Opana ER Side Effects
Generic Name: Oxymorphone
Please note - some side effects for Opana ER may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Opana ER - for the consumer
Opana ER Extended-Release Tablets
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Opana ER Extended-Release Tablets:
Seek medical attention right away if any of these SEVERE side effects occur when using Opana ER Extended-Release Tablets:Anxiety; constipation; decreased appetite; dizziness; drowsiness; dry mouth; gas; headache; lightheadedness; nausea; sweating; vomiting.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; mental or mood changes; seizure; severe or persistent dizziness or drowsiness; severe or persistent headache or vomiting; shallow, slowed, or difficult breathing; trouble urinating; unusual swelling; vision changes.
For the professional
Opana ER
Tables 2 and 3 list the most frequently occurring adverse reactions (in at least 5% of patients) from the placebo-controlled trials in patients with low back pain.
| Open-Label Titration Period |
Double-Blind Treatment Period | ||
| Opana ER | Opana ER | Placebo | |
| Preferred Term | (N = 325) | (N = 105) | (N = 100) |
| Constipation | 26.2% | 6.7% | 1.0% |
| Somnolence | 19.1% | 1.9% | 0% |
| Nausea | 18.2% | 11.4% | 9.0% |
| Dizziness | 11.1% | 4.8% | 3.0% |
| Headache | 10.5% | 3.8% | 2.0% |
| Pruritus | 6.8% | 2.9% | 1.0% |
| Open-Label Titration Period |
Double-Blind Treatment Period | ||
| Opana ER | Opana ER | Placebo | |
| Preferred Term | (N = 250) | (N = 70) | (N = 72) |
| Nausea | 19.6% | 2.9% | 1.4% |
| Constipation | 11.6% | 5.7% | 1.4% |
| Headache | 11.6% | 2.9% | 0% |
| Somnolence | 11.2% | 2.9% | 0% |
| Vomiting | 8.8% | 0% | 1.4% |
| Pruritus | 7.6% | 0% | 0% |
| Dizziness | 6.4% | 0% | 0% |
Adverse Reactions Reported in Placebo-Controlled Trials
The following table lists adverse reactions that were reported in at least 2% of patients in placebo-controlled trials (N=5)
| MedDRA Preferred Term | Opana ER (N=1259) | Placebo (N=461) |
| Nausea | 33.1% | 13.2% |
| Constipation | 27.6% | 13.2% |
| Dizziness (Exc Vertigo) | 17.8% | 7.6% |
| Somnolence | 17.2% | 2.2% |
| Vomiting | 15.6% | 4.1% |
| Pruritus | 15.2% | 7.6% |
| Headache | 12.2% | 5.6% |
| Sweating increased | 8.6% | 8.7% |
| Dry mouth | 6.4% | 0.7% |
| Sedation | 5.9% | 7.6% |
| Diarrhea | 4.3% | 5.6% |
| Insomnia | 4.0% | 2.0% |
| Fatigue | 3.9% | 1.3% |
| Appetite decreased | 2.9% | 0.4% |
| Abdominal pain | 2.5% | 1.5% |
Adverse Reactions Reported in All Clinical Trials
A total of 2011 patients were treated with Opana ER in the Phase 2/3 controlled and open-label clinical trials. The clinical trials consisted of patients with moderate to severe chronic pain and post surgical pain.
The adverse reactions are presented in the following manner: most common, common, and less common adverse reactions.
The most common adverse drug reactions (≥10%) reported at least once by patients treated with Opana ER in the clinical trials were nausea, constipation, dizziness (exc. vertigo), vomiting, pruritus, somnolence, headache, sweating increased, and sedation.
The common (≥1% - <10%) adverse drug reactions reported at least once by patients treated with Opana ER in the clinical trials organized by MedDRA’s (Medical Dictionary for Regulatory Activities) System Organ Class were:
Eye disorders: vision blurred
Gastrointestinal disorders: diarrhea, abdominal pain, dyspepsia
General disorders and administration site conditions: dry mouth, appetite decreased, fatigue, lethargy, weakness, pyrexia, dehydration, weight decreased, edema
Nervous system disorders: insomnia
Psychiatricdisorders: anxiety, confusion, disorientation, restlessness, nervousness, depression
Respiratory, thoracic and mediastinal disorders: dyspnea
Vascular disorders: flushing and hypertension
Other less common adverse reactions known with opioid treatment that were seen <1% in the Opana ER trials include the following in alphabetical order.
Abdominal distention, agitation, allergic reactions, bradycardia, central nervous system depression, clamminess, depressed level of consciousness, dermatitis, difficult micturition, dysphoria, euphoric mood, feeling jittery, hallucination, hot flashes, hypersensitivity, hypotension, hypoxia, ileus, mental impairment, mental status changes, miosis, oxygen saturation decreased, palpitation, postural hypotension, respiratory depression, respiratory distress, respiratory rate decreased, syncope, tachycardia, urinary retention, urticaria, and visual disturbances.
TopMore resources:
Opana ER Extended-Release Tablets
Oxymorphone - Includes detailed dosage instructions.
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