Possible Side Effects & Safety of COTEMPLA XR-ODT

What are the possible side effects of COTEMPLA XR-ODT?³¹

COTEMPLA XR-ODT can cause serious side effects, including:

Abuse, Misuse, and Addiction
Heart-related problems
Mental (psychiatric) problems
Painful and prolonged erections (priapism)
Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon)
Slowing of growth (height and weight)
Eye problems (increased pressure in the eye and glaucoma)
New or worsening tics or worsening Tourette’s syndrome

Reference 31: Cleveland Clinic. ADHD Medication: How They Work & Side Effects. Cleveland Clinic Health Library. Last reviewed October 6, 2022. Accessed December 17, 2025. https://my.clevelandclinic.org/health/treatments/11766‑adhd‑medication

The most common side effects include:³²

decreased appetite
anxiety
trouble sleeping
dizziness
nausea
irritability

vomiting
mood swings
indigestion
increased heart rate
stomach pain
increased blood pressure
weight loss

These are not all the possible side effects of COTEMPLA XR-ODT. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Reference 32: Neos Therapeutics Brands, LLC; U.S. Food and Drug Administration. COTEMPLA XR‑ODT (methylphenidate) Medication Guide. DailyMed. Revised September 2025. Accessed December 17, 2025. https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=33f70f58‑c871‑42c8‑8adb‑345caeafefcd

What is the most important information I should know about COTEMPLA XR-ODT?³³

COTEMPLA XR-ODT is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep COTEMPLA XR-ODT in a safe place to protect it from theft. Never give your COTEMPLA XR-ODT to anyone else, because it may cause death or harm them. Selling or giving away COTEMPLA XR-ODT may harm others and is against the law.

COTEMPLA XR-ODT can cause serious side effects, including:

Abuse, misuse, and addiction

COTEMPLA XR-ODT has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of COTEMPLA XR-ODT, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death.
The risk of overdose and death is increased with higher doses of COTEMPLA XR-ODT or when it is used in ways that are not approved, such as snorting or injection.
Your healthcare provider should check your child’s risk for abuse, misuse, and addiction before treatment with COTEMPLA XR-ODT and will monitor your child during treatment.
COTEMPLA XR-ODT may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
Do not give COTEMPLA XR-ODT to anyone else

Risks for people with serious heart disease.

Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check your child carefully for heart problems before starting COTEMPLA XR-ODT. Tell your healthcare provider if your child has any heart problems, heart disease, or heart defects

Call your healthcare provider or go to the nearest hospital emergency room right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with COTEMPLA XR-ODT.

Mental (psychiatric) problems, including:

New or worse behavior and thought problems
New or worse bipolar illness
New psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms

Tell your healthcare provider about any mental problems your child has, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider right away if your child has any new or worsening mental symptoms or problems during treatment with COTEMPLA XR-ODT, especially hearing voices, seeing or believing things that are not real, or new manic symptoms

Painful and prolonged erections (priapism).

Priapism has happened in males who take products that contain methylphenidate. If your child develops priapism, get medical help right away.

Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon).

Signs and symptoms may include:
- fingers or toes may feel numb, cool, painful
- fingers or toes may change color from pale, to blue, to red
Tell your healthcare provider if your child has numbness, pain, skin color change, or sensitivity to temperature in their fingers or toes.

Call your healthcare provider right away if your child has any signs of unexplained wounds appearing on fingers or toes during treatment with COTEMPLA XR-ODT.

Slowing of growth (height and weight) in children.

Children should have their height and weight checked often during treatment with COTEMPLA XR-ODT.
COTEMPLA XR-ODT treatment may be stopped if your child is not gaining weight or height.

Eye problems (increased pressure in the eye and glaucoma).

Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.

New or worsening tics or worsening Tourette’s syndrome.

Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with COTEMPLA XR-ODT.

