Generic Name: dexmethylphenidate
ConsumerProfessional Managing Side Effects
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 XR.
Common side effects of Focalin XR include: metabolic disease, central nervous system disease, gastrointestinal disease, headache, nutrition disorder, and decreased appetite. Other side effects include: anxiety, dyspepsia, and xerostomia. See below for a comprehensive list of adverse effects.
Applies to dexmethylphenidate: oral capsule extended release, oral tablet
Along with its needed effects, dexmethylphenidate (the active ingredient contained in Focalin XR) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking dexmethylphenidate:
Fast, pounding, or irregular heartbeat
jerking of the arms and legs
sudden loss of consciousness
Some side effects of dexmethylphenidate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
stomach discomfort, upset, or pain
Twitching
Frequency not reported: Angina, arrhythmia, palpitations, increased or decreased pulse, tachycardia, increased or decreased blood pressure, cerebral arteritis and/or occlusion
Postmarketing reports: Peripheral vasculopathy (including Raynaud's phenomenon)[Ref]
Very common (10% or more): Psychiatric disorders (up to 46%), insomnia (up to 17%), feeling jittery (up to 12%), anxiety (up to 11%)
Common (1% to 10%): Depression, mood swings, irritability
Frequency not reported: Transient depressed mood, aggressive behavior, libido changes (all reported by patients taking methylphenidate)[Ref]
Very common (10% or more): Nervous system disorders (up to 50%), headache (up to 39%)
Common (1% to 10%): Dizziness
Frequency not reported: Drowsiness, dyskinesia, headache, Tourette's syndrome, toxic psychosis, neuroleptic malignant syndrome (reported by patients taking methylphenidate)[Ref]
Frequency not reported: Hypersensitivity reactions (including angioedema, anaphylaxis, skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura)[Ref]
Postmarketing reports: Rhabdomyolysis
Very common (10% or more): GI disorders (up to 44%), dry mouth (up to 20%), abdominal pain (up to 15%)
Common (1% to 10%): Dyspepsia, nausea, vomiting[Ref]
Very common (10% or more): Metabolism/nutrition disorders (up to 34%), decreased appetite (up to 30%)
Common (1% to 10%): Anorexia
Frequency not reported: Weight loss during prolonged therapy[Ref]
Very common (10% or more): Respiratory/thoracic/mediastinal disorders (up to 16%)
Common (1% to 10%): Nasal congestion, pharyngolaryngeal pain[Ref]
Dermatologic
Common (1% to 10%): Pruritus
Frequency not reported: Scalp hair loss (reported by patients taking methylphenidate)[Ref]
Common (1% to 10%): Fever[Ref]
Frequency not reported: Priapism (reported by patients taking methylphenidate)
Hematologic
Frequency not reported: Leukopenia and/or anemia (reported by patients taking methylphenidate)[Ref]
Frequency not reported: Abnormal liver function (ranging from transaminase elevation to hepatic coma; reported by patients taking methylphenidate)[Ref]
Nervousness and insomnia are the most common adverse reactions reported with other methylphenidate products. In children, the following adverse reactions may occur more frequently: loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia.