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Medications and Drugs

Brand Names: Focalin, Focalin XR

Generic Name: dexmethylphenidate (Pronunciation: dex METH il FEN i date)

What is dexmethylphenidate (Focalin, Focalin XR)?

Dexmethylphenidate is a mild stimulant to the central nervous system (brain and nerves).

Dexmethylphenidate is used to treat attention deficit hyperactivity disorder (ADHD).

Dexmethylphenidate may also be used for purposes not listed in this medication guide.

Dexmethylphenidate 10 mg-TEV

round, white, imprinted with 93, 5277

Dexmethylphenidate 2.5 mg-TEV

round, blue, imprinted with 93, 5275

Dexmethylphenidate 5 mg-TEV

round, yellow, imprinted with 93, 5276

Focalin XR 25 mg

capsule, blue/white, imprinted with NVR, D25

Focalin XR 35 mg

capsule, blue/brown, imprinted with NVR, D35

Focalin XR 40 mg

capsule, green/white, imprinted with NVR, D40

What are the possible side effects of dexmethylphenidate (Focalin, Focalin XR)?

Get emergency medical help if you have any of these signs of an allergic reaction: fever; hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dexmethylphenidate and call your doctor at once if you have any of these serious side effects:

  • dangerously high blood pressure (severe headache, ringing in your ears, chest pain, numbness);
  • seizure (convulsions);
  • fast or uneven heart rate;
  • blurred vision or other visual changes;
  • unusual behavior, confusion; or
  • twitching or tics.

Less serious side effects may include:

  • sleep problems (insomnia);
  • loss of appetite;
  • upset stomach;
  • feeling restless, anxious, or jittery;
  • dry mouth, sore throat; or
  • headache.

This is not a complete list of side effects and others may occur. Call your 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 dexmethylphenidate (Focalin, Focalin XR)?

Do not use dexmethylphenidate if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before using this medication, tell your doctor if you have severe depression, seizures or epilepsy, high blood pressure, heart disease, a heart rhythm disorder, congestive heart failure, if you have recently had a heart attack, or if you have a history of mental illness or drug/alcohol addiction.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking dexmethylphenidate, tell your doctor if you have any type of heart problems.

Long-term use of dexmethylphenidate can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Dexmethylphenidate may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

Keep track of the amount of medicine used from each new bottle. Dexmethylphenidate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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