Focalin Side Effects

Generic Name: dexmethylphenidate

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

Side Effects of Focalin - for the Consumer

Focalin

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:

Dizziness; drowsiness; headache; loss of appetite; nausea; nervousness; stomach pain; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur when using Focalin:

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, restlessness); 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, anxiety, depression, irritability, panic attacks, persistent crying, unusual sadness); one-sided weakness; seizures; severe or persistent dizziness or headache; shortness of breath; slurred speech; suicidal thoughts or attempts; tremor; uncontrolled speech or muscle movements; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Focalin XR Extended-Release Capsules:

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, restlessness); 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, panic attacks, persistent crying, severe or persistent anxiety, unusual sadness); one-sided weakness; seizures; severe or persistent dizziness or headache; shortness of breath; slurred speech; suicidal thoughts or attempts; tremor; uncontrolled speech or muscle movements; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Focalin Side Effects - for the Professional

Focalin

The pre-marketing development program for Focalin included exposures in a total of 696 participants in clinical trials (684 patients, 12 healthy adult subjects). These participants received Focalin 5, 10, or 20 mg/day. The 684 ADHD patients (ages 6 to 17 years) were evaluated in two controlled clinical studies, two clinical pharmacology studies, and two uncontrolled long-term safety studies. Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse events, and results of physical examinations, vital sign and body weight measurements, and laboratory analyses.

Adverse events during exposure were primarily obtained by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard COSTART dictionary terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Findings in Clinical Trials with Focalin

Adverse Events Associated with Discontinuation of Treatment

No Focalin-treated patients discontinued due to adverse events in two placebo-controlled trials. Overall, 50 of 684 children treated with Focalin (7.3%) experienced an adverse event that resulted in discontinuation. The most common reasons for discontinuation were twitching (described as motor or vocal tics), anorexia, insomnia, and tachycardia (approximately 1% each).

Adverse Events Occurring at an Incidence of 5% or More Among Focalin-Treated Patients

Table 1 enumerates treatment-emergent adverse events for two, placebo-controlled, parallel group trials in children with ADHD at Focalin doses of 5, 10, and 20 mg/day. The table includes only those events that occurred in 5% or more of patients treated with Focalin where the incidence in patients treated with Focalin was at least twice the incidence in placebo-treated patients. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

Table 1  Treatment-Emergent Adverse Events1 Occurring During Double-Blind Treatment in Clinical Trials of Focalin®

Body System	Preferred Term	Focalin (n=79)	Placebo (n=82)
Body as a Whole
	Abdominal Pain	15%	6%
	Fever	5%	1%
Digestive System
	Anorexia	6%	1%
	Nausea	9%	1%

1 Events, regardless of causality, for which the incidence for patients treated with Focalin was at least 5% and twice the incidence among placebo-treated patients. Incidence has been rounded to the nearest whole number.

Adverse Events with Other Methylphenidate HCl Products

Nervousness and insomnia are the most common adverse reactions reported with other methylphenidate products. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed below may also occur.

Other reactions include:

Cardiac: angina, arrhythmia, palpitations, pulse increased or decreased, tachycardia

Gastrointestinal: nausea

Immune: hypersensitivity reactions including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura

Nervous System: dizziness, drowsiness, dyskinesia, headache, rare reports of Tourette’s syndrome, toxic psychosis

Vascular: blood pressure increased or decreased, cerebral arteritis and/or occlusion

Although a definite causal relationship has not been established, the following have been reported in patients taking methylphenidate:

Blood/lymphatic: leukopenia and/or anemia

Hepatobiliary: abnormal liver function, ranging from transaminase elevation to hepatic coma

Psychiatric: transient depressed mood, aggressive behavior

Skin/subcutaneous: scalp hair loss

Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten year old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.

In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.

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Side Effects by Body System - for Healthcare Professionals

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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