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Safety & Side Effects

Find important information about side effects

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.
  • 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.

  • Your healthcare provider may often ask you to stop taking Quillivant XR for some time to check your ADHD symptoms
  • Your healthcare provider may check your blood, heart, and blood pressure while you are taking Quillivant XR
  • Children should have their height and weight checked often. If a problem is found, your healthcare provider may ask you to stop taking Quillivant XR
  • In case of poisoning, immediately call 1-800-222-1222, or, go to the nearest hospital emergency room
  • If you miss a dose of Quillivant XR, be sure to speak with your healthcare provider
  • 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 side effects to the FDA at 1-800-FDA-1088.

For more information about the possible side effects of Quillivant XR, see full Prescribing Information.

FDA, Food and Drug Administration

See Quillivant XR dosing & administration information.

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Important Safety Information & Approved Use

DYANAVEL® XR (amphetamine), Quillivant XR® (methylphenidate HCI), and QuilliChew ER® (methylphenidate HCI) are federally controlled substances (CII) because they can be a target for people who abuse prescription medicines or street drugs. DYANAVEL XR, Quillivant XR, and QuilliChew ER have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Keep these medicines in a safe place to prevent abuse and misuse. Selling or giving away these medicines 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 DYANAVEL XR, Quillivant XR, and QuilliChew ER 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.

See Additional Important Safety Information.

Important Safety Information & Approved Use

DYANAVEL® XR (amphetamine), Quillivant XR® (methylphenidate HCl), and QuilliChew ER® (methylphenidate HCl) are federally controlled substances (CII) because they can be a target for people who abuse prescription medicines or street drugs. DYANAVEL XR, Quillivant XR, and QuilliChew ER have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Keep these medicines in a safe place to prevent abuse and misuse. Selling or giving away these medicines 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 DYANAVEL XR, Quillivant XR, and QuilliChew ER 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.

DYANAVEL XR, or Quillivant XR and QuilliChew ER, should not be taken if you or your child are allergic to amphetamine or methylphenidate hydrochloride, respectively, or any of the ingredients in these medicines, or are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI including the antibiotic linezolid and the intravenous medicine methylene blue.

DYANAVEL XR, Quillivant XR, and QuilliChew ER can cause serious side effects. Tell the doctor:

  • if you or your child have heart problems, heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in children 6 to 17 years old with heart problems or defects, and sudden death, stroke, and heart attack have happened in adults. Your doctor should check you or your child carefully for heart problems before starting any of these medicines. Call the doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking any of these medicines.
  • Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment.
  • if you or your child have mental problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worsening behavior and thought problems or bipolar illness may occur. New symptoms such as seeing or hearing things that are not real, believing things that are not true, being suspicious, or having new manic symptoms may occur. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
  • if you or your child have circulation problems in fingers and toes (called 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 DYANAVEL XR, Quillivant XR, or QuilliChew ER.
  • if your child is having slowing of growth (height and weight); Your child should have his or her height and weight checked often while taking DYANAVEL XR, Quillivant XR, or QuilliChew ER.
  • 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.
  • There have been cases of increased eye pressure and acute angle closure glaucoma, an emergency that results from a rapid increase in your eye pressure with Quillivant XR and QuilliChew ER. Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.
  • if you or your child develop painful and prolonged erections (priapism), seek medical help right away. Priapism has occurred with methylphenidate (Quillivant XR and QuilliChew ER). Because priapism can cause long-lasting damage, it should be checked by a doctor right away.
  • if you or your child have symptoms of serotonin syndrome - agitation, hallucinations, coma, or other changes in mental status; fast heartbeat; sweating or fever; nausea, vomiting, diarrhea; high or low blood pressure; problems controlling movements or muscle twitching; muscle stiffness or tightness. Serotonin syndrome may occur when DYANAVEL XR is taken with certain other medicines and may be life-threatening. Stop DYANAVEL XR and call your doctor or go to the nearest hospital emergency room.
  • if you or your child have phenylketonuria (PKU). QuilliChew ER contains phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU or who are allergic to phenylalanine.
  • if you or your child are pregnant or plan to become pregnant. It is not known if DYANAVEL XR, Quillivant XR, or QuilliChew ER will harm your unborn baby. There is a pregnancy registry for females who are exposed to DYANAVEL XR, Quillivant XR, or QuilliChew ER during pregnancy. The purpose of the registry is to collect information about the health of females exposed to DYANAVEL XR, Quillivant XR, or QuilliChew ER and their baby. If you or your child becomes pregnant during treatment with DYANAVEL XR, Quillivant XR, or QuilliChew ER, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
  • You and your child should not breastfeed while you are taking DYANAVEL XR. You and your healthcare provider should decide if you will take Quillivant XR or QuilliChew ER or breastfeed.

Common side effects of amphetamine products include:

  • dry mouth
  • nausea
  • extreme mood changes
  • decreased appetite
  • trouble sleeping
  • dizziness
  • weight loss
  • restlessness
  • increased heart rate
  • stomach pain

Common side effects of methylphenidate products inlude:

  • decreased appetite
  • stomach pain
  • irritability
  • trouble sleeping
  • weight loss
  • mood swings
  • nausea
  • anxiety
  • fast heart beat
  • vomiting
  • dizziness
  • increased blood pressure
  • indigestion

Talk to your doctor if you or your child have any side effects that bother you or do not go away.

Avoid drinking alcohol while taking DYANAVEL XR, Quillivant XR, or QuilliChew ER.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

APPROVED USE

DYANAVEL XR, Quillivant XR, and QuilliChew ER are central nervous system (CNS) stimulant prescription medicines used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older. These medicines may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if DYANAVEL XR, Quillivant XR, and QuilliChew ER are safe and effective in children under 6 years of age.

See Medication Guide for DYANAVEL XR, Quillivant XR, and QuilliChew ER.

See Full Prescribing Information for DYANAVEL XR, Quillivant XR, and QuilliChew ER, including Boxed Warning about Abuse, Misuse and Addiction.

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