Opana
- Generic Name: oxymorphone hydrochloride
- Brand Name: Opana
Opana (Oxymorphone Hydrochloride) side effects drug center
Opana Side Effects Center
What Is Opana Used For?
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.
What Are Side Effects of Opana?
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.
Dosage for Opana
The dose of Opana is determined by the patient's age, condition, medical status, type and severity of the pain, and other factors.
What Drugs, Substances, or Supplements Interact with Opana?
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.
Opana During Pregnancy and Breastfeeding
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.
Additional Information
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.
Opana 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 give naloxone and/or 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;
- a light-headed feeling, like you might pass out;
- seizure (convulsions);
- chest pain, wheezing, cough with yellow or green mucus;
- severe vomiting;
- high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea; or
- low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.
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 (Oxymorphone Hydrochloride)
Opana Professional Information
SIDE EFFECTS
The following serious adverse reactions are described, or described in greater detail, in other sections:
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Interactions with Benzodiazepines and Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Anaphylaxis, Angioedema, and Other Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
- Severe Hypotension [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Withdrawal [see WARNINGS AND PRECAUTIONS]
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)
&Copy; 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.