Side effects of focalin

Contents

Focalin XR

SIDE EFFECTS

Focalin XR was administered to 46 children and 7 adolescents with ADHD for up to 7 weeks and 206 adults with ADHD in clinical studies. During the clinical studies, 101 adult patients were treated for at least 6 months.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and listings that follow, MedDRA terminology has been used to classify reported adverse events. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Events Associated With Discontinuation Of Treatment In Acute Clinical Studies With Focalin XR-Children

Overall, 50 of 684 children treated with Focalin immediate-release formulation (7.3%) experienced an adverse event that resulted in discontinuation. The most common reasons for discontinuation were twitching (described as motor or vocal tics), anorexia, insomnia, and tachycardia (approximately 1% each). None of the 53 Focalin XR-treated pediatric patients discontinued treatment due to adverse events in the 7-week, placebo-controlled study.

Adverse Events Occurring At An Incidence Of 5% Or More Among Focalin XR-Treated Patients-Children

Table 1 enumerates treatment-emergent adverse events for the placebo-controlled, parallel-group study in children and adolescents with ADHD at flexible Focalin XR doses of 5–30 mg/day. The table includes only those events that occurred in 5% or more of patients treated with Focalin XR and for which the incidence in patients treated with Focalin XR was at least twice the incidence in placebo-treated patients. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse event incidence rate in the population studied.

Table 1: Treatment-Emergent Adverse Events1 Occurring During Double-Blind Treatment–Pediatric Patients

F ocalin XR
N=53
Placebo
N=47
No. of Patients with AEs
Total 76% 57%
Primary System Organ Class/Adverse Event Preferred Term
Gastrointestinal Disorders 38% 19%
Dyspepsia 8% 4%
Metabolism and Nutrition Disorders 34% 11%
Decreased Appetite 30% 9%
Nervous System Disorders 30% 13%
Headache 25% 11%
Psychiatric Disorders 26% 15%
Anxiety 6% 0%
1Events, regardless of causality, for which the incidence for patients treated with Focalin XR was at least 5% and twice the incidence among placebo-treated patients. Incidence has been rounded to the nearest whole number.

Table 2 below enumerates the incidence of dose-related adverse events that occurred during a fixed-dose, double-blind, placebo-controlled trial of Focalin XR up to 30mg/day versus placebo in children and adolescents with ADHD.

Table 2: Dose-related Adverse Events from a Fixed-dose Study of Double-Blind Treatment in Pediatric Patients by Organ-System and Preferred Term

Adverse Events Associated With Discontinuation Of Treatment In Clinical Studies With Focalin XR-Adults

Adverse Events Occurring At An Incidence Of 5% Or More Among Focalin XR-Treated Patients-Adults

Table 3 enumerates treatment-emergent adverse events for the placebo-controlled, parallel-group study in adults with ADHD at fixed Focalin XR doses of 20, 30, and 40 mg/day. The table includes only those events that occurred in 5% or more of patients in a Focalin XR dose group and for which the incidences in patients treated with Focalin XR appeared to increase with dose. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

Table 3: Treatment-Emergent Adverse Events1 Occurring During Double-Blind Treatment–Adults

Focalin XR 20 mg
N=57
Focalin XR 30 mg
N=54
Focalin XR 40 mg
N=54
Placebo
N=53
No. of Patients with AEs
Total 84% 94% 85% 68%
Primary System Organ Class/ Adverse Event Preferred Term
Gastrointestinal Disorders 28% 32% 44% 19%
Dry Mouth 7% 20% 20% 4%
Dyspepsia 5% 9% 9% 2%
Nervous System Disorders 37% 39% 50% 28%
Headache 26% 30% 39% 19%
Psychiatric Disorders 40% 43% 46% 30%
Anxiety 5% 11% 11% 2%
Respiratory, Thoracic and Mediastinal Disorders 16% 9% 15% 8%
Pharyngolaryngeal Pain 4% 4% 7% 2%
1Events, regardless of causality, for which the incidence was at least 5% in a Focalin XR group and which appeared to increase with randomized dose. Incidence has been rounded to the nearest whole number.

Two other adverse reactions occurring in clinical trials with Focalin XR at a frequency greater than placebo, but which were not dose related were: feeling jittery (12% and 2%, respectively) and dizziness (6% and 2%, respectively).

Table 4 summarizes changes in vital signs and weight that were recorded in the adult study (N=218) of Focalin XR in the treatment of ADHD.

Table 4: Changes (Mean ± SD) in Vital Signs and Weight by Randomized Dose During Double-Blind Treatment–Adults

Postmarketing Experience

The following additional adverse reactions have been identified during postapproval use of Focalin XR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency:

Musculoskeletal: rhabdomyolysis

Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis

Adverse Events With Other Methylphenidate HCl Dosage Forms

Nervousness and insomnia are the most common adverse reactions reported with other methylphenidate products. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed below may also occur.

