective responses on scales measuring "Drug Liking", "Euphoria", "Amphetamine Effects", and "Benzedrine Effects" that were greater than placebo but less than those produced by an equivalent dose (20 mg) of intravenous d-amphetamine.
VYVANSE may produce physical dependence from continued therapy. Physical dependence is a state of adaptation manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist. Withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of CNS stimulants include extreme fatigue and depression.
VYVANSE may produce tolerance from continued therapy. Tolerance is a state of adaptation in which exposure to a specific dose of a drug results in a reduction of the drug’s desired and/or undesired effects over time.
Read the entire FDA prescribing information for Vyvanse (Lisdexamfetamine Dimesylate)
© Vyvanse Patient Information is supplied by Cerner Multum, Inc. and Vyvanse Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
Health Solutions From Our Sponsors