Quillivant XR is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Quillivant XR has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Keep Quillivant XR in a safe place to prevent abuse and misuse. Never give your Quillivant XR to anyone else, because it may cause death or harm them. Selling or giving away Quillivant XR may harm others and is against the law.
Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with Quillivant XR and will monitor you or your child during treatment. Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Quillivant XR should not be taken if you or your child are allergic to methylphenidate hydrochloride, or any of the ingredients in Quillivant XR, or are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.
The following have been reported with the use of methylphenidate hydrochloride and other 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
- Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with Quillivant XR
- Mental (psychiatric) problems:
- New or worse behavior and thought problems
- New or worse bipolar illness
- May cause new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
- Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon):
- Fingers or toes may feel numb, cool, painful, or may change color from pale, to blue, to red
Call your healthcare provider right away if you or your child have any:
- Heart-related symptoms such as chest pain, shortness of breath, or fainting
- New or worsening mental (psychiatric) symptoms or new manic symptoms
- Signs of unexplained wounds appearing on fingers or toes while taking Quillivant XR
- New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with Quillivant XR.
- Eye problems (increased pressure in the eye and glaucoma). Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.
Quillivant XR should not be taken if you or your child:
- Are allergic to methylphenidate hydrochloride, or any of the ingredients in Quillivant XR. See the end of the Medication Guide for a complete list of ingredients in Quillivant XR
- Are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor, or MAOI
Quillivant XR may not be right for you or your child. Before starting Quillivant XR tell your or your child’s healthcare provider about all health conditions (or a family history of) including:
- Heart problems, heart defects, high blood pressure
- Mental problems including psychosis, mania, bipolar illness, or depression
- Circulation problems in fingers and toes
- New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with Quillivant XR.
- Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism seek medical help right away. Because priapism can cause long lasting damage, it should be checked by a health care provider right away.
- Eye problems (increased pressure in the eye and glaucoma). Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.
- Slowing of growth. Children should have their height and weight checked often while taking Quillivant XR
- Are pregnant or plan to become pregnant. It is not known if Quillivant XR will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
- Are breastfeeding or plan to breastfeed. Quillivant XR passes into your breast milk. You and your healthcare provider should decide if you will take Quillivant XR or breastfeed
Tell your healthcare provider about all of the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. Quillivant XR and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Quillivant XR.
Your healthcare provider will decide whether Quillivant XR can be taken with other medicines.
Especially tell your healthcare provider if you or your child takes:
- Antidepression medicines including MAOIs
- Cold or allergy medicines that contain decongestants
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your healthcare provider and pharmacist.
Do not start any new medicine while taking Quillivant XR without talking to your healthcare provider first.
- The most common side effects of Quillivant XR include decreased appetite, trouble sleeping, nausea, vomiting, indigestion, stomach pain, weight loss, anxiety, dizziness, irritability, mood swings, fast heart beat, increased blood pressure
- These are not all the possible side effects of Quillivant XR
Call your healthcare provider for medical advice about side effects.
You may report adverse events related to Tris Pharma products by calling 1-732-940-0358 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch, where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.
For more information about the possible side effects of Quillivant XR, see full Prescribing Information.
FDA, Food and Drug Administration
