Side Effects of Focalin (dexmethylphenidate)

Focalin (dexmethylphenidate) is a central nervous system (CNS) stimulant used to treat attention deficit hyperactivity disorder (ADHD) in children and adults. Focalin stimulates the central nervous system in a manner that is similar to amphetamines; however, its actions are milder than amphetamines.

Focalin stimulates the brain by increasing the level of neurotransmitters, dopamine and norepinephrine, in the brain (neurotransmitters are chemicals produced by nerves that are released and attach to other nearby nerves as a means of communication among nerves). The exact mechanism of action of the drug in people with ADHD is unknown. 

Drug interactions of Focalin include monoamine oxidase inhibitors (MAOIs), because of risks of a hypertensive crisis. Focalin and MAOIs should be separated by at least 14 days. Focalin should be used with caution with blood pressure medications or individuals with high blood pressure because it can increase blood pressure and decrease effectiveness of blood pressure medications. 

There are no adequate studies done on Focalin to determine safe and effective use in pregnant women. 

It is unknown if Focalin enters breast milk; therefore, it is best to be cautious before using it in nursing mothers. Consult your doctor before breastfeeding. 

What are the common side effects of Focalin?

Common side effects of Focalin include

• increased blood pressure,
• indigestion,
• loss of appetite,
• dry mouth,
• headache,
• sleeplessness, and
• anxiety.

What are the serious side effects of Focalin?

Serious side effects of Focalin include tolerance, psychological dependence, abnormal behavior, and psychosis if used long-term.

Dexmethylphenidate may be abused and it is a Schedule II controlled medication. Long term abuse can cause tolerance, psychological dependence, abnormal behavior, and psychosis. Use cautiously in people with a history of drug or alcohol abuse.

Drug Abuse And Dependence

Controlled Substance

• Focalin contains dexmethylphenidate hydrochloride, a Schedule II controlled substance.

Abuse

• CNS stimulants, including Focalin, other methylphenidate-containing products, and amphetamines have a high potential for abuse. Abuse is characterized by impaired control over drug use despite harm, and craving.
• Signs and symptoms of CNS stimulant abuse include
  • increased heart rate,
  • respiratory rate,
  •  blood pressure, and/or sweating,
  • dilated pupils,
  • hyperactivity,
  •  restlessness,
  • insomnia,
  • decreased appetite,
  • loss of coordination,
  • tremors,
  • flushed skin,
  • vomiting, and/or
  • abdominal pain.
• Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed.
• Abusers of CNS stimulants may chew, snort, inject, or use other unapproved routes of administration which may result in overdose and death.
• To reduce the abuse of CNS stimulants including Focalin, assess the risk of abuse prior to prescribing.
• After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants, monitor for signs of abuse while on therapy, and reevaluate the need for Focalin use.

Dependence

Tolerance

• Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug's desired and/or undesired effects over time) can occur during chronic therapy with CNS stimulants, including Focalin.

Dependence

• Physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) can occur in patients treated with CNS stimulants including Focalin.
• Withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Clinically Important Interactions With Focalin

Table 2 presents clinically important drug interactions with Focalin.

Table 2: Clinically Important Drug Interactions with Focalin

The following are discussed in more detail in other sections of the labeling:

• Abuse and Dependence
• Known hypersensitivity to methylphenidate or other ingredients of Focalin
• Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors
• Serious Cardiovascular Events
• Blood Pressure and Heart Rate Increases
• Psychiatric Adverse Reactions
• Priapism
• Peripheral Vasculopathy, including Raynaud's phenomenon
• Long-term Suppression of Growth

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

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