Dexmethylphenidate Hydrochloride (dexmethylphenidate hydrochloride 15 mg) Dailymed

• Patients new to methylphenidate: Recommended starting dose is 5 mg once daily for pediatric patients and 10 mg once daily for adults with or without food in the morning (2.2).
• Patients currently on methylphenidate: Dexmethylphenidate hydrochloride extended-release capsules dosage is half (1/2) the current total daily dosage of methylphenidate (2.2).
• Patients currently on Focalin tablets: Give the same daily dose of dexmethylphenidate hydrochloride extended-release capsules (2.2).
• Titrate weekly in increments of 5 mg in pediatric patients and 10 mg in adult patients (2.2).
• Maximum recommended daily dose: 30 mg in pediatric patients and 40 mg in adults (2.2).
• Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce (2.3).

2.1Pretreatment Screening

Prior to treating patients with dexmethylphenidate hydrochloride extended-release capsules, assess:

• for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions ( 5.2 )].
• the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating dexmethylphenidate hydrochloride extended-release capsules [see Warnings and Precautions (5.10)].

2.2 Recommended Dosage

Patients New to Methylphenidate

The recommended starting dosage of dexmethylphenidate hydrochloride extended-release capsules for patients who are not currently taking dexmethylphenidate or racemic methylphenidate, or for patients who are on stimulants other than methylphenidate are:

• Pediatric patients: Start with 5 mg orally once daily in the morning with or without food.
• Adult patients: Start with 10 mg orally once daily in the morning with or without food.

Patients Currently on Methylphenidate

The recommended starting dose of dexmethylphenidate hydrochloride extended-release capsules for patients currently using methylphenidate is half (1/2) the total daily dose of racemic methylphenidate.

Patients currently using Focalin tablets may be given the same daily dose of dexmethylphenidate hydrochloride extended-release capsules.

Titration Schedule

The dose may be titrated weekly in increments of 5 mg in pediatric patients and 10 mg in adult patients. The dose should be individualized according to the needs and response of the patient. Daily doses above 30 mg in pediatrics and 40 mg in adults have not been studied and are not recommended.

2.3 AdministrationInstructions

Dexmethylphenidate hydrochloride extended-release capsules are administered orally and may be taken whole or the capsule may be opened and the entire contents sprinkled onto applesauce. If the patient is using the sprinkled administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.

2.4 Dosage Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse reactions occur, reduce the dosage, or if necessary, discontinue dexmethylphenidate hydrochloride extended-release capsules. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

3 Dosage Forms And Strengths

• 5 mg extended-release capsules – two-piece hard-gelatin capsule with aqua-blue-opaque cap and aqua-blue-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5550” on body.
• 10 mg extended-release capsules – two-piece hard-gelatin capsule with ivory-opaque cap and ivory-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5551” on body.
• 15 mg extended-release capsules – two-piece hard-gelatin capsule with blue-green-opaque cap and blue-green-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5552” on body.
• 20 mg extended-release capsules – two-piece hard-gelatin capsule with white-opaque cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5553” on body.
• 25 mg extended-release capsules – two-piece hard-gelatin capsule with aqua blue opaque cap and white opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5045” on body.
• 30 mg extended-release capsules – two-piece hard-gelatin capsule with ivory-opaque cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5554” on body.
• 35 mg extended-release capsules – two-piece hard-gelatin capsule with aqua blue opaque cap and ivory opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5046” on body.
• 40 mg extended-release capsules – two-piece hard-gelatin capsule with blue-green cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with “TEVA” on cap and “5562” on body.

Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg of dexmethylphenidate hydrochloride (3).

4 Contraindications

• Hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release capsules. Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions (6.1)].
• Concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions (7.1)].

• Known hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release capsules (4).
• Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days (4).

