Opana Side Effects

Generic Name: oxymorphone

Please note - some side effects for Opana may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Opana - for the Consumer

Opana

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Opana:

Anxiety; constipation; dizziness; drowsiness; dry mouth; gas; headache; lightheadedness; nausea; sweating; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; mental or mood changes; seizure; severe or persistent dizziness or drowsiness; severe or persistent headache or vomiting; shallow, slowed, or difficult breathing; trouble urinating; unusual swelling; vision changes.

Opana ER Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Opana ER Extended-Release Tablets:

Anxiety; constipation; decreased appetite; dizziness; drowsiness; dry mouth; gas; headache; lightheadedness; nausea; sweating; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; mental or mood changes; seizure; severe or persistent dizziness or drowsiness; severe or persistent headache or vomiting; shallow, slowed, or difficult breathing; trouble urinating; unusual swelling; vision changes.

Opana Side Effects - for the Professional

Opana

Adverse Reactions Reported in Placebo-Controlled Trials

The following table lists adverse reactions that were reported in at least 2% of patients in placebo-controlled trials.

Adverse Reactions Reported in All Clinical Trials

A total of 591 patients were treated with Opana in the Phase 2/3 controlled clinical trials. The clinical trials consisted of patients with acute post-operative pain (n=557) and cancer pain (n=34) trials.

The adverse reactions are presented in the following manner: most common, common, and less common adverse reactions.

The most common adverse drug reactions (≥10%) reported at least once by patients treated with Opana in the clinical trials were nausea and pyrexia.

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:

Cardiac disorders: tachycardia
Gastrointestinal disorders: vomiting, constipation, dry mouth, abdominal distention, and flatulence
General disorders and administration site conditions: sweating increased
Nervous system disorders: dizziness (exc vertigo), somnolence, headache, anxiety, and sedation
Psychiatric disorders: confusion
Respiratory, thoracic and mediastinal disorders: hypoxia
Skin & subcutaneous tissue disorders: pruritus
Vascular disorders: hypotension

Other less common adverse reactions known with opioid treatment that were seen <1% in the Opana trials include the following:

Abdominal pain, agitation, allergic reactions, vision blurred, bradycardia, central nervous system depression, clamminess, appetite decreased, dehydration, depressed level of consciousness, depression, dermatitis, diarrhoea, difficult micturition, disorientation, dyspepsia, dysphoria, dyspnea, edema, euphoric mood, fatigue, feeling jittery, flushing, hallucination, hot flashes, hypersensitivity, hypertension, ileus, insomnia, lethargy, mental impairment, mental status changes, miosis, nervousness, oxygen saturation decreased, palpitation, postural hypotension, respiratory depression, respiratory distress, respiratory rate decreased, restlessness, syncope, urinary retention, urticaria, visual disturbances, weakness, and weight decreased.

Side Effects by Body System

Nervous system

Nervous system side effects have included drowsiness, sedation, lightheadedness, unusual tiredness, weakness, headache, dysphoria, dizziness, mental impairment, CNS depression, euphoria, miosis, diplopia, blurred vision, nervousness, restlessness, confusion, mental clouding, trouble sleeping, paradoxical CNS stimulation, hallucinations, and mental depression.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, dry mouth, constipation, biliary tract spasm, cramps or pain, loss of appetite, paralytic ileus, and toxic megacolon in patients with inflammatory bowel disease.

Cardiovascular

Cardiovascular side effects have included hypotension, orthostatic hypotension (particularly in ambulatory patients), tachycardia, bradycardia, palpitations, and flushing.

Respiratory

Respiratory side effects have included respiratory depression, atelectasis, allergic bronchospastic reaction, allergic laryngeal edema, apnea and allergic laryngospasm.

Genitourinary

Genitourinary side effects have included ureteral spasm, urinary retention or hesitancy, and antidiuretic effect.

Dermatologic

Dermatologic side effects have included sweating.

Hypersensitivity

Hypersensitivity side effects have included allergic dermatitis, urticaria, skin rash, hives and/or itching, and swelling of the face.

Other

Other side effects have included tolerance, psychological dependence, and physical dependence.

Ocular

Ocular side effects including miosis, diplopia, and blurred vision have been reported.

General

General side effects including fatigue and asthenia have been reported.

Local

Local side effects including injection site reactions have been reported with the use of oxymorphone injection.

Hepatic

Hepatic side effects including biliary colic have been reported.

Renal

Renal side effects including ureteral spasm, urinary hesitation, urinary retention, and oliguria have been reported.

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