Oxymorphone: Side Effects, Uses & Monitoring
OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.
- Data source
- FDA labeling via NIH DailyMed (label 5ca97412…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Constipation | 26.2% |
| Somnolence | 19.1% |
| Nausea | 18.2% |
| Dizziness (exc vertigo) | 17.8% |
| Dizziness | 11.1% |
| Headache | 10.5% |
| Vomiting | 8.8% |
| Sweating increased | 8.7% |
| Sedation | 7.6% |
| Pruritus | 6.8% |
| Dry mouth | 6.4% |
| Diarrhea | 5.6% |
| Insomnia | 4% |
| Fatigue | 3.9% |
| Appetite decreased | 2.9% |
| Abdominal pain | 2.5% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. OPANA ER is not intended for use as a prn analgesic. OPANA ER is not indicated for pain in the immediate post-operative period (12-24 hours following surgery) for patients not previously taking opioids because of the risk of oversedation and respiratory depression requiring reversal with opioid antagonists. OPANA ER is not indicated for pain in the post-operative period if the pain is mild or not expected to persist for an extended period of time.
Conditions associated with Oxymorphone in labeling
Frequently Asked Questions
What is Oxymorphone used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Oxymorphone?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Oxymorphone. Individual risk varies.
Does Oxymorphone require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Oxymorphone.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.