Other reactions include:

Cardiac: angina, arrhythmia, palpitations, pulse increased or decreased, tachycardia

Gastrointestinal: abdominal pain, nausea

Immune: hypersensitivity reactions including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura

Metabolism/Nutrition: anorexia, weight loss during prolonged therapy

Nervous System: dizziness, drowsiness, dyskinesia, headache, rare reports of Tourette’s syndrome, toxic psychosis

Vascular: blood pressure increased or decreased, cerebral arteritis and/or occlusion

Although a definite causal relationship has not been established, the following have been reported in patients taking methylphenidate:

Blood/Lymphatic: leukopenia and/or anemia

Hepatobiliary: abnormal liver function, ranging from transaminase elevation to hepatic coma

Psychiatric: transient depressed mood, aggressive behavior, libido changes

Skin/Subcutaneous: scalp hair loss

Urogenital: priapism

Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a 10-year-old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.

Read the entire FDA prescribing information for Focalin XR (Dexmethylphenidate Hydrochloride)

Focalin Side Effects

Generic Name: dexmethylphenidate

Medically reviewed by Drugs.com. Last updated on Jan 21, 2019.

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

In Summary

More frequent side effects include: fever. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to dexmethylphenidate: oral capsule extended release, oral tablet

Warning

Oral route (Capsule, Extended Release; Tablet)

Give cautiously to patients with a history of drug dependence or alcoholism. Chronic, abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal from abusive use since severe depression may occur.

Along with its needed effects, dexmethylphenidate (the active ingredient contained in Focalin) 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:

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 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

  • 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

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)

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

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)

Hypersensitivity

Frequency not reported: Hypersensitivity reactions (including angioedema, anaphylaxis)

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

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

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

Dermatologic

Common (1% to 10%): Pruritus

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

Other

Common (1% to 10%): Fever

Genitourinary

Methylphenidate:

Frequency not reported: Priapism

Hematologic

Frequency not reported: Leukopenia, thrombocytopenia, anemia

Hepatic

Frequency not reported: Abnormal liver function ranging from transaminase elevation to severe hepatic injury

Ocular

Frequency not reported: Blurred vision, difficulties in visual accommodation

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

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.

Related questions

  • Focalin vs Adderall: What’s the difference?

Medical Disclaimer

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  • ADHD

Focalin

Focalin is the brand name of the drug dexmethylphenidate, which is used to manage the symptoms of attention deficit hyperactivity disorder (ADHD).

The drug may also be used off-label to help people who suffer from narcolepsy (a sleep disorder).

Focalin is in a class of drugs known as central nervous system stimulants. It works by increasing levels of the neurotransmitters, norepinephrine and dopamine in the brain.

This medication was approved by the Food and Drug Administration (FDA) in 2005 and is manufactured by Novartis.

Focalin Warnings

The federal government requires that Focalin carry a black-box warning because the drug can be habit-forming and should be used very carefully by people who have a history of substance abuse.

You shouldn’t take more Focalin than your doctor prescribes. If you do take too much, you may notice that the drug no longer controls symptoms.

Don’t stop taking Focalin without first talking to your doctor, especially if you overuse the medicine. You may develop severe depression if you stop taking the drug suddenly.

Don’t give away, sell, or let anyone use your prescription of Focalin – it’s a federally controlled substance, and illicit use of this drug may result in severe penalties.

You should store this medication in a secure place where no one else can access it.

Before taking this drug, you should tell your doctor if you have ever used street drugs or abused alcohol or prescription medicines.

If Focalin is used for a long time, it may affect a child’s growth rate, weight, and final adult height. You should talk to your doctor about these risks.

Before taking Focalin, tell your doctor if you or a family member has or has ever experienced Tourette’s syndrome (a condition that causes repeated motions or sounds); facial, motor, or verbal tics (muscle twitches); an irregular heartbeat; sudden death in a family member; depression, bipolar disorder, or mania; or suicidal thoughts or actions.

You should also tell your physician if you have or have ever had the following:

  • A heart attack
  • Heart or blood vessel disease; a heart defect; or other heart problems
  • High blood pressure
  • Circulation issues in your fingers or toes
  • Glaucoma (an eye condition)
  • Anxiety or agitation
  • Mental illness
  • Seizures
  • A peripheral vascular disease such as Raynaud’s syndrome
  • An abnormal electroencephalogram (EEG)
  • Thyroid disease

You shouldn’t use Focalin if you’ve taken a monoamine oxidase inhibitor (MAOI) in the last 14 days, as a dangerous interaction can occur.

Call your doctor if your symptoms worsen while taking Focalin or don’t improve after one month.

The ‘Focalin High’ and Abuse

Focalin is required to carry a black-box warning because it is a highly addictive stimulant that can lead to drug dependence.

Focalin is listed by the U.S. government as a Schedule II substance, defined as defined as a drug “with a high potential for abuse… with use potentially leading to severe psychological or physical dependence,” according to the Drug Enforcement Administration.

Abuse of Focalin can cause serious heart and blood-pressure problems that may lead to death.

Pregnancy and Focalin

It’s not known whether Focalin will harm an unborn baby.

You should tell your doctor if you are pregnant or might become pregnant before taking this drug.

It’s also unknown whether Focalin will pass into breast milk or harm a breastfeeding baby.

Talk to your physician about breastfeeding before taking this medication.

