Focalin Side Effects

Generic Name: dexmethylphenidate

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

Not all side effects for Focalin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to dexmethylphenidate: oral capsule extended release, oral tablet

In addition to its needed effects, some unwanted effects may be caused by dexmethylphenidate (the active ingredient contained in Focalin). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking dexmethylphenidate:

Less common
  • Fast, pounding, or irregular heartbeat
Rare
  • Blurred vision
  • vision changes
Incidence not known
  • Convulsions
  • jerking of the arms and legs
  • muscle spasm
  • sudden loss of consciousness

Some of the side effects that can occur with dexmethylphenidate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Acid or sour stomach
  • belching
  • heartburn
  • indigestion
  • loss of appetite
  • nausea
  • stomach discomfort, upset, or pain
  • throat pain
  • weight loss
Less common
  • Twitching

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Hematologic

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

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.[Ref]

Dermatologic

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

Psychiatric

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

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).[Ref]

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.[Ref]

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.[Ref]

Respiratory

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

Genitourinary

Genitourinary side effects have included in rare instances prolonged and painful erections known as priapism.

References

1. "Product Information. Focalin (dexmethylphenidate)." Mikart Inc, Atlanta, GA.

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