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Daytrana Side Effects

Generic Name: methylphenidate hydrochloride

Please note - some side effects for Daytrana may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Daytrana - for the Consumer

Daytrana System

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Daytrana System:

Headache; loss of appetite; mild sore throat; nausea; nervousness; redness, mild itching, or small bumps on the skin at the application site; stuffy nose; trouble sleeping; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Daytrana System:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavior changes (eg, aggression, hostility, restlessness); blurred vision or other vision problems; chest pain or discomfort; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, abnormal thought, agitation, anxiety, depression, irritability, panic attacks, persistent crying, unresponsiveness, unusual sadness); one-sided weakness; purple or brownish red spots on the skin; seizures; severe or persistent dizziness or headache; shortness of breath; slurred speech; suicidal thoughts or attempts; swelling or blisters at the application site; tremor; uncontrolled muscle movements; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Daytrana Side Effects - for the Professional

Daytrana

Detailed information on serious and adverse reactions of particular importance is provided in the BoxedWarning and Warnings and Precautions (5) sections:

The most commonly reported (frequency ≥ 5% and twice the rate of placebo) adverse reactions in a controlled trial in children aged 6-12 included appetite decreased, insomnia, nausea, vomiting, weight decreased, tic, affect lability, and anorexia. The most commonly reported (frequency ≥ 5% and twice the rate of placebo) adverse reactions in a controlled trial in adolescents aged 13-17 were appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain and anorexia [see AdverseReactions (6.1)].

The most common (≥ 2% of subjects) adverse reaction associated with discontinuations in double-blind clinical trials in children or adolescents was application site reactions [see Adverse Reactions (6.3)].

The overall Daytrana development program included exposure to Daytrana in a total of 2,152 participants in clinical trials, including 1,529 children aged 6-12, 223 adolescents aged 13-17, and 400 adults. The 1,752 child and adolescent subjects aged 6-17 years were evaluated in 10 controlled clinical studies, 7 open-label clinical studies, and 5 clinical pharmacology studies. In a combined studies pool of children using Daytrana with a wear time of 9 hours, 212 subjects were exposed for ≥ 6 months and 115 were exposed for ≥ 1 year; 85 adolescents have been exposed for ≥ 6 months. Most patients studied were exposed to Daytrana patch sizes of 12.5 cm2, 18.75 cm2, 25 cm2 or 37.5 cm2, with a wear time of 9 hours.

In the data presented below, the adverse reactions reported during exposure were obtained primarily by general inquiry at each visit, and were recorded by the 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 reactions without first grouping similar types of events into a smaller number of standardized event categories.

Throughout this section adverse reactions reported are events that were considered to be reasonably associated with the use of Daytrana based on comprehensive assessment of the available adverse event information. A causal association for Daytrana often cannot be reliably established in individual cases. Further, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trials Experience

Adverse Reactions Associated With Discontinuation of Treatment

In a 7-week double-blind, parallel-group, placebo-controlled study in children with ADHD conducted in the outpatient setting, 7.1% (7/98) of patients treated with Daytrana discontinued due to adverse events compared with 1.2% (1/85) receiving placebo. The most commonly reported (≥ 1% and twice the rate of placebo) adverse reactions leading to discontinuation in the Daytrana group were application site reaction (2%), tics (1%), headache (1%), and irritability (1%).

In a 7-week double-blind, parallel-group, placebo-controlled study in adolescents with ADHD conducted in the outpatient setting, 5.5% (8/145) of patients treated with Daytrana discontinued due to adverse reactions compared with 2.8% (2/72) receiving placebo. The most commonly reported adverse reactions leading to discontinuation in the Daytrana group were application site reaction (2%) and decreased appetite/anorexia (1.4%).

Commonly Observed Adverse Reactions in Double-Blind, Placebo-Controlled Trials

Skin Irritation and Application Site Reactions

Daytrana is a dermal irritant. In addition to the most commonly reported adverse reactions presented in Table 2, the majority of subjects in those studies had minimal to definite skin erythema at the patch application site. This erythema generally caused no or minimal discomfort and did not usually interfere with therapy or result in discontinuation from treatment. Erythema is not by itself a manifestation of contact sensitization. However, contact sensitization should be suspected if erythema is accompanied by evidence of a more intense local reaction (edema, papules, vesicles) that does not significantly improve within 48 hours or spreads beyond the patch site [see Warnings and Precautions (5.6)].

Most Commonly Reported Adverse Reactions

Table 2 lists treatment-emergent adverse reactions reported in ≥ 1% Daytrana-treated children or adolescents with ADHD in two 7 week double-blind, parallel-group, placebo-controlled studies conducted in the outpatient setting. Overall, in these studies, 75.5% of children and 78.6% of adolescents experienced at least 1 adverse event.

