Zenzedi (dextroamphetamine sulfate tablets, USP) is a prescription medicine for the treatment of narcolepsy. Zenzedi is also indicated as a treatment for ADHD in pediatric patients ages 3 to 16 years as an integral part of a total treatment program for ADHD that may include counseling or other therapies.
Important Safety Information
Zenzedi (dextroamphetamine sulfate tablets, USP) is a federally controlled substance (CII) with a high risk of abuse or dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Zenzedi may harm others and is illegal.
Do not take Zenzedi if you or your child:
- has a history of advanced heart disease or hardening of the arteries, moderate to severe high blood pressure, hyperthyroidism, known hypersensitivity or other serious cardiac problems that may place you or your child at increased vulnerability to the sympathomimetic effects of a stimulant drug, or glaucoma
- is very anxious, tense, or agitated
- has a history of drug abuse
- is taking or has taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI
Warnings and Precautions
Serious heart problems can occur when taking stimulant medicines, such as Zenzedi, and include:
- 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 or your child has any heart problems, including heart defects, abnormal heart rhythm, high blood pressure, disease known as cardiomyopathy, coronary artery disease, or a family history of these problems or sudden cardiac death. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Zenzedi.
Mental (psychiatric) problems can occur including:
- new or worsening behavior and thought problems
- new or worsening bipolar illness
New aggressive behavior or psychotic symptoms can occur in children and teenagers such as:
- seeing things or hearing voices
- believing things that are not true
- being suspicious
Tell your doctor about any drug abuse, alcohol abuse, or mental problems that you or your child has had, or about a family history of suicide, bipolar illness, or depression, new or worsening aggressive behavior or hostility. Call your doctor right away if you or your child has any new or worsening mental symptoms or problems while taking Zenzedi.
Circulation problems in fingers and toes:
- fingers or toes may feel numb, cool, painful
- fingers or toes may change color from pale, to blue, to red
Tell your doctor if you or your child has any numbness, pain, color change, or sensitivity to temperature in your fingers and toes or a family history of health conditions including circulation problems in fingers and toes. Call your doctor right away if you or your child has any signs of unexplained wounds appearing on fingers and toes while taking Zenzedi.
Zenzedi may cause serious side effects, including:
- slowing of growth (height and weight) in children, seizures, eyesight changes or blurred vision, and serotonin syndrome. Serotonin syndrome can be life threatening and happens when Zenzedi is taken with certain medicines. Symptoms include agitation, hallucinations, coma or other changes in mental status, problems controlling your movements or muscle twitching, fast heartbeat, high or low blood pressure, sweating or fever, nausea or vomiting, diarrhea, and muscle stiffness or tightness
The most common side effects reported with Zenzedi treatment include: fast heartbeat, tremors, trouble sleeping, stomach upset, dry mouth, decreased appetite, headache, dizziness, and weight loss.
Talk to your doctor if you or your child have side effects that are bothersome or do not go away, if you or your child is pregnant, plan on becoming pregnant, or are breast-feeding, about all health conditions (or a family history of), and about the medicines you or your child take. Your doctor will decide whether Zenzedi can be taken with other medicines and if Zenzedi is right for you or your child.
For additional safety information, consult the Zenzedi full Prescribing Information and Medication Guide.
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.