Focalin XR Oral

Focalin XR Oral Warning

Misuse or abuse of dexmethylphenidate may result in serious (possibly fatal) heart and blood pressure problems.

Dexmethylphenidate may be habit-forming and should be used cautiously by people who have mental/mood disorders or a history of alcohol/drug abuse. Such patients may be more likely to increase their dose of this drug unnecessarily or take this medication too often. With prolonged use or abuse of this medication, drug dependence and abnormal behavior may occur. Withdrawal symptoms may occur after stopping the drug. Consult your doctor or pharmacist for more details. (See also How to Use section.)

Focalin XR Oral Side Effects

Trouble sleeping, dizziness, dry mouth, heartburn, nausea, stomach pain, headache, nervousness, loss of appetite, or weight loss may occur. If any of these effects persist or worsen, notify your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

• high fever
• uncontrolled muscle movements (e.g., stiffness, twitching, shaking)
• mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, hallucinations, abnormal behavior/thoughts)
• outbursts of words/sounds
• severe sweating
• swelling of the ankles/feet
• extreme tiredness
• blurred vision

Seek immediate medical attention if any of these rare but very serious side effects occur:

• shortness of breath
• fainting
• blurred vision
• slurred speech
• confusion
• easy bleeding/bruising
• chest/jaw/left arm pain
• severe headache
• fast/irregular/pounding heartbeat
• signs of infection (fever, persistent sore throat)
• seizures
• weakness

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. In the US, you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088.

In Canada, you may report side effects to Health Canada at 1-866-234-2345.