Table 2 Number (%) of Subjects with Commonly Reported Adverse Reactions (≥ 1% in the Daytrana Group) in 7-Week Placebo-controlled Studies in Either Children or Adolescents - Safety Population
Adolescents Children
* Six subjects had affect lability, all judged as mild and described as increased emotionally sensitive, emotionality, emotional instability, emotional lability, and intermittent emotional
System Organ Class
Preferred term		 Placebo
N = 72		 Daytrana
N = 145		 Placebo
N = 85		 Daytrana
N = 98
Cardiac Disorders
     Tachycardia 0 (0) 1 (0.7) 0 (0) 1 (1.0)
Gastrointestinal disorders
     Abdominal pain 0 (0) 7 (4.8) 5 (5.9) 7 (7.1)
     Nausea 2 (2.8) 14 (9.7) 2 (2.4) 12 (12.2)
     Vomiting 1 (1.4) 5 (3.4) 4 (4.7) 10 (10.2)
Investigations
     Weight decreased 1 (1.4) 8 (5.5) 0 (0) 9 (9.2)
Metabolism and nutrition disorders
     Anorexia 1 (1.4) 7 (4.8) 1 (1.2) 5 (5.1)
     Decreased appetite 1 (1.4) 37 (25.5) 4 (4.7) 25 (25.5)
Nervous system disorders
     Dizziness 1 (1.4) 8 (5.5) 1 (1.2) 0 (0)
     Headache 9 (12.5) 18 (12.4) 10 (11.8) 15 (15.3)
Psychiatric disorders
     Affect lability 1 (1.4) 0 (0) 0 (0) 6 (6.1)*
     Insomnia 2 (2.8) 9 (6.2) 4 (4.7) 13 (13.3)
     Irritability 5 (6.9) 16 (11) 4 (4.7) 7 (7.1)
     Tic 0 (0) 0 (0) 0 (0) 7 (7.1)

Adverse Reactions With the Long-Term Use of Daytrana

In a long-term open-label study of up to 12 months duration in 326 children wearing Daytrana 9 hours daily, the most common (≥ 10%) adverse reactions were decreased appetite, headache, and weight decreased. A total of 30 subjects (9.2%) were withdrawn from the study due to adverse events and 22 additional subjects (6.7%) discontinued treatment as the result of an application site reaction. Other than application site reactions, affect lability (5 subjects, 1.5%) was the only additional adverse reaction leading to discontinuation reported with a frequency of greater than 1%.

In a long-term open-label study of up to 6 months duration in 162 adolescents wearing Daytrana 9 hours daily, the most common (≥ 10%) adverse reactions were decreased appetite and headache. A total of 9 subjects (5.5%) were withdrawn from the study due to adverse events and 3 additional subjects (1.9%) discontinued treatment as the result of an application site reaction. Other adverse reactions leading to discontinuation that occurred with a frequency of greater than 1% included affect lability and irritability (2 subjects each, 1.2%).

Postmarketing Experience

In addition, the following adverse reactions have been identified during the postapproval use of Daytrana. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to Daytrana exposure.

Cardiac Disorders: palpitation

Eye Disorders: visual disturbances, blurred vision, mydriasis, accommodation disorder

General Disorders and Administration Site Disorders: application site reactions such as bleeding, bruising, burn, burning, dermatitis, discharge, discoloration, discomfort, dryness, eczema, edema, erosion, erythema, excoriation, exfoliation, fissure, hyperpigmentation, hypopigmentation, induration, infection, inflammation, irritation, pain, papules, paresthesia, pruritus, rash, scab, swelling, ulcer, urticaria, vesicles, and warmth.

Immune System Disorders: hypersensitivity reactions including generalized erythematous and urticarial rashes, allergic contact dermatitis, angioedema, and anaphylaxis

Investigations: blood pressure increased

Nervous System Disorders: convulsion, dyskinesia

Psychiatric Disorders: transient depressed mood, hallucination, nervousness

Skin and Subcutaneous Tissue Disorders: alopecia

Adverse Reactions With Oral Methylphenidate Products

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, pulse increased or decreased

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: drowsiness, 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

Skin/Subcutaneous: scalp hair loss

Neuroleptic Malignant Syndrome: 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 ten-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.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects have frequently included tic. Convulsions and migraine have also been reported. Dizziness, drowsiness, dyskinesia, and Tourette's syndrome have been reported rarely. Neuroleptic malignant syndrome (NMS) and reversible ischemic neurological deficit have been reported very rarely.

Most reported cases of neuroleptic malignant syndrome (NMS) involved patients who were treated concomitantly with other drugs associated with NMS.

