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Dexmethylphenidate Side Effects

Not all side effects for dexmethylphenidate 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. 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

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]

Psychiatric

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]

Hypersensitivity

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]

Musculoskeletal

Postmarketing reports: Rhabdomyolysis

Gastrointestinal

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]

Metabolic

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]

Respiratory

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]

Other

Common (1% to 10%): Fever[Ref]

Genitourinary

Frequency not reported: Priapism (reported by patients taking methylphenidate)

Hematologic

Frequency not reported: Leukopenia and/or anemia (reported by patients taking methylphenidate)[Ref]

Hepatic

Frequency not reported: Abnormal liver function (ranging from transaminase elevation to hepatic coma; reported by patients taking methylphenidate)[Ref]

General

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.

References

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

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