Focalin-xr: 7 things you should know

3. Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

  • A headache, abdominal pain, decreased appetite, nausea, nervousness, and fever. May also cause muscle twitching, sleeplessness, increased blood pressure, and a fast heartbeat.
  • Focalin XR is associated with abuse and dependence. The risk of dependence is greater with the extended-release capsules and in people with a history of drug dependence and alcoholism. Psychotic episodes have also been reported, particularly with overuse.
  • May impair judgment or reaction skills. Exercise caution before driving or operating machinery until the full effects of Focalin XR are known.
  • May aggravate preexisting symptoms of anxiety, tension, and agitation. May precipitate the emergence of psychotic thoughts such as hallucinations, delusions or mania in people without a prior history of such thoughts. Discontinuation of treatment may be appropriate.
  • May not be suitable for people with certain heart conditions, glaucoma, a history of tics or a family history of Tourette’s syndrome, with certain psychiatric disorders, or with a history of alcohol overuse or drug dependence. Has been associated with an increased risk of sudden death in people with structural heart abnormalities or other serious heart problems; may also increase the risk of a stroke or heart attack in adults.
  • May increase the risk of seizures and peripheral circulatory problems and cause visual problems.
  • Reports indicate some temporary slowing of growth may occur when long-term Focalin XR is given to children. Doctors should monitor height and weight and consider treatment interruption if growth suppression is suspected.
  • Rare cases of priapism (painful erections lasting more than 6 hours) have been reported.
  • May interact with some other medications including monoamine oxidase inhibitors (MAO inhibitors) (do not use within 14 days of discontinuation of an MAO inhibitor), halogenated anesthetics (do not take Focalin XR on the day of surgery), coumarin anticoagulants, anticonvulsants, antidepressants and drugs used to treat high blood pressure.
  • Alcohol may contribute to the side effects of Focalin XR and should be avoided.
  • Classified as a Schedule II controlled substance, meaning that Focalin XR has a high potential for abuse. Keep personal supplies of Focalin XR in a safe place, out of view of potential drug seekers.
  • Should not be used in children under the age of six.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, .

Focalin vs Adderall: Main Differences and Similarities

If you have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD), you may be prescribed Focalin or Adderall. These medications are grouped into a class of medications known as stimulants. They treat ADHD by increasing the release of specific neurotransmitters in the brain. These neurotransmitters include norepinephrine and dopamine and allow an affected person to maintain focus and concentration. While they are chemically similar medications, they have some differences to be aware of.

Focalin is a brand name medication known by its generic name, dexmethylphenidate. It is indicated to treat ADHD in patients age 6 years and older. Focalin is also an isomer, or close relative, of methylphenidate, the active ingredient in Ritalin. As an isomer, it is supposed to have a more potent effect with fewer side effects compared to Ritalin.

Focalin is available as an oral tablet with strengths of 2.5 mg, 5 mg, and 10 mg. There is also an extended-release oral tablet called Focalin XR that comes in strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg. While there is a generic version of Focalin XR available, there is no generic version of the immediate release formulation.

Focalin is quickly absorbed after administration and reaches maximum concentrations in the blood after 1 to 1.5 hours. It is usually dosed twice daily, with at least 4 hours between each dose. Focalin XR can be given once daily due to its longer-acting effects. Focalin can also be taken with or without food.

Adderall

Adderall is known by its generic name, dextroamphetamine/levoamphetamine salts. Like Focalin, Adderall also treats ADHD in patients age 6 years and older. However, it also treats narcolepsy, a chronic sleep disorder where a person has trouble staying awake throughout the day.

Adderall comes in an immediate-release oral tablet with strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg. Extended-release oral tablets (Adderall XR) comes in strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg. Generic formulations of Adderall are currently available.

Adderall reaches maximum concentrations approximately 3 hours after administration with effects usually lasting for about 4 to 6 hours. Extended-release Adderall is dosed once daily with effects lasting up to 12 hours. Unlike Focalin, the dosing of Adderall may need to be reduced in those with kidney impairment. This is because Adderall can accumulate in the body during kidney injury and increase the risk of side effects.

Focalin vs Adderall Side by Side Comparison

Both Focalin and Adderall work similarly as stimulant medications. They are also different in several ways. These similarities and differences can be explored in the comparison table below.

