The types of adverse events reported in the AS studies were similar to those reported in the OA/Approximately 1,700 patients were treated with CELEBREX in Some adverse reactions occurred in higher percentages of patients than in the arthritis pre-marketing trials (treatment durations up to 12 weeks; see The following additional adverse reactions occurred in ≥0.1% and <1% of patients taking CELEBREX, at an incidence greater than placebo in the long-term polyp prevention studies, and were either not reported during the controlled arthritis pre-marketing trials or occurred with greater frequency in the long-term, placebo-controlled polyp prevention studies:The following adverse reactions have been identified during post approval use of CELEBREX. By this action, it relieves pain and reduces swelling and inflammation.
Select one or more newsletters to continue. In elderly females, celecoxib Cmax and AUC are higher than those for elderly males, but these increases are predominantly due to lower body weight in elderly females.
Caucasians. For more information, ask your doctor or pharmacist.Call your doctor for medical advice about side effects. incidence of complicated ulcers between CELEBREX and the combined group of ibuprofen and diclofenac were not statistically significant.Patients on CELEBREX and concomitant low-dose ASA (N=882) experienced 4-fold higher rates of complicated ulcers compared to those not on ASA (N=3105). Among subjects with RA, 55.7% (453/813) escalated celecoxib to the 200 mg twice daily dose, 56.5% (470/832) escalated ibuprofen to 800 mg three times daily, and 54.6% (432/791) escalated naproxen to the 500 mg twice daily dose; however, the RA population accounted for only 10% of the trial population.Because relatively few celecoxib patients overall (5.8% [470/8072]) dose-escalated to 200 mg twice daily, the results of the PRECISION trial are not suitable for determining the relative CV safety of celecoxib at 200 mg twice daily compared to ibuprofen and naproxen at the doses taken.The trial had two prespecified analysis populations:Celecoxib, at the 100 mg twice daily dose, as compared with either naproxen or ibuprofen at the doses taken, met all four prespecified non-inferiority criteria (p<0.001 for non-inferiority in both comparisons) for the APTC endpoint, a composite of cardiovascular death (including hemorrhagic death), non-fatal myocardial infarction, and non-fatal stroke [see Table 5]. We comply with the HONcode standard for trustworthy health information - Version: 17.01.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Revised: May 2019The following adverse reactions are discussed in greater detail in other sections of the labeling:Because clinical trials are conducted under widely varying conditions, adverse 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 practice.
In some patients with systemic onset JRA, both celecoxib and naproxen were associated with mild cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Celebrex is used to treat pain or inflammation caused by many conditions such as Celebrex may cause stomach or intestinal bleeding, which can be fatal.
The cause and clinical significance of this finding is unknown.A pharmacokinetic study in subjects with mild (Child-Pugh Class A) and moderate (Child-Pugh Class B) hepatic impairment has shown that steady-state celecoxib AUC is increased about 40% and 180%, respectively, above that seen in healthy control subjects. NSAIDs work by reducing a substance in the body that leads to inflammation and pain.