Bextra Side Effects

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Bextra Side Effects

Of the patients treated with Bextra Tablets in controlled arthritis trials for Bextra side effects, 2665 were patients with OA, and 2684 were patients with RA. More than 4000 patients have received a chronic total daily dose of Bextra 10 mg or more. More than 2800 patients have received Bextra 10 mg/day,or more, for at least 6 months and 988 of these have received Bextra for at least 1 year.

Osteoarthritis and Rheumatoid Arthritis

All Bextra side effects are listed, regardless of causality, that occurred in ≥ 2.0% of patients receiving Bextra 10 and 20mg/day in studies of three months or longer from 7 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group.

In these placebo- and active-controlled clinical trials, the discontinuation rate due to adverse events was 7.5% for arthritis patients receiving Bextra (valdecoxib) 10 mg daily, 7.9% for arthritis patients receiving valdecoxib 20 mg daily and 6.0% for patients receiving placebo.

In the seven controlled OA and RA studies, the following Bextra side effects occurred in 0.1-1.9% of patients treated with 10 -20 mg daily, regardless of causality.

• Application site disorders: Cellulitis, dermatitis contact
• Cardiovascular: Aggravated hypertension, aneurysm, anginapectoris, arrhythmia, cardiomyopathy, congestive heart failure, coronary artery disorder, heart murmur, hypotension
• Central, peripheral nervous system: Cerebrovascular disorder, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, pares-thesia, tremor, twitching, vertigo
• Endocrine: Goiter
• Female reproductive: Amenorrhea, dysmenorrhea, leukorrhea, mastitis, menstrual disorder, menorrhagia, menstrual bloating, vagi-nal hemorrhage
• Gastrointestinal: Abnormal stools, constipation, diverticulosis, dry mouth, duodenal ulcer, duodenitis, eructation, esophagitis, fecal incontinence, gastric ulcer, gastritis, gastroenteritis, gastroe-sophageal reflux, hematemesis, hematochezia, hemorrhoids, hem-orrhoids bleeding, hiatal hernia, melena, stomatitis, stool frequency increased, tenesmus, tooth disorder, vomiting
• General: Allergy aggravated, allergic reaction, asthenia, chest pain, chills, cyst NOS, edema generalized, face edema, fatigue, fever, hot flushes, halitosis, malaise, pain, periorbital swelling, peripheral pain Hearing and vestibular: Ear abnormality, earache, tinnitus
• Heart rate and rhythm: Bradycardia, palpitation, tachycardia
• Hemic: Anemia
• Liver and biliary system: Hepatic function abnormal, hepatitis, ALT increased, AST increased
• Male reproductive: Impotence, prostatic disorder
• Metabolic and nutritional: Alkaline phosphatase increased, BUN increased, CPK increased, creatinine increased, diabetes mellitus, glycosuria, gout, hypercholesterolemia, hyperglycemia, hyperkalemia, hyperlipemia, hyperuricemia, hypocalcemia, hypokalemia, LDH increased, thirst increased, weight decrease, weight increase, xerophthalmia
• Musculoskeletal: Arthralgia, fracture accidental, neck stiffness, osteoporosis, synovitis, tendonitis
• Neoplasm: Breast neoplasm, lipoma, malignant ovarian cyst
• Platelets (bleeding or clotting): Ecchymosis, epistaxis, hematoma NOS, thrombocytopenia
• Psychiatric: Anorexia, anxiety, appetite increased, confusion, depression, depression aggravated, insomnia, nervousness, morbid dreaming, somnolence
• Resistance mechanism disorders: Herpes simplex, herpes zoster, infection fungal,infection soft tissue, infection viral, moniliasis, moniliasis genital, otitis media
• Respiratory: Abnormal breath sounds, bronchitis, bronchospasm, coughing, dyspnea, emphysema, laryngitis, pneumonia, pharyngitis, pleurisy, rhinitis
• Skin and appendages: Acne, alopecia, dermatitis, dermatitis fun-gal, eczema, photosensitivity allergic reaction, pruritus, rash ery-thematous, rash maculopapular, rash psoriaform, skin dry, skin hypertrophy, skin ulceration, sweating increased, urticaria
• Special senses: Taste perversion
• Urinary system: Albuminuria, cystitis, dysuria, hematuria, micturition frequency increased, pyuria, urinary incontinence, urinary tract infection
• Vascular: Claudication intermittent, hemangioma acquired, varicose vein
• Vision: Blurred vision, cataract, conjunctival hemorrhage, con-junctivitis, eye pain, keratitis, vision abnormal
• White cell and RES disorders: Eosinophilia, leukopenia, leukocytosis, lymphadenopathy, lymphangitis, lymphopenia

There may be additional undocumented Bextra side effects.

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