Olicoxib Adverse Reactions

Clinical Trial Experience: The following adverse reactions were reported in patients who received parecoxib (N=5,402) in 28 placebo-controlled clinical trials.
Very common (Events occurring ≥10%): Gastrointestinal disorders: Nausea.
Common (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, pruritus.
Vascular disorders: Hypotension.
Uncommon (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.
Uncommon to rare (Events occurring <0.5%): Cardiac disorders: Myocardial infarction.
Ear and labyrinth disorders: Earache.
Gastrointestinal disorders: Esophagitis, gastroesophageal reflux, hypoactive bowel sounds, pancreatitis, perioral 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 increased, 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 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 Experience: In post-marketing experience, the following rare, serious adverse events have been reported in association with the use of parecoxib: Renal failure, acute renal failure, aseptic meningitis, congestive heart failure, circulatory collapse, erythema multiforme, hepatic failure, hepatomegaly, jaundice, Stevens-Johnson syndrome 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 syndrome, the following events have been reported in association with the use of valdecoxib and cannot be ruled out for OLICOXIB Injection: Myocardial infarction (very rare), exfoliative dermatitis and toxic epidermal necrolysis (see Precautions). The reported rate of serious skin events appears to be greater for valdecoxib as compared to other COX-2 selective inhibitors.