5 Warnings And Precautions

• Risks to Patients with Serious Cardiac Disease : Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease (5.2).
• Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse (5.3).
• Psychiatric Adverse Reactions: Prior to initiating dexmethylphenidate hydrochloride extended-release capsules, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing dexmethylphenidate hydrochloride extended-release capsules (5.4).
• Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention (5.5).
• Peripheral Vasculopathy, including Raynaud’s Phenomenon: Careful observation for digital changes is necessary during dexmethylphenidate hydrochloride extended-release capsules treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy (5.6).
• Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted (5.7).
• Acute Angle Closure Glaucoma: Dexmethylphenidate hydrochloride extended-release capsules-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist (5.8).
• Increased Intraocular Pressure (IOP) and Glaucoma: Prescribe dexmethylphenidate hydrochloride extended-release capsules to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor patients with a history of increased IOP or open angle glaucoma (5.9).
• Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating dexmethylphenidate hydrochloride extended-release capsules, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate (5.10).

5.1 Abuse, Misuse, and Addiction

Dexmethylphenidate hydrochloride extended-release capsules have a high potential for abuse and misuse. The use of dexmethylphenidate hydrochloride extended-release capsules exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Dexmethylphenidate hydrochloride extended-release capsules can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2)]. Misuse and abuse of CNS stimulants, including dexmethylphenidate hydrochloride extended-release capsules, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing dexmethylphenidate hydrochloride extended-release capsules, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store dexmethylphenidate hydrochloride extended-release capsules in a safe place, preferably locked, and instruct patients to not give dexmethylphenidate hydrochloride extended-release capsules to anyone else. Throughout dexmethylphenidate hydrochloride extended-release capsules treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

5.2 Risks to Patients with Serious Cardiac Disease

Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage.

Avoid dexmethylphenidate hydrochloride extended-release use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.

5.3 Increased Blood Pressure and Heart Rate

CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 beats per minute). Some patients may have larger increases.

Monitor all dexmethylphenidate hydrochloride extended-release-treated patients for hypertension and tachycardia.

5.4 PsychiatricAdverse Reactions

Exacerbation of Pre-existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating dexmethylphenidate hydrochloride extended-release treatment, screen patients for risk factors for developing manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

New Psychotic or Manic Symptoms CNS stimulants, at the recommended dosage, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0% of placebo-treated patients. If such symptoms occur, consider discontinuing dexmethylphenidate hydrochloride extended-release capsules.

5.5 Priapism

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in both adult and pediatric male patients. Although priapism was not reported with methylphenidate initiation, it developed after some time on methylphenidate, often subsequent to an increase in dosage. Priapism also occurred during methylphenidate withdrawal (drug holidays or during discontinuation).

Dexmethylphenidate hydrochloride extended-release-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

5.6 PeripheralVasculopathy, Including Raynauds Phenomenon

CNS stimulants, including dexmethylphenidate hydrochloride extended-release capsules, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in postmarketing reports and at the therapeutic dosage of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant.

Careful observation for digital changes is necessary during dexmethylphenidate hydrochloride extended-release treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for dexmethylphenidate hydrochloride extended-release-treated patients who develop signs or symptoms of peripheral vasculopathy.

5.7 Long-TermSuppression of Growthin Pediatric Patients

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.

In a 7-week, double-blind, placebo-controlled study of dexmethylphenidate hydrochloride extended-release capsules, the mean weight gain was greater for pediatric patients (ages 6 to 17 years) receiving placebo (+0.4 kg) than for patients receiving dexmethylphenidate hydrochloride extended-release capsules (-0.5 kg).

Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturaulic subgroups of newly methylphenidate-treated and non-medication treated patients over 36 months (to the ages of 10 to 13 years), suggests that pediatric patients who received methylphenidate for 7 days per week throughout the year had a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this development period.

Closely monitor growth (weight and height) in dexmethylphenidate hydrochloride extended-release-treated pediatric patients. Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

5.8 Acute AngleClosure Glaucoma

There have been reports of angle closure glaucoma associated with methylphenidate treatment.

Although the mechanism is not clear, dexmethylphenidate hydrochloride extended-release-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.

