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Concerta

Concerta (Methylphenidate Extended-Release Tablets) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Concerta Side Effects Center

What Is Concerta?

Concerta (methylphenidate extended release tablets) is a central nervous system stimulant used for treating attention deficit hyperactivity disorder (ADHD).

What Are Side Effects of Concerta?

Side effects of Concerta include:

Chronic use of Concerta may lead to dependency. Severe depression may occur upon discontinuation of Concerta.

Dosage for Concerta

The recommended dose of Concerta is 18-72 mg daily.

What Drugs, Substances, or Supplements Interact with Concerta?

Concerta may interact with MAO inhibitors, blood thinners, clonidine, dobutamine, epinephrine, isoproterenol, cold/allergy medicine that contains phenylephrine (a decongestant), potassium citrate, sodium acetate, sodium bicarbonate, citric acid and potassium citrate, sodium citrate and citric acid, medications to treat high or low blood pressure, stimulant medications, diet pills, seizure medicines, or antidepressants. Tell your doctor all medications and supplements you use.

Concerta During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant while using Concerta; it is unknown if Concerta will harm a fetus. It is unknown if Concerta passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Concerta Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Concerta Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
  • signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
  • signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
  • penis erection that is painful or lasts 4 hours or longer.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Methylphenidate can affect growth in children. Your child's height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate.

Common side effects may include:

  • sweating, increased blood pressure;
  • mood changes, anxiety, feeling nervous or irritable, trouble sleeping;
  • fast heart rate, pounding heartbeats or fluttering in your chest;
  • loss of appetite, weight loss;
  • dry mouth, nausea, vomiting, stomach pain, indigestion; or
  • headache, dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Concerta (Methylphenidate Extended-Release Tablets)

 

Concerta Professional Information

SIDE EFFECTS

The following are discussed in more detail in other sections of the labeling:

  • Drug Dependence [see BOX WARNING]
  • Hypersensitivity to Methylphenidate [see CONTRAINDICATIONS]
  • Agitation [see CONTRAINDICATIONS]
  • Glaucoma [see CONTRAINDICATIONS]
  • Tics [see CONTRAINDICATIONS]
  • Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS and DRUG INTERACTIONS]
  • Serious Cardiovascular Events [see WARNINGS AND PRECAUTIONS]
  • Psychiatric Adverse Events [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Priapism [see WARNINGS AND PRECAUTIONS]
  • Long-Term Suppression of Growth [see WARNINGS AND PRECAUTIONS]
  • Visual Disturbance [see WARNINGS AND PRECAUTIONS]
  • Potential for Gastrointestinal Obstruction [see WARNINGS AND PRECAUTIONS]
  • Hematologic Monitoring [see WARNINGS AND PRECAUTIONS]

The most common adverse reaction in double-blind clinical trials (>5%) in pediatric patients (children and adolescents) was abdominal pain upper. The most common adverse reactions in double-blind clinical trials (>5%) in adult patients were decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, and hyperhidrosis [see Commonly Observed Adverse Reactions In Double-Blind, Placebo-Controlled Clinical Trials].

The most common adverse reactions associated with discontinuation (≥1%) from either pediatric or adult clinical trials were anxiety, irritability, insomnia, and blood pressure increased [see Discontinuation Due To Adverse Reactions].

The development program for CONCERTA® included exposures in a total of 3906 participants in clinical trials. Children, adolescents, and adults with ADHD were evaluated in 6 controlled clinical studies and 11 open-label clinical studies (see Table 3). Safety was assessed by collecting adverse events, vital signs, weights, and ECGs, and by performing physical examinations and laboratory analyses.

Table 3. CONCERTA® Exposure in Double-Blind and Open-Label Clinical Studies

Patient Population N Dose Range
Children 2216 18 to 54 mg once daily
Adolescents 502 18 to 72 mg once daily
Adults 1188 18 to 108 mg once daily

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using their own terminology. Consequently, to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Throughout this section, adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of CONCERTA® based on the comprehensive assessment of the available adverse event information. A causal association for CONCERTA® often cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.

The majority of adverse reactions were mild to moderate in severity.

Commonly Observed Adverse Reactions In Double-Blind, Placebo-Controlled Clinical Trials

Adverse reactions in either the pediatric or adult double-blind adverse reactions tables may be relevant for both patient populations.

