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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
  • 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


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]

Nervous system

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]


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)


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.


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

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