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Vyvanse

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Vyvanse

Vyvanse

Vyvanse Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Vyvanse (lisdexamfetamine dimesylate) is used to treat attention deficit hyperactivity disorder (ADHD) in adults and in children who are 6 to 12 years old. It is a central nervous system stimulant. Common side effects include nausea, vomiting, stomach/abdominal pain, loss of appetite, dry mouth, headache, nervousness, dizziness, trouble sleeping, sweating, weight loss, irritability, or restlessness.

In patients who are starting treatment for the first time or switching from another medication, 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 used only if prescribed. Infants born to mothers who are dependent on this medication may be born premature, have low birth weight, and withdrawal symptoms. Tell your doctor if you notice mood changes, agitation, or unusual tiredness in your newborn. This medication passes into breast milk and could have undesirable effects on a nursing infant. Breast-feeding 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Vyvanse in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Vyvanse Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, stomach/abdominal pain, loss of appetite, dry mouth, headache, nervousness, dizziness, trouble sleeping, sweating, weight loss, irritability, or restlessness may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medicine because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blurred vision, fast/pounding/irregular heartbeat, mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, hallucinations, abnormal thoughts/behavior), uncontrolled movements, muscle twitching/shaking, outbursts of words/sounds, change in sexual ability/interest, swelling ankles/feet, extreme tiredness, rapid/unexplained weight loss.

Seek immediate medical attention if any of these rare but very serious side effects occur: shortness of breath, fainting, chest/jaw/left arm pain, seizures, weakness on one side of the body, slurred speech, confusion, sudden vision changes.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Vyvanse (Lisdexamfetamine Dimesylate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Vyvanse FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 clinical practice.

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 Clinical Trials

In the controlled trial in patients ages 6 to 12 years (Study 1), 9% (20/218) of Vyvanse-treated patients discontinued due to adverse reactions compared to 1% (1/72) of placebo-treated patients. The most frequent adverse reactions leading to discontinuation (i.e. leading to discontinuation in at least 1% of Vyvanse-treated patients and at a rate at least twice that of placebo) were ECG voltage criteria for ventricular hypertrophy, tic, vomiting, psychomotor hyperactivity, insomnia, and rash [2 instances for each adverse reaction, i.e., 2/218 (1%)].

In the controlled trial in patients ages 13 to 17 years (Study 4), 4% (10/233) of Vyvanse-treated patients discontinued due to adverse reactions compared to 1% (1/77) of placebo-treated patients. The most frequent adverse reactions leading to discontinuation were irritability (3/233; 1%), decreased appetite (2/233; 1%), and insomnia (2/233; 1%).

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 frequent adverse reactions leading to discontinuation (i.e. leading to discontinuation in at least 1% of Vyvanse-treated patients and at a rate at least twice that 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%).

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 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) 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 23% 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%

Table 2 : Adverse Reactions Reported by 2% or More of Adolescent (Ages 13 to 17 Years) Patients 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%

Table 3 : Adverse Reactions Reported by 2% or More of Adult Patients 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%
Blood Pressure Increased 3% 0%
Hyperhidrosis 3% 0%
Restlessness 3% 0%
Weight Decreased 3% 0%
Dyspnea 2% 0%
Heart Rate Increased 2% 0%
Tremor 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

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

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.

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: palpitations, cardiomyopathy, mydriasis, diplopia, difficulties with visual accommodation, blurred vision, eosinophilic hepatitis, anaphylactic reaction, hypersensitivity, dyskinesia, tics, depression, dermatillomania, aggression, Stevens-Johnson Syndrome, angioedema, urticaria, seizures, libido changes, and frequent or prolonged erections.

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

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Vyvanse - User Reviews

Vyvanse User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Vyvanse sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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