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Side Effects > Opana ER

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).


For the consumer

For the professional

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:

Anxiety; constipation; decreased appetite; dizziness; drowsiness; dry mouth; gas; headache; lightheadedness; nausea; sweating; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Opana ER Extended-Release Tablets:

Severe 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.

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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.

Table 2: Treatment-Emergent Adverse Events Reported in ≥5% of Patients During the Open-Label Titration Period and Double-Blind Treatment Period by Preferred Term —Number (%) of Treated Patients (12-Week Study In Opioid-Naïve 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%
Table 3. Treatment-Emergent Adverse Events Reported in ≥5% of Patients During the Open-Label Titration Period and Double-Blind Treatment Period by Preferred Term —Number (%) of Treated Patients (12-Week Study In Opioid-Experienced Patients with Low Back Pain)
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)

Table 4: Adverse Reactions Reported in Placebo-Controlled Clinical Trials with Incidence ≥2% in Patients Receiving Opana ER.
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.

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More resources:

Drugs.com Opana

MedFacts Oxymorphone

MedFacts Opana ER Extended-Release Tablets

MedFacts Opana

Micromedex Oxymorphone - Includes detailed dosage instructions.

FDA Opana ER

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