Children And Adolescents

Table 4 lists the adverse reactions reported in 1% or more of CONCERTA®-treated children and adolescent subjects in 4 placebo-controlled, double-blind clinical trials.

Table 4. Adverse Reactions Reported by ≥1% of CONCERTA®-Treated Children and Adolescent Subjects in 4 Placebo-Controlled, Double-Blind Clinical Trials of CONCERTA®

System/Organ Class
   Adverse Reaction		 CONCERTA®
(n=321)
%		 Placebo
(n=318)
%
Gastrointestinal Disorders
  Abdominal pain upper 6.2 3.8
  Vomiting 2.8 1.6
General Disorders and Administration Site Conditions
  Pyrexia 2.2 0.9
Infections and Infestations
  Nasopharyngitis 2.8 2.2
Nervous System Disorders
  Dizziness 1.9 0
Psychiatric Disorders
  Insomnia* 2.8 0.3
Respiratory, Thoracic and Mediastinal Disorders
  Cough 1.9 0.9
  Oropharyngeal pain 1.2 0.9
*Terms of Initial insomnia (CONCERTA®=0.6%) and Insomnia (CONCERTA®=2.2%) are combined into Insomnia.

The majority of adverse reactions were mild to moderate in severity.

Adults

Table 5 lists the adverse reactions reported in 1% or more of CONCERTA®-treated adults in 2 placebo-controlled, double-blind clinical trials.

Table 5. Adverse Reactions Reported by ≥1% of CONCERTA®-Treated Adult Subjects in 2 Placebo-Controlled, Double-Blind Clinical Trials*

System/Organ Class
   Adverse Reaction		 CONCERTA®
(n=415)
%		 Placebo
(n=212)
%
Cardiac Disorders
  Tachycardia 4.8 0
  Palpitations 3.1 0.9
Ear and Labyrinth Disorders
  Vertigo 1.7 0
Eye Disorders
  Vision blurred 1.7 0.5
Gastrointestinal Disorders
  Dry mouth 14.0 3.8
  Nausea 12.8 3.3
  Dyspepsia 2.2 0.9
  Vomiting 1.7 0.5
  Constipation 1.4 0.9
General Disorders and Administration Site Conditions
  Irritability 5.8 1.4
Infections and Infestations
  Upper respiratory tract infection 2.2 0.9
Investigations
  Weight decreased 6.5 3.3
Metabolism and Nutrition Disorders
  Decreased appetite 25.3 6.6
  Anorexia 1.7 0
Musculoskeletal and Connective Tissue Disorders
  Muscle tightness 1.9 0
Nervous System Disorders
  Headache 22.2 15.6
  Dizziness 6.7 5.2
  Tremor 2.7 0.5
  Paresthesia 1.2 0
  Sedation 1.2 0
  Tension headache 1.2 0.5
Psychiatric Disorders
  Insomnia 12.3 6.1
  Anxiety 8.2 2.4
  Initial insomnia 4.3 2.8
  Depressed mood 3.9 1.4
  Nervousness 3.1 0.5
  Restlessness 3.1 0
  Agitation 2.2 0.5
  Aggression 1.7 0.5
  Bruxism 1.7 0.5
  Depression 1.7 0.9
  Libido decreased 1.7 0.5
  Affect lability 1.4 0.9
  Confusional state 1.2 0.5
  Tension 1.2 0.5
Respiratory, Thoracic and Mediastinal Disorders
  Oropharyngeal pain 1.7 1.4
Skin and Subcutaneous Tissue Disorders
  Hyperhidrosis 5.1 0.9
* Included doses up to 108 mg.

The majority of ADRs were mild to moderate in severity.

Other Adverse Reactions Observed In CONCERTA® Clinical Trials

This section includes adverse reactions reported by CONCERTA®-treated subjects in double-blind trials that do not meet the criteria specified for Table 4 or Table 5 and all adverse reactions reported by CONCERTA®-treated subjects who participated in open-label and postmarketing clinical trials.