Focalin Adderall
Prescribed For
  • ADHD
  • ADHD
  • Narcolepsy
Drug Classification
  • Stimulant
  • Stimulant
Manufacturer
  • Novartis
  • Shire US Inc.
Common Side Effects
  • Decreased appetite
  • Dry mouth
  • Headache
  • Nausea
  • Anxiety
  • Trouble Sleeping
  • Dizziness
  • Stomach ache
  • Weight loss
  • Irritability
  • Increased Sweating
  • Confusion
  • Agitation
  • Unusual moods or behavior
  • Decreased appetite
  • Nervousness
  • Anxiety
  • Fear
  • Sweating
  • Muscle Spasms
  • Twitching
  • Stomach ache
  • Hallucinations
  • Seizures
  • Dry mouth
  • Trouble Sleeping
  • Nausea
  • Vomiting
  • Diarrhea
Is there a generic?
  • Yes
  • Dexmethylphenidate
  • Yes
  • Amphetamine-dextroamphetamine
Is it covered by insurance?
  • Varies according to your provider
  • Varies according to your provider
Dosage Forms
  • Oral capsule, extended release
  • Oral tablet
  • Oral capsule, extended release
  • Oral tablet
Average Cash Price
  • $478 (per 30 capsules)
  • $622 (per 100 tablets)
SingleCare Discount Price
  • Focalin Price
  • Adderall Price
Drug Interactions
  • MAO inhibitors
  • Tricyclic antidepressants
  • Antacids/Proton pump inhibitors
  • Calcium carbonate
  • Bupropion
  • Clonidine
  • Antihypertensives
  • Hydrochlorothiazide
  • Clomipramine
  • Desipramine
  • Dopamine agonists
  • Imipramine
  • Antipsychotics
  • Haloperidol
  • Phenobarbital
  • Phenytoin
  • Primidone
  • Reserpine
  • St. John’s Wort
  • Guanethidine
  • Warfarin
  • MAO inhibitors
  • Tricyclic antidepressants
  • Acetazolamide
  • Buspirone
  • Antacids/Proton pump inhibitors
  • Chlorpromazine
  • Ethosuximide
  • Fentanyl
  • Glutamic acid
  • Guanethidine
  • Haloperidol
  • Antihypertensives
  • Hydrochlorothiazide
  • Lithium
  • Meperidine
  • Methenamine
  • Phenobarbital
  • Phenytoin
  • Propoxyphene
  • Quinidine
  • Reserpine
  • Ritonavir
  • St. John’s Wort
  • Tramadol
Can I use while planning pregnancy, pregnant, or breastfeeding?
  • Focalin is in Pregnancy Category C. Consult a physician regarding taking Ritalin while pregnant or breastfeeding.
  • Adderall is in Pregnancy Category C. Consult a physician regarding taking Adderall while pregnant or breastfeeding.

Summary

Focalin and Adderall are two stimulant medications that can both treat Attention Deficit Hyperactivity Disorder (ADHD). However, Adderall can also treat narcolepsy. Both medications contain different active ingredients, although they produce similar effects. Focalin contains dexmethylphenidate while Adderall contains a combination of amphetamine/dextroamphetamine salts.

Both medications are dosed similarly and have a similar onset and duration of action. They both also come in immediate-release and extended-release formulations that can be used depending on the severity of the condition. Although both medications have similar side effects and drug interactions, they do have slightly different precautions. For instance, Adderall needs to be dose adjusted in patients with renal impairment while Focalin does not carry this limitation.

Both medications should only be used in collaboration with your doctor. Because they are Schedule II medications, there is a potential risk for abuse and/or dependence. Therefore, it’s necessary to only use these medications with close supervision. This information should only be used as a comparison tool to find differences between two stimulant medications.

What is the ADHD Medication Focalin?

Focalin (Generic Name: dexmethylphenidate HCL) is a central nervous system stimulant ADHD medication primarily used to treat attention deficit hyperactivity disorder (ADHD) in children ages 6-12, adolescents, and adults. Focalin may improve focus, and decrease impulsivity and hyperactive behavior, hallmark ADHD symptoms in some patients with the condition. It contains the same active ingredient as medications like Ritalin and Daytrana. According to the FDA, Focalin is a federally controlled substance (CII) because it can be abused or lead to dependence. It has not been studied in children under the age of 6.

The American Academy of Pediatrics recommends treatment with behavioral therapy for ADHD before medication for children under the age of 6. For children ages 6 to 11, the AAP says “The primary care clinician should prescribe US Food and Drug Administration–approved medications for ADHD and/or evidence-based parent- and/or teacher-administered behavior therapy as treatment for ADHD, preferably both.” Likewise, the National Institute of Mental Health finds the most successful treatment plans use a combination of ADHD medication, like Focalin, and behavior therapies.

Focalin can also be used to treat narcolepsy.

How Is Focalin Used to Treat ADHD Symptoms?

Before starting or refilling a Focalin prescription, read the medication guide included with your pills, as it may be updated with new information.

This guide should not replace a conversation with your doctor, who has a holistic view of your or your child’s medical history, other diagnoses, and other prescriptions. If you have questions, ask your doctor or pharmacist before you begin taking the medication.

What Dosage of Focalin Is Used to Treat ADHD Symptoms?

As with all medications, follow your Focalin prescription instructions exactly. Focalin is taken orally, with or without food, twice daily. Doses should be taken at least 4 hours apart.

Tablets are available in 2.5mg, 5mg, and 10mg dosages.

During treatment, your doctor may periodically ask you to stop taking Focalin so that he or she can monitor ADHD symptoms; check vital statistics including blood, heart, and blood pressure; or evaluate height and weight. If any problems are found, your doctor may recommend discontinuing treatment.

Some patients report developing a tolerance to Focalin after long-term usage. If you notice that your dosage is no longer controlling your symptoms, talk to your doctor to plan a course of action.

What Side Effects Are Associated with Focalin?

The most common side effects of Focalin are as follows: stomach ache, nausea, decreased appetite, and fever.

Other serious side effects include the following: serious allergic reaction, slowing of growth in children, seizures, eyesight changes or blurred vision, and priapism.

Taking Focalin may impair your or your teenager’s ability to drive, operate machinery, or perform other potentially dangerous tasks. This side effect usually wears off with time. If side effects are bothersome, or do not go away, talk to your doctor. Most people taking this medication do not experience any of these side effects.

