Clinical Trials: The following adverse reactions were reported in patients who received parecoxib (Dynastat) (N = 5,402) in 28 placebo-controlled clinical trials.
Events occurring ≥10%: Gastrointestinal disorders: nausea.
Events occurring ≥1% and <10%: Gastrointestinal disorders: abdominal pain, constipation, dyspepsia, vomiting.
General disorders and administration site conditions: edema peripheral.
Infections and infestations: alveolar osteitis (dry socket).
Nervous system disorders: dizziness.
Psychiatric disorders: insomnia.
Renal and urinary disorders: oliguria.
Skin and subcutaneous tissue disorders: sweating increased, pruritis.
Vascular disorders : hypotension.
Events occurring ≥0.5% and <1%: Gastrointestinal disorders: mouth dry, flatulence.
Musculoskeletal and connective tissue disorders: back pain.
Cardiac disorders: bradycardia.
Infections and infestations: pharyngitis.
Skin and subcutaneous tissue disorders: rash.
Vascular disorders: hypertension.
Events occurring <0.5%: Cardiac disorders: myocardial infarction.
Ear and labyrinth disorders: earache.
Gastrointestinal disorders: esophagitis, gastroesophageal reflux, hypoactive bowel sounds, pancreatitis, peri-oral swelling.
General disorders and administration site conditions: injection site pain, injection site reaction, asthenia.
Immune system disorders: anaphylactoid reaction.
Investigations: BUN increased, creatine phosphokinase increased, creatinine increase, LDH increased.
Injury, poisoning and procedural complications: skin post-operative complications.
Metabolism and nutrition disorders: anorexia, hyperglycemia.
Musculoskeletal and connective tissue disorders: arthralgia.
Nervous system disorders: cerebrovascular disorder.
Psychiatric disorders: agitation.
Renal and urinary disorders: renal failure acute.
Respiratory, thoracic and mediastinal disorders: embolism pulmonary.
Skin and subcutaneous tissue disorders: ecchymosis, urticaria.
Vascular disorders: hypertension aggravated, hypotension postural.
Following coronary artery bypass graft surgery, patients administered parecoxib (Dynastat) have a higher risk of adverse events, such as cardiovascular thromboembolic events (e.g., myocardial infarction and cerebrovascular accident), deep surgical infections or sternal wound healing complications.
Post-marketing Surveillance: In post-marketing experience, the following rare, serious adverse events have been reported in association with the use of parecoxib (Dynastat): circulatory collapse, erythema multiforme, Stevens-Johnson syndrome, renal failure, and hypersensitivity reactions including anaphylaxis and angioedema (see Precautions).
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 (Dynastat).