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Ritalin LA

Last reviewed on RxList: 10/31/2017
Ritalin LA Side Effects Center

Last reviewed on RxList 10/31/2016

Ritalin LA (methylphenidate hydrochloride) is a central nervous system stimulant used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy. Ritalin LA is available in generic form. Common side effects of Ritalin LA include:

  • headache,
  • stomach pain,
  • loss of appetite,
  • trouble sleeping (insomnia),
  • dizziness,
  • nausea,
  • vomiting,
  • weight loss,
  • lightheadedness,
  • irritability,
  • nervousness,
  • blurred vision or other vision problems,
  • dry mouth,
  • constipation,
  • sweating,
  • skin rash,
  • numbness/tingling/cold feeling in your hands or feet,
  • blue fingers/toes,
  • elevated blood pressure, or
  • (rarely) drowsiness.

The recommended starting dose of Ritalin LA is 20 mg once daily. Dosage may be adjusted in weekly 10 mg increments to a maximum of 60 mg/day taken once daily in the morning, depending on tolerability and effectiveness. Ritalin LA may interact with MAO inhibitors, blood thinners, clonidine, dobutamine, epinephrine, isoproterenol, phenylbutazonie, cold/allergy medicine containing phenylephrine, potassium citrate, sodium acetate, sodium bicarbonate, citric acid (Vitamin C), potassium citrate, sodium citrate, medications to treat high or low blood pressure, stimulants, diet pills, seizure medicine, or antidepressants. Tell your doctor all medications and supplements you use. Ritalin LA should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding. Do not stop taking Ritalin LA suddenly or you may have withdrawal symptoms.

Our Ritalin LA (methylphenidate hydrochloride) 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.

Ritalin LA Consumer Information

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 taking methylphenidate and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeats;
  • feeling like you might pass out;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • aggression, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches);
  • easy bruising, purple spots on your skin; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • stomach pain, nausea, vomiting, loss of appetite;
  • vision problems, dizziness, mild headache;
  • sweating, mild skin rash;
  • numbness, tingling, or cold feeling in your hands or feet;
  • nervous feeling, sleep problems (insomnia); or
  • weight loss.

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 Ritalin LA (Methylphenidate Hydrochloride Extended-Release Capsules)

Ritalin LA Professional Information

SIDE EFFECTS

The clinical program for Ritalin LA® (methylphenidate hydrochloride) extended-release capsules consisted of six studies: two controlled clinical studies conducted in children with ADHD aged 6-12 years and four clinical pharmacology studies conducted in healthy adult volunteers. These studies included a total of 256 subjects; 195 children with ADHD and 61 healthy adult volunteers. The subjects received Ritalin LA in doses of 10-40 mg per day. Safety of Ritalin LA was assessed by evaluating frequency and nature of adverse events, routine laboratory tests, vital signs, and body weight.

Adverse events during exposure were obtained primarily by general inquiry and recorded by 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 events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and listings that follow, MEDRA terminology has been used to classify reported adverse events. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Events in a Double-Blind, Placebo-Controlled Clinical Trial with Ritalin LA

Treatment-Emergent Adverse Events

A placebo-controlled, double-blind, parallel-group study was conducted to evaluate the efficacy and safety of Ritalin LA in children with ADHD aged 6-12 years. All subjects received Ritalin LA for up to 4 weeks, and had their dose optimally adjusted, prior to entering the double-blind phase of the trial. In the two-week double-blind treatment phase of this study, patients received either placebo or Ritalin LA at their individually-titrated dose (range 10 mg-40 mg).

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

Adverse events with an incidence > 5% during the initial four-week single-blind Ritalin LA titration period of this study were headache, insomnia, upper abdominal pain, appetite decreased, and anorexia.

Treatment-emergent adverse events with an incidence > 2% among Ritalin LA-treated subjects, during the two-week double-blind phase of the clinical study, were as follows:

Preferred term Ritalin LA®
N=65
N (%)
Placebo
N=71
N (%)
Anorexia 2 (3.1) 0 (0.0)
Insomnia 2 (3.1) 0 (0.0)

Adverse Events Associated with Discontinuation of Treatment

In the two-week double-blind treatment phase of a placebo-controlled parallel-group study in children with ADHD, only one Ritalin LA-treated subject (1/65, 1.5%) discontinued due to an adverse event (depression).

In the single-blind titration period of this study, subjects received Ritalin LA for up to 4 weeks. During this period a total of six subjects (6/161, 3.7%) discontinued due to adverse events. The adverse events leading to discontinuation were anger (in 2 patients), hypomania, anxiety, depressed mood, fatigue, migraine and lethargy.

Adverse Events with Other Methylphenidate HCl Dosage Forms

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, palpitations, pulse increased or decreased, tachycardia

Gastrointestinal: abdominal pain, nausea

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: dizziness, drowsiness, dyskinesia, headache, rare reports of Tourette's syndrome, toxic psychosis

Vascular: blood pressure increased or decreased; cerebrovascular vasculitis; cerebral occlusions; cerebral hemorrhages and cerebrovascular accidents

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, aggressive behavior

Skin/Subcutaneous: scalp hair loss

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.

Drug Abuse And Dependence

Ritalin LA® (methylphenidate hydrochloride) extended-release capsules, like other products containing methylphenidate, is a Schedule II controlled substance. (See WARNINGS for boxed warning containing drug abuse and dependence information.)

Read the entire FDA prescribing information for Ritalin LA (Methylphenidate Hydrochloride Extended-Release Capsules)

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