Report to your doctor any heart-related problems or a family history of heart and blood pressure problems. Patients with structural cardiac abnormalities and other serious heart problems have experienced sudden death, stroke, heart attack, and increased blood pressure while taking Focalin. Stimulants can increase blood pressure and heart rate. Physicians should monitor these vital signs closely during treatment. Call your doctor immediately if you or your child experiences warning signs such as chest pain, shortness of breath, or fainting while taking Focalin.

Also disclose to your physician all mental health issues including any family history of suicide, bipolar illness, tics, or depression. Focalin may create new or exacerbate existing behavior problems, bipolar illness, or Tourette’s syndrome. It can cause psychotic or manic symptoms in children and teenagers. Call your doctor immediately if you or your child experiences new or worsening mental health symptoms including hallucinations or sudden suspicions.

Discuss circulation problems with your doctor before taking Focalin, which has been known to cause numbness, coolness, or pain in fingers or toes, including Raynaud’s phenomenon. Report to your doctor any new blood-flow problems, pain, skin color changes, or sensitivities to temperature while taking Focalin.

Stimulants like Focalin have a high potential for abuse and addiction, especially among people who do not have ADHD. It is a “Schedule II Stimulant,” a designation that the Drug Enforcement Agency uses for drugs with a high potential for abuse. Other Schedule II drugs include Dexedrine, Ritalin, and cocaine. People with a history of drug abuse should use caution when trying this medication. Taking the medication exactly as prescribed can reduce potential for abuse.

The above is not a complete list of potential side effects. If you notice any health changes not listed above, discuss them with your doctor or pharmacist.

What Precautions Are Associated with Focalin?

Store Focalin in a secure place out of reach of children, and at room temperature. Do not share your Focalin prescription with anyone, even another person with ADHD. Sharing prescription medication is illegal, and can cause harm.

You should not take Focalin if you or your child have:

  • glaucoma
  • tics or Tourette’s syndrome
  • a history of drug abuse
  • severe feelings of anxiety, tension, or agitation
  • an allergy to stimulant medications or any other ingredients in Focalin
  • taken or plan to take a monoamine oxidase inhibitor (MAOI) within 14 days

If you are thinking of becoming pregnant, discuss the use of Focalin with your doctor. Animal studies indicate potential harm to a fetus. It is not known if Focalin is passed through breastmilk, so it is recommended that mothers do not nurse while taking it.

What Interactions Are Associated with Focalin?

Before taking Focalin, discuss all other active prescription medications with your doctor. Focalin can have a dangerous, possibly fatal, interaction with antidepressants including MAOIs.

Tell your doctor if you are taking seizure medications, blood thinners, blood pressure medication, or any medication containing a decongestant.

Share a list of all vitamin or herbal supplements, and prescription and non-prescription medications you take with the pharmacist when you fill your prescription, and let all doctors and physicians know you are taking Focalin before having any surgery or laboratory tests. The above is not a complete list of all possible drug interactions.

Sources:

Visit your doctor or health care professional for regular checks on your progress. This prescription requires that you follow special procedures with your doctor and pharmacy. You will need to have a new written prescription from your doctor or health care professional every time you need a refill.

This medicine may affect your concentration, or hide signs of tiredness. Until you know how this drug affects you, do not drive, ride a bicycle, use machinery, or do anything that needs mental alertness.

Tell your doctor or health care professional if this medicine loses its effects, or if you feel you need to take more than the prescribed amount. Do not change the dosage without talking to your doctor or health care professional.

For males, contact you doctor or health care professional right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of serious problem and must be treated right away to prevent permanent damage.

Decreased appetite is a common side effect when starting this medicine. Eating small, frequent meals or snacks can help. Talk to your doctor if you continue to have poor eating habits. Height and weight growth of a child taking this medicine will be monitored closely.

Do not take this medicine close to bedtime. It may prevent you from sleeping.

If you are going to need surgery, a MRI, CT scan, or other procedure, tell your doctor that you are taking this medicine. You may need to stop taking this medicine before the procedure.

Tell your doctor or healthcare professional right away if you notice unexplained wounds on your fingers and toes while taking this medicine. You should also tell your healthcare provider if you experience numbness or pain, changes in the skin color, or sensitivity to temperature in your fingers or toes.

Medically reviewed by ADDitude’s ADHD Medical Review Panel

What is the ADHD Medication Focalin XR?

Focalin XR (Generic Name: dexmethylphenidate HCL) is a once-daily central nervous system stimulant ADHD medication primarily used to treat attention deficit hyperactivity disorder (ADHD or ADD) in children ages 6-12, adolescents, and adults. Focalin XR may improve focus, and decrease impulsivity and hyperactive behavior, hallmark ADHD symptoms. It contains the same active ingredient as medications like Ritalin and Daytrana. According to the FDA, Focalin XR is a federally controlled substance (CII) because it can be abused or lead to dependence. It has not been studied in children under the age of 6.

The American Academy of Pediatrics recommends treatment with behavioral therapy for ADHD before medication for children under the age of 6. For children ages 6 to 11, the AAP says “The primary care clinician should prescribe US Food and Drug Administration–approved medications for ADHD and/or evidence-based parent- and/or teacher-administered behavior therapy as treatment for ADHD, preferably both.” Likewise, the National Institute of Mental Health finds the most successful treatment plans use a combination of ADHD medication, like Focalin XR, and behavior therapies.