Other Medications

Tell your healthcare provider about all of the medicines that your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
COTEMPLA XR-ODT and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted during treatment with COTEMPLA XR-ODT.
Your healthcare provider will decide whether COTEMPLA XR-ODT can be taken with other medicines. Especially tell your healthcare provider if your child takes:
- anti-depression medicines including MAOIs
Know the medicines that your child takes. Keep a list of the medicines with you to show your healthcare provider and pharmacist.

Do not start any new medicine during treatment with COTEMPLA XR-ODT without talking to your healthcare provider first.

Reference 33: Neos Therapeutics, Inc; U.S. Food and Drug Administration. Cotempla XR‑ODT (methylphenidate) Extended‑Release Orally Disintegrating Tablets: Prescribing Information. Revised June 2017. Accessed December 17, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf

What should I avoid during treatment with COTEMPLA XR-ODT?

You should avoid drinking alcohol during treatment with COTEMPLA XR-ODT

Common side effects of COTEMPLA XR-ODT include:

Decreased appetite, trouble sleeping, nausea, vomiting, indigestion, stomach pain, weight loss, anxiety, dizziness, irritability, mood swings, increased heart rate, and increased blood pressure.

These are not all the possible side effects of COTEMPLA XR-ODT. Call your healthcare provider for medical advice about side effects.

COTEMPLA XR-ODT is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. COTEMPLA XR-ODT is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs. Keep COTEMPLA XR-ODT in a safe place to protect it from theft. Selling or giving away your COTEMPLA XR-ODT may cause death or harm to others and is against the law.

For additional safety information, click here for Medication Guide and Full Prescribing Information and discuss with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Important Safety Information

WARNING: ABUSE, MISUSE, AND ADDICTION

COTEMPLA XR-ODT 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 COTEMPLA XR-ODT, can result in overdose and death, and this risk is increased with higher doses of unapproved methods of administration, such as snorting or injection.

Before prescribing COTEMPLA XR-ODT, 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 COTEMPLA XR-ODT treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Indication

COTEMPLA XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Limitations of Use

The use of COTEMPLA XR-ODT is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.

Contraindications

Known hypersensitivity to methylphenidate or other ingredients in COTEMPLA XR-ODT. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products.
Concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor because of the risk of hypertensive crisis.

Warnings and Precautions

Abuse, Misuse, and Addiction: COTEMPLA XR-ODT has a high potential for abuse and misuse. The use of COTEMPLA XR-ODT exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. COTEMPLA XR-ODT can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including COTEMPLA XR-ODT, 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 COTEMPLA XR-ODT, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, and proper disposal of any unused drug. Advise patients to store COTEMPLA XR-ODT in a safe place, preferably locked, and instruct patients not to give COTEMPLA XR-ODT to anyone else. Throughout COTEMPLA XR-ODT treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Risks to Patients with Serious Cardiac Disease: Sudden death has occurred in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosages. Avoid COTEMPLA XR-ODT use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
Increased Blood Pressure and Heart Rate: CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase approximately 3 to 6 bpm). Some patients may have larger increases. Monitor all COTEMPLA XR-ODT-treated patients for hypertension and tachycardia.
Psychiatric Adverse Reactions: Exacerbation of Pre-Existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating COTEMPLA XR-ODT treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression). New Psychotic or Manic Symptoms CNS stimulants, at the recommended dosage, may cause psychotic or manic symptoms (e.g. hallucinations, delusional thinking or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0% of placebo-treated patients. If such symptoms occur, consider discontinuing COTEMPLA XR-ODT.
Priapism: Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in both adult and pediatric male patients. Although priapism was not reported with methylphenidate initiation, it developed after some time on methylphenidate, often after an increase in dosage. Priapism also occurred during methylphenidate withdrawal (drug holidays or during discontinuation). COTEMPLA XR-ODT-treated patients who develop abnormally sustained or frequent and painful erections should see immediate medical attention.
Peripheral Vasculopathy, including Raynaud’s Phenomenon: CNS stimulants, including COTEMPLA XR-ODT, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports and at therapeutic dosages of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant. Careful observation for digital changes is necessary during COTEMPLA XR-ODT treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for COTEMPLA XR-ODT-treated patients who develop signs or symptoms of peripheral vasculopathy.
Long-Term Suppression of Growth in Pediatric Patients: COTEMPLA XR-ODT is not approved for use and is not recommended in pediatric patients below 6 years of age. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or nonmedication-treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and nonmedication-treated pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that pediatric patients who received methylphenidate for 7 days per week throughout the year had 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), without evidence of growth rebound during this development period. Closely monitor growth (weight and height) in COTEMPLA XR-ODT-treated pediatric patients who are not growing or gaining height and weight as expected may need to have their treatment interrupted.
Acute Angle Closure Glaucoma: There have been reports of angle closure glaucoma associated with methylphenidate treatment. Although the mechanism is not clear, COTEMPLA XR-ODT-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.
Increased Intraocular Pressure and Glaucoma: There have been reports of an elevation of intraocular pressure (IOP) associated with methylphenidate treatment. Prescribe COTEMPLA XR-ODT to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor COTEMPLA XR-ODT-treated patients with a history of abnormally increased IOP or open angle glaucoma.
Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported. Before initiating COTEMPLA XR-ODT, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor COTEMPLA XR-ODT-treated patients for the emergence or worsening of tics or Tourette’s syndrome and discontinue treatment if clinically appropriate.

