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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Opana:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Opana ER Extended-Release Tablets:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Opana Side Effects - for the Professional

Opana

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

• Respiratory depression [see Warnings and Precautions (5.1)]
• Misuse and abuse [see Warnings and Precautions (5.2) and Drug Abuse and Dependence (9)]
• CNS depressant effects [see Warnings and Precautions (5.3)]

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.

Clinical Trials Experience

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 (ExcudingVertigo)	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 Opana. 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

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Side Effects by Body System - for Healthcare Professionals

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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