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Methylphenidate Side Effects

In Summary

Commonly reported side effects of methylphenidate include: insomnia, nausea, headache, vomiting, decreased appetite, and xerostomia. Other side effects include: anxiety, tic disorder, hyperhidrosis, and irritability. See below for a comprehensive list of adverse effects.

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, oral tablet extended release disintegrating

Other dosage forms:

Warning

Oral route (Tablet, Extended Release, Disintegrating)

CNS stimulants, including methylphenidate extended-release orally disintegrating tablets, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.

Oral route (Capsule, Extended Release; Tablet; Tablet, Extended Release)

Use cautiously in emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because of abuse potential. Chronic abuse can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior, including psychotic episodes. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked.

Oral route (Powder for Suspension, Extended Release; Tablet, Extended Release Chewable)

CNS stimulants, including methylphenidate hydrochloride, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy

Oral route (Tablet, Chewable; Solution)

Use caution when prescribing to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with abnormal behavior. Psychotic episodes can occur, especially with parenteral abuse. Carefully supervise withdrawal from abusive use to avoid the onset of severe depression. Follow-up may be required following withdrawal from chronic therapeutic use, as symptoms of the underlying disorder may emerge.

Along with its needed effects, methylphenidate 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

Less Common

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

The more commonly reported adverse reactions have included decreased appetite, abdominal pain, nausea, vomiting, dyspepsia, insomnia, weight loss, anxiety, dizziness, irritability, affect lability, tachycardia, and increased blood pressure.[Ref]

Other

Common (1% to 10%): Lethargy, ear infection, pyrexia, fatigue, ear and labyrinth disorders, asthenia, injury/poisoning/procedural complications

Postmarketing reports: Hyperpyrexia[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, thirst[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, serotonin syndrome (in combination with serotonergic drugs)[Ref]

Endocrine

Common (1% to 10%): Reproductive system and breast disorders

Rare (less than 0.1%): Gynecomastia

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

Among patients 7 to 10 years old, consistently medicated (i.e., receiving methylphenidate for 7 days per week) for over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated patients over 36 months (ages of 10 to 13 years), a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), has been observed compared to non-medicated patients. This slowing in growth rate has been observed without evidence of growth rebound.[Ref]

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, growth suppression, arthralgia[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

Postmarketing reports: Angina pectoris, bradycardia extrasystole, supraventricular tachycardia, ventricular extrasystole, chest pain, chest discomfort[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

Very common (10% or more): Infections and infestations (45.2%)

Common (1% to 10%): Immune systems disorders, influenza[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, mydriasis, diplopia[Ref]

Genitourinary

Uncommon (0.1% to 1%): Hematuria, pollakiuria

Frequency not reported: Increased erection, prolonged erection, priapism[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, thrombocytopenia, thrombocytopenia purpura[Ref]

References

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

2. "Product Information. Cotempla XR-ODT (methylphenidate)." Neos Therepeautics, Inc, Grand Praire, TX.

3. "Product Information. Adhansia XR (methylphenidate)." Adlon Therapeutics, Wilson, NC.

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

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

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

7. "Product Information. Methylin (methylphenidate)." Mallinckrodt Medical Inc, St. Louis, MO.

8. "Product Information. Jornay PM (methylphenidate)." Ironshore Pharmaceuticals Inc., Durham, NC.

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

10. "Product Information. Daytrana (methylphenidate)." Noven Pharmaceuticals, Inc., New York, NY.

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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