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 are:
- taking or have 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.
Serious problems can occur while taking Vyvanse. Tell the doctor:
- if you or your child have heart problems, heart defects, high blood pressure, or a family history of these problems. Sudden death has occurred in people with heart problems or defects taking stimulant medicines. Sudden death, stroke and heart attack have happened in adults taking stimulant medicines. Your doctor should check you or your child carefully for heart problems before starting Vyvanse. 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 (psychiatric) problems, or a family history of suicide, bipolar illness, or depression. New or worse behavior and thought problems or new or worse bipolar illness may occur. New psychotic symptoms (such as seeing or hearing things that are not real, believing things that are not true, being suspicious) or new manic symptoms may occur. Call the doctor right away if there are any new or worsening mental symptoms or problems 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 or weight). The doctor should check your child’s height and weight often while on Vyvanse, and may stop treatment if a problem is found.
- if you or your child have symptoms of serotonin syndrome: agitation, hallucinations, coma, or changes in mental status; problems controlling movements or muscle twitching, stiffness, or tightness; fast heartbeat; sweating or fever; nausea, vomiting or diarrhea. Call your doctor or go to the emergency room if symptoms occur. Serotonin syndrome may occur if Vyvanse is taken with certain medicines and may be life-threatening.
- if you or your child are pregnant or plan to become pregnant. It is not known if Vyvanse may harm your unborn baby.
- if you or your child are breastfeeding or plan to breastfeed. Do not breastfeed while taking Vyvanse. Talk to your doctor about the best way to feed your baby if you take Vyvanse.
What are possible side effects of Vyvanse?
The most common side effects of Vyvanse in ADHD 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 in adults with moderate to severe B.E.D. include:
- dry mouth
- trouble sleeping
- decreased appetite
- increased heart rate
- constipation
- feeling jittery
- anxiety
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.
Shire is committed to helping ensure the proper use of stimulant medication. Please see the Proper Use of Prescription Stimulant Medication for additional information.
