Vioxx

[Rofecoxib]

Immune System

anaphylactic/ anaphylactoid reaction, angioedema, bronchospasm, hypersensitivity vasculitis.

Metabolism and nutrition

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hyponatremia.

Nervous System

aseptic meningitis, epilepsy aggravated.

Psychiatric

confusion, hallucinations.

Skin and Skin Appendages

severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Urogenital System

acute renal failure, breast malignant neoplasm, hyperkalemia, interstitial nephritis, prostatic malignant neoplasm, urolithiasis, worsening chronic renal failure. In 1-year controlled clinical trials and in extension studies for up to 86 weeks (approximately 800 patients treated with VIOXX for one year or longer), the adverse experience profile was qualitatively similar to that observed in studies of shorter duration.

Rheumatoid Arthritis

Approximately 1,100 patients were treated with VIOXX in the Phase III rheumatoid arthritis efficacy studies. These studies included extensions of up to 1 year. The adverse experience profile was generally similar to that reported in the osteoarthritis studies. In studies of at least three months, the incidence of hypertension in RA patients receiving the 25 mg once daily dose of VIOXX was 10.0% and the incidence of hypertension in patients receiving naproxen 500 mg twice daily was 4.7%.

Analgesia, including primary dysmenorrhea Approximately one thousand patients were treated with VIOXX in analgesia studies. All patients in post-dental surgery pain studies received only a single dose of study medication. Patients in primary dysmenorrhea studies may have taken up to 3 daily doses of VIOXX, and those in the post-orthopedic surgery pain study were prescribed 5 daily doses of VIOXX. The adverse experience profile in the analgesia studies was generally similar to those reported in the osteoarthritis studies. The following additional adverse experience, which occurred at an incidence of at least 2% of patients treated with VIOXX, was observed in the post-dental pain surgery studies: post-dental
extraction alveolitis (dry socket). Clinical Studies in OA and RA with VIOXX 50 mg (Twice the highest dose recommended for chronic use)

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