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Safety Information at a Glance

It is important to understand potential risks of medication. Below is a summary of the safety information of Vyvanse.

Abuse and Dependence Abuse and dependence

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is against the law.

Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who Should Not Take Vyvanse?

Who Should Not Take Vyvanse? You or your child should not take Vyvanse if you or your child:

  • Is taking or has taken within the past 14 days an anti-depressant medicine called a monoamine oxidase inhibitor (MAOI)
  • Is sensitive to, allergic to, or had a reaction to other stimulant medicines
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Potential Risks and Side Effects

Vyvanse is a stimulant medicine. The following have been reported with use of stimulant medicines. See additional safety information below.

Heart-related problems Heart-related problems including:

  • Sudden death in people who have heart problems or heart defects
  • Sudden death, stroke, and heart attack in adults
  • Increased blood pressure and heart rate

Tell the doctor about any heart problems, heart defects, and/or high blood pressure, or if you have a family history of these problems. The doctor should check blood pressure and heart rate regularly during treatment.

Call your doctor right away if you have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.

Mental (psychiatric) problems Mental (psychiatric) problems including:

  • New or worse behavior and thought problems
  • New or worse bipolar illness

In Children (6–17):

  • New psychotic symptoms such as:
    • Seeing things or hearing voices that are not real
    • Believing things that are not true
    • Being suspicious
  • New manic symptoms

Tell your doctor about any mental problems you have, or if you have a family history of suicide, bipolar illness, or depression.

Call the doctor to discuss any new or worsening mental symptoms or problems while taking Vyvanse.

Circulation problems in fingers and toes Circulation problems in fingers and toes
[peripheral vasculopathy, including Raynaud's phenomenon]:

  • Fingers or toes may feel numb, cool, painful, sensitive to temperature and/or change color from pale, to blue, to red.

Tell your doctor if you have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call the doctor to report these signs or symptoms or if any unexplained wounds on fingers or toes appear while taking Vyvanse. 

Slowing of growth (height and weight) in children Slowing of growth (height and weight) in children

Your child should have his or her height and weight checked often while taking Vyvanse for ADHD. The doctor may stop treatment if a problem is found during these check-ups.

Tell the doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed. Tell the doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed.

Tell your doctor if you have any kidney problems. Your doctor may lower your dose Tell your doctor if you have any kidney problems. Your doctor may lower your dose

Learn about side effects of Vyvanse The most common side effects of Vyvanse reported in ADHD studies were:

  • Anxiety
  • Decreased appetite
  • Diarrhea
  • Dizziness
  • Dry mouth
  • Irritability
  • Loss of appetite
  • Nausea
  • Trouble sleeping
  • Upper stomach pain
  • Vomiting
  • Weight loss

Learn about side effects of Vyvanse The most common side effects of Vyvanse reported in studies of adults with moderate to severe B.E.D. were:

  • Dry mouth
  • Trouble sleeping
  • Decreased appetite
  • Increased heart rate
  • Constipation
  • Feeling jittery
  • Anxiety

These are not all the possible side effects of Vyvanse. Ask the doctor or pharmacist for more information and talk to the doctor about any side effects you or your child may be experiencing.

Please see the Vyvanse Prescribing Information and Medication Guide for more information.

Talk to the doctor about this information and any side effects you or your child may have.

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IMPORTANT SAFETY INFORMATION

Vyvanse® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is against the law.

Vyvanse is a stimulant medicine. Tell the doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Who should not take Vyvanse?

Do not take Vyvanse if you or your child is:

  • taking or has taken an anti-depression medicine called a monoamine oxidase inhibitor (MAOI) within the past 14 days.
  • sensitive or allergic to, or had a reaction to other stimulant medicines.

Problems that can occur while taking Vyvanse. Tell the doctor:

  • if you or your child have heart problems or heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in people with heart problems or defects, and sudden death, stroke and heart attack have happened in adults. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment. Call the doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.
  • if you or your child have mental problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worsening behavior and thought problems or bipolar illness may occur. New symptoms such as seeing or hearing things that are not real, believing things that are not true, being suspicious, or having new manic symptoms may occur. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
  • if you or your child have circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, painful, sensitive to temperature and/or change color from pale, to blue, to red. Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking Vyvanse.
  • if your child is having slowing of growth (height and weight); Vyvanse may cause this serious side effect. Your child should have his or her height and weight checked often while taking Vyvanse. The doctor may stop treatment if a problem is found during these check-ups.
  • if you or your child are pregnant, breast-feeding, or plan to become pregnant or breast-feed.

What are possible side effects of Vyvanse?

The most common side effects of Vyvanse reported in ADHD studies include:

    • anxiety
    • decreased appetite
    • diarrhea
    • dizziness
    • dry mouth
    • irritability
    • loss of appetite
    • nausea
    • trouble sleeping
    • upper stomach pain
    • vomiting
    • weight loss

The most common side effects of Vyvanse reported in studies of adults with moderate to severe B.E.D. include:

    • dry mouth
    • trouble sleeping
    • decreased appetite
    • increased heart rate
    • constipation
    • feeling jittery
    • anxiety

What is Vyvanse?

Vyvanse® (lisdexamfetamine dimesylate) is a prescription medicine used for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients 6 years and above, and for the treatment of moderate to severe Binge Eating Disorder (B.E.D.) in adults. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.

For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.