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Focalin XR

Last reviewed on RxList: 1/22/2019
Focalin XR Side Effects Center

Last reviewed on RxList 1/22/2019

Focalin XR (dexmethylphenidate hydrochloride) is a mild central nervous system (CNS) stimulant used to treat attention deficit hyperactivity disorder (ADHD). Common side effects of Focalin XR include:

Tell your doctor if you experience serious side effects of Focalin XR including:

  • numbness/pain/skin color change/sensitivity to temperature in the fingers or toes,
  • fast/pounding/irregular heartbeat,
  • mental/mood/behavior changes (such as agitation, aggression, mood swings, abnormal thoughts, thoughts of suicide),
  • uncontrolled muscle movements (such as twitching, shaking),
  • sudden outbursts of words or sounds that are hard to control, or
  • vision changes (such as blurred vision).

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 breastfeeding. 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.

Focalin XR Consumer Information

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

Dexmethylphenidate can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Call your doctor at once if you have:

  • signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
  • signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
  • signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
  • a seizure (convulsions);
  • blurred vision or other visual changes; or
  • penis erection that is painful or lasts 4 hours or longer (rare).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

  • loss of appetite;
  • nausea, stomach pain; or
  • fever.

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)

Focalin XR Professional Information

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 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

  F ocalin 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:

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)

Related Resources for Focalin XR

Read the Focalin XR User Reviews »

© Focalin XR Patient Information is supplied by Cerner Multum, Inc. and Focalin XR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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