ADVERSE REACTIONS
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.
| MedDRA Preferred Term | OPANA (N=557) | Placebo (N=270) |
| Nausea | 19.0% | 11.5% |
| Pyrexia | 14.2% | 8.1% |
| Somnolence | 9.3% | 2.2% |
| Vomiting | 9.0% | 7.0% |
| Pruritus | 7.9% | 3.7% |
| Headache | 6.8% | 4.4% |
| Dizziness (Exc Vertigo) | 6.5% | 2.2% |
| Constipation | 4.1% | 1.1% |
| Confusion | 2.7% | 0.7% |
Adverse Reactions Reported in All Clinical Trials
A total of 591 patients were treated with OPANA in the Phase 2/3 controlled clinical trials. The clinical trials consisted of patients with acute post-operative pain (n=557) and cancer pain (n=34) trials.
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 in the clinical trials were nausea and pyrexia.
The common (≥1% - <10%) adverse drug reactions reported at least once by patients treated with OPANA in the clinical trials organized by MedDRA’s (Medical Dictionary for Regulatory Activities) System Organ Class were:
Cardiac disorders: tachycardia
Gastrointestinal disorders: vomiting, constipation, dry mouth, abdominal distention, and flatulence
General disorders and administration site conditions: sweating increased
Nervous system disorders: dizziness (exc vertigo), somnolence, headache, anxiety, and sedation
Psychiatric disorders: confusion
Respiratory, thoracic and mediastinal disorders: hypoxia
Skin & subcutaneous tissue disorders: pruritus
Vascular disorders: hypotension
Other less common adverse reactions known with opioid treatment that were seen <1% in the OPANA trials include the following:
Abdominal pain, agitation, allergic reactions, vision blurred, bradycardia, central nervous system depression, clamminess, appetite decreased, dehydration, depressed level of consciousness, depression, dermatitis, diarrhoea, difficult micturition, disorientation, dyspepsia, dysphoria, dyspnea, edema, euphoric mood, fatigue, feeling jittery, flushing, hallucination, hot flashes, hypersensitivity, hypertension, ileus, insomnia, lethargy, mental impairment, mental status changes, miosis, nervousness, oxygen saturation decreased, palpitation, postural hypotension, respiratory depression, respiratory distress, respiratory rate decreased, restlessness, syncope, urinary retention, urticaria, visual disturbances, weakness, and weight decreased.
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REPORTS OF SUSPECTED OPANA SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Opana. The information is not vetted and should not be considered as verified clinical evidence.
Possible Opana side effects / adverse reactions in 41 year old male
Reported by a individual with unspecified qualification from United States on 2011-10-07
Patient: 41 year old male weighing 108.0 kg (237.5 pounds)
Reactions: Cholesterosis, Sudden Death, Hepatic Steatosis, Visceral Congestion, Aspiration, Pulmonary Congestion, Coronary Ostial Stenosis, Pulmonary Oedema, Brain Oedema, Multiple Drug Overdose
Adverse event resulted in: death
Suspect drug(s):
Methadone HCL
Indication: Back Disorder
Meprobamate
Indication: Back Disorder
Opana
Indication: Back Disorder
Carisoprodol
Indication: Back Disorder
Fentanyl
Indication: Back Disorder
Possible Opana side effects / adverse reactions in 30 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-21
Patient: 30 year old male
Reactions: Anaphylactic Reaction, Drug Dependence
Suspect drug(s):
Opana
Possible Opana side effects / adverse reactions in 25 year old male
Reported by a consumer/non-health professional from United States on 2011-10-24
Patient: 25 year old male
Reactions: Drug Diversion, Drug Screen Negative
Suspect drug(s):
Opana
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