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Focalin XR

"March 4, 2013 -- Nearly 30% of children with ADHD continue to struggle with the condition as adults, and some may develop other mental health issues, commit suicide, or end up in jail, a new study shows.

"We suffer from the misconceptio"...

Focalin XR

Focalin XR

Focalin XR Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Focalin XR (dexmethylphenidate hydrochloride) is used to treat attention deficit hyperactivity disorder (ADHD). It is a mild central nervous system (CNS) stimulant. Common side effects include trouble sleeping, dizziness, dry mouth, heartburn, nausea, stomach pain, headache, nervousness, loss of appetite, or weight loss.

The recommended starting dose of Focalin XR is 5 mg/day for pediatric patients and 10 mg/day for adult patients. Dosage may be adjusted in 5 mg increments for pediatric patients and in 10 mg increments for adult patients. Focalin XR may interact with MAO inhibitors, antacids, blood pressure medications, blood thinners, clonidine, seizure medications, or antidepressants. Tell your doctor all medications you use. Focalin XR should be used only when prescribed during pregnancy. It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding. Withdrawal symptoms may occur if this drug is stopped abruptly.

Our Focalin XR (dexmethylphenidate hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Focalin XR in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dexmethylphenidate and call your doctor at once if you have any of these serious side effects:

  • dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, chest pain, numbness, seizure);
  • fast or uneven heart rate;
  • blurred vision or other visual changes;
  • unusual behavior, confusion; or
  • twitching or tics.

Less serious side effects may include:

  • sleep problems (insomnia);
  • loss of appetite;
  • upset stomach;
  • feeling restless, anxious, or jittery;
  • dry mouth, sore throat; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Focalin XR (Dexmethylphenidate Hydrochloride) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Focalin XR Overview - Patient Information: Side Effects

SIDE EFFECTS: Trouble sleeping, nervousness, dizziness, dry mouth, heartburn, nausea, stomach pain, headache, loss of appetite, weight loss, or blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast/pounding/irregular heartbeat, mental/mood/behavior changes (such as agitation, aggression, mood swings, abnormal thoughts), uncontrolled muscle movements (such as twitching, shaking), sudden outbursts of words/sounds that are hard to control.

Get medical help right away if you have any very serious side effects, including: fainting, seizure, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), symptoms of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Focalin XR (Dexmethylphenidate Hydrochloride)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Focalin XR FDA Prescribing Information: Side Effects
(Adverse Reactions)

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

  Focalin 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 EVENT Focalin XR 10 mg/d
N=64
Focalin XR 20 mg/d
N=60
Focalin XR 30 mg/d
N=58
Placebo
N=63
Gastrointestinal Disorders 22% 23% 29% 24%
Vomiting 2% 8% 9% 0
Metabolism and Nutritional Disorders 16% 17% 22% 5%
Anorexia 5% 5% 7% 0
Psychiatric Disorders 19% 20% 38% 8%
Insomnia 5% 8% 17% 3%
Depression 0 0 3% 0
Mood Swings 0 0 3% 2%
Other Adverse Events
Irritability 0 2% 5% 0
Nasal Congestion 0 0 5% 0
Pruritus 0 0 3% 0

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

In the adult placebo-controlled study, 10.7% of the Focalin XR-treated patients and 7.5% of the placebo-treated patients discontinued for adverse events. Among Focalin XR-treated patients, insomnia (1.8%, n=3), feeling jittery (1.8%, n=3), anorexia (1.2%, n=2), and anxiety (1.2%, n=2) were the reasons for discontinuation reported by more than 1 patient.

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

  Focalin XR 20
mg (N=57)
Focalin XR 30
mg (N=54)
Focalin XR 40
mg (N=54)
Placebo
(N=53)
Pulse (bpm) 3.1 ± 11.1 4.3 ± 11.7 6.0 ± 10.1 -1.4 ± 9.3
Diastolic BP (mmHg) -0.2 ± 8.2 1.2 ± 8.9 2.1 ± 8.0 0.3 ± 7.8
Weight (kg) -1.4 ± 2.0 -1.2 ± 1.9 -1.7 ± 2.3 -0.1 ± 3.9

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:

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) »

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Focalin XR - User Reviews

Focalin XR User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Focalin XR sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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