IMPORTANT SAFETY INFORMATION

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Vyvanse may harm others and is illegal.

• Do not take Vyvanse if you:
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI
  • are sensitive to, allergic to, or had a reaction to other stimulant medicines
• Some people have had the following problems when taking stimulant medicines, such as Vyvanse:
  1. 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 your doctor if you have any heart problems, heart defects, high blood pressure, or a family history of these problems. The doctor should check your 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.

  2. Mental (psychiatric) problems including:

     • new or worse behavior and thought problems
     • new or worse bipolar illness
     • new psychotic symptoms (in children and teenagers with ADHD) such as:
       • seeing things or hearing voices that are not real
       • believing things that are not true
       • being suspicious
     • new manic symptoms

     Tell the doctor about any drug abuse, alcohol abuse or mental problems that you have had, or about a family history of suicide, bipolar illness, or depression.
     Call the doctor right away if you have any new or worsening mental symptoms or problems while taking Vyvanse.

  3. 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 you have any of these signs or symptoms or develop unexplained wounds on fingers or toes while taking Vyvanse.

• Vyvanse may cause serious side effects in children taking it for ADHD, including:
  • slowing of growth (height and weight). 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.
• Tell the doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed.
• 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
• 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

INDICATIONS

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.