Adverse Reactions

Adverse Reactions in Studies with Other Methylphenidate Products in Children, Adolescents, and Adults with ADHD: Commonly reported (≥2% of the methylphenidate group and at least twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include:

Appetite decreased
Weight decreased
Nausea
Abdominal pain
Dyspepsia
Dry mouth
Vomiting
Insomnia
Anxiety
Nervousness
Restlessness
Affect lability
Agitation
Irritability
Dizziness
Vertigo
Tachycardia
Palpitations
Hyperhidrosis
Pyrexia
Tremor
Blurred Vision
Blood pressure increased
Heart rate increased

Adverse Reactions in Studies with COTEMPLA XR-ODT in Children with ADHD: There is limited experience with COTEMPLA XR-ODT in controlled trials. Based on this limited experience, the adverse reaction profile of COTEMPLA XR-ODT appears similar to other methylphenidate extended release-products.

Drug Interactions

Monoamine Oxidase Inhibitors (MAOI): Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Do not administer COTEMPLA XR-ODT concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment.
Gastric pH Modulators: May change the release profile and alter the pharmacodynamics of COTEMPLA XR-ODT. Concomitant use of COTEMPLA XR-ODT with a gastric pH modulator (i.e., a H2-blocker or a proton pump inhibitor) is not recommended.
Antihypertensive Drugs: COTEMPLA XR-ODT may decrease the effectiveness of drug used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.
Halogenated Anesthetics: Concomitant use of halogenated anesthetics and COTEMPLA XR-ODT may increase the risk of sudden blood pressure and heart rate increase during surgery. Avoid use of COTEMPLA XR-ODT in patients being treated with anesthetics on the day of surgery.
Risperidone: Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.

Pregnancy and Lactation

Fetal/Neonatal adverse reactions: CNS stimulants, such as COTEMPLA XR-ODT, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.
Lactation: Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

Pediatric Use

The safety and effectiveness of COTEMPLA XR-ODT have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release methylphenidate products, patients 4 to <6 years of age had higher systemic methylphenidate exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss.

The safety and effectiveness of COTEMPLA XR-ODT have been established in pediatric patients 6 to 17 years of age in one adequate and well-controlled study in pediatric patients 6 to 12 years, pharmacokinetic data in adolescents, and safety information from other methylphenidate-containing products.

Please click here for Full Prescribing Information.

What are the possible side effects of COTEMPLA XR-ODT?31

The most common side effects include:32