5.9 IncreasedIntraocular Pressure and Glaucoma

There have been reports of an elevation of intraocular pressure (IOP) associated with methylphenidate treatment [see Adverse Reactions (6.2)].

Prescribe dexmethylphenidate hydrochloride to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor dexmethylphenidate hydrochloride extended-release-treated patients with a history of abnormally increased IOP or open angle glaucoma.

5.10 Motor and VerbalTics, and Worsening of Tourettes Syndrome

CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported [see Adverse Reactions (6.2)].

Before initiating dexmethylphenidate hydrochloride extended-release capsules, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor dexmethylphenidate hydrochloride-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.

6 Adverse Reactions

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

• Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)]
• Known hypersensitivity to methylphenidate or other ingredients of dexmethylphenidate hydrochloride extended-release capsules [see Contraindications (4)]
• Hypertensive Crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications (4), Drug Interactions (7.1)]
• Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2)]
• Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3)]
• Psychiatric Adverse Reactions [see Warnings and Precautions (5.4)]
• Priapism [see Warnings and Precautions (5.5)]
• Peripheral Vasculopathy, Including Raynaud’s Phenomenon [see Warnings and Precautions (5.6)]
• Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.7)]
• Acute Angle Closure Glaucoma [see Warnings and Precautions (5.8)]
• Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.9)]
• Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.10)]

The most common adverse reactions (greater than or equal to 5% and twice the rate of placebo):

• Pediatric patients 6 to 17 years: dyspepsia, decreased appetite, headache, and anxiety (6.1).
• Adults: dry mouth, dyspepsia, headache, pharyngolaryngeal pain, and anxiety (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 ClinicalTrials 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.

Adverse Reactions in Studies with Dexmethylphenidate Hydrochloride Extended-Release Capsules in Pediatric Patients with ADHD

The safety data in this section is based on data from a 7-week controlled clinical study of dexmethylphenidate hydrochloride extended-release capsules in 100 (103 randomized) pediatric patients with ADHD ages 6 to 17 years (ages 6 to 12, n = 86; ages 13 to 17, n = 17).

This study was a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the time of onset, duration of efficacy, tolerability, safety of dexmethylphenidate hydrochloride extended-release capsules 5 mg to 30 mg/day who met The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD [see Clinical Studies (14.1)].

Most Common Adverse Reactions (incidence of greater than or equal to 5% and at least twice placebo): dyspepsia, decreased appetite, headache, and anxiety.

Adverse Reactions Leading to Discontinuation : 50 of 684 (7.3%) pediatric patients treated with Focalin tablets 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 the placebo-controlled, parallel-group study in children and adolescents with ADHD at flexible dexmethylphenidate hydrochloride extended-release capsules doses of 5 to 30 mg/day. The table includes only those events that occurred in 5% or more of patients treated with dexmethylphenidate hydrochloride extended-release capsules and for which the incidence in patients treated with dexmethylphenidate hydrochloride extended-release capsules was at least twice the incidence in placebo-treated patients.

Table 1: Common Adverse Reactions in Pediatric Patients (6 to 17 years of age) With ADHD

System organ class Adverse reaction	Dexmethylphenidate Hydrochloride Extended-Release Capsules N = 53	Placebo N = 47
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%
Abbreviation: ADHD, attention deficit hyperactivity disorder.

Table 2 below enumerates the incidence of dose-related adverse reactions that occurred during a fixed-dose, double-blind, placebo-controlled trial in pediatric patients with ADHD taking dexmethylphenidate hydrochloride extended-release capsules up to 30 mg daily versus placebo. The table includes only those reactions that occurred in patients treated with dexmethylphenidate hydrochloride extended-release capsules for which the incidence was at least 5% and greater than the incidence among placebo-treated patients.

