Daytrana Side Effects Center

Last updated on RxList: 7/12/2021
Daytrana Side Effects Center

What Is Daytrana?

Daytrana (methylphenidate) is a central nervous system stimulant used to treat attention deficit hyperactivity disorder (ADHD).

What Are Side Effects for Daytrana?

Common side effects of Daytrana include:

  • mild redness,
  • irritation, or
  • bumps on the skin under the patch.

This will usually improve even if the patch is left on. Other side effects of Daytrana include:

Daytrana may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor if you have serious side effects of Daytrana 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, thoughts of suicide),
  • uncontrolled muscle movements (such as twitching, shaking),
  • sudden outbursts of words or sounds that are hard to control, or
  • slow healing sores or ulcers on the tips of fingers or toes.

Dosage for Daytrana

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.

What Drugs, Substances, or Supplements Interact with Daytrana?

Daytrana may interact with:

Tell your doctor all medications you use.

Daytrana During Pregnancy and Breastfeeding

Daytrana should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop using this medication.

Additional Information

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.

SLIDESHOW

ADHD Symptoms in Children See Slideshow
Daytrana Consumer Information

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

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

  • redness, swelling, blistering, or skin color changes where the skin patch was worn (may also spread to other areas);
  • blurred vision;
  • a seizure;
  • 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; or
  • penis erection that is painful or lasts 4 hours or longer.

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.

Methylphenidate can affect growth in children. Your child's height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate.

Common side effects may include:

  • dizziness, mood swings;
  • tics;
  • nausea, vomiting, stomach pain, loss of appetite, weight loss;
  • sleep problems (insomnia); or
  • skin redness, bumps, or itching where a patch was worn.

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.

QUESTION

The abbreviated term ADHD denotes the condition commonly known as: See Answer
Daytrana Professional Information

SIDE EFFECTS

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

  • Drug dependence [see BOXED WARNING]
  • Hypersensitivity to Methylphenidate [see CONTRAINDICATIONS]
  • Marked anxiety, tension, or agitation [see CONTRAINDICATIONS]
  • Glaucoma [see CONTRAINDICATIONS]
  • Tics or a family history of Tourette's syndrome [see CONTRAINDICATIONS]
  • Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS and DRUG INTERACTIONS]
  • Serious Cardiovascular Events [see WARNINGS AND PRECAUTIONS]
  • Increase in Blood Pressure [see WARNINGS AND PRECAUTIONS]
  • Psychiatric Adverse Events [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Priapism [see WARNINGS AND PRECAUTIONS]
  • Peripheral Vasculopathy [see WARNINGS AND PRECAUTIONS]
  • Long-Term Suppression of Growth [see WARNINGS AND PRECAUTIONS]
  • Chemical Leukoderma [see WARNINGS AND PRECAUTIONS]
  • Contact Sensitization [see WARNINGS AND PRECAUTIONS]
  • Visual Disturbance [see WARNINGS AND PRECAUTIONS]
  • External Heat [see WARNINGS AND PRECAUTIONS]
  • Hematologic Monitoring [see WARNINGS AND PRECAUTIONS]

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 ADVERSE REACTIONS].

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].

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

Because clinical trials are conducted under widely varying conditions, adverse reactions 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 practice.

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 (10)
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 (14) 5 (3.4) 4 (4.7) 10 (10.2)
Investigations
Weight decreased 1 (14) 8 (5.5) 0 (0) 9 (9.2)
Metabolism and nutrition disorders
Anorexia 1 (14) 7 (4.8) 1 (12) 5 (5.1)
Decreased appetite 1 (14) 37 (25.5) 4 (4.7) 25 (25.5)
Nervous system disorders
Dizziness 1 (14) 8 (5.5) 1 (12) 0 (0)
Headache 9 (12.5) 18 (12.4) 10 (11.8) 15 (15.3)
Psychiatric disorders
Affect lability 1 (14) 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 DAYTRANA9 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, and accommodation disorder

General Disorders and Administration Site Disorders: fatigue, 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, lethargy, somnolence, serotonin syndrome in combination with serotonergic drugs, and extrapyramidal disorder

Psychiatric Disorders: depression, hallucination, nervousness, and 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 Disorders: angina, arrhythmia, and pulse increased or decreased

Immune System Disorders: hypersensitivity reactions including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura

Metabolism and Nutrition Disorders: anorexia and weight loss during prolonged therapy

Nervous System Disorders: drowsiness, rare reports of Tourette's syndrome and toxic psychosis.

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.

Vascular Disorders: blood pressure increased or decreased and cerebral arteritis and/or occlusion

Although a definite causal relationship has not been established, the following have been reported in patients taking methylphenidate:

Blood and Lymphatic System Disorders: leukopenia and/or anemia

Hepatobiliary Disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury

Psychiatric Disorders: transient depressed mood

Skin and Subcutaneous Tissue Disorders: scalp hair loss

Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis

DRUG INTERACTIONS

Monoamine Oxidase Inhibitors (MAOI)

Concomitant use of MAOIs and CNS stimulants, including DAYTRANA, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see CONTRAINDICATIONS]. Concomitant use of DAYTRANA with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated.

Vasopressor Agents

Because of a possible effect on blood pressure, DAYTRANA should be used cautiously with pressor agents.

Antihypertensive Drugs

DAYTRANA may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed [see WARNINGS AND PRECAUTIONS].

Coumarin Anticoagulants, Antidepressants, And Selective Serotonin Reuptake Inhibitors

Human pharmacologic studies have shown that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and some tricyclic drugs (e.g., imipramine, clomipramine, desipramine) and selective serotonin reuptake inhibitors. Downward dose adjustments of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentrations (or, in the case of coumarin, coagulation times), when initiating or discontinuing methylphenidate.

Risperidone

Combined use of methylphenidate with risperidone when there is a change in dosage, whether an increase or decrease, of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.

Drug Abuse And Dependence

Controlled Substance

DAYTRANA is classified as a Schedule II controlled substance by federal regulation.

Abuse

See warning containing drug abuse information [see BOXED WARNING].

Dependence

See warning containing drug dependence information [see BOXED WARNING].

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

© Daytrana Patient Information is supplied by Cerner Multum, Inc. and Daytrana Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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