Nervousness and insomnia may be controllable by reducing the dosage and omitting the drug in the afternoon or evening.

It is unclear whether CNS stimulant drugs (i.e., dextroamphetamine, methylphenidate, amphetamine-dextroamphetamine) have a role in either the development or worsening of tic disorders such as Tourette's syndrome. According to several case reports, use of CNS stimulant medications may have precipitated or exacerbated tic disorders in some patients with ADHD. Based on these cases, in Tourette's-susceptible patients, CNS stimulants may exacerbate motor and phonic tics that do not subside following discontinuation of the offending agent. In several controlled studies involving patients with ADHD and tic disorders, in the majority of patients, tics did not increase following use of CNS stimulants. In addition, controlled studies have not found that methylphenidate worsens motor tics in Tourette's syndrome nor has it increased tics in patients without Tourette's. However, it should be noted that tics were reported in 7% of patients using the methylphenidate patch compared to 1% to those taking it orally. Additional studies are required in order to clarify this association.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and abdominal pain. Nausea and vomiting appears to occur more frequently with the transdermal patch compared with oral administration.

Cardiovascular

Cardiovascular side effects have rarely included changes in blood pressure and pulse rate, cerebral arteritis, occlusion, angina, arrhythmia, palpitations, bradycardia, extrasystoles, ventricular extrasystoles, supraventricular tachycardia, Raynaud's phenomenon, and tachycardia. A case of cardiac arrest has also been reported. Additionally, cerebrovascular vasculitis, cerebral hemorrhages, and cerebrovascular accidents have been reported.

Other

Other side effects have rarely included headache, peripheral coldness, and auricular swelling. A withdrawal syndrome has been reported with the abrupt discontinuation of methylphenidate.

Hepatic

Hepatic side effects have rarely included abnormal liver function ranging from transaminase elevation to hepatic coma; however, causality has not been established. Increased blood alkaline phosphatase, increased blood bilirubin, and increased hepatic enzymes have also been reported.

Hematologic

Hematologic side effects have rarely included leukopenia, anemia, pancytopenia, thrombocytopenic purpura, and thrombocytopenia; however, causality has not been established.

Psychiatric

Psychiatric side effects have frequently included emotional lability and insomnia. Hallucination, mania, obsessive-compulsive disorder, and nervousness have also been reported. Emotional lability and insomnia appear to occur more frequently with the transdermal patch compared with oral administration. In patients wearing the transdermal patch for 12 hrs a day, the incidence of insomnia was 30%. Transient depressed mood and aggressive behavior have been reported rarely; however, causality has not been determined.

Dermatologic

Dermatologic side effects have included bullous conditions, exfoliative conditions, urticarias, pruritus, rashes, eruptions, erythema, and exanthemas. Scalp hair loss has been reported rarely; however, causality has not been determined.

Methylphenidate topical patch is a dermal irritant. The resulting erythema does not typically cause an interference or discontinuation of treatment. However, further evaluation should be sought, if erythema, edema, and/or papules do not resolve or significantly reduce within 24 hours of patch removal. Consideration should be given to sensitization if erythema is accompanied by edema, papules, vesicles, or other evidence of more intense local reactions. Diagnosis of allergic contact dermatitis should include appropriate diagnostic testing.

Ocular

Ocular side effects have included visual disturbances, mydriasis, difficulties with accommodation, diplopia, and blurring of vision.

Respiratory

Respiratory side effects associated with methylphenidate topical patch have frequently included nasopharyngitis and nasal congestion.

Metabolic

Metabolic side effects have included anorexia, decreased appetite, and weight loss (primarily with prolonged therapy). Anorexia, decreased appetite, and weigh loss appears to occur more frequently with the transdermal patch compared with oral administration. In patients wearing the transdermal patch for 12 hrs a day, the incidence of anorexia was 46%.

Local

Local side effects associated with the topical patch have included application site reactions such as bleeding, bruising, burn, burning, dermatitis, discharge, discoloration, discomfort, dryness, eczema, edema, erosion, erythema, excoriation, exfoliation, fissure, hyperpigmentation, hypopigmentation, induration, infection, inflammation, irritation, pain, papules, paresthesia, pruritus, rash, scab, swelling, ulcer, urticaria, vesicles, and warmth.

Hypersensitivity

One subject has been reported to have experienced erythema and edema at methylphenidate transdermal system application sites with concurrent urticarial lesions on the abdomen and legs resulting in treatment discontinuation. This subject was not transitioned to oral methylphenidate.

Hypersensitivity side effects including generalized erythematous and urticarial rashes, allergic contact dermatitis, angioedema, and anaphylaxis have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia, myalgia, and muscle twitching have been reported.

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More Daytrana resources

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

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