Important Safety Information
Medication Guide and Prescribing Information
DYANAVEL XR tablet Tris ADHD medication
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For patients 6 years and older with ADHD

DYANAVEL® XR tablet side effects and safety information

Find important information about side effects and safety

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

DYANAVEL XR should not be taken if you or your child are allergic to amphetamine, or any of the ingredients in DYANAVEL 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 amphetamine 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 DYANAVEL 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 DYANAVEL XR
  • Symptoms of serotonin syndrome:
    • Agitation, hallucinations, coma, or changes in mental status; problems controlling movements or muscle twitching, stiffness, or tightness; fast heartbeat; sweating or fever; nausea, vomiting or diarrhea. Call your doctor or go to the emergency room if symptoms occur. Serotonin syndrome may occur if DYANAVEL XR is taken with certain medicines and may be life-threatening
  • Slowing of growth (height and weight) in children:
    • Your child should have his or her height and weight checked often while taking DYANAVEL XR for Attention Deficit Hyperactivity Disorder (ADHD). The doctor may stop treatment if a problem is found during these check-ups.

Children should have their height and weight checked often while taking DYANAVEL XR. DYANAVEL XR treatment may be stopped if a problem is found during check-ups.

DYANAVEL XR should not be taken if you or your child:

  • Are allergic to amphetamine, or any of the ingredients in DYANAVEL XR. See the end of the Medication Guide for a complete list of ingredients in DYANAVEL XR
  • Are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor, or MAOI

DYANAVEL XR may not be right for you or your child. Before starting DYANAVEL 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
  • Are pregnant or plan to become pregnant. It is not known if DYANAVEL 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. DYANAVEL XR passes into your breast milk. You and your healthcare provider should decide if you will take DYANAVEL 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. DYANAVEL 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 DYANAVEL XR.

Your healthcare provider will decide whether DYANAVEL 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 DYANAVEL XR without talking to your healthcare provider first.

  • Your healthcare provider may often ask you to stop taking DYANAVEL XR for some time to check your ADHD symptoms
  • Your healthcare provider may check your blood, heart, and blood pressure while you are taking DYANAVEL XR
  • Children should have their height and weight checked often. If a problem is found, your healthcare provider may ask you to stop taking DYANAVEL 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 DYANAVEL XR, be sure to speak with your healthcare provider
  • Painful and prolonged erections, known as priapism, have occurred with methylphenidate. If they occur, seek medical help right away. Because priapism can cause lasting damage, it should be checked by a healthcare provider right away
  • The most common side effects of DYANAVEL 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 DYANAVEL 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 DYANAVEL XR, see full Prescribing Information.

FDA, Food and Drug Administration.

See DYANAVEL XR tablet 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 abused or lead to dependence. Keep these medicines in a safe place to prevent misuse and abuse. Selling or giving away these medicines may harm others and is against the law. Tell your doctor 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 HCI), and QuilliChew ER® (methylphenidate HCI) are federally controlled substances (CII) because they can be abused or lead to dependence. Keep these medicines in a safe place to prevent misuse and abuse. Selling or giving away these medicines may harm others and is against the law. Tell your doctor 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.

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. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment. 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.
  • 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.
  • 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. Tell your doctor if you or your child become pregnant during treatment with any of these medicines.
  • if you or your child is breastfeeding or plan to breastfeed. DYANAVEL XR, Quillivant XR, and QuilliChew ER pass into breast milk. You or your child should not breastfeed while you are taking any of these medicines.

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 negative 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 and Dependence.

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