Roxicodone Intensol Side Effects

Generic Name: oxycodone

Please note - some side effects for Roxicodone Intensol 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 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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