Blood and Lymphatic System Disorders: Leukopenia

Eye Disorders: Accommodation disorder, Dry eye

Vascular Disorders: Hot flush

Gastrointestinal Disorders: Abdominal discomfort, Abdominal pain, Diarrhea

General Disorders and Administrative Site Conditions: Asthenia, Fatigue, Feeling jittery, Thirst

Infections and Infestations: Sinusitis

Investigations: Alanine aminotransferase increased, Blood pressure increased, Cardiac murmur, Heart rate increased

Musculoskeletal and Connective Tissue Disorders: Muscle spasms

Nervous System Disorders: Lethargy, Psychomotor hyperactivity, Somnolence

Psychiatric Disorders: Anger, Hypervigilance, Mood altered, Mood swings, Panic attack, Sleep disorder, Tearfulness, Tic

Reproductive System and Breast Disorders: Erectile dysfunction

Respiratory, Thoracic and Mediastinal Disorders: Dyspnea

Skin and Subcutaneous Tissue Disorders: Rash, Rash macular

Vascular Disorders: Hypertension

Discontinuation Due To Adverse Reactions

Adverse reactions in the 4 placebo-controlled studies of children and adolescents leading to discontinuation occurred in 2 CONCERTA® patients (0.6%) including depressed mood (1, 0.3%) and headache and insomnia (1, 0.3%), and 6 placebo patients (1.9%) including headache and insomnia (1, 0.3%), irritability (2, 0.6%), headache (1, 0.3%), psychomotor hyperactivity (1, 0.3%), and tic (1, 0.3%).

In the 2 placebo-controlled studies of adults, 25 CONCERTA® patients (6.0%) and 6 placebo patients (2.8%) discontinued due to an adverse reaction. Those events with an incidence of >0.5% in the CONCERTA® patients included anxiety (1.7%), irritability (1.4%), blood pressure increased (1.0%), and nervousness (0.7%). In placebo patients, blood pressure increased and depressed mood had an incidence of >0.5% (0.9%).

In the 11 open-label studies of children, adolescents, and adults, 266 CONCERTA® patients (7.0%) discontinued due to an adverse reaction. Those events with an incidence of >0.5% included insomnia (1.2%), irritability (0.8%), anxiety (0.7%), decreased appetite (0.7%), and tic (0.6%).

Tics

In a long-term uncontrolled study (n=432 children), the cumulative incidence of new onset of tics was 9% after 27 months of treatment with CONCERTA®.

In a second uncontrolled study (n=682 children) the cumulative incidence of new-onset tics was 1% (9/682 children). The treatment period was up to 9 months with mean treatment duration of 7.2 months.

Blood Pressure And Heart Rate Increases

In the laboratory classroom clinical trials in children (Studies 1 and 2), both CONCERTA® once daily and methylphenidate three times daily increased resting pulse by an average of 2 to 6 bpm and produced average increases of systolic and diastolic blood pressure of roughly 1 to 4 mm Hg during the day, relative to placebo. In the placebo-controlled adolescent trial (Study 4), mean increases from baseline in resting pulse rate were observed with CONCERTA® and placebo at the end of the double-blind phase (5 and 3 beats/minute, respectively). Mean increases from baseline in blood pressure at the end of the double-blind phase for CONCERTA® and placebo-treated patients were 0.7 and 0.7 mm Hg (systolic) and 2.6 and 1.4 mm Hg (diastolic), respectively. In one placebo-controlled study in adults (Study 6), dose-dependent mean increases of 3.9 to 9.8 bpm from baseline in standing pulse rate were observed with CONCERTA® at the end of the double-blind treatment vs. an increase of 2.7 beats/minute with placebo. Mean changes from baseline in standing blood pressure at the end of double-blind treatment ranged from 0.1 to 2.2 mm Hg (systolic) and 0.7 to 2.2 mm Hg (diastolic) for CONCERTA® and was 1.1 mm Hg (systolic) and -1.8 mm Hg (diastolic) for placebo. In a second placebo-controlled study in adults (Study 5), mean changes from baseline in resting pulse rate were observed for CONCERTA® and placebo at the end of the double-blind treatment (3.6 and –1.6 beats/minute, respectively). Mean changes from baseline in blood pressure at the end of the double–blind treatment for CONCERTA® and placebo-treated patients were –1.2 and –0.5 mm Hg (systolic) and 1.1 and 0.4 mm Hg (diastolic), respectively [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following additional adverse reactions have been identified during postapproval use of CONCERTA®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency:

Blood and Lymphatic System Disorders: Pancytopenia, Thrombocytopenia, Thrombocytopenic purpura

Cardiac Disorders: Angina pectoris, Bradycardia, Extrasystoles, Supraventricular tachycardia, Ventricular extrasystoles

