Arcoxia Adverse Reactions

In clinical trials, Arcoxia was evaluated for safety in approximately 4800 individuals, including approximately 3400 patients with OA, RA or chronic low back pain (approximately 600 patients with OA or RA were treated for 1 year or longer).
The following drug-related adverse experiences were reported in clinical 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 Arcoxia and at an incidence greater than placebo: Asthenia/fatigue, dizziness, lower extremity edema, hypertension, dyspepsia, heartburn, nausea, headache, increased ALT and AST.
The adverse experience profile was similar in patients with OA or RA treated with Arcoxia for 1 year or longer.
Seven thousand one hundred eleven (7111) patients were enrolled in an additional study in OA that compared the GI tolerability of etoricoxib 90 mg once daily (1.5 times above the dose recommended for OA) and diclofenac sodium 50 mg 3 times daily over a mean period of 9 months. The adverse experience profile on Arcoxia was generally similar to that reported in the Phase IIb/III placebo-controlled clinical studies; however, hypertension adverse experiences occurred at a higher rate on Arcoxia than on diclofenac.
In the initial clinical development program, approximately 3100 patients were treated with etoricoxib 60 mg daily for 12 weeks or longer. 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.
In a clinical study for ankylosing spondylitis, patients were treated with Arcoxia 90 mg once daily for up to 1 year (n=126). The adverse experience profile in this study was generally similar to that reported in chronic studies in OA, RA and chronic low back pain.
In a clinical study for acute gouty arthritis, patients were treated with Arcoxia 120 mg once daily for 8 days.
In clinical studies for acute analgesia, patients were treated with Arcoxia 120 mg once daily for 1-7 days. The adverse experience profile in these studies was generally similar to that reported in the combined OA, RA and chronic low back pain studies.
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 and 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: Renal insufficiency, including renal failure, usually reversible upon discontinuation of therapy (see Precautions).