Side effects and safety information for Quillivant XR

Understanding the risks and benefits of your medicine is an important part of managing ADHD.

Quillivant XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Quillivant XR in a safe place to prevent misuse and abuse. Selling or giving away Quillivant XR may harm others, and is against the law. Tell your healthcare professional if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines, or street drugs.

It is not known if Quillivant XR is safe and effective in children under 6 years of age.

Side Effects Quilliavnt XR

What is the most important information I should know about Quillivant XR?

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

Tell your healthcare professional if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your healthcare professional should check your or your child carefully for heart problems before starting Quillivant XR.

Your healthcare professional should check your or your child's blood pressure and heart rate regularly during treatment with Quillivant XR.

Call your healthcare professional right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Quillivant XR.

 

Mental (Psychiatric) problems

All Patients

  • New or worse behavior and thought problems
  • New or worse bipolar illness

Children and Teenagers

  • New psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your healthcare professional about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare professional right away if you or your child have any new or worsening mental symptoms or problems while taking Quillivant XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

 

Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon)

  • Fingers or toes may feel numb, cool, painful
  • Fingers or toes may change color from pale, to blue, to red

Tell your healthcare professional if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.

Call your healthcare professional right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking Quillivant XR.

Who should not take Quillivant XR?

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 professional 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
  • Are pregnant or plan to become pregnant. It is not known if Quillivant XR will harm your unborn baby. Talk to your healthcare professional if you are pregnant or plan to become pregnant
  • Are breastfeeding or plan to breast feed. Quillivant XR passes into your breast milk. You and your healthcare professional should decide if you will take Quillivant XR or breast feed

Tell your healthcare professional 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 professional will decide whether Quillivant XR can be taken with other medicines.

Especially tell your healthcare professional 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 professional and pharmacist.

Do not start any new medicine while taking Quillivant XR without talking to your healthcare professional first.

What are possible side effects of Quillivant XR?

See "What is the most important information I should know about Quillivant XR?" for information on reported heart and mental problems.

Other serious side effects include:

  • Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a healthcare professional immediately
  • Slowing of growth (height and weight) in children

Common side effects include:

Decreased Indigestion Irritability
appetite Stomach pain Mood swings
Trouble sleeping Weight loss Fast heart beat
Nausea Anxiety Increased blood
Vomiting Dizziness pressure

Talk to your healthcare professional if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your healthcare professional or pharmacist for more information.

Call your healthcare professional for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.