Abuse, Misuse, and Addiction. VYVANSE has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of VYVANSE, other amphetamine-containing medicines, and methylphenidate-containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of VYVANSE or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider (HCP) should check your or your child’s risk for abuse, misuse, and addiction before starting treatment with VYVANSE and will monitor you or your child during treatment. VYVANSE may lead to physical dependence after prolonged use, even if taken as directed by your HCP. Do not give VYVANSE to anyone else. Keep VYVANSE in a safe place and properly dispose of any unused medicine.
Tell your HCP if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Vyvanse is a federally controlled substance (CII) because it contains lisdexamfetamine dimesylate that can be a target for people who abuse prescription medicines or street drugs. Keep Vyvanse in a safe place to protect it from theft. Never sell or give your Vyvanse to anyone else because it may cause death or harm to them and it is against the law.
Who should not take Vyvanse?
Do not take Vyvanse if you or your child are:
- allergic to amphetamine products or any of the ingredients in Vyvanse. See Medication Guide for a list of ingredients.
- taking, or have stopped taking in the last 14 days, a medicine called a Monoamine Oxidase Inhibitor (MAOI).
- being treated with the antibiotic linezolid or intravenous methylene blue.
Vyvanse may cause serious side effects, including:
- Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your HCP should check you or your child carefully for heart problems before starting treatment with Vyvanse. Tell your HCP if you or your child have any heart problems, heart disease, heart defects, or high blood pressure. Call your HCP right away or go to the ER right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Vyvanse.
- Increased blood pressure and heart rate. Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with Vyvanse.
- Mental (psychiatric) problems, including: new or worse behavior and thought problems; new or worse bipolar illness; new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms. Tell your HCP about any mental problems you or your child have or about a family history of suicide, bipolar illness, or depression. Call your HCP right away if you or your child have any new or worsening mental symptoms or problems during treatment with Vyvanse, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
- Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with Vyvanse. Vyvanse treatment may be stopped if your child is not growing or gaining weight.
- Circulation problems in fingers and toes (Peripheral vasculopathy, including Raynaud’s phenomenon). Tell your HCP if your or your child’s fingers or toes feel numb, cool, painful, change color from pale, to blue, to red, or if they are sensitive to temperature. Call your HCP right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with Vyvanse.
- New or worsening tics or worsening Tourette’s syndrome. Tell your HCP if you or your child have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome. Tell your HCP if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with Vyvanse.
- Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome may happen when Vyvanse is taken with certain other medicines. Stop taking Vyvanse and call your HCP or go to the nearest hospital ER right away if you or your child develop any of the following signs and symptoms of serotonin syndrome: agitation, flushing, coma, loss of coordination, dizziness, seeing or hearing things that are not real (hallucination), high body temperature (hyperthermia), fast heartbeat, seizures, sweating, confusion, tremors, stiff muscles, or muscle twitching, changes in blood pressure, nausea, vomiting, diarrhea.
Before taking Vyvanse, tell your HCP about all medical conditions, including if you or your child:
- have kidney problems.
- are pregnant or plan to become pregnant. Vyvanse may harm the unborn baby.
- are breastfeeding or plan to breastfeed. Vyvanse passes into breast milk. You or your child should not breastfeed during treatment with Vyvanse. Talk to your HCP about the best way to feed the baby during treatment with Vyvanse.
What are possible side effects of Vyvanse?
The most common side effects of Vyvanse in children 6 to 17 and adults with ADHD include:
- loss of appetite (anorexia)
- decreased appetite
- dry mouth
- trouble sleeping
- stomach pain
- weight loss
The most common side effects of Vyvanse in adults with moderate to severe B.E.D. include:
- dry mouth
- decreased appetite
- trouble sleeping
- increased heart rate
- feeling jittery
What is Vyvanse?
Vyvanse 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 use in children under 6 years of age with ADHD. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity. It is not known if Vyvanse is safe and effective for use in children with B.E.D.
For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your HCP.
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.
Takeda is committed to helping ensure the proper use of stimulant medication. Please see the Proper Use of Prescription Stimulant Medication for additional information.
There is a pregnancy registry for females who are exposed to VYVANSE during pregnancy. The purpose of the registry is to collect information about the health of females exposed to VYVANSE and their baby. If you or your child becomes pregnant during treatment with VYVANSE, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/adhd-medications/.