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Cotempla XR-ODT Side Effects

Generic name: methylphenidate

Medically reviewed by Drugs.com. Last updated on Dec 12, 2023.

Note: This document contains side effect information about methylphenidate. Some dosage forms listed on this page may not apply to the brand name Cotempla XR-ODT.

Applies to methylphenidate: oral capsule extended release, oral capsule extended release biphasic 30/70, oral capsule extended release biphasic 40/60, oral capsule extended release biphasic 50/50, 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)

Warning: Abuse, Misuse, and AddictionMethylphenidate have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing methylphenidate, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout methylphenidate treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction

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

Abuse, Misuse, and AddictionMethylphenidate hydrochloride has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.Before prescribing methylphenidate hydrochloride, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout methylphenidate hydrochloride treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Serious side effects of Cotempla XR-ODT

Along with its needed effects, methylphenidate (the active ingredient contained in Cotempla XR-ODT) 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

Incidence not known

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

Symptoms of overdose

Other side effects of Cotempla XR-ODT

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

Less common

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 (the active ingredient contained in Cotempla XR-ODT) 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]

Frequently asked questions

References

1. Product Information. Metadate CD (methylphenidate). Celltech Pharmaceuticals Inc. 2022.

2. Product Information. Metadate ER (methylphenidate). Celltech Pharmaceuticals Inc. 2002.

3. Product Information. Concerta (methylphenidate). Alza. 2002.

4. Cerner Multum, Inc. UK Summary of Product Characteristics.

5. Cerner Multum, Inc. Australian Product Information.

6. Product Information. Quillivant XR (methylphenidate). NextWave Pharmaceuticals. 2013.

7. Product Information. Cotempla XR-ODT (methylphenidate). Neos Therepeautics, Inc. 2019.

8. Product Information. Methylin (methylphenidate). Mallinckrodt Medical Inc. 2019.

9. Product Information. Adhansia XR (methylphenidate). Adlon Therapeutics. 2019.

10. Product Information. Daytrana (methylphenidate). Noven Pharmaceuticals, Inc. 2019.

11. Product Information. Jornay PM (methylphenidate). Ironshore Pharmaceuticals Inc. 2019.

12. Product Information. Ritalin (methylphenidate). Novartis Pharmaceuticals. 2001.

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.