ADVERSE REACTIONS
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 Which Occurred at a Frequency of ≥1% and at a Higher Incidence than in the Placebo Group in Single Dose Studies | 5/400 mg
(n=923) | 400 mg Ibuprofen
(n=913) | 5 mg Oxycodone HCl
(n = 286) | Placebo
(n=315) |
| Digestive |
| Nausea | 81 (8.8%) | 44 (4.8%) | 46 (16.1%) | 21 (6.7%) |
| Vomiting | 49 (5.3%) | 16 (1.8%) | 30 (10.5%) | 10 (3.2%) |
| Flatulence | 9 (1.0%) | 7 (0.8%) | 3 (1.0%) | 0 |
| Nervous System |
| Somnolence | 67 (7.3%) | 38 (4.2%) | 12 (4.2%) | 7 (2.2%) |
| Dizziness | 47 (5.1%) | 21 (2.3%) | 17 (5.9%) | 8 (2.5%) |
| Skin and Appendages |
| Sweat | 15 (1.6%) | 7 (0.8%) | 4 (1.4%) | 1 (0.3%) |
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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