The following drug-related adverse experiences were reported in studies in patients with OA, RA, or chronic low back pain treated for up to 12 weeks. These occurred in ≥1% of patients treated with Etoricoxib and at an incidence greater than placebo: asthenia/fatigue, dizziness, lower extremity edema, hypertension, dyspepsia, heartburn, nausea, headache, ALT increased, AST increased.
The Adverse experience profile was similar in patients with OA or RA treated with Etoricoxib for year or longer.
The following adverse reaction have been reported in post-marketing Experience: Blood and lymphatic system disorder: thrombocytopenia.
Immune system disorders: hypersensitivity reactions, including anaphylactic/anaphylactoid reactions including shock.
Metabolism and nutrition disorders: hyperkalemia.
Psychiatric disorders: anxiety, insomnia, confusion, hallucinations, depression, restlessness.
Nervous system disorders: dysgeusia, somnolence.
Eye disorder: blurred vision.
Cardiac disorder: congestive heart failure, palpitations, angina, arrhythmia.
Vascular disorders: hypertensive crisis.
Respiratory, thoracic and mediastinal disorders: bronchospasm.
Gastrointestinal disorders: abdominal pain, oral ulcers, peptic ulcers including perforation and bleeding (mainly in elderly patients), vomiting, diarrhea.
Hepatobiliary disorders: Hepatitis, jaundice, hepatic failure.
Skin and subcutaneus tissue disorders: angioedema, pruritus, erythema, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, fixed drug eruption.
Renal and urinary disorders: renal insuffciency, including renal failure (see PRECAUTIONS).
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