Focalin Side Effects

Generic name: dexmethylphenidate

Note: This document contains side effect information about dexmethylphenidate. Some of the dosage forms listed on this page may not apply to the brand name Focalin.

Some side effects of Focalin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to dexmethylphenidate: oral capsule extended release, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking dexmethylphenidate (the active ingredient contained in Focalin) 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 of dexmethylphenidate 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.

For Healthcare Professionals

Applies to dexmethylphenidate: oral capsule extended release, oral tablet

Cardiovascular

Cardiovascular side effects associated with racemic forms of methylphenidate have frequently included tachycardia. Angina, arrhythmia, palpitations, cerebral arteritis and/or occlusion, and changes in heart rate have also been associated with racemic forms of methylphenidate. Hypertension and hypotension have been reported rarely.

Gastrointestinal

Gastrointestinal side effects associated with the use of extended-release capsules in pediatric patients have frequently included dyspepsia and decreased appetite.

Gastrointestinal side effects associated with the use of extended-release capsules in adult patients have frequently included dry mouth and dyspepsia.

Gastrointestinal side effects associated with dexmethylphenidate (the active ingredient contained in Focalin) immediate-release in relation to placebo therapy have included abdominal pain (15% vs. 6%), anorexia (6% vs. 1%), and nausea (9% vs. 1%).

Gastrointestinal side effects associated with racemic methylphenidate have frequently included loss of appetite.

Nervous system

Nervous system side effects associated with the use of extended-release capsules in pediatric patients have frequently included headache (25%) and anxiety (6%).

Nervous system side effects associated with the use of extended-release capsules in adult patients have frequently included headache (26%), feeling jittery (12%), dizziness (6%), and anxiety (5%).

Nervous system side effects associated with racemic methylphenidate have frequently included insomnia. Dizziness, drowsiness, dyskinesia, headache, and toxic psychosis have also been reported with racemic methylphenidate. Tourette's syndrome has been reported rarely.

Hypersensitivity

Hypersensitivity side effects associated with racemic methylphenidate have included skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura.

Hematologic

Hematologic side effects associated with racemic methylphenidate have included leukopenia and/or anemia. However, causality has not been definitely established.

Hepatic

Hepatic side effects associated with racemic methylphenidate have included abnormal liver function, ranging from elevated transaminase levels to hepatic coma. However, causality has not been definitely established.

Dermatologic

Dermatologic side effects associated with racemic form of methylphenidate have included scalp hair loss. However, causality has not been definitely established.

Psychiatric

Psychiatric side effects associated with racemic methylphenidate have included transient depressed mood. However, causality has not been definitely established.

Other

Other side effects associated with the use of dexmethylphenidate (the active ingredient contained in Focalin) immediate-release, in relation to placebo therapy, have included fever (5% vs. 1%).

Other side effects associated with methylphenidate have rarely included neuroleptic malignant syndrome (NMS).

The manufacturer reports a 10-year-old male, after receiving oral methylphenidate for a duration of approximately 18-months, experienced a NMS-like event within 45 minutes of receiving a single oral venlafaxine. Causality was not determined.

Metabolic

Metabolic side effects associated with the use of extended-release capsules in pediatric patients have frequently included decreased appetite (30%).

Metabolic side effects associated with racemic methylphenidate have included weight loss especially during prolonged therapy.

Respiratory

Respiratory side effects associated with the use of extended-release capsules in adult patients have frequently included pharyngolaryngeal pain (4%).

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