Label Changes for:

Ultram ER (tramadol HCl) Extended-Release Tablets

February 2008

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.


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


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Serotonin Syndrome Risk

PRECAUTIONS

  • Use in Renal and Hepatic Disease
  • Information for Patients
    • ...Patients should be informed that ULTRAM ER may cause seizures and/or serotonin syndrome with concomitant use of serotonergic agents (including SRIs, NRIs, and
      triptans) or drugs that significantly reduce the metabolic clearance of tramadol...
  • Drug Interactions
    • CYP2D6 and CYP3A4 Inhibitors
    • Serotonergic Drugs
    • Triptans

ADVERSE REACTIONS

  • The frequency of adverse events generally increased with doses...
  • Table 2

WARNINGS

Serotonin Syndrome Risk

The development of a potentially life-threatening serotonin syndrome may occur with use of tramadol products, including ULTRAM ER, particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs and triptans, with drugs which impair metabolism of serotonin (including MAOIs) and with drugs which impair metabolism of tramadol (CYP2D6 and CYP3A4 inhibitors). This may occur within the recommended dose...

Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea)...

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