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Daytrana

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Daytrana

Daytrana Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Daytrana (methylphenidate) is used to treat attention deficit hyperactivity disorder (ADHD). It is a central nervous system stimulant. Common side effects include mild redness/irritation of the skin under the patch. This will usually improve even if the patch is left on. Headache, stomach pain, loss of appetite, trouble sleeping, dizziness, nausea, vomiting, lightheadedness, irritability, nervousness, stuffy nose, dry mouth, constipation, or (rarely) drowsiness may also occur.

Daytrana patch should be applied to the hip area 2 hours before an effect is needed and should be removed 9 hours after application. Dose titration, final dosage, and wear time is individualized to the needs and response of the patient. Daytrana may interact with blood pressure medications, blood thinners, clonidine, seizure medicines, or antidepressants. Tell your doctor all medications you use. Daytrana should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding. Withdrawal symptoms may occur if you suddenly stop using this medication.

Our Daytrana (methylphenidate) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Daytrana in Detail - Patient Information: Side Effects

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

Stop using methylphenidate and call your doctor at once if you have:

  • fast, pounding, or uneven heartbeats, feeling light-headed, fainting;
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, seizure);
  • redness, swelling, itching, or blistering where the skin patch was worn (may also spread to other areas);
  • headache with fever, weakness, joint pain, diarrhea, and/or vomiting;
  • aggression, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches); or
  • confusion, crying, feeling irritable.

Common side effects may include:

  • vision problems;
  • mild skin redness, bumps, or itching;
  • nausea, loss of appetite, weight loss;
  • sleep problems (insomnia); or
  • stuffy nose, sore throat.

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 Daytrana (Methylphenidate Transdermal) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Daytrana Overview - Patient Information: Side Effects

SIDE EFFECTS: Nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, nausea, vomiting, headache, blue fingers/toes, or cold hands/feet may occur. Mild irritation or redness at the application site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, 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), uncontrolled muscle movements (such as twitching, shaking), sudden outbursts of words/sounds that are hard to control, vision changes (such as blurred vision), slow healing sores/ulcers on the tips of fingers/toes.

Get medical help right away if you have any very serious side effects, including: fainting, seizure, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), symptoms of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion).

Rarely, males (including young boys and teens) may have a painful or prolonged erection lasting 4 or more hours while using this medication. Caregivers/parents should also be watchful for this serious side effect in boys. If a painful or prolonged erection occurs, stop using this drug and get medical help right away, or permanent problems could occur. Ask your doctor or pharmacist for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Daytrana (Methylphenidate Transdermal)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Daytrana FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Detailed information on serious and adverse reactions of particular importance is provided in the Boxed Warning 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.

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

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].

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

System Organ Class Preferred term Adolescents Children
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)
* Six subjects had affect lability, all judged as mild and described as increased emotionally sensitive, emotionality, emotional instability, emotional lability, and intermittent emotional

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: palpitations

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, libido changes

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.

Read the entire FDA prescribing information for Daytrana (Methylphenidate Transdermal) »

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Daytrana - User Reviews

Daytrana User Reviews

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Here is a collection of user reviews for the medication Daytrana sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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