Coxiron Adverse Reactions

The following drug-related adverse experiences were reported in patients with osteoarthritis (OA), rheumatoid arthritis (RA) or chronic low back pain treated for up to 12 weeks. These occurred in ≥1% of patients treated with etoricoxib: 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 one year or longer.
Compared with diclofenac, hypertension occurred at a higher rate on etoricoxib than on diclofenac.
There was no discernible difference in the rate of serious thrombotic cardiovascular events between patients receiving etoricoxib 60 mg or non-naproxen NSAIDs. However, the rate of these events was higher in patients receiving etoricoxib compared with those receiving naproxen 500 mg twice daily.
The adverse experience profile in ankylosing spondylitis when etoricoxib 90 mg given once daily for up to 1 year was generally similar to that reported in the chronic use in OA, RA and chronic low back pain.
The adverse experience profile in acute gouty arthritis when etoricoxib 120 mg given once daily for eight days was generally similar to that reported in the combined OA, RA and chronic low back pain.
The adverse experience profile in acute analgesia when etoricoxib 120 mg given once daily for one to seven days was generally similar to that reported in the combined OA, RA and chronic low back pain.
Post-marketing experience: The following adverse reactions have been reported in post-marketing experience: Immune system disorders: hypersensitivity reactions, including anaphylactic/anaphylactoid reactions.
Psychiatric disorders: anxiety, insomnia, confusion, hallucinations.
Nervous system disorders: dysgeusia, somnolence.
Cardiac disorders: congestive heart failure.
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.
Skin and subcutaneous tissue disorders: angioedema, pruritus, rash, Stevens-Johnson syndrome, urticaria.
Renal and urinary disorders: serial insufficiency, including renal failure, usually reversible upon discontinuation of therapy.