Focalin XR Side Effects

Generic name: dexmethylphenidate

Medically reviewed by Drugs.com. Last updated on Dec 30, 2023.

Note: This document provides detailed information about Focalin XR Side Effects associated with dexmethylphenidate. Some dosage forms listed on this page may not apply specifically to the brand name Focalin XR.

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

Important warnings This medicine can cause some serious health issues

Oral route (capsule, extended release; tablet)

Abuse, Misuse, and Addiction. Dexmethylphenidate hydrochloride has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction.

Misuse and abuse of CNS stimulants, including dexmethylphenidate hydrochloride, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.Before prescribing dexmethylphenidate hydrochloride, assess each patient’s risk for abuse, misuse, and addiction.

Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug.

Throughout dexmethylphenidate hydrochloride treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

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 side effects

• anxiety

Less common side effects

• 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
• change in vision
• chest pain or discomfort
• chest tightness or heaviness
• chills
• confusion
• cough
• dark urine
• diarrhea
• difficulty in speaking
• difficulty swallowing
• dizziness
• double vision
• drowsiness
• eye pain
• 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
• loss of vision
• 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
• trouble 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)
• blurred vision
• change in consciousness
• chest pain or discomfort
• confusion,
• dark urine,
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry eyes, mouth, nose, or throat
• false or unusual sense of well-being
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth
• fever
• headache
• holding false beliefs that cannot be changed by fact
• inability to speak
• increased sensitivity of the eyes to light
• loss of consciousness
• muscle cramps, spasms, pain, stiffness, or twitching
• nausea
• nervousness
• overactive reflexes
• pain or discomfort in the arms, jaw, back, or neck
• pale, clammy skin,
• palpitations
• pounding in the ears
• redness of the face, neck, arms, and occasionally, upper chest
• seeing, hearing, or feeling things that are not there
• seizures
• shivering
• slow or fast heartbeat
• slurred speech
• sweating
• talking or acting with excitement you cannot control
• temporary blindness
• thirst
• trembling or shaking
• trouble breathing
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness
• vomiting
• weakness in the arm or leg on one side of the body, sudden and severe

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 side effects

• 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 adverse events

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

Frequently asked questions

• Focalin vs Adderall: What's the difference?

Further information

Focalin XR side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer