Celebrex

[celecoxib]

Side Effects & Drug Interactions
ADVERSE REACTIONS

Of the CELEBREX treated patients in the premarketing controlled clinical trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post-surgical pain. More than 8,500 patients have received a total daily dose of CELEBREX of 200 mg (100 mg BID or 200 mg QD) or more, including more than 400 treated at 800 mg (400 mg BID). Approximately 3,900 patients have received CELEBREX at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more. Adverse events from CELEBREX premarketing controlled arthritis trials:

Table 6

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lists all adverse events, regardless of causality, occurring in 2% of patients receiving CELEBREX from 12 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group.

Table 6
Adverse Events Occurring in 2% of CELEBREX Patients
From CELEBREX Premarketing Controlled Arthritis Trials

Celebrex Placebo Naproxen Diclofenac Ibuprofen
(100-200 mg BID 500 mg BID 75 mg BID 800 mg TID or 200 mg QD)
n=4146) (n=1864) (n=1366) (n=387) (n=345)

Gastrointestinal Abdominal pain 4.1% 2.8% 7.7% 9.0% 9.0%
Diarrhea 5.6% 3.8% 5.3% 9.3% 5.8%
Dyspepsia 8.8% 6.2% 12.2% 10.9% 12.8%
Flatulence 2.2% 1.0% 3.6% 4.1% 3.5%
Nausea 3.5% 4.2% 6.0% 3.4% 6.7%

Body as a whole
Back pain 2.8% 3.6% 2.2% 2.6% 0.9%
Peripheral edema 2.1% 1.1% 2.1% 1.0% 3.5%
Injury-accidental 2.9% 2.3% 3.0% 2.6% 3.2%
Central and peripheral nervous system
Dizziness 2.0% 1.7% 2.6% 1.3% 2.3%
Headache 15.8% 20.2% 14.5% 15.5% 15.4%

Psychiatric
Insomnia 2.3% 2.3% 2.9% 1.3% 1.4%
Respiratory Pharyngitis 2.3% 1.1% 1.7% 1.6% 2.6%
Rhinitis 2.0% 1.3% 2.4% 2.3% 0.6%

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