Celeflam Adverse Reactions

Adverse reactions are listed by system organ class and ranked by frequency in Table 2, reflecting data from the following sources: Adverse reactions reported in osteoarthritis patients and rheumatoid arthritis patients at incidence rates greater than 0.01% and greater than those reported for placebo during 12 placebo- and/or active-controlled clinical trials of duration up to 12 weeks at Celecoxib daily doses from 100 mg up to 800 mg. In additional studies using non-selective NSAID comparators, approximately 7,400 arthritis patients have been treated with Celecoxib at daily doses up to 800 mg, including approximately 2,300 patients treated for 1 year or longer. The adverse reactions observed with Celecoxib in these additional studies were consistent with those for osteoarthritis and rheumatoid arthritis patients listed in Table 2 as follows.
Adverse reactions reported at incidence rates greater than placebo for subjects treated with Celecoxib 400 mg daily in long-term polyp prevention trials of duration up to 3 years, the Adenoma Prevention with Celecoxib (APC) and Prevention of Colorectal Sporadic Adenomatous Polyps (PreSAP) trials.
Adverse drug reactions from post-marketing surveillance as spontaneously reported during a period in which an estimated >70 million patients were treated with Celecoxib (various doses, durations, and indications). Even though these were identified as reactions from post-marketing reports, trial data was consulted to estimate frequency. Frequencies are based on a cumulative meta-analysis with pooling of trials representing exposure in 38,102 patients. (See Table 2.)

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In final data (adjudicated) from the APC and PreSAP trials in patients treated with Celecoxib 400 mg daily for up to 3 years (pooled data from both trials; the excess rate over placebo for myocardial infarction was 7.6 events per 1,000 patients (uncommon) and there was no excess rate for stroke (types not differentiated) over placebo.