Focalin and Focalin XR

The below information on Focalin and Focalin XR has been taken from official FDA sources, but we cannot guarantee it's accuracy. Please use this site for educational purposes only. This site does not replace a proper discussion with your doctor.


    Brand Name:Focalin and Focalin XR
    Generic:Dexmethylphenidate Hydrochloride
    Availability:Prescription
This drug was approved by the FDA in one form or another on:
2001-11-13 ,
This drug is made in one form or another by the following companies:
Novartis Pharmaceuticals Corporation
This drug is available in the following forms:
Tablets and Capsules Extended Release
View the actual FDA approved label for this drug at the following links:
http://www.fda.gov/cder/foi/label/2007/021278s008,021802s009lbl.pdf

About Focalin and Focalin XR

FOCALIN® is a central nervous system stimulant prescription medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). FOCALIN® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Side Effects of Focalin and Focalin XR

The following have been reported with use of dexmethylphenidate hydrochloride and other stimulant medicines.

  1. 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

    Tell your doctor if you or your child have 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 FOCALIN®.

    Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with FOCALIN®.

    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 FOCALIN®.

  2. Mental (Psychiatric) problems:
  3. All Patients

    • new or worse behavior and thought problems
    • new or worse bipolar illness
    • new or worse aggressive behavior or hostility

    Children and Teenagers

    • 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 FOCALIN®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

  4. Other serious side effects include:
    • slowing of growth (height and weight) in children
    • seizures, mainly in patients with a history of seizures
    • eyesight changes or blurred vision
  5. Common side effects include:
    • stomach ache
    • decreased appetite
    • nausea
    • fever

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

Who Should Not Take Focalin and Focalin XR

FOCALIN® should not be taken if you or your child:

  • are very anxious, tense, or agitated
  • have an eye problem called glaucoma
  • have tics or Tourette’s syndrome, or a family history of Tourette’s syndrome. Tics are hard to control repeated movements or sounds.
  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
  • are allergic to anything in FOCALIN®. See the end of this Medication Guide for a complete list of ingredients.

FOCALIN® should not be used in children less than 6 years old because it has not been studied in this age group.

Interactions with Focalin and Focalin XR

Tell your doctor about all of the medicines that you or your child take including prescription and
nonprescription medicines, vitamins, and herbal supplements. FOCALIN® 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 FOCALIN®.

Your doctor will decide whether FOCALIN® can be taken with other medicines.
Especially tell your doctor if you or your child takes:

  • anti-depression medicines including MAOIs
  • seizure medicines
  • blood thinner medicines
  • blood pressure medicines
  • 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 doctor
and pharmacist.

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