Focalin XR can also be used to treat narcolepsy.

How Is Focalin XR Used to Treat ADHD Symptoms?

Before starting or refilling a Focalin XR prescription, read the medication guide included with your pills, as it may be updated with new information.

This guide should not replace a conversation with your doctor, who has a holistic view of your or your child’s medical history, other diagnoses, and other prescriptions. If you have questions, ask your doctor or pharmacist before you begin taking the medication.

What Dosage of Focalin XR Is Used to Treat ADHD Symptoms?

As with all medications, follow your Focalin XR prescription instructions exactly. Focalin XR is taken orally, with or without food, once daily. The medication is typically taken first thing in the morning; it should be taken at the same time each day for the best results.

Capsules should be swallowed whole with water or other liquids. If your child is unable to swallow the capsule, it can be opened and sprinkled over a spoonful of applesauce. Taken this way, the mixture should be swallowed whole without chewing, followed by a drink of water or other liquid. Capsules should never by crushed or chewed.

Tablets are available in 5mg, 10mg, 20mg, 25mg, 30mg, 35mg and 40mg dosages. The time-release formulation is designed to maintain a steady level of medication in your body throughout the day.

During treatment, your doctor may periodically ask you to stop taking Focalin XR so that he or she can monitor ADHD symptoms; check vital statistics including blood, heart, and blood pressure; or evaluate height and weight. If any problems are found, your doctor may recommend discontinuing treatment.

Some patients report developing a tolerance to Focalin XR after long-term use. If you notice that your dosage is no longer controlling your symptoms, talk to your doctor to plan a course of action.

Focalin XR Side Effects

Side effects of Focalin XR may include:

  • stomach ache
  • headache
  • nausea
  • decreased appetite
  • sleep disturbances
  • anxiety
  • dry mouth
  • dizziness
  • serious allergic reaction
  • slowing of growth in children
  • seizures
  • eyesight changes or blurred vision
  • priapism

Taking Focalin XR may impair your or your teenager’s ability to drive, operate machinery, or perform other potentially dangerous tasks. This side effect usually wears off with time. If side effects are bothersome, or do not go away, talk to your doctor. Most people taking this medication do not experience any of these side effects.

Report to your doctor any heart-related problems or a family history of heart and blood pressure problems before beginning any new prescription. Patients with structural cardiac abnormalities and other serious heart problems have experienced sudden death, stroke, heart attack, and increased blood pressure while taking Focalin XR. Stimulants can increase blood pressure and heart rate. Physicians should monitor these vital signs closely during treatment. Call your doctor immediately if you or your child experiences warning signs such as chest pain, shortness of breath, or fainting while taking Focalin XR.

Also disclose to your physician all mental health issues including any family history of suicide, bipolar illness, tics, or depression. Focalin XR may create new or exacerbate existing behavior problems, bipolar illness, or Tourette’s syndrome. It can cause psychotic or manic symptoms in children and teenagers. Call your doctor immediately if you or your child experiences new or worsening mental health symptoms including hallucinations or sudden suspicions.

Discuss circulation problems with your doctor before taking Focalin XR, which has been known to cause numbness, coolness, or pain in fingers or toes, including Raynaud’s phenomenon. Report to your doctor any new blood-flow problems, pain, skin color changes, or sensitivities to temperature while taking Focalin XR.

Stimulants like Focalin XR have a high potential for abuse and addiction, especially among people who do not have ADHD. It is a “Schedule II” stimulant, a designation that the Drug Enforcement Agency uses for drugs with a high potential for abuse. Other Schedule II drugs include Dexedrine, Ritalin, and cocaine. People with a history of drug abuse should use caution when trying this medication. Taking the medication exactly as prescribed can reduce potential for abuse.

The above is not a complete list of potential side effects. If you notice any health changes not listed above, discuss them with your doctor or pharmacist.

What Precautions Are Associated with Focalin XR?

Store Focalin XR in a secure place out of reach of children, and at room temperature. Do not share your Focalin XR prescription with anyone, even another person with ADHD. Sharing prescription medication is illegal, and can cause harm.

You should not take Focalin XR if you or your child have:

  • glaucoma
  • tics or Tourette’s syndrome
  • a history of drug abuse
  • severe feelings of anxiety, tension, or agitation
  • an allergy to stimulant medications or any other ingredients in Focalin XR
  • taken or plan to take a monoamine oxidase inhibitor (MAOI) within 14 days

If you are thinking of becoming pregnant, discuss the use of Focalin XR with your doctor. Animal studies indicate potential harm to a fetus. It is not known if Focalin XR is passed through breastmilk, so it is recommended that mothers do not nurse while taking it.

What Interactions Are Associated with Focalin XR?

Before taking Focalin XR, discuss all other active prescription medications with your doctor. Focalin XR can have a dangerous, possibly fatal, interaction with antidepressants including MAOIs.

Tell your doctor if you are taking seizure medications, blood thinners, blood pressure medication, antacids, or any medication containing a decongestant.

Share a list of all vitamin or herbal supplements, and prescription and non-prescription medications you take with the pharmacist when you fill your prescription, and let all doctors and physicians know you are taking Focalin XR before having any surgery or laboratory tests. The above is not a complete list of all possible drug interactions.

