Cotempla XR-ODT Side Effects
Generic name: methylphenidate
Medically reviewed by Drugs.com. Last updated on Oct 10, 2020.
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 Cotempla XR-ODT.
For the Consumer
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:
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 (Powder for Suspension, Extended Release; Tablet, Extended Release Chewable; Capsule, Extended Release; Tablet; Tablet, Extended Release)
Warning: Abuse and DependenceCNS 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. Use cautiously in patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
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.
Side effects requiring immediate medical attention
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:
- 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
- uncontrolled vocal outbursts or tics (uncontrolled and repeated body movements)
- unusual bleeding or bruising
Incidence not known
- arm, back or jaw pain
- bleeding gums
- bloody nose
- chest discomfort
- chest tightness or heaviness
- dark urine
- difficulty with speaking
- difficulty with swallowing
- double vision
- fast, pounding, or irregular heartbeat or pulse
- feeling like surroundings are not real
- feeling sad or empty
- feeling that others are watching you or controlling your behavior
- feeling that others can hear your thoughts
- feeling, seeing, or hearing things that are not there
- heavier menstrual periods
- inability to move the arms, legs, or facial muscles
- inability to speak
- itching skin
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of interest or pleasure
- mood swings
- muscle pain, stiffness, or spasms
- numbness of the hands
- overactive reflexes
- painful or difficult urination
- pale skin
- paleness or cold feeling in the fingertips and toes
- poor coordination
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, irritated eyes
- red, swollen, or scaly skin
- redness, soreness, or itching skin
- right upper quadrant tenderness
- seeing, hearing, or feeling things that are not there
- severe or sudden headache
- slow speech
- slowed growth in children
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stuffy or runny nose
- sudden loss of coordination
- sudden slurring of speech
- swollen glands
- talking or acting with excitement you cannot control
- tingling or pain in the fingers or toes when exposed to cold temperatures
- trembling or shaking
- trouble concentrating
- trouble sleeping
- troubled breathing with exertion
- twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- 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
- bigger, dilated, or enlarged pupils of the eyes
- confusion as to time, place, or person
- dark urine
- 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, stiffness, or twitching
- overactive reflexes
- pounding in the ears
- rapid, shallow breathing
- unusual excitement, nervousness, or restlessness
Side effects not requiring immediate medical attention
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:
- Loss of appetite
- stomach pain
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
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]
Common (1% to 10%): Lethargy, ear infection, pyrexia, fatigue, ear and labyrinth disorders, asthenia, injury/poisoning/procedural complications
Postmarketing reports: Hyperpyrexia[Ref]
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]
Very common (10% or more): Decreased appetite (27.1%), metabolism and nutrition disorders (11.5%)
Common (1% to 10%): Anorexia, decreased weight, thirst[Ref]
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
Very common (10% or more): Nervous system disorders (23.5%), headache (23.2%)
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)
Common (1% to 10%): Reproductive system and breast disorders
Rare (less than 0.1%): Gynecomastia
Very common (10% or more): Nasopharyngitis (19.1%), respiratory/thoracic/mediastinal disorders (10.6%)
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]
Very common (10% or more): Administration site and general disorders (12.9%)
Postmarketing reports: Patch application site reactions[Ref]
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
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]
Very common (10% or more): Infections and infestations (45.2%)
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]
Uncommon (0.1% to 1%): Hematuria, pollakiuria
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]
Very rare (less than 0.01%): Leukopenia, thrombocytopenia, anemia, decreased platelet count, abnormal white blood count
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. Methylin (methylphenidate)." Mallinckrodt Medical Inc, St. Louis, MO.
6. "Product Information. Jornay PM (methylphenidate)." Ironshore Pharmaceuticals Inc., Durham, NC.
7. "Product Information. Concerta (methylphenidate)." Alza, Palo Alto, CA.
8. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
9. "Product Information. Daytrana (methylphenidate)." Noven Pharmaceuticals, Inc., New York, NY.
10. Cerner Multum, Inc. "Australian Product Information." O 0
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Frequently asked questions
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More about Cotempla XR-ODT (methylphenidate)
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- Drug class: CNS stimulants
- FDA Approval History
Related treatment guides
Some side effects may not be reported. You may report them to the FDA.