Pharmacy Editor: Melissa Conrad Stöppler, MD
Focalin (dexmethylphenidate) is a mild stimulant to the central nervous system used to treat attention deficit hyperactivity disorder (ADHD). It is taken orally in tablet form. Side effects of Focalin can include:
- restlessness,
- anxiousness,
- feeling jittery,
- stomach upset,
- loss of appetite,
- dry mouth,
- sore throat,
- headache, or
- sleep problems (insomnia)
Focalin should not be used in children under 6 years, since safety and efficacy in this age group have not been established. Adequate and well-controlled studies in pregnant women have not been conducted. Focalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether dexmethylphenidate is excreted in human milk.
Our Focalin AR 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.
SLIDESHOW
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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 (Dexmethylphenidate Hydrochloride)
QUESTION
The abbreviated term ADHD denotes the condition commonly known as: See AnswerSIDE EFFECTS
The following are discussed in more detail in other sections of the labeling:
- Abuse and Dependence [see BOXED WARNING, WARNINGS AND PRECAUTIONS, Drug Abuse And Dependence]
- Known hypersensitivity to methylphenidate or other ingredients of Focalin [see CONTRAINDICATIONS]
- Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS, DRUG INTERACTIONS]
- Serious Cardiovascular Events [see WARNINGS AND PRECAUTIONS]
- Blood Pressure and Heart Rate Increases [see WARNINGS AND PRECAUTIONS]
- Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Priapism [see WARNINGS AND PRECAUTIONS]
- Peripheral Vasculopathy, including Raynaud's phenomenon [see WARNINGS AND PRECAUTIONS]
- Long-term Suppression of Growth [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical Trials Experience With Focalin In Pediatric Patients With ADHD
The safety data in this section is based on data related to Focalin exposure during the premarketing development program in a total of 696 participants in clinical trials (684 patients, 12 healthy adult subjects). These participants received Focalin 5, 10, or 20 mg/day. The 684 ADHD patients (ages 6 to 17 years) were evaluated in 2 controlled clinical studies, 2 clinical pharmacology studies, and 2 open-label long-term safety studies.
Most Common Adverse Reactions (incidence of greater than or equal to 5% and at least twice placebo): abdominal pain, fever, anorexia, and nausea
Adverse Reactions Leading To Discontinuation
Overall, 50 of 684 (7.3%) pediatric patients treated with Focalin experienced an adverse reaction 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). Table 1 enumerates adverse reactions for two, placebo-controlled, parallel group studies in pediatric patients with ADHD taking Focalin doses of 5, 10, and 20 mg/day. The table includes only those reactions that occurred in patients treated with Focalin for which the incidence was at least 5% and twice the incidence among placebo-treated patients.
Table 1: Common Adverse Reactions in Pediatric
Patients (6 to 17 years of age) with ADHD
| System Organ Class | Adverse Reactions | Focalin (N = 79) |
Placebo (N = 82) |
| Body as a Whole | Abdominal Pain | 15% | 6% |
| Fever | 5% | 1% | |
| Digestive System | Anorexia | 6% | 1% |
| Nausea | 9% | 1% |
Postmarketing Experience
The following additional adverse reactions have been identified during post approval use of dexmethylphenidate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Musculoskeletal: rhabdomyolysis
Immune System Disorders: hypersensitivity reactions such as angioedema, anaphylactic reactions
Adverse Reactions Reported With All Ritalin And Focalin Formulations
The following adverse reactions associated with the use of all Ritalin and Focalin formulations were identified in clinical trials, spontaneous reports, and literature. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Infections and Infestations: nasopharyngitis
Blood and the Lymphatic System Disorders: leukopenia, thrombocytopenia, anemia
Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis
Metabolism and Nutrition Disorders: decreased appetite, reduced weight gain, and suppression of growth during prolonged use in pediatric patients
Psychiatric Disorders: insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood
Nervous System Disorders: headache, dizziness, tremor, dyskinesia including choreoatheetoid movements, drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents) , serotonin syndrome in combination with serotonergic drugs
Eye Disorders: blurred vision, difficulties in visual accommodation
Cardiac Disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris
Respiratory, Thoracic and Mediastinal Disorders: cough
Gastrointestinal Disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia
Hepatobiliary Disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury
Skin and Subcutaneous Tissue Disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura
Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis
Investigations: weight loss (adult ADHD patients)
Additional Adverse Reactions Reported With Other Methylphenidate-Containing Products
The list below shows adverse reactions not listed with Ritalin and Focalin formulations that have been reported with other methylphenidate products based on clinical trials data and postmarketing spontaneous reports.
Blood and Lymphatic Disorders: pancytopenia
Immune System Disorders: hypersensitivity reactions such as auricular swelling
Psychiatric Disorders: affect lability, mania, disorientation, libido changes,
Nervous System Disorders: migraine
Eye Disorders: diplopia, mydriasis
Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole, supraventricular tachycardia, ventricular extrasystole
Vascular Disorders: peripheral coldness, Raynaud's phenomenon
Respiratory, Thoracic and Mediastinal Disorders: pharyngolaryngeal pain, dyspnea
Gastrointestinal Disorders: diarrhea, constipation
Skin and Subcutaneous Tissue Disorders: angioneurotic edema, erythema, fixed drug eruption
Musculoskeletal, Connective Tissue and Bone Disorders: myalgia, muscle twitching
Renal and Urinary Disorders: hematuria
Reproductive System and Breast Disorders: gynecomastia
General disorders: fatigue
Urogenital disorders: priapism
Read the entire FDA prescribing information for Focalin (Dexmethylphenidate Hydrochloride)
Read the Focalin User Reviews »
© Focalin Patient Information is supplied by Cerner Multum, Inc. and Focalin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.