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Concerta

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Concerta

Concerta

Concerta Side Effects Center

Pharmacy Editor: Omudhome Ogbru, PharmD

Concerta (methylphenidate extended release tablets) is a central nervous system stimulant used for treating attention deficit hyperactivity disorder (ADHD). Adverse effects of Concerta include abdominal pain, decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight loss, irritability, and hyperhidrosis. Chronic use of Concerta may lead to dependency. Severe depression may occur upon discontinuation of Concerta.

The recommended dose of Concerta is 18-72 mg daily. Concerta should not be taken with monoamine oxidase inhibitors (MAOIs) (for example, phenelzine [Nardil]). There are no adequate studies of methylphenidate in pregnant women. It is not known if methylphenidate is secreted in breast milk.

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

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Concerta in Detail - Patient Information: Side Effects

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

Stop taking methylphenidate and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeats;
  • feeling like you might pass out;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • aggression, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches);
  • easy bruising, purple spots on your skin; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • stomach pain, nausea, vomiting, loss of appetite;
  • vision problems, dizziness, mild headache;
  • sweating, mild skin rash;
  • numbness, tingling, or cold feeling in your hands or feet;
  • nervous feeling, sleep problems (insomnia); or
  • weight loss.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Concerta Overview - Patient Information: Side Effects

SIDE EFFECTS: Nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, nausea, vomiting, headache, or blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast/pounding/irregular heartbeat, mental/mood/behavior changes (such as agitation, aggression, mood swings, abnormal thoughts), uncontrolled muscle movements (such as twitching, shaking), sudden outbursts of words/sounds that are hard to control.

Get medical help right away if you have any very serious side effects, including: fainting, seizure, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), symptoms of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Concerta (Methylphenidate Extended-Release Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Concerta FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

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 ADVERSE REACTIONS].

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 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

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

Nervous System Disorders: Convulsion, Grand mal convulsion, Dyskinesia

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

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

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Concerta - User Reviews

Concerta User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Concerta sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

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