Tables 1 and 2 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 1: Treatment-Emergent Adverse Reactions 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
       

Oxymorphone HCl ER Tablets
     

Oxymorphone HCl ER Tablets
      Placebo
Preferred Term       (N = 325)       (N = 105)       (N = 100)
Constipation       26%       7%       1%
Somnolence       19%       2%       0%
Nausea       18%       11%       9%
Dizziness       11%       5%       3%
Headache       11%       4%       2%
Pruritus       7%       3%       1%
                 
 

Table 2: Treatment-Emergent Adverse Reactions 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
       

Oxymorphone HCl ER Tablets
     

Oxymorphone HCl ER Tablets
      Placebo
Preferred Term       (N = 250)       (N = 70)       (N = 72)
Nausea       20%       3%       1%
Constipation       12%       6%       1%
Headache       12%       3%       0%
Somnolence       11%       3%       0%
Vomiting       9%       0%       1%
Pruritus       8%       0%       0%
Dizziness       6%       0%       0%
                 

The following table lists adverse reactions that were reported in at least 2% of patients in placebo-controlled trials (N=5).
 

Table 3: Adverse Reactions Reported in Placebo-Controlled Clinical Trials with Incidence ≥2% in Patients Receiving Oxymorphone HCl ER Tablets.
MedDRA Preferred Term      

Oxymorphone HCl ER Tablets (N=1259)
      Placebo (N=461)
Nausea       33%       13%
Constipation       28%       13%
Dizziness (Excl Vertigo)       18%       8%
Somnolence       17%       2%
Vomiting       16%       4%
Pruritus       15%       8%
Headache       12%       6%
Sweating increased       9%       9%
Dry mouth       6%       <1%
Sedation       6%       8%
Diarrhea       4%       6%
Insomnia       4%       2%
Fatigue       4%       1%
Appetite decreased       3%       <1%
Abdominal pain       3%       2%
           

The common (≥1% to <10%) adverse drug reactions reported at least once by patients treated with oxymorphone hydrochloride extended-release tablets in the clinical trials organized by MedDRA’s (Medical Dictionary for Regulatory Activities) System Organ Class and not represented in Table 1 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 Psychiatric disorders: 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 oxymorphone hydrochloride extended-release tablets trials include the following: Bradycardia, palpitation, syncope, tachycardia, postural hypotension, miosis, abdominal distention, ileus, hot flashes, allergic reactions, hypersensitivity, urticaria, oxygen saturation decreased, central nervous system depression, depressed level of consciousness, agitation, dysphoria, euphoric mood, hallucination, mental status changes, difficult micturition, urinary retention, hypoxia, respiratory depression, respiratory distress, clamminess, dermatitis, hypotension.

Post-marketing ExperienceThe following adverse reactions have been identified during post approval use of oxymorphone hydrochloride extended-release tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nervous system disorder: amnesia, convulsion, memory impairment

DRUG INTERACTIONS AlcoholConcomitant use of alcohol with oxymorphone hydrochloride extended-release tablets can result in an increase of oxymorphone plasma levels and potentially fatal overdose of oxymorphone. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products containing alcohol while on oxymorphone hydrochloride extended-release tablet therapy.

CNS DepressantsConcurrent use of oxymorphone hydrochloride extended-release tablets and other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol can increase the risk of respiratory depression, hypotension, profound sedation, or coma. Monitor patients receiving CNS depressants and oxymorphone hydrochloride extended-release tablets for signs of respiratory depression and hypotension. When such combined therapy is contemplated, reduce the initial dose of one or both agents.

Mixed Agonist/Antagonist Opioid AnalgesicsMixed agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol, or buprenorphine) may reduce the analgesic effect of oxymorphone hydrochloride extended-release tablets or may precipitate withdrawal symptoms in these patients. Avoid the use of mixed agonist/antagonist analgesics in patients receiving oxymorphone hydrochloride extended-release tablets.

CimetidineCimetidine can potentiate opioid-induced respiratory depression. Monitor patients for respiratory depression when oxymorphone hydrochloride extended-release tablets and cimetidine are used concurrently.

AnticholinergicsAnticholinergics or other medications with anticholinergic activity when used concurrently with opioid analgesics may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor patients for signs of respiratory and central nervous system depression when oxymorphone hydrochloride extended-release tablets are used concurrently with anticholinergic drugs.

USE IN SPECIFIC POPULATIONS PregnancyThe safety of using oxymorphone in pregnancy has not been established with regard to possible adverse effects on fetal development. The use of oxymorphone hydrochloride extended-release tablets in pregnancy, in nursing mothers, or in women of child-bearing potential requires that the possible benefits of the drug be weighed against the possible hazards to the mother and the child.

Prolonged use of opioid analgesics during pregnancy may cause fetal-neonatal physical dependence.

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