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Opana

Last reviewed on RxList: 1/3/2017
Opana Side Effects Center

Last reviewed on RxList 10/12/2016

Opana (oxymorphone hydrochloride) is a narcotic pain reliever used to treat moderate to severe pain. The extended-release form of Opana is for around-the-clock treatment of pain. Opana is available in generic form. Common side effects of Opana include:

  • nausea,
  • vomiting,
  • fever,
  • constipation,
  • increased sweating,
  • lightheadedness,
  • headache,
  • dizziness,
  • drowsiness,
  • rash, or
  • itching.

Tell your doctor if you have serious side effects of Opana including:

  • mental/mood changes,
  • severe stomach or abdominal pain,
  • changes in the amount of urine,
  • vision changes,
  • slow or fast heartbeat, or
  • difficulty urinating.

The dose of Opana is determined by the patient's age, condition, medical status, type and severity of the pain, and other factors. Opana may interact with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, other medicines that can make you sleepy or slow your breathing, pentazocine, nalbuphine, butorphanol, or buprenorphine. Other drugs may interact with Opana. Tell your doctor all prescription and over-the-counter medications you use. During pregnancy, Opana should be used only when prescribed. Using it near the expected delivery date is not recommended because of possible harm to the fetus. Infants born to mothers who used this drug may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor if you notice symptoms in your newborn. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding. Stopping this drug abruptly may cause withdrawal symptoms.

Our Opana (oxymorphone hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Opana Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using oxymorphone and call your doctor at once if you have a serious side effect such as:

  • shallow breathing, slow heartbeat;
  • seizure (convulsions);
  • cold, clammy skin;
  • confusion;
  • severe weakness or dizziness; or
  • feeling light-headed, fainting.

Less serious side effects are more likely to occur, such as:

  • nausea, vomiting, constipation;
  • dizziness, drowsiness, headache;
  • fever; or
  • mild rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Opana (Oxymorphone Hydrochloride)

Opana Professional Information

SIDE EFFECTS

The following serious adverse reactions are described, or described in greater detail, in other sections:

Clinical Trials Experience

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 practice.

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 (Excluding Vertigo) 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 opioids. 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

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis: Anaphylaxis has been reported with ingredients contained in OPANA

Immune System Disorders: Angioedema, and other hypersensitivity reactions:

Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Opana (Oxymorphone Hydrochloride)

Related Resources for Opana

Read the Opana User Reviews »

© Opana Patient Information is supplied by Cerner Multum, Inc. and Opana Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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