Table 2: Dose-Related Adverse Reactions in Pediatric Patients (6 to 17 years of age) With ADHD

System organ  class Adverse reaction	Dexmethylphenidate Hydrochloride Extended-Release Capsules	Dexmethylphenidate Hydrochloride Extended-Release Capsules	Dexmethylphenidate Hydrochloride Extended-Release Capsules
	10 mg/day	20 mg/day	30 mg/day	Placebo
	N = 64	N = 60	N = 58	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 reactions
Irritability	0%	2%	5%	0%
Nasal congestion	0%	0%	5%	0%
Pruritus	0%	0%	3%	0%
Abbreviation: ADHD, attention deficit hyperactivity disorder.

Adverse Reactions in Studies with Dexmethylphenidate Hydrochloride Extended-Release Capsules in Adult Patients with ADHD

The safety data in this section is based on data from a 5-week controlled clinical study of dexmethylphenidate hydrochloride extended-release capsules in 218 adult patients (221 randomized) with ADHD ages 18 to 60 years. In this study, 101 adult patients were treated for at least 6 months.

This study was a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of dexmethylphenidate hydrochloride extended-release capsules 20 mg, 30 mg, or 40 mg daily who met DSM-IV criteria for ADHD [see Clinical Studies (14.2 )].

Most Common Adverse Reactions (incidence of greater than or equal to 5% and at least twice placebo): dry mouth, dyspepsia, headache, anxiety, and pharyngolaryngeal pain.

Adverse Reactions Leading to Discontinuation: During the double-blind phase of the study, 10.7% of the dexmethylphenidate hydrochloride extended-release-treated patients and 7.5% of the placebo-treated patients discontinued due to adverse reactions. Three patients (1.8%) in the dexmethylphenidate hydrochloride extended-release discontinued due to insomnia and jittery respectively; and two patients (1.2%) in the dexmethylphenidate hydrochloride extended-release discontinued due to anorexia and anxiety, respectively.

Table 3 enumerates adverse reactions for the placebo-controlled, parallel-group study in adults with ADHD at fixed dexmethylphenidate hydrochloride extended-release capsules doses of 20, 30, or 40 mg/day. The table includes only those events that occurred in 5% or more of patients in a dexmethylphenidate hydrochloride extended-release capsules dose group and for which the incidences in patients treated with dexmethylphenidate hydrochloride extended-release capsules appeared to increase with dose.

Table 3: Dose-Related Adverse Reactions in Adult Patients (18 to 60 years of age) With ADHD

System organ class Adverse reaction	Dexmethylphenidate Hydrochloride Extended-Release Capsules, 20 mg	Dexmethylphenidate Hydrochloride Extended-Release Capsules, 30 mg	Dexmethylphenidate Hydrochloride Extended-Release Capsules, 40 mg	Placebo
	N = 57	N = 54	N = 54	N = 53
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%

Two other adverse reactions occurring in clinical trials with dexmethylphenidate hydrochloride extended-release capsules 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 dexmethylphenidate hydrochloride extended-release capsules in the treatment of ADHD.

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

	Dexmethylphenidate Hydrochloride Extended-Release Capsules, 20 mg (N = 57)	Dexmethylphenidate Hydrochloride Extended-Release Capsules, 30 mg (N = 54)	Dexmethylphenidate Hydrochloride Extended-Release Capsules, 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

6.2 PostmarketingExperience

The following additional adverse reactions have been identified during postapproval 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, including angioedema and anaphylaxis

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, depression

Nervous System Disorders: headache, dizziness, tremor, dyskinesia, including choreoathetoid  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, trismus

Investigations: weight loss (adult ADHD patients)

Vascular Disorders: peripheral coldness, Raynaud's phenomenon

Additional Adverse Reactions Reported with Other Methylphenidate Products

The ul below shows adverse reactions not uled 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, bullous conditions, eruptions, exanthemas

Psychiatric Disorders: affect lability, mania, disorientation, libido changes

Nervous System Disorders: migraine, motor and verbal tics

Eye Disorders: diplopia, increased intraocular pressure, mydriasis

Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole, supraventricular tachycardia, ventricular extrasystole

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, hyperpyrexia

Urogenital Disorders: priapism