Important Safety Information
Adzenys XR-ODT is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Adzenys XR-ODT in a safe place to prevent misuse and abuse. Selling or giving away Adzenys XR-ODT may harm others and is against the law.
Tell your doctor if you or your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Who should not take Adzenys XR-ODT?
Do not take Adzenys XR-ODT if you or your child is:
- allergic to methylphenidate or any ingredients in Adzenys XR-ODT.
- taking or has taken an anti-depression medicine called monoamine oxidase inhibitor (MAOI) within the past 14 days.
Adzenys XR-ODT is a stimulant medicine. Tell your doctor about health conditions, including if:
- you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in people with heart problems or defects, and sudden death, stroke and heart attack have happened in adults. Your doctor should check for heart problems prior to prescribing Adzenys XRODT and will check you or your child’s blood pressure and heart rate during treatment. Call the 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 Adzenys XR-ODT.
- you or your child has mental problems, or a family history of suicide, bipolar illness, or depression. This is important because the following could occur: new or worse behavior and thought problems, new or worse bipolar illness, new psychotic symptoms (hearing voices, believing things that are not true, are suspicious) or new manic symptoms. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
- you or your child has 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 Adzenys XR-ODT.
- your child is having slowing of growth (height and weight). Your child should have his or her height and weight checked often while taking Adzenys XR-ODT. The doctor may stop treatment if a problem is found during these check-ups.
- you or your child has kidney problems. Your doctor may lower the dose.
- you or your child is, or plans to become pregnant.
- you or your child is breastfeeding, or plans to breastfeed. You should not breastfeed while taking Adzenys XR-ODT.
- you or your child takes any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Adzenys XR-ODT and some medicines may interact with each other and cause serious side effects.
Do not start any new medicine while taking Adzenys XR-ODT without talking to your doctor first.
What should I avoid while taking Adzenys XR-ODT?
Common side effects of Adzenys XR-ODT include:
- Decreased appetite and problems sleeping.
- Children 6 — 12 Years also include: Stomach pain, extreme mood change, vomiting, nervousness, nausea, and fever.
- Children 13 — 17 Years also include: Stomach pain and weight loss.
- Adults also include: Dry mouth, headache, weight loss, nausea, anxiety, restlessness, dizziness, fast heart beat, diarrhea, weakness, and urinary tract infections.
These are not all the possible side effects of Adzenys XR-ODT. Call your doctor for medical advice about side effects.
What is Adzenys XR-ODT?
Adzenys XR-ODT is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and above.
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.