Side Effects of Daytrana (methylphenidate)

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

It stimulates the CNS in a manner similar to amphetamines; however, its actions are milder than amphetamines. Amphetamines stimulate 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 Daytrana in people with ADHD is unknown. Methylphenidate is the active ingredient in Ritalin and Concerta and also is available as pills and liquids. 

Common side effects of Daytrana include

• decreased appetite,
• sleeplessness,
• allergic contact dermatitis,
• nausea,
• vomiting,
• weight loss,
• dizziness,
• abdominal pain, and
• emotional instability.

Serious side effects of Daytrana include abuse. Long term abuse of Daytrana can cause tolerance, psychological dependence, abnormal behavior, and psychosis.

Drug interactions of Daytrana include monoamine oxidase inhibitors (MAOIs) because of risks of hypertensive crisis.

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

It is unknown if Daytrana enters breast milk; therefore, it is best to be cautious before using it in breastfeeding mothers.

The most common side effects with methylphenidate are:

• nervousness,
• agitation,
• anxiety, and
• insomnia.

Insomnia can be limited by taking the drug before noon. For children taking methylphenidate for ADHD, the most common side effects are

• loss of appetite,
• abdominal pain,
• weight loss, and
• sleep problems.

The rate and severity of these side effects are less than those seen with dextroamphetamine (Dexedrine).

Other important side effects of methylphenidate include:

• nausea,
• vomiting,
• dizziness,
• palpitations,
• headache,
• involuntary movements,
• chest pain,
• increased heart rate,
• increased blood pressure, and
• psychosis.

There have been rare reports of Tourette's syndrome, a syndrome in which there are uncontrollable tics such as grimacing occurring with methylphenidate use. Because of the potential for side effects, methylphenidate should be used with caution by patients who have relatives with Tourette's syndrome or have the syndrome themselves or who have

• severe anxiety,
• seizures,
• psychosis,
• emotional instability,
• major depression,
• glaucoma, or
• motor tics.

Sudden discontinuation of long-term methylphenidate therapy may unmask depression. Gradual withdrawal, under supervision, is recommended.

Methylphenidate is habit forming and should be used cautiously in individuals with a history of drug or alcohol abuse. Chronic abuse can lead to tolerance and psychological dependence leading to abnormal behavior.

Priapism defined as painful and nonpainful penile erection lasting more than 4 hours, have been reported in pediatric and adult patients treated with stimulants. The erection usually resolves when the drug is stopped. Prompt medical attention is required in the event of suspected priapism.

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

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

The following adverse reactions associated with the use of all Daytrana, Daytrana-SR, and other methylphenidate products 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.

Adverse Reactions Reported With Daytrana And Daytrana-SR

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 for Daytrana and Daytrana-SR that have been reported with other methylphenidate-containing products.

Blood and Lymphatic Disorders: pancytopenia

Immune System Disorders: hypersensitivity reactions such as auricular swelling, bullous conditions, eruptions, exanthemas

Psychiatric Disorders: affect lability, mania, disorientation and libido

Nervous System Disorders: migraine

Eye Disorders: diplopia, mydriasis

Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, 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, hyperpyrexia

Urogenital Disorders: priapism

Clinically Important Interactions With Daytrana And Daytrana-SR

Table 1 presents clinically important drug interactions with Daytrana and Daytrana-SR

Table 1: Clinically Important Drug Interactions with Daytrana and Daytrana-SR

Drug Abuse And Dependence

Controlled Substance

Daytrana and Daytrana-SR contain methylphenidate hydrochloride, a Schedule II controlled substance.

Abuse

CNS stimulants, including Daytrana and Daytrana-SR, 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 Daytrana and Daytrana-SR, 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 Daytrana and Daytrana-SR 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 Daytrana and Daytrana-SR.

Dependence

Physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with CNS stimulants including Daytrana and Daytrana-SR. 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.