"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
Opana ER Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Opana ER (oxymorphone hydrochloride) is used to treat moderate to severe pain. The extended-release form of this medication is for around-the-clock treatment of pain. It is a narcotic pain reliever. This medication is available in generic form. Common side effects include nausea, vomiting, headache, constipation, dry mouth, mild itching, lightheadedness, dizziness, or drowsiness.
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 breast-feeding. 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Opana ER in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- shallow breathing, slow heartbeat;
- seizure (convulsions);
- cold, clammy skin;
- severe weakness or dizziness; or
- feeling light-headed, fainting.
Less serious side effects are more likely to occur, such as:
- nausea, vomiting, constipation;
- dizziness, headache;
- dry mouth;
- sweating; or
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. 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) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Opana ER Overview - Patient Information: Side Effects
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, shortness of breath, mental/mood changes, fainting, vision changes.
Tell your doctor immediately if any of these rare but very serious side effects occur: slow/fast heartbeat, difficulty urinating, severe stomach/abdominal pain, change in the amount of urine, seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Opana ER (Oxymorphone Hydrochloride Extended Release)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Opana ER FDA Prescribing Information: Side Effects
The following serious adverse reactions are discussed elsewhere in the labeling:
- Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Chronic Pulmonary Disease [see WARNINGS AND PRECAUTIONS]
- Head Injuries and Increased Intracranial Pressure [see WARNINGS AND PRECAUTIONS]
- Interactions with Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Hypotensive Effect [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Effects [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
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 OPANA ER 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 OPANA ER 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-Na´ve Patients with Low Back Pain)
|Preferred Term||Open-Label Titration Period||Double-Blind Treatment Period|
(N = 325)
(N = 105)
(N = 100)
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|
(N = 250)
(N = 70)
(N = 72)
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 OPANA ER.
|MedDRA Preferred Term||OPANA ER
|Dizziness (Excl Vertigo)||18%||8%|
|Dry mouth||6%||< 1%|
|Appetite decreased||3%||< 1%|
The common ( ≥ 1% to < 10%) adverse drug reactions reported at least once by patients treated with OPANA ER 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
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 OPANA ER 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.
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.
Read the entire FDA prescribing information for Opana ER (Oxymorphone Hydrochloride Extended Release) »
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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