Focalin XR Side Effects

Generic Name: dexmethylphenidate

Please note - some side effects for Focalin XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Focalin XR - for the Consumer

Focalin XR Extended-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Focalin XR Extended-Release Capsules:

Anxiety, dizziness; drowsiness; dry mouth; headache; indigestion; loss of appetite; nausea; nervousness; stomach pain; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; joint pain; purple or brownish red spots on the skin); behavior changes (eg, aggression, hostility); blurred vision or other vision problems; chest pain; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, depression, irritability, persistent crying, severe or persistent anxiety, unusual sadness); seizures; severe or persistent dizziness or headache; suicidal thoughts or attempts; uncontrolled speech or muscle movements; yellowing of the eyes or skin.

Focalin XR Side Effects - for the Professional

Focalin XR

Most common adverse reactions (at least 5% and twice the incidence among placebo-treated patients) are dyspepsia, decreased appetite, headache, and anxiety for pediatric patients and dry mouth, dyspepsia, headache, and anxiety for adult patients (6).

Side Effects by Body System

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 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 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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