Eye Disorders: Diplopia, Mydriasis, Visual impairment

General Disorders: Chest pain, Chest discomfort, Drug effect decreased, Hyperpyrexia, Therapeutic response decreased

Hepatobiliary disorders: Hepatocellular injury, Acute hepatic failure

Immune System Disorders: Hypersensitivity reactions such as Angioedema, Anaphylactic reactions, Auricular swelling, Bullous conditions, Exfoliative conditions, Urticarias, Pruritus NEC, Rashes, Eruptions, and Exanthemas NEC

Investigations: Blood alkaline phosphatase increased, Blood bilirubin increased, Hepatic enzyme increased, Platelet count decreased, White blood cell count abnormal

Musculoskeletal, Connective Tissue and Bone Disorders: Arthralgia, Myalgia, Muscle twitching, Rhabdomyolysis

Nervous System Disorders: Convulsion, Grand mal convulsion, Dyskinesia, Serotonin syndrome in combination with serotonergic drugs

Psychiatric Disorders: Disorientation, Hallucination, Hallucination auditory, Hallucination visual, Mania, Logorrhea, Libido changes

Reproductive System and Breast Disorders: Priapism

Skin and Subcutaneous Tissue Disorders: Alopecia, Erythema Vascular Disorders: Raynaud’s phenomenon

DRUG INTERACTIONS

MAO Inhibitors

CONCERTA® should not be used in patients being treated (currently or within the preceding 2 weeks) with MAO inhibitors [see CONTRAINDICATIONS].

Vasopressor Agents

Because of possible increases in blood pressure, CONCERTA® should be used cautiously with vasopressor agents [see WARNINGS AND PRECAUTIONS].

Coumarin Anticoagulants, Antidepressants, And Selective Serotonin Reuptake Inhibitors

Human pharmacologic studies have shown that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (eg, phenobarbital, phenytoin, primidone), and some antidepressants (tricyclics and selective serotonin reuptake inhibitors). Downward dose adjustment of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentrations (or, in the case of coumarin, coagulation times), when initiating or discontinuing concomitant methylphenidate.

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.

Drug Abuse And Dependence

Controlled Substance

Methylphenidate is a Schedule II controlled substance under the Controlled Substances Act.

Abuse

As noted in the Box Warning, CONCERTA® should be given cautiously to 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.

In two placebo-controlled human abuse potential studies, single oral doses of CONCERTA® were compared to single oral doses of immediate-release methylphenidate (IR MPH) and placebo in subjects with a history of recreational stimulant use to assess relative abuse potential. For the purpose of this assessment, the response for each of the subjective measures was defined as the maximum effect within the first 8 hours after dose administration.

In one study (n=40), both CONCERTA® (108 mg) and 60 mg IR MPH compared to placebo produced statistically significantly greater responses on the five subjective measures suggestive of abuse potential. In comparisons between the two active treatments, however, CONCERTA® (108 mg) produced variable responses on positive subjective measures that were either statistically indistinguishable from (Abuse Potential, Drug Liking, Amphetamine, and Morphine Benzedrine Group [Euphoria]) or statistically less than (Stimulation – Euphoria) responses produced by 60 mg IR MPH.

In another study (n=49), both doses of CONCERTA® (54 mg and 108 mg) and both doses of IR MPH (50 mg and 90 mg) produced statistically significantly greater responses compared to placebo on the two primary scales used in the study (Drug Liking, Euphoria). When doses of CONCERTA® (54 mg and 108 mg) were compared to IR MPH (50 mg and 90 mg), respectively, CONCERTA® produced statistically significantly lower subjective responses on these two scales than IR MPH. CONCERTA® (108 mg) produced responses that were statistically indistinguishable from the responses on these two scales produced by IR MPH (50 mg). Differences in subjective responses to the respective doses should be considered in the context that only 22% of the total amount of methylphenidate in CONCERTA® tablets is available for immediate release from the drug overcoat [see System Components And Performance].

Although these findings reveal a relatively lower response to CONCERTA® on subjective measures suggestive of abuse potential compared to IR MPH at roughly equivalent total MPH doses, the relevance of these findings to the abuse potential of CONCERTA® in the community is unknown.

Dependence

As noted in the Box Warning, 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.

Read the entire FDA prescribing information for Concerta (Methylphenidate Extended-Release Tablets)

&Copy; Concerta Patient Information is supplied by Cerner Multum, Inc. and Concerta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.