Opana ER Side Effects

Generic Name: oxymorphone

Please note - some side effects for Opana ER 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 ER - for the Consumer

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 ER Side Effects - for the Professional

Opana ER

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

• Respiratory depression [see Warnings and Precautions (5.2)]
• Misuse and abuse [see Warning and Precautions (5.3) and Drug Abuse and Dependence (9)]
• CNS depressant effects [see Warnings and Precautions (5.4)]

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 controlled clinical trials. The clinical trials consisted of patients with moderate to severe chronic non-malignant pain, cancer pain, and post surgical pain.

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 Events Reported in ³5% 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)

	Open-Label Titration Period	Double-Blind Treatment Period
	Opana ER	Opana ER	Placebo
Preferred Term	(N = 325)	(N = 105)	(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 Events 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)

	Open-Label Titration Period	Double-Blind Treatment Period
	Opana ER	Opana ER	Placebo
Preferred Term	(N = 250)	(N = 70)	(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 Opana ER.

MedDRA Preferred Term	Opana ER (N=1259)	Placebo (N=461)
Nausea	33%	13%
Constipation	28%	13%
Dizziness (Exc 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 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
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 Opana ER trials include the following: Bradycardia, palpitation, syncope, tachycardia, postural hypotension, miosis, visual disturbance, abdominal distention, ileus, feeling jittery, hot flashes, allergic reactions, hypersensitivity, urticaria, oxygen saturation decreased, central nervous system depression, depressed level of consciousness, agitation, dysphoria, euphoric mood, hallucination, mental impairment, mental status changes, difficult micturition, urinary retention, hypoxia, respiratory depression, respiratory distress, respiratory rate decreased, 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 

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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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