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Opana ER

Last reviewed on RxList: 5/31/2017
Opana ER Side Effects Center

Last reviewed on RxList 10/6/2016

Opana ER (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 ER is available in generic form. Common side effects of Opana ER include:

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

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

The dose of Opana ER is determined by the patient's age, condition, and medical status, the type and severity of the pain, and other factors. Opana ER may interact with other narcotics, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing, pentazocine, nalbuphine, butorphanol, or buprenorphine. Tell your doctor all medications you use. During pregnancy, Opana ER 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 have used this medication 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. Withdrawal symptoms may occur if you suddenly stop using this medication.

Our Opana ER (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.

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Opana ER Consumer Information

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • weak or shallow breathing, breathing that stops during sleep;
  • a light-headed feeling, like you might pass out;
  • seizure (convulsions);
  • chest pain, wheezing, cough with yellow or green mucus;
  • severe vomiting; or
  • low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

  • dizziness, drowsiness;
  • headache, tiredness; or
  • stomach pain, nausea, vomiting, constipation.

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 ER (Oxymorphone Hydrochloride Extended Release)

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Opana ER Professional Information

SIDE EFFECTS

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

Clinical Trial 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 clinical practice.

The safety of oxymorphone hydrochloride extended-release tablets was evaluated in a total of 2011 patients in open-label and controlled clinical trials. The clinical trials enrolled of patients with moderate to severe chronic non-malignant pain, cancer pain, and post surgical pain. The most common serious adverse events reported with administration of oxymorphone hydrochloride extended-release tablets were chest pain, pneumonia and vomiting.

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)

Preferred Term Open-Label Titration Period Double-Blind Treatment Period
Oxymorphone Hydrochloride Extended - Release Tablets
(N = 325)
Oxymorphone Hydrochloride Extended - Release Tablets
(N = 105)
Placebo
(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)

Preferred Term Open-Label Titration Period Double-Blind Treatment Period
Oxymorphone Hydrochloride Extended - Release Tablets
(N = 250)
Oxymorphone Hydrochloride Extended - Release Tablets
(N = 70)
Placebo
(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 Hydrochloride Extended-Release Tablets

MedDRA Preferred Term Oxymorphone Hydrochloride Extended - Release 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 Experience

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

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

Related Resources for Opana ER

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Read the Opana ER User Reviews »

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

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