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Increased risk of bleedingulcersand tearsperforationof the esophagustube leading from the mouth to the stomachstomach and intestinesanytime during use without warning symptoms that may cause death.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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The effects of celecoxib on the pharmacokinetics and/or pharmacodynamics of glyburideketoconazolesee DRUG INTERACTIONSphenytoinand tolbutamide have been studied in vivo and clinically important interactions have not been found.

Because clinical trials are conducted under widely varying conditionsadverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practiceThe adverse reaction information from clinical trials doeshoweverprovide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Clinical trials of other COX-2 selective and non-selective NSAIDs of up to three-years duration have shown an increased risk of serious cardiovascular thrombotic eventsmyocardial infarctionand strokewhich can be fatalAs a resultall NSAIDs are considered potentially associated with this risk.

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The celebrex sales tally was just shy of 1 billion for the first half of the year, and even the slightest ramp-up in sales could exceed 2 billion for 2006.

Advise patients to stop celebrex immediately if they develop any type of rash and to contact their healthcare provider as soon as possible see warnings and precautions 5.

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rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure some with fatal outcome have been reported with nsaids, including celebrex see adverse reactions .

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