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Opana (Oxymorphone Hydrochloride) - Side Effects and Adverse Reactions



The following serious adverse reactions are discussed elsewhere in the labeling:

  • Respiratory depression [see Warnings and Precautions ]
  • Misuse and abuse [see Warnings and Precautions and Drug Abuse and Dependence (9)]
  • CNS depressant effects [see Warnings and Precautions]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trials Experience

A total of 591 patients were treated with OPANA in controlled clinical trials. The clinical trials consisted of patients with acute post-operative pain (n=557) and cancer pain (n=34) trials.

The following table lists adverse reactions that were reported in at least 2% of patients receiving OPANA in placebo-controlled trials (acute post-operative pain (N=557)).

Table 1: Adverse Reactions Reported in Placebo-Controlled Trials

 MedDRA Preferred Term  OPANA (N=557)  Placebo (N=270)
 Nausea  19%  12%
 Pyrexia  14%  8%
 Somnolence  9%  2%
 Vomiting  9%  7%
 Pruritus  8%  4%
 Headache  7%  4%
 Dizziness (ExcudingVertigo)  7%  2%
 Constipation  4%  1%
 Confusion  3%  <1%

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 and not represented in Table 1:

     Cardiac disorders: tachycardia
     Gastrointestinal disorders: dry mouth, abdominal distention, and flatulence
     General disorders and administration site conditions: sweating increased
     Nervous system disorders: anxiety and sedation
     Respiratory, thoracic and mediastinal disorders: hypoxia
     Vascular disorders: hypotension

Other less common adverse reactions known with opioid treatment that were seen <1% in the OPANA trials includes the following:
Abdominal pain, ileus, diarrhea, agitation, disorientation, restlessness, feeling jittery, hypersensitivity, allergic reactions, bradycardia, central nervous system depression, depressed level of consciousness, lethargy, mental impairment, mental status changes, fatigue, depression, clamminess, flushing, hot flashes, dehydration, dermatitis, dyspepsia, dysphoria, edema, euphoric mood, hallucination, hypertension, insomnia, miosis, nervousness, palpitation, postural hypotension, syncope, dyspnea, respiratory depression, respiratory distress, respiratory rate decreased, oxygen saturation decreased, difficult micturition, urinary retention, urticaria, vision blurred, visual disturbances, weakness, appetite decreased, and weight decreased.

Post-marketing Experience

The following adverse reactions have been identified during post approval use of OPANA. 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


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

    Indication: Back Disorder

    Indication: Back Disorder

    Indication: Back Disorder

    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):

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):

See index of all Opana side effect reports >>

Drug label data at the top of this Page last updated: 2013-03-21

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