More Information on Focalin XR and Other ADHD Medications:

Your Toughest ADHD Medication Questions, Answered!
6 Things You Didn’t Know About the ADHD Brain

Medications

Stimulants: Adderall, Ritalin, Metadate, Methylin, Daytrana, Concerta, Dexedrine, Focalin, Quillivant XR and Vyvance are the stimulant medications currently on the market.

Strattera: Stattera, or atomoxetine HCl has been available since January 2003. This is a non-stimulant, non-controlled substance medication. Straterra works on a different neurotransmitter compared to the stimulants that increase dopamin activity. Straterra is a selective norepinephrine reuptake inhibitor, meaning it increases the norepinephrine activity. Straterra is available in 5mg, 10mg, 18mg, 25mg, 40mg, 60mg, 80mg and 100mg capsules. The target dose is 1.2mg/kg in a single daily dose, but should be initiated at 0.5mg/kg to prevent side effects. In some patients (kids over 70kg body weight or adults), the dose was pushed up to a maximum of 100mg per day in a single daily dose or evenly distributed in a morning and late evening dose. If drowsiness occurs, the entire dose may be given at night.

Side effects may include allergic reactions (rare), weight loss, mild temporary growth retardation, hypertension and rapid heart rate, orthostatic hypotension (feeling dizzy when getting up from sitting due to a fall in blood pressure), urinary retention, dry mouth, abdominal pain3, irritability, constipation, nausea, sleeping difficulties, erectile and ejaculatory disturbances. Strattera is a milder medication with less dramatic effects compared to the fast acting stimulant medications. Yet, for some individuals who are unable to tolerate stimulant medications, Strattera may be an excellent alternative. These are, for the most part, individuals with anxiety disorders, nervous tic disorders, obsessive compulsive disorder or some patients with autism or other milder degrees of Pervasive Developmental Disorders (PDD’s) who are unable to tolerate stimulant medications. Strattera may take a longer time time to exert its functions, usually 1-2 weeks. On some occasions, Strattera may be added to stimulant medications in order to enhance their effect.

Adderall: Adderall, an excellent first line medication for AD/HD. It is safe, effective, long acting (6-10 hours) and easily dosed. Unlike Ritalin, which is slow acting and comes in 20mg sustained release (SR) tablets that cannot be broken into smaller pieces, Adderall comes in 5, 7.5, 10, 12.5, 15, 20, and 30 mg tablets, all scorable to halves and quarters that make dosing much easier, enabling one to customize the dose specifically to the child’s needs, with great dosing flexibility.

Adderall XR or “extended release” stays in the system for 12 hours, covering the homeworks needs and some of the evening difficulties. The Adderall XR comes in a capsule form of 5mg, 10mg, 15mg, 20mg, 25mg, or 30mg. Another advantage is that this medication comes in sprinkle form that may be sprinkled on food, overcoming the need to swallow tablets or crush and ingest tablets that taste badly. A very effective course of action is to start with the short active Adderall, fine tune the dose based on the individual’s needs and then switch to the Adderal XR. Usually an additional 25-30% in total milligrams is required for this adjustment.

For example, a person who did best with 10mg of Adderall (short acting) will do very well with Adderall XR 15mg. This increases the duration of the same effect from 8-10 hours.

Concerta: Concerta is a 12 hour (slow release) methylphenidate. This is the same substance as Ritalin, Meladate, Methylin, Daytrana and Quillivant XR. Concerta is an excellent alternative for Adderall, especially in the younger children who are irritable and cry easily as a side effect of Adderall or Dexedrine. Concerta must be swallowed and can’t be broken to small pieces since the mechanism of release is a small laser drilled hole at the pole of the capsule through which the medicine gets release during the course of the day.

Daytrana: Daytrana is the patch. It’s applied at the hip area and releases the same medicine as Concerta. The advantages include, no need to swallow, a full control on the duration of the activity (can be placed before the child wakes up or later during the day and may be taken off at any time.) Once taken off the effect continues for 3 hours. The disadvantages include a frequent rash, the child may take it off himself and some technical problems applying the patch reported by some people.

Quillivant XR: Quillivant XR is a liquid form of methylphenidate extended release that works well for 9-12 hours. It is an excellent first like medication since it provides the best available dosing flexibility with the measuring syringe, provided by the company.

Vyvance: Vyvance or Lisdexamfetamine, is a prodrug. Prodrug means that it has no effect at its given form, yet once ingested it converts into the active medication. In the Vyvance case, it converts to Dextroamphetamine and Amphetamine or Dexedrine. Dexedrine is a component of Adderall. Adderall is made of Dextroamphetamine and Amphetamine. The only difference between Vyvance and Dexedrine is the duration of action. Vyvance works 11-14 hours. Dexedrine works 4 hours and Dexedrine SR works 8 hours. Adderall is a more effective medication for most people and surprisingly, is very well tolerated.

Focalin and Focalin XR: Focalin is a component of Ritalin. The generic name is Detromethylphenidate (Dextro = Right) or the right side of the methylphenidate molecule. By splitting the Ritalin molecule and using just the right side of it, many of the side effects related to left side may be eliminated. This is an individual effect, but in some cases Focalin may eliminate the anxiety, tics, decreased appetite, OCD or sleeping problems that may occur in Ritalin.

