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.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure the medicine is working properly and to decide if you should continue to use it. Blood tests may be needed to check for any unwanted effects.

Do not use dexmethylphenidate (the active ingredient contained in Focalin XR) together with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start using this medicine during the 2 weeks after you stop an MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, headaches, restlessness, stomach or bowel symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions (seizures).

You or your child will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Dexmethylphenidate may cause serious heart or blood vessel problems. This may be more likely to occur in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, trouble breathing, or fainting while using this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, including an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you or your child see, hear, or feel things that are not there, or have any unusual thoughts, especially if they are new or getting worse quickly.

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor right away. Some signs of dependence may include:

• A strong desire or need to continue using the medicine.
• A need to increase the dose to receive the same effects.
• Withdrawal effects after stopping the medicine, including irritability, anxiety, unusual tiredness or weakness, nightmares, trouble sleeping or oversleeping, increased appetite, agitation, or slowing of mental and physical activity.

This medicine may cause slow growth and weight loss. If your child is using this medicine, the doctor will need to keep track of your child's height and weight.

If you or your child experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.

Symptoms of an overdose include: agitation, 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, fast, pounding, or irregular heartbeat or pulse, fever, headache, inability to speak, loss of consciousness, muscle cramps, spasms, pain, or stiffness, nausea, nervousness, overactive reflexes, pain or discomfort in the arms, jaw, back, or neck, pale, clammy skin, palpitations, pounding in the ears, 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 tiredness or weakness, vomiting, or weakness in the arm or leg on one side of the body, sudden and severe. Call your doctor right away if you notice these symptoms.

This medicine may cause Raynaud's phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold temperatures. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.

Check with your doctor immediately if blurred vision, change in vision, eye pain, or loss of vision while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine on the day you have your surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, and especially those for appetite control, asthma, colds, cough, hay fever, allergies, or sinus problems.

Serious side effects of Focalin XR

Along with its needed effects, dexmethylphenidate 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:

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:

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

See also:

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