OxyContin Side Effects

Generic Name: oxycodone

Please note - some side effects for OxyContin 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 OxyContin - for the Consumer

OxyContin Sustained-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 OxyContin Sustained-Release Tablets:

Constipation; dizziness; drowsiness; headache; nausea; sleeplessness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating; fast, slow, or irregular heartbeat; seizures; severe dizziness, lightheadedness, or fainting; slowed or difficult breathing; tremor; vision changes.

OxyContin Side Effects - for the Professional

OxyContin

The safety of OxyContin® was evaluated in double-blind clinical trials involving 713 patients with moderate to severe pain of various etiologies. In open-label studies of cancer pain, 187 patients received OxyContin in total daily doses ranging from 20 mg to 640 mg per day. The average total daily dose was approximately 105 mg per day.

Serious adverse reactions which may be associated with OxyContin Tablet therapy in clinical use are those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, and (to an even lesser degree) circulatory depression, hypotension, or shock.

The non-serious adverse events seen on initiation of therapy with OxyContin are typical opioid side effects. These events are dose-dependent, and their frequency depends upon the dose, the clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual. They should be expected and managed as a part of opioid analgesia. The most frequent (>5%) include: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, sweating, and asthenia.

In many cases the frequency of these events during initiation of therapy may be minimized by careful individualization of starting dosage, slow titration, and the avoidance of large swings in the plasma concentrations of the opioid. Many of these adverse events will cease or decrease in intensity as OxyContin therapy is continued and some degree of tolerance is developed.

Clinical trials comparing OxyContin with immediate-release oxycodone and placebo revealed a similar adverse event profile between OxyContin and immediate-release oxycodone. The most common adverse events (>5%) reported by patients at least once during therapy were:

The following adverse experiences were reported in OxyContin®-treated patients with an incidence between 1% and 5%. In descending order of frequency they were anorexia, nervousness, insomnia, fever, confusion, diarrhea, abdominal pain, dyspepsia, rash, anxiety, euphoria, dyspnea, postural hypotension, chills, twitching, gastritis, abnormal dreams, thought abnormalities, and hiccups.

The following adverse reactions occurred in less than 1% of patients involved in clinical trials or were reported in postmarketing experience.

General: accidental injury, chest pain, facial edema, malaise, neck pain, pain, and symptoms associated with either an anaphylactic or anaphylactoid reaction

Cardiovascular: migraine, syncope, vasodilation, ST depression

Digestive: dysphagia, eructation, flatulence, gastrointestinal disorder, increased appetite, nausea and vomiting, stomatitis, ileus

Hemic and Lymphatic: lymphadenopathy

Metabolic and Nutritional: dehydration, edema, hyponatremia, peripheral edema, syndrome of inappropriate antidiuretic hormone secretion, thirst

Nervous: abnormal gait, agitation, amnesia, depersonalization, depression, emotional lability, hallucination, hyperkinesia, hypesthesia, hypotonia, malaise, paresthesia, seizures, speech disorder, stupor, tinnitus, tremor, vertigo, withdrawal syndrome with or without seizures

Respiratory: cough increased, pharyngitis, voice alteration

Skin: dry skin, exfoliative dermatitis, urticaria

Special Senses: abnormal vision, taste perversion

Urogenital: amenorrhea, decreased libido, dysuria, hematuria, impotence, polyuria, urinary retention, urination impaired

Side Effects by Body System

General

In general, the adverse effects that occur with oxycodone are similar with the immediate- and controlled-release products. Adverse effects may be dose-related in opioid naive patients. Patients who are tolerant to the analgesic effect of oxycodone may be tolerant to the dose-related side effects, except constipation.

Nervous system

Nervous system side effects are common and include drowsiness (23% to 24%), sedation, dizziness (13% to 16%), headache (7%). dry mouth (7%), and lightheadedness. Many of the central nervous system adverse effects may be minimized by slow titration of the dose.

Respiratory

Respiratory depression may occur with any opioid, including oxycodone. Other effects may include apnea, respiratory arrest, and rarely circulatory collapse.

Severe adverse effects such as respiratory depression can be treated with the opiate antagonist naloxone. (The usual adult dose of naloxone is 1 to 2 mg every 5 minutes as necessary to a maximum of 10 mg. The dose can be administered intravenously, intramuscularly, subcutaneously, and sublingually.)

Gastrointestinal

Nausea (23% to 27%), vomiting (12% to 14%), and constipation (23% to 26%) occur commonly.

Other

Withdrawal symptoms, after either abrupt cessation or fast tapering of narcotic analgesics, may occur and include agitation, palpitations, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting, piloerection, and sweating.

Psychosis has also been reported during withdrawal from oxycodone.

Psychiatric

Psychiatric adverse effects reported include paranoia, psychosis, and hallucinations.

Dermatologic

Pruritus has been reported rarely. Diphenhydramine (25 to 50 mg) has been shown to be helpful for opioid-associated pruritus.

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