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What are possible side effects of Cotempla XR-ODT?

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

  • Abuse and dependence.
  • Heart-related problems.
  • Mental (psychiatric) problems.
  • Painful and prolonged erections (priapism).
  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon).
  • Slowing of growth (height and weight).

The most common side effects of methylphenidate products include:
  • Decreased appetite
  • Trouble sleeping
  • Nausea
  • Vomiting
  • Indigestion
  • Stomach pain
  • Weight loss
  • Anxiety
  • Dizziness
  • Irritability
  • Mood swings
  • Increased heart rate
  • Increased blood pressure

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


These are not all the possible side effects of Cotempla XR-ODT. Ask your child's doctor or pharmacist for more information.


Call your child's doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Cotempla XR-ODT is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep Cotempla XR-ODT in a safe place to protect it from theft. Never give your Cotempla XR-ODT to anyone else, because it may cause death or harm them. Selling or giving away Cotempla XR-ODT may harm others and is against the law.

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

Step one

Abuse and dependence.

COTEMPLA XR-ODT, other methylphenidate containing medicines, and amphetamines have a high chance for abuse and can cause physical and psychological dependence. Your child's doctor should check your child for signs of abuse and dependence before and during treatment with Cotempla XR-ODT.

  • Tell your child's doctor if your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.
  • Your child's doctor can tell you more about the differences between physical and psychological dependence and drug addiction.

Step two

Heart-related problems, including:

  • Sudden death in children who have heart problems or heart defects.
  • Increased blood pressure and heart rate.

Your child's doctor should check your child carefully for heart problems before starting Cotempla XR-ODT. Tell the doctor if your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your child's doctor should check your child's blood pressure and heart rate regularly during treatment with Cotempla XR-ODT.

Call your child's doctor or go to the nearest hospital emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Cotempla XR-ODT.


Step three

Mental (psychiatric) problems, including:

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

Tell your child's doctor about any mental problems your child has, or about a family history of suicide, bipolar illness, or depression.

Call the doctor right away if your child has any new or worsening mental symptoms or problems during treatment with Cotempla XR-ODT, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

What is Cotempla XR-ODT?

Cotempla XR-ODT is a central nervous system stimulant medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. Cotempla XR-ODT may help increase attention and decrease impulsiveness and hyperactivity in children 6 to 17 years of age with ADHD.

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

Who should not take Cotempla XR-ODT?

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

  • Allergic to methylphenidate or any of the ingredients in Cotempla XR-ODT. See the Medication Guide for a complete list of ingredients in Cotempla XR-ODT.
  • Taking, or have taken within the past 14 days, an anti-depression medicine called monoamine oxidase inhibitor (MAOI).

What should I tell my child's doctor before my child takes Cotempla XR-ODT?

Before taking Cotempla XR-ODT, tell your child's doctor about all health conditions including if your child has:

  • 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 child's doctor about all of the medicines that your child takes including prescription and over-the-counter medicines, vitamins, and herbal supplements. Cotempla 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 during treatment with Cotempla XR-ODT. Your child's doctor will decide whether Cotempla XR-ODT can be taken with other medicines.

It's especially important to tell your child's doctor if your child takes:

  • Anti-depression medicines including monoamine oxidase inhibitor (MAOIs).

Know the medicines that your child takes. Keep a list of your child's medicines with you to show the doctor and pharmacist. Do not start your child on any new medicine during treatment with Cotempla XR-ODT without talking to your child's doctor first.

How should Cotempla XR-ODT be stored?

  • Store Cotempla XR-ODT at room temperature between 68°F and 77°F (20°C and 25°C).
  • Store Cotempla XR-ODT in a safe place, like a locked cabinet.
  • Store Cotempla XR-ODT in the blister packaging until it is ready to be taken.
  • Dispose of remaining, unused, or expired Cotempla XR-ODT by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Cotempla XR-ODT with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away Cotempla XR-ODT in the household trash.

Keep Cotempla XR-ODT and all medicines out of the reach of children.

What are the ingredients in Cotempla XR-ODT?

Active Ingredients: Methylphenidate

Inactive Ingredients: Mannitol, Fructose, Microcrystalline Cellulose, Crospovidone, Methacrylic Acid, Polystyrene Sulfonate, Citric Acid, Colloidal Silicon Dioxide, Grape Flavor, Natural Masking Type Powder, Triethyl Citrate, Magnesium Stearate, Ethylcellulose, Sucralose, Lake Blend Purple, and Polyethylene Glycol

Important Safety Information

Cotempla XR-ODT is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Cotempla XR-ODT in a safe place to protect it from theft. Selling or giving away your Cotempla XR-ODT may cause death or harm to others and is against the law.

Who should not take Cotempla XR-ODT?

Do not give Cotempla XR-ODT to your child if they are:
  • allergic to methylphenidate or any ingredients in Cotempla XR-ODT.
  • taking or has taken an anti-depression medicine called monoamine oxidase inhibitor (MAOI) within the past 14 days.

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

Cotempla XR-ODT can cause serious side effects. Tell your healthcare provider about health conditions, including if your child:
  • has ever abused or been dependent on alcohol, prescription medicines, or street drugs. Cotempla XR-ODT has a high chance for abuse and can cause physical and psychological dependence.
  • 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. Increased blood pressure and heart rate have been reported. Your healthcare provider should check for heart problems prior to prescribing Cotempla XR-ODT and will check your child's blood pressure and heart rate regularly during treatment. Call the healthcare provider or go to the nearest hospital emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while during treatment.
  • 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, or seeing or believing things that are not real) or new manic symptoms. Call your healthcare provider right away if there are any new or worsening mental symptoms or problems during treatment.
  • develops painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. Get medical help right away if your child develops priapism.
  • has circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon). Fingers or toes may feel numb, cool, painful, and/or change color from pale, to blue, to red. Tell your healthcare provider if your child has numbness, pain, skin color change, or sensitivity to temperature in their fingers or toes. Call the healthcare provider right away if any signs of unexplained wounds appear on fingers or toes while taking Cotempla XR-ODT.
  • is having slowing of growth (height and weight). Your child should have his or her height and weight checked often while taking Cotempla XR-ODT. Treatment may be stopped if your child is not gaining weight or height.
  • is pregnant or plans to become pregnant. It is not known if Cotempla XR-ODT will harm the unborn baby. If your child becomes pregnant during treatment with Cotempla XR-ODT, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants.
  • is breastfeeding, or plans to breastfeed. You and your healthcare provider should decide if your child will take Cotempla XR-ODT or breastfeed.
  • takes any medicines, including prescription and over-the-counter medicines (especially for depression, including MAOIs), vitamins, and herbal supplements. Cotempla XR-ODT and some medicines may interact with each other and cause serious side effects, or sometimes the dose of the other medicine will need to be adjusted.

Do not start any new medicine while taking Cotempla XR-ODT without talking to your healthcare provider first.

What should I avoid during treatment with Cotempla XR-ODT?
  • You should avoid drinking alcohol during treatment with Cotempla XR-ODT.
Common side effects of Cotempla XR-ODT include:

Decreased appetite, trouble sleeping, nausea, vomiting, indigestion, stomach pain, weight loss, anxiety, dizziness, irritability, mood swings, increased heart rate, and increased blood pressure.

These are not all the possible side effects of Cotempla XR-ODT. Call your healthcare provider for medical advice about side effects.

What is Cotempla XR-ODT?

Cotempla XR-ODT is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. COTEMPLA XR-ODT is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep Cotempla XR-ODT in a safe place to protect it from theft. Selling or giving away your Cotempla XR-ODT may cause death or harm to others and is against the law.

For additional safety information, click here for Full Prescribing Information and Medication Guide and discuss with your healthcare provider

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.

Cotempla XR-ODT is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Cotempla XR-ODT in a safe place to protect it from theft. Selling or giving away your Cotempla XR-ODT may cause death or harm to others and is against the law.

Who should not take Cotempla XR-ODT?

Do not give Cotempla XR-ODT to your child if they are:
  • allergic to methylphenidate or any ingredients in Cotempla XR-ODT.
  • taking or has taken an anti-depression medicine called monoamine oxidase inhibitor (MAOI) within the past 14 days.

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

Cotempla XR-ODT can cause serious side effects. Tell your healthcare provider about health conditions, including if your child:
  • has ever abused or been dependent on alcohol, prescription medicines, or street drugs. Cotempla XR-ODT has a high chance for abuse and can cause physical and psychological dependence.
  • 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. Increased blood pressure and heart rate have been reported. Your healthcare provider should check for heart problems prior to prescribing Cotempla XR-ODT and will check your child's blood pressure and heart rate regularly during treatment. Call the healthcare provider or go to the nearest hospital emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while during treatment.
  • 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, or seeing or believing things that are not real) or new manic symptoms. Call your healthcare provider right away if there are any new or worsening mental symptoms or problems during treatment.
  • develops painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. Get medical help right away if your child develops priapism.
  • has circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon). Fingers or toes may feel numb, cool, painful, and/or change color from pale, to blue, to red. Tell your healthcare provider if your child has numbness, pain, skin color change, or sensitivity to temperature in their fingers or toes. Call the healthcare provider right away if any signs of unexplained wounds appear on fingers or toes while taking Cotempla XR-ODT.
  • is having slowing of growth (height and weight). Your child should have his or her height and weight checked often while taking Cotempla XR-ODT. Treatment may be stopped if your child is not gaining weight or height.
  • is pregnant or plans to become pregnant. It is not known if Cotempla XR-ODT will harm the unborn baby. If your child becomes pregnant during treatment with Cotempla XR-ODT, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants.
  • is breastfeeding, or plans to breastfeed. You and your healthcare provider should decide if your child will take Cotempla XR-ODT or breastfeed.
  • takes any medicines, including prescription and over-the-counter medicines (especially for depression, including MAOIs), vitamins, and herbal supplements. Cotempla XR-ODT and some medicines may interact with each other and cause serious side effects, or sometimes the dose of the other medicine will need to be adjusted.

Do not start any new medicine while taking Cotempla XR-ODT without talking to your healthcare provider first.

What should I avoid during treatment with Cotempla XR-ODT?
  • You should avoid drinking alcohol during treatment with Cotempla XR-ODT.
Common side effects of Cotempla XR-ODT include:

Decreased appetite, trouble sleeping, nausea, vomiting, indigestion, stomach pain, weight loss, anxiety, dizziness, irritability, mood swings, increased heart rate, and increased blood pressure.

These are not all the possible side effects of Cotempla XR-ODT. Call your healthcare provider for medical advice about side effects.

What is Cotempla XR-ODT?

Cotempla XR-ODT is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. COTEMPLA XR-ODT is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep Cotempla XR-ODT in a safe place to protect it from theft. Selling or giving away your Cotempla XR-ODT may cause death or harm to others and is against the law.

For additional safety information, click here for Full Prescribing Information and Medication Guide and discuss with your healthcare provider

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.