Indication
Vyvanse is a prescription medicine for the treatment of ADHD in children ages 6 to 17 and adults. Vyvanse should be used as part of a total treatment program that may include counseling or other therapies.
Important Safety Information
Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is illegal. Vyvanse is a stimulant. Misuse of stimulants may cause sudden death and serious heart problems.
- Vyvanse should not be taken by patients who have:
Heart disease or hardening of the arteries, moderate to severe high blood pressure, overactive thyroid gland (hyperthyroidism), glaucoma, agitated states, a history of drug abuse, taken an anti-depression medicine called a monoamine oxidase inhibitor (MAOI) within the last 14 days, or sensitivity to, are allergic to, or had a reaction to other stimulant medicines.
- Vyvanse is a stimulant medicine. The following have been reported with use of stimulant medicines.
Heart-related problems:
sudden death in patients who have heart problems or heart defects
stroke and heart attack in adults
increased blood pressure and heart rate
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Call your 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.
Mental (Psychiatric) problems:
All Patients
new or worse behavior and thought problems
new or worse bipolar illness
new or worse aggressive behavior or hostility
Children and Teenagers
new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Vyvanse, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
- Serious side effects have been reported with use of stimulant medicines such as Vyvanse, including:
- seizures, mainly in patients with a history of seizures
- eyesight changes or blurred vision
- motion and verbal tics. Patients with tics or Tourette's syndrome may experience a worsening of symptoms while taking Vyvanse.
- slowing of growth. 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.
- The most common side effects reported in studies of Vyvanse were:
- upper belly pain
- nausea
- dry mouth
- dizziness
- weight loss
- trouble sleeping
- irritability
- decreased appetite
- vomiting
This is not a complete summary of safety information. For additional safety information, please click here for Full Prescribing Information and Medication Guide, including Warning about Potential for Abuse, 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.