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

Summary

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. Continue reading for a comprehensive list of adverse effects.

Applies to dexmethylphenidate: oral capsule extended release, oral tablet.

Serious side effects of Focalin XR

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:

More common

• Anxiety

Less common

• Discouragement
• fast, pounding, or irregular heartbeat or pulse
• feeling sad or empty
• fever
• irritability
• lack of appetite
• loss of interest or pleasure
• mood swings
• tiredness
• trouble concentrating
• trouble sleeping

Incidence not known

• Agitation
• arm, back or jaw pain
• black, tarry stools
• bleeding gums
• blood in the urine
• bloody nose
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• chills
• confusion
• cough
• dark urine
• diarrhea
• difficulty in speaking
• difficulty swallowing
• dizziness
• double vision
• drowsiness
• fainting
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• feeling, seeing, or hearing things that are not there
• headache
• heavier menstrual periods
• hives, itching, or skin rash
• inability to move the arms, legs, or facial muscles
• inability to speak
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• muscle cramps, pain, stiffness, or spasms
• nausea
• nervousness
• overactive reflexes
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• poor coordination
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness, soreness, or itching skin
• restlessness
• right upper quadrant tenderness
• seizures
• severe mood or mental changes
• shivering
• slow speech
• slowed growth in children
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sores, welts, or blisters
• stuffy or runny nose
• sweating
• swollen glands
• talking or acting with excitement you cannot control
• trembling or shaking
• tremor
• troubled breathing with exertion
• twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• unusual behavior
• unusual bleeding or bruising
• unusual tiredness or weakness
• weight loss
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking dexmethylphenidate:

Symptoms of overdose

• Agitation
• bigger, dilated, or enlarged pupils (black part of the eye)
• dry eyes, mouth, nose, or throat
• false or unusual sense of well-being
• feeling of warmth
• holding false beliefs that cannot be changed by fact
• increased sensitivity of the eyes to light
• loss of consciousness
• muscle twitching
• overactive reflexes
• redness of the face, neck, arms, and occasionally, upper chest
• unusual excitement, nervousness, or restlessness

Other side effects of Focalin XR

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:

More common

• Belching
• heartburn
• indigestion
• stomach discomfort, upset, or pain
• vomiting

Incidence not known

• Hair loss

For Healthcare Professionals

Applies to dexmethylphenidate: oral capsule extended release, oral tablet.

General

The most commonly reported adverse reactions have included dyspepsia, decreased appetite, headache, and anxiety.

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, restlessness, agitation, psychosis^[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, serotonin syndrome (in combination with serotonergic drugs)^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions (including angioedema, anaphylaxis)^[Ref]

Musculoskeletal

Frequency not reported: Arthralgia, muscle cramps

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

Frequency not reported: Dry mouth^[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, reduced weight gain, growth suppression during prolonged use in pediatric patients^[Ref]

Respiratory

Very common (10% or more): Respiratory/thoracic/mediastinal disorders (up to 16%)

Common (1% to 10%): Nasal congestion, pharyngolaryngeal pain

Frequency not reported: Nasopharyngitis, cough^[Ref]

Dermatologic

Common (1% to 10%): Pruritus

Frequency not reported: Scalp hair loss, hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, erythema multiforme rash, thrombocytopenic purpura^[Ref]

Other

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

Genitourinary

Methylphenidate:

Frequency not reported: Priapism

Hematologic

Frequency not reported: Leukopenia, thrombocytopenia, anemia^[Ref]

Hepatic

Frequency not reported: Abnormal liver function ranging from transaminase elevation to severe hepatic injury^[Ref]

Ocular

Frequency not reported: Blurred vision, difficulties in visual accommodation