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What are possible side effects of Adzenys XR-ODT?

Adzenys XR-ODT can cause serious side effects, including:

  • Heart-related problems and mental problems.
  • Slowing of growth (height and weight) in children.

Common side effects of Adzenys XR-ODT include decreased appetite and problems sleeping.

Common Side Effects of Adzenys XR-ODT
Children
(6-12 yrs)
Adolescents
(13-17 yrs)
Adults
  • Decreased appetite
  • Problems sleeping
  • Stomach pain
  • Extreme mood change
  • Vomiting
  • Nervousness
  • Nausea
  • Fever
  • Decreased appetite
  • Problems sleeping
  • Stomach pain
  • Weight loss
  • Decreased appetite
  • Problems sleeping
  • Dry mouth
  • Nausea
  • Dizziness
  • Weakness
  • Headache
  • Anxiety
  • Fast heart beat
  • Urinary tract infections
  • Weight loss
  • Restlessness
  • Diarrhea

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


These are not all the possible side effects Adzenys XR-ODT. Ask your doctor or pharmacist for more information.


Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

What is the most important information I should know about Adzenys XR-ODT?

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.

Adzenys XR-ODT is a stimulant medicine. Some patients have had the following problems when taking stimulant medicines.

1. Heart-related problems:

  • Sudden death in patients who have heart problems or heart defects.
  • Sudden death, stroke and heart attack in adults.
  • Increased blood pressure and heart rate.

Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting Adzenys XR-ODT.

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with Adzenys XR-ODT.

Call your 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.

2. Mental (Psychiatric) problems

All Patients:

  • New or worse behavior and thought problems.
  • New or worse bipolar illness.
  • New psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms.

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

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

3. 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 from pale, to blue, to red.

Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. Call your doctor right away if you have or your child has any unexplained wounds appearing on fingers or toes while taking Adzenys XR-ODT.

What is Adzenys XR-ODT?

Adzenys XR-ODT is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Adzenys XR-ODT may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

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

Who should not take Adzenys XR-ODT?

Adzenys XR-ODT should not be taken if you or your child is:

  • Allergic to amphetamine, or any of the ingredients in Adzenys XR-ODT. See the end of this section for a complete list of ingredients in Adzenys XR-ODT.
  • Taking or have taken within the past 14 days an anti-depression medicine called monoamine oxidase inhibitor or MAOI.

What should I tell my doctor before taking Adzenys XR-ODT?

Adzenys XR-ODT may not be right for you or your child. Before starting Adzenys XR-ODT, tell your or your child's doctor about all health conditions (or a family history of) including:

  • Heart problems, heart defects, or high blood pressure
  • Mental problems including psychosis, mania, bipolar illness, or depression
  • Circulation problems in fingers and toes

Tell your doctor:

  • If you or your child has kidney problems. Your doctor may lower the dose.
  • If you or your child is pregnant, or plan to become pregnant. It is not known if Adzenys XR-ODT will harm your unborn baby.
  • If you or your child is breastfeeding or plan to breastfeed. Adzenys XR-ODT passes into breast milk. You should not breastfeed while you are taking Adzenys XR-ODT.

Tell your doctor about all of the medicines that you or your child takes 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. Sometimes the doses of other medicines will need to be adjusted while taking Adzenys XR-ODT.

Your doctor will decide whether Adzenys XR-ODT can be taken with other medicines.

Especially tell your doctor if you or your child takes: Anti-depression medicines including MAOIs.

Know the medicines that you or your child take. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Adzenys XR-ODT without talking to your doctor first.

How should Adzenys XR-ODT be taken?

  • Take Adzenys XR-ODT exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  • Take Adzenys XR-ODT once daily in the morning.
     -  Leave the tablet in the blister pack until you are ready to take or give it.
     -  Use dry hands to open the blister pack.
     -  Tear along the perforation, bend the blister where indicated and peel back the blister's labeled backing to take out the tablet. Do not push the tablet through the foil.
     -  Place the tablet on the tongue.
     -  Take Adzenys XR-ODT as soon as you open the blister pack. The tablet will dissolve in your mouth (saliva) so that it can be swallowed.
     -  Do not crush or chew.
  • Adzenys XR-ODT can be taken with or without food.
  • Your doctor may sometimes stop Adzenys XR-ODT treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of your or your child's blood, heart, and blood pressure while taking Adzenys XR-ODT.
  • Children should have their height and weight checked often while taking Adzenys XR-ODT. Adzenys XR-ODT treatment may be stopped if a problem is found during these check-ups.

If you or your child take(s) too much Adzenys XR-ODT, call your doctor or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.

Avoid taking Adzenys XR-ODT while drinking alcohol.

What are the ingredients in Adzenys XR-ODT?

Active Ingredients: Amphetamine
Inactive Ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol.

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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 amphetamine 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 XR-ODT 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?
  • drinking alcohol
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.

For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.

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.

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 amphetamine 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 XR-ODT 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?
  • drinking alcohol
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.

For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.

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.