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U.S. Department of Health and Human Services

Safety

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Concerta (methylphenidate HCl) Extended-Release Tablets


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

  • Hypersensitivity to Methylphenidate

WARNINGS AND PRECAUTIONS

  • Psychiatric Adverse Events
    • Pre-Existing Psychosis
    • Emergence of New Psychotic or Manic Symptoms
    • Aggression

ADVERSE REACTIONS

  • Initial Section
  • Table 3
  • Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials
    • Children and Adolescents
      • Table 4
    • Adults
      • Table 5
  • Blood Pressure and Heart Rate Increases
  • Postmarketing Experience

PATIENT COUNSELING INFORMATION

  • Information for Patients
    • Stimulants may impair the ability to operate potentially hazardous machinery...

MEDICATION GUIDE

  • What are possible side effects of Concerta?
    • Common side effects include...

CONTRAINDICATIONS

Hypersensitivity to Methylphenidate

Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with Concerta. Therefore, Concerta is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product...

WARNINGS AND PRECAUTIONS

Psychiatric Adverse Events

Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder...