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U.S. Department of Health and Human Services


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OxyContin (oxycodone HCl controlled-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.

Summary View

Sections Modified


  • The following adverse reactions occurred in less than 1% of patients involved in clinical trials or were reported in postmarketing experience. (The adverse reaction categories have been re- organized. The adverse events listed below include only the new reactions added.)
    • Cardiac Disorders
      • Palpitations (in the context of withdrawal)
    • Investigations
      • Increased hepatic enzymes