DAYTRANA® (methylphenidate)

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What is DAYTRANA?

DAYTRANA contains a prescription central nervous system (brain) stimulant medicine used to treat ADHD in children and adolescents 6 to 17 years old. Use of DAYTRANA may help increase attention and decrease impulsive and hyperactive behavior. DAYTRANA is a patch that you apply to your skin on your hip. DAYTRANA should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. It is not known if DAYTRANA is safe and effective in children less than 6 years.

IMPORTANT SAFETY INFORMATION

IMPORTANT:

DAYTRANA is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DAYTRANA in a safe place to protect it from theft. Selling or giving away DAYTRANA may harm others and is against the law. Tell the prescribing doctor if your child has ever abused or been dependent on alcohol, prescription medicines or street drugs.

DAYTRANA should not be used if your child:

has been diagnosed as very anxious, tense, or agitated
has an eye problem called glaucoma
has tics (repeated movements or sounds that cannot be controlled)
has a diagnosis or family history of Tourette's syndrome
is taking a monoamine oxidase inhibitor (MAOI) medicine or has discontinued an MAOI medicine in the last 2 weeks
or is allergic to methylphenidate, acrylic adhesive, or silicone adhesive.

Serious side effects have been reported with DAYTRANA or other stimulant medicines including:

Heart problems including:

sudden death in people with heart problems or heart defects
stroke and heart attack in adults
increased blood pressure and heart rate

Remove DAYTRANA and call the doctor right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting. Tell the doctor if your child or a family member has any heart problems, heart defects, or increased blood pressure and heart rate.

Mental (psychiatric) problems including:

new or worse aggressive behavior, hostility, anger or irritability
new or worse bipolar illness or mania (an extreme increase in activity or talking)
new or worse psychosis (hearing or seeing things that are not real, being suspicious, or distrustful, believing things that are not true)
other unusual or extreme changes in behavior or mood

Tell your doctor right away if your child has any new or worsening mental symptoms or problems while using DAYTRANA. Tell the doctor about any mental problems your child or family members have experienced including suicide or depression, bipolar illness, mania, or psychosis.

Circulation problems in fingers and toes: fingers or toes may feel numb, cool, painful and/or may change color 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 signs of unexplained wounds appearing on fingers or toes while using DAYTRANA

Tell your doctor if you, your child, or a family member has a history of vitiligo.

Be sure to tell the doctor if your child is pregnant or breast feeding.

Possible serious side effects of DAYTRANA include:

Seizures (this usually happens in children with a history of seizures)
Painful and prolonged erections (priapism). Because of the potential for lasting damage, seek medical help right away.
Slowing of growth (weight and height). You should have your child’s height and weight checked while using DAYTRANA.
Loss of skin color (chemical leukoderma). Call your doctor immediately if you have changes in your skin color.
Allergic skin rash. Stop using DAYTRANA and see your doctor right away if you have swelling or blisters at or around the application site.
Eyesight changes or blurred vision.

If the patch is worn longer than 9 hours in a day, or if more than 1 patch is worn at a time, too much medicine has been applied. Avoid exposing DAYTRANA to direct external heat sources such as hair dryers, heating pads, electric blankets, heated water beds, or other heat sources while wearing the patch. Heating the patch could cause too much medicine to pass into your child's body and cause serious side effects.

The most common side effects seen while using DAYTRANA include: skin problems (redness, small bumps, itching) where the patch is applied, poor appetite, nausea, vomiting, stomach pain, weight loss, tics, trouble sleeping, mood swings, and dizziness.

Please read Medication Guide and Full Prescribing Information including the Boxed Warning regarding abuse and dependence.

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

DAYTRANA^® is a registered trademark of Noven Therapeutics, LLC.

What is DAYTRANA?

DAYTRANA is a prescription central nervous system (brain) stimulant medicine used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children and adolescents 6 to 17 years of age. DAYTRANA may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. DAYTRANA is not recommended for use in children under 6 years of age with ADHD.

IMPORTANT SAFETY INFORMATION

Abuse, misuse, and addiction: DAYTRANA 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 DAYTRANA in a safe place to protect it from theft. Never give your DAYTRANA to anyone else because it may cause death or harm them. Selling or giving away DAYTRANA may harm others and is against the law. Tell your healthcare provider (HCP) if your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.

DAYTRANA should not be used if your child is:

Allergic to methylphenidate or any of the ingredients in DAYTRANA.
Taking, or has stopped taking within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

DAYTRANA may cause serious side effects including:

Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Tell your child’s HCP if your child has any heart problems, heart disease, or heart defects. Remove the DAYTRANA transdermal system (patch) and call your child’s HCP or go to the nearest 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 DAYTRANA.
Increased blood pressure and heart rate. Your child’s healthcare provider should check their blood pressure and heart rate regularly during treatment with DAYTRANA.
Mental (psychiatric) problems. Including new or worse behavior or thought problems; new or worse bipolar illness; new psychotic symptoms (such as hearing voices or seeing or believing things that are not real), or manic symptoms. Tell your child’s HCP about any mental problems they have or about family history of suicide or depression, bipolar illness, or depression. Call your child’s HCP right away if your child has any new or worsening mental symptoms or problems while using DAYTRANA.
Seizures. Your child’s HCP may stop treatment with DAYTRANA if they have a seizure.
Painful and prolonged erections (priapism). Priapism that may require surgery has happened in people who take products that contain methylphenidate. If your child develops priapism, get medical help right away.
Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, or painful. Fingers and toes may change color from pale, to blue, to red. Tell your child’s HCP if your child has any numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes. Call your child’s HCP right away if they have any signs of unexplained wounds appearing on fingers or toes during treatment with DAYTRANA.
Slowing of growth (height and weight) in children. Your child should have their height and weight checked often during treatment with DAYTRANA.
Eye problems (increased pressure in the eye and glaucoma). Call your child’s HCP right away if they develop changes in their vision, eye pain, swelling, or redness.
New or worsening tics or worsening Tourette’s syndrome. Tell your child’s HCP if they get any new or worsening tics or worsening Tourette’s syndrome during treatment with DAYTRANA.
Loss of skin color. Call your child’s HCP right away if they have changes in skin color. DAYTRANA may be stopped if your child has changes in skin color.
Allergic skin rash. Stop using DAYTRANA and tell your child’s HCP right away if they develop swelling or blisters at or around the application site.

Before taking DAYTRANA, tell your HCP about all the medications your child takes and their medical conditions, including if they:

Are pregnant or plan to become pregnant. DAYTRANA may harm the unborn baby. There is a pregnancy registry for females who are exposed to DAYTRANA during pregnancy. The purpose of the registry is to collect information about the health of women exposed to DAYTRANA and their baby. To learn more about registering with the National Pregnancy Registry of Psychostimulants Medications call 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/.
Are breastfeeding or plan to breastfeed. DAYTRANA passes into breast milk. Talk to your HCP about the best way to feed the baby during treatment with DAYTRANA.

The most common side effects of DAYTRANA in children 6 to 12 years old include: Decreased appetite, trouble sleeping, nausea, vomiting, weight loss, tics; changes in mood, and trouble eating.

The most common side effects of DAYTRANA in children 13 to 17 years old include: Decreased appetite, nausea, trouble sleeping, weight loss, dizziness, stomach pain, and trouble eating.

DAYTRANA may also cause skin problems where it is applied (redness, small bumps, itching).

Please read the Medication Guide and Full Prescribing Information, including the Boxed Warning.

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

What is DAYTRANA?

IMPORTANT SAFETY INFORMATION

DAYTRANA should not be used if your child is:

Allergic to methylphenidate or any of the ingredients in DAYTRANA.
Taking, or has stopped taking within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

DAYTRANA may cause serious side effects including:

Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Tell your child’s HCP if your child has any heart problems, heart disease, or heart defects. Remove the DAYTRANA transdermal system (patch) and call your child’s HCP or go to the nearest 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 DAYTRANA.
Increased blood pressure and heart rate. Your child’s healthcare provider should check their blood pressure and heart rate regularly during treatment with DAYTRANA.
Mental (psychiatric) problems. Including new or worse behavior or thought problems; new or worse bipolar illness; new psychotic symptoms (such as hearing voices or seeing or believing things that are not real), or manic symptoms. Tell your child’s HCP about any mental problems they have or about family history of suicide or depression, bipolar illness, or depression. Call your child’s HCP right away if your child has any new or worsening mental symptoms or problems while using DAYTRANA.
Seizures. Your child’s HCP may stop treatment with DAYTRANA if they have a seizure.
Painful and prolonged erections (priapism). Priapism that may require surgery has happened in people who take products that contain methylphenidate. If your child develops priapism, get medical help right away.
Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, or painful. Fingers and toes may change color from pale, to blue, to red. Tell your child’s HCP if your child has any numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes. Call your child’s HCP right away if they have any signs of unexplained wounds appearing on fingers or toes during treatment with DAYTRANA.
Slowing of growth (height and weight) in children. Your child should have their height and weight checked often during treatment with DAYTRANA.
Eye problems (increased pressure in the eye and glaucoma). Call your child’s HCP right away if they develop changes in their vision, eye pain, swelling, or redness.
New or worsening tics or worsening Tourette’s syndrome. Tell your child’s HCP if they get any new or worsening tics or worsening Tourette’s syndrome during treatment with DAYTRANA.
Loss of skin color. Call your child’s HCP right away if they have changes in skin color. DAYTRANA may be stopped if your child has changes in skin color.
Allergic skin rash. Stop using DAYTRANA and tell your child’s HCP right away if they develop swelling or blisters at or around the application site.

Before taking DAYTRANA, tell your HCP about all the medications your child takes and their medical conditions, including if they:

Are pregnant or plan to become pregnant. DAYTRANA may harm the unborn baby. There is a pregnancy registry for females who are exposed to DAYTRANA during pregnancy. The purpose of the registry is to collect information about the health of women exposed to DAYTRANA and their baby. To learn more about registering with the National Pregnancy Registry of Psychostimulants Medications call 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/.
Are breastfeeding or plan to breastfeed. DAYTRANA passes into breast milk. Talk to your HCP about the best way to feed the baby during treatment with DAYTRANA.

The most common side effects of DAYTRANA in children 6 to 12 years old include: Decreased appetite, trouble sleeping, nausea, vomiting, weight loss, tics; changes in mood, and trouble eating.

The most common side effects of DAYTRANA in children 13 to 17 years old include: Decreased appetite, nausea, trouble sleeping, weight loss, dizziness, stomach pain, and trouble eating.

DAYTRANA may also cause skin problems where it is applied (redness, small bumps, itching).

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