Combunox Side Effects

Please note - some side effects for Combunox 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 Combunox - for the consumer

Combunox

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 Combunox:

Anxiety; constipation; diarrhea; dizziness; drowsiness; headache; indigestion; infection; nausea; nervousness; sleeplessness; stomach pain; swelling; tiredness; upset stomach; vomiting; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; blurred vision or other eye problems; chest pain; dark urine; fainting; fast or irregular heartbeat; fever; increased or decreased urination; irregular or difficult breathing; mental or mood changes; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent stomach pain; stiff neck; swelling of the arms or legs; unusual tiredness or weakness; unusual weight gain; vomit that looks like coffee grounds; yellowing of the skin or eyes.

For the professional

Combunox

Listed below are the adverse event incidence rates from single dose analgesia trials in which a total of 2437 patients received either Combunox, ibuprofen (400 mg), oxycodone HCl (5 mg), or placebo. Adverse event information is also provided from an additional 334 patients who were exposed to Combunox in a multiple dose analgesia trial, without placebo or active component comparison arms, given up to four times daily for up to 7 days.

Adverse events that were reported by at least 1% of patients taking Combunox but were observed at a greater incidence in the placebo treated patients were fever, headache and pruritus.

Adverse events that occurred in less than 1% and in at least two Combunox treated patients in Single Dose studies not listed above include the following: Body as Whole: abdominal pain, asthenia, chest pain, enlarged abdomen. Cardiovascular System: hypotension, syncope, tachycardia, vasodilation. Digestive System: constipation, dry mouth, dyspepsia, eructation, ileus. Hemic and Lymphatic System: anemia. Metabolic and Nutritional Disorders: edema. Nervous System: euphoria, insomnia, nervousness. Respiratory System: hypoxia, lung disorder, pharyngitis. Urogenital System: urinary retention.

Adverse events that occurred in the Multiple Dose study in at least 2% of patients treated with Combunox include the following: Body as Whole: asthenia (3.3%), fever (3.0%), headache (10.2%). Cardiovascular System: vasodilation (3.0%). Digestive System: constipation (4.5%), diarrhea (2.1%), dyspepsia (2.1%), nausea (25.4%), vomiting (4.5%). Nervous System: dizziness (19.2%), somnolence (17.4%).

Adverse events that occurred in less than 2% of and at least two Combunox treated patients in the Multiple Dose study not listed previously include the following: Body as Whole: back pain, chills, infection. Cardiovascular System: thrombophlebitis. Hemic and Lymphatic System: ecchymosis. Metabolic and Nutritional Disorders: hypokalemia. Musculoskeletal System: arthritis. Nervous System: abnormal thinking, anxiety, hyperkinesia, hypertonia. Skin and Appendages: rash. Special Senses: amblyopia, taste perversion. Urogenital System: urinary frequency.

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