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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.
Focalin XR Side Effects
Medically reviewed by Drugs.com. Last updated on Oct 13, 2022.
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.
Warning
Oral route (Capsule, Extended Release; Tablet)
Just under half – 49% – of Americans get their health insurance through their employer, according to the Henry J. Kaiser Family Foundation. Another 19% of Americans are insured under Medicaid, 14% under Medicare, seven% under non-group plans and two% under other public insurers, while nine% of U.S. citizens remain uninsured.
CNS stimulants, including dexmethylphenidate hydrochloride, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.
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
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
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
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
More about Focalin XR (dexmethylphenidate)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (110)
- Drug images
- Dosage information
- Patient tips
- During pregnancy
- Generic availability
- Support group
- FDA approval history
- Drug class: CNS stimulants
- En español
Patient resources
- Drug Information
- Focalin XR (Advanced Reading)
Professional resources
Other formulations
Related treatment guides
References
1. “Product Information. Focalin (dexmethylphenidate).” Mikart Inc (2001):
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
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IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
AND INDICATION
What is the most important information I should know about FOCALIN XR?
FOCALIN XR is a federal controlled substance (CII) because it can be abused or lead to dependence. Keep FOCALIN XR in a safe place to prevent misuse and abuse. Selling or giving away FOCALIN XR may harm others, and is against the law.
INDICATION
What is FOCALIN XR?
- FOCALIN XR is a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). FOCALIN XR may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
AND INDICATION
What is the most important information I should know about FOCALIN XR?
FOCALIN XR is a federal controlled substance (CII) because it can be abused or lead to dependence. Keep FOCALIN XR in a safe place to prevent misuse and abuse. Selling or giving away FOCALIN XR may harm others, and is against the law.
INDICATION
What is FOCALIN XR?
- FOCALIN XR is a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). FOCALIN XR may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
- FOCALIN XR should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Tell your doctor if you or your child have abused or been dependent on alcohol, prescription medicines, or street drugs.
Who should not take FOCALIN XR?
FOCALIN XR should not be taken if you or your child:
- are allergic to methylphenidate hydrochloride, or any of the ingredients in FOCALIN XR.
- are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines:
- Heart-related problems: Sudden death in patients who have heart problems or heart defects, stroke and heart attack in adults, increased blood pressure and heart rate. Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting FOCALIN XR and then check blood pressure and heart rate regularly during treatment with FOCALIN XR. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking FOCALIN XR.
- Mental (psychiatric) problems: New or worse behavior and thought problems, new or worse bipolar illness, new or worse aggressive behavior or hostility, new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms. Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking FOCALIN XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
FOCALIN XR may not be right for you or your child. Before starting FOCALIN XR, tell your or your child’s doctor about all health conditions (or family history) including:
- if you are pregnant or plan to become pregnant. It is not known if FOCALIN XR will harm your unborn baby.
- There is a pregnancy registry to collect information about the health of pregnant females exposed to FOCALIN XR and their baby. If you or your child becomes pregnant during treatment with FOCALIN XR, talk to your healthcare provider about registering with the National Pregnancy Registry of ADHD medications at 1-866-961-2388 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-medications/ .
Tell your doctor about all of the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not start any new medicine while taking FOCALIN XR without talking to your doctor first.
What are the possible side effects of FOCALIN XR?
FOCALIN XR may cause serious side effects, including:
- painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develops priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.
- circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon), where fingers or toes may feel numb, cool, painful, or may change color from pale, to blue, to red. Tell your doctor if you or your child have numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
- Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking FOCALIN XR.
- slowing of growth (height and weight) in children. Children should have their height and weight checked often while taking FOCALIN XR. Treatment may be stopped if a problem is found during these check-ups.
Common side effects include:
- Children (6-17 years): Dyspepsia, decreased appetite, headache, anxiety
- Adults: Dry mouth, dyspepsia, headache, anxiety, pharyngolaryngeal pain
FOCALIN XR can be taken with or without food. Do not chew, crush, or divide the capsules or the beads in the capsule. If you or your child cannot swallow the capsule, open it and sprinkle the small beads of medicine over a spoonful of applesauce and swallow it right away without chewing.
INDICATION
What is FOCALIN XR?
- FOCALIN XR is a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). FOCALIN XR may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
- FOCALIN XR should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNING and Medication Guide.
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