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Metadate ER Side Effects

Generic Name: methylphenidate

Note: This document contains side effect information about methylphenidate. Some of the dosage forms listed on this page may not apply to the brand name Metadate ER.

For the Consumer

Applies to methylphenidate: oral capsule extended release, oral powder for suspension extended release, oral solution, oral tablet, oral tablet chewable, oral tablet extended release, oral tablet extended release chewable

Other dosage forms:

Along with its needed effects, methylphenidate (the active ingredient contained in Metadate ER) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking methylphenidate:

More common
  • Fast heartbeat
Less common
  • Chest pain
  • fever
  • joint pain
  • skin rash or hives
Rare
  • Black, tarry stools
  • blood in the urine or stools
  • blurred vision or other changes in vision
  • crusting, dryness, or flaking of the skin
  • muscle cramps
  • pinpoint red spots on the skin
  • scaling, severe redness, soreness, or swelling of the skin
  • seizures
  • uncontrolled vocal outbursts or tics (uncontrolled and repeated body movements)
  • unusual bleeding or bruising
Incidence not known
  • Confusion
  • depression
  • feeling like surroundings are not real
  • numbness of the hands
  • painful or difficult urination
  • pale skin
  • paleness or cold feeling in the fingertips and toes
  • red, irritated eyes
  • red, swollen, or scaly skin
  • seeing, hearing, or feeling things that are not there
  • severe or sudden headache
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden loss of coordination
  • sudden slurring of speech
  • tingling or pain in the fingers or toes when exposed to cold
  • unusual behavior
  • unusual tiredness or weakness
  • weight loss
  • yellow skin or eyes

Get emergency help immediately if any of the following symptoms of overdose occur while taking methylphenidate:

Symptoms of overdose
  • Agitation
  • anxiety
  • bigger, dilated, or enlarged pupils of the eyes
  • confusion as to time, place, or person
  • dark-colored urine
  • diarrhea
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry eyes, mouth, nose, or throat
  • false or unusual sense of well-being
  • fast, slow, irregular, pounding, or racing heartbeat or pulse
  • holding false beliefs that cannot be changed by fact
  • increased sensitivity of the eyes to light
  • loss of consciousness
  • muscle pain or stiffness
  • muscle twitching
  • nervousness
  • overactive reflexes
  • pounding in the ears
  • rapid, shallow breathing
  • sweating
  • tremors
  • unusual excitement, nervousness, or restlessness

Some side effects of methylphenidate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Headache
  • loss of appetite
  • nervousness
  • stomach pain
  • stuffy nose
  • trouble sleeping
  • unusually warm skin
Less common
  • Anger
  • decreased appetite
  • dizziness
  • drowsiness
  • fear
  • irritability
  • muscle aches
  • nausea
  • runny nose
  • scalp hair loss
  • talking, feeling, and acting with excitement
  • vomiting

For Healthcare Professionals

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]

References

1. "Product Information. Metadate CD Capsules (methylphenidate)" Celltech Pharmaceuticals, Inc, Applegate, WI.

2. "Product Information. Quillivant XR (methylphenidate)." NextWave Pharmaceuticals , Vernon Hills, IL.

3. "Product Information. Metadate ER (methylphenidate)." Celltech Pharmacueticals Inc, Appleton, WI.

4. "Product Information. Concerta (methylphenidate)." Alza, Palo Alto, CA.

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

6. Cerner Multum, Inc. "Australian Product Information." O 0

7. "Product Information. Ritalin (methylphenidate)." Novartis Pharmaceuticals, East Hanover, NJ.

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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