Ritalin-SR

• It is used to treat attention deficit problems with hyperactivity.
• It is used to treat narcolepsy.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to methylphenidate or any other part of Ritalin SR.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you or a family member have any of these health problems: Blood vessel disease, high blood pressure, heart structure problems or other heart problems, or Tourette's syndrome or tics.
• If you have any of these health problems: Glaucoma; nervous, anxious, or tense state; or overactive thyroid.
• If you have ever had any of these health problems: Drug abuse or stroke.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.

This is not a list of all drugs or health problems that interact with Ritalin SR.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Applies to methylphenidate: oral capsule extended release, oral powder for reconstitution extended release, oral solution, oral tablet, oral tablet chewable, oral tablet chewable extended release, oral tablet disintegrating extended release, oral tablet extended release, transdermal film extended release

General

In children, the following adverse reactions may occur more frequently: loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia.[Ref]

Other

Very common (10% or more): Infections and infestations (45.2%)
Common (1% to 10%): Lethargy, ear infection, pyrexia, fatigue, ear and labyrinth disorders, reproductive system and breast disorders, growth retardation (reduced weight and height gain), thirst, asthenia, influenza, erectile dysfunction, injury/poisoning/procedural complications
Uncommon (0.1% to 1%): Chest pain
Rare (less than 0.1%): Gynecomastia
Frequency not reported: Increased erection, prolonged erection, chest discomfort, hyperpyrexia, abuse and dependence
Postmarketing reports: Priapism[Ref]

Psychiatric

Very common (10% or more): Psychiatric disorders (27.9%), insomnia (13.3%), irritability (11%)
Common (1% to 10%): Anxiety, restlessness, sleep disorder, agitation, affect lability, aggression, depression, depressed mood, abnormal behavior, bruxism, confusional state, initial insomnia, decreased libido, nervousness, emotional poverty, tension, panic attack
Uncommon (0.1% to 1%): Psychotic disorders, hallucinations (auditory, visual, tactile), anger, suicidal ideation, altered mood, mood swings, tearfulness, tics, worsening of pre-existing tics or Tourette's syndrome, hypervigilance
Rare (less than 0.1%): Mania, disorientation, libido disorder
Very rare (less than 0.01%): Suicidal attempt/completed suicide, transient depressed mood, abnormal thinking, apathy, repetitive behaviors, over-focusing
Frequency not reported: Delusions, thought disturbances, confessional state, logorrhea[Ref]

Metabolic

Very common (10% or more): Decreased appetite (27.1%), metabolism and nutrition disorders (11.5%)
Common (1% to 10%): Anorexia, decreased weight[Ref]

Gastrointestinal

Very common (10% or more): Gastrointestinal disorders (23.5%), dry mouth (21.5%), nausea (12.2%), vomiting (10.2%)
Common (1% to 10%): Abdominal pain (upper and general), diarrhea, dyspepsia, toothache, stomach discomfort
Uncommon (0.1% to 1%): Constipation[Ref]

Nervous system

Very common (10% or more): Nervous system disorders (23.5%), headache (23.2%)
Common (1% to 10%): Dizziness, dyskinesia, tremor, drowsiness, feeling jittery, psychomotor hyperactivity, somnolence, vertigo, paresthesia, motion sickness, tension headache
Uncommon (0.1% to 1%): Sedation, tremor
Very rare (less than 0.01%): Convulsions, choreoathetoid movements, reversible ischemic neurological deficit, cerebrovascular disorders (vasculitis, cerebral hemorrhages, cerebrovascular accidents, cerebral arteritis, cerebral occlusion), neuroleptic malignant syndrome (NMS)
Frequency not reported: Grand mal convulsions, migraine, sedation[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (19.1%), respiratory/thoracic/mediastinal disorders (10.6%)
Common (1% to 10%): Upper respiratory tract infection, cough, oropharyngeal/pharyngolaryngeal pain, sinusitis, dyspnea[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal and connective tissue disorders (14.4%),
Common (1% to 10%): Joint sprain, arthralgia
Uncommon (0.1% to 1%): Myalgia, muscle twitching, muscle tightness, muscle spasms
Very rare (less than 0.01%): Muscle cramps
Frequency not reported: Rhabdomyolysis[Ref]

Local

Very common (10% or more): Administration site and general disorders (12.9%)
Postmarketing reports: Patch application site reactions[Ref]

Cardiovascular

Common (1% to 10%): Palpitations, tachycardia, cardiac disorders, vascular disorders, arrhythmias, hypertension, hot flush, changes in blood pressure and heart rate (usually an increase)
Uncommon (0.1% to 1%): Cardiac murmur
Rare (less than 0.1%): Angina pectoris
Very rare (less than 0.01%): Cardiac arrest, myocardial infarction, peripheral coldness, Raynaud's phenomenon, sudden cardiac death
Frequency not reported: Supraventricular tachycardia, bradycardia, ventricular extrasystoles, extrasystoles[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, urticaria, fever, scalp hair loss/alopecia, dermatitis, excoriation hyperhidrosis, skin and subcutaneous tissue disorders
Uncommon (0.1% to 1%): Angioneurotic edema, bullous conditions, exfoliative conditions
Rare (less than 0.1%): Macular rash, erythema
Very rare (less than 0.01%): Thrombocytopenic purpura, exfoliative dermatitis, erythema multiforme, fixed drug eruption[Ref]

Immunologic

Common (1% to 10%): Immune systems disorders[Ref]

Ocular

Common (1% to 10%): Eye disorders, eye pain
Uncommon (0.1% to 1%): Diplopia, blurred vision
Rare (less than 0.1%): Visual accommodation difficulties, mydriasis, visual disturbance
Frequency not reported: Dry eye
Postmarketing reports: Visual impairment[Ref]

Genitourinary

Uncommon (0.1% to 1%): Hematuria, pollakiuria[Ref]

Hepatic

Uncommon (0.1% to 1%): Hepatic enzyme elevations
Very rare (less than 0.01%): Abnormal liver function, hepatic coma, increased blood alkaline phosphatase, increased blood bilirubin
Postmarketing reports: Hepatocellular injury, acute hepatic failure[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions (angioedema, anaphylaxis, auricular swelling, exanthemas)[Ref]

Hematologic

Very rare (less than 0.01%): Leukopenia, thrombocytopenia, anemia, decreased platelet count, abnormal white blood count
Postmarketing reports: Pancytopenia[Ref]

Some side effects of Ritalin-SR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.