Dynastat Adverse Reactions

The most common adverse reaction for Dynastat is nausea. The most serious reactions occur uncommonly to rarely, and include cardiovascular events such as myocardial infarction and severe hypotension, as well as hypersensitivity events such as anaphylaxis, angioedema and severe skin reactions. Following coronary artery bypass graft surgery, patients administered Dynastat have a higher risk of adverse reactions such as: cardiovascular/thromboembolic events (including myocardial infarction, stroke/TIA, pulmonary embolus, and deep vein thrombosis; see Contraindications and Pharmacology: Pharmacodynamics under Actions), deep surgical infections, and sternal wound healing complications.
Tabulated list of adverse reactions: The following adverse reactions were reported for patients who received parecoxib (N=5,402) in 28 placebo-controlled clinical trials. Reports from post-marketing experience have been listed as "frequency not known" because the respective frequencies cannot be estimated from the available data. Within each frequency grouping, adverse reactions are listed using MedDRA terminology and presented in order of decreasing seriousness. (See table.)

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In post-marketing experience, in addition to the severe cutaneous adverse reaction erythema multiforme and Stevens-Johnson's syndrome, toxic epidermal necrolysis has been reported in association with the use of valdecoxib, and cannot be ruled out for parecoxib (see Precautions). In addition, the following rare, serious adverse reactions have been reported in association with the use of NSAIDs and cannot be ruled out for Dynastat: bronchospasm and hepatitis.