Medical Editor: John P. Cunha, DO, FACOEP
Bextra (valdecoxib) is a nonsteroidal anti-inflammatory drugs (NSAID) that has been used to relieve the signs and symptoms of osteoarthritis and adult rheumatoid arthritis and for the treatment of primary dysmenorrhea. Bextra has been withdrawn from the U.S. market. Side effects of Bextra (valdecoxib) include diarrhea, nausea, upset stomach, headache, indigestion, stomach cramps, upper respiratory tract infection (nose, throat, or sinuses), back pain, dizziness, gas, muscle pain, rash, and stuffy nose.
The recommended dose of Bextra (valdecoxib) for the relief of the signs and symptoms of arthritis is 10 mg once daily. The recommended dose of Bextra for treatment of primary dysmenorrhea is 20 mg twice daily, as needed. Bextra (valdecoxib) may interact with aspirin, ACE-inhibitors, furosemide, thiazide diuretics, anticonvulsants, lithium, anticoagulants, ketoconazole and fluconazole, oral contraceptives, and diazepam. Tell your doctor all medications and supplements you use. In late pregnancy Bextra should be avoided because it may cause premature closure of the ductus arteriosus. It is not known whether Bextra is otherwise harmful to a developing fetus. It is also not known whether Bextra is present in human breast milk.
Our Bextra (valdecoxib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Of the patients treated with BEXTRA Tablets in controlled arthritis trials, 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
Table 4 lists all adverse events, regardless of causality, that occurred in ≥2.0% of patients receiving BEXTRA 10 and 20 mg/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.
Table 4 Adverse Events with Incidence ≥2.0% in Valdecoxib Treatment
Groups : Controlled Arthritis Trials of Three Months or Longer
|(Total Daily Dose)|
|Autonomic Nervous System Disorders|
|Body as a Whole|
|Central and Peripheral Nervous System Disorders|
|Gastrointestinal System Disorders|
|Musculoskeletal System Disorders|
|Respiratory System Disorders|
|Upper respiratory tract infection||6.0||6.7||5.7||6.3||4.3||6.4|
|Skin and Appendages Disorders|
In these placebo- and active-controlled clinical trials, the discontinuation rate due to adverse events was 7.5% for arthritis patients receiving 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 adverse events occurred in 0.1–1.9% of patients treated with BEXTRA 10–20 mg daily, regardless of causality.
Gastrointestinal: Abnormal stools, constipation, diverticulