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U.S. Department of Health and Human Services


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Opana ER (oxymorphone hydrochloride extended-release) Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg

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


January 2013

Summary View


Important Administration Instructions
  • Occasionally, the inactive ingredients of OPANA ER may be eliminated as a soft mass in the stool that may resemble the original tablet. Patients should be informed that the active medication has already been absorbed by the time the patient sees the soft mass