To simplify the AD/HD stimulants medications understand: There are two groups. There are two groups. Ritalin-like and Adderall-like.

    Group 1

  • Ritalin
  • Methylphenidate
  • Ritalin LA
  • Ritalin SR
  • Metadate
  • Metadate CD
  • Methylin
  • Methylin ER
  • Concerta
  • Daytrana
  • Quillivant XR
  • Focalin (Dextromethylphenidate)
  • Focalin XR

These are all the same. The only difference is the mechanism of release. Focalin is a portion (isomer) of Ritalin.

    Group 2

  • Adderall
  • Aderall XR
  • Dexedrine
  • Dexedrine SR
  • Dextroamphetamine
  • Vyvance (once ingested)
  • ProCentra (4 hr liquid Dextroamphetamine)

Adderall and Adderall XR are Dexroamphetamin + Amphetamine, therefore, they will all have a similar effect. It must be noted, however, that for some unclear reason, some people will respond well to a particular medication, yet less effectively or poorly to the same preparation with a slightly different system.

In all, there are 12 Ritalin like medications and 5 Adderall like medications on the market. It may be confusing, but not if you think of it as just 2 drugs.

Treatment expectations: The treatment with stimulant medications is the backbone of treating AD/HD and the most important and effective measure of it. Parents have to be prepared for the fact that treatment may be prolonged. I like to compare treatment with stimulants and AD/HD in general, with placing glasses on eyes “which are out of focus.” This approach and understanding helps the child deal with his condition on a more acceptable level, not as a mental or psychiatric disorder, but more as a physical disability. I tell them, “Your attention span is out of focus. Taking Adderall in the morning is doing for your attention span what my glasses do for my eyes.” They are also told that “Without my glasses, despite having the ability to do well, I will not be able to read and I will most likely fail.” The same applies to AD/HD and medication. The parents should understand that fluctuating grades, a common aspect of AD/HD, may be similarly explained. A child who needs glasses, without them may do poorly, but when a lot of pressure mounts on him he will give it a great effort, placing his face close to the books, trying very hard to satisfy his parents, eventually succeeding to get a good grade because he has the mental ability. This effort, however, will be very difficult to maintain and a relapse to the lower grades is expected. The same thing may happen to children with AD/HD, resulting in their parents blaming them for being lazy, “Because you can do it, you have done it before.” This leads to increased frustration and more friction within the family.

Stimulants correct the underlying physiological abnormality causing AD/HD by increasing dopamine concentrations in the brain. The effect usually starts 1/2 hour after taking the medication. And with Adderall preparations, this lasts for an average of 8 or 12 hours. The effects must be clearly noticeable; a “questionable” response is unacceptable. Stimulants work in 70-80% of children with AD/HD. The effect of the stimulants may completely or partially correct the AD/HD. Once AD/HD is corrected, comorbid disorders must also be addressed. These include ODD (oppositional defiant disorder), anxiety disorder, OCD (obsessive compulsive disorder), and PDD (pervasive developmental disorder). These will be discussed in the next section.

Dosing and side effects: Dosing with the stimulant medication is not clearly formulated. This is more of an art than a science and requires sensitivity to improvements and side effects. Parents (rightfully) are most concerned with side effects. Even though side effects may exist, I like parents to regard AD/HD treatments with medications as a risk free proposition. “You like it, we will go ahead. You don’t like it, we can always decrease the dose or stop the medication.” I promise my patients’ parents that I will not let their children suffer any side effects. This however places a great responsibility upon the parents to watch, observe, and be sensitive to any undesirable changes that only they can detect, such as minor “changes in personality, mild irritability, etc.” Therefore, any changes of the doses of medications should be made over weekends and holidays, so that possible dose related side effects may be readily observed and corrected. About 80-90% of side effects are dos related and resolve as proper adjustments are made.

Dosing with short acting Adderall starts low and is gradually increased, as directed by the physician, until the best effect is obtained. Certain increases may be made on a weekly basis. And if side effects are observed, the dose should be decreased to the previous one that did not cause the side effects. This approach may minimize the side effects.

Some side effects of the stimulant medication include, most commonly, a decrease in appetite. An allergic reaction (rash), which is an indication to stop the medication and never use it again, is rare. Side effects that are dose related (too much medicine) include increased irritability, tiredness, and “zoning out” (being too focused on one thing). These respond to lowering of the dose. In about 2% of children, nervous tics may develop, eye twitches, facial grimacing, neck movement, or frequent throat clearing. This may require stopping the treatment or decreasing the dose. Other unusual side effects may include abdominal pain, headaches, sleeping difficulties (if dosing late in the afternoon), and increased heart rate. No fatality was directly related to stimulant medications if dosed appropriately.

Other pages of the AD/HD section:
AD/HD Main Page
What is AD/HD? | How is AD/HD diagnosed?
The DSM V criteria for AD/HD
How does a child with AD/HD present?
The well-behaved difficult to diagnose child
Cognitive dysfunctions of AD/HD
The physiological basis for AD/HD
What are the best treatments for AD/HD?
Medications | Comorbid disorders
When should medication start?
AD/HD Symptom Questionnaire
Contracted, structured and rewarded learning program
Associations/Links | Local Psychologists/Support

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