Label Changes for:
OxyContin (oxycodone HCl controlled-release) Tablets
June 2008
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
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. |
Sections Modified
ADVERSE REACTIONS
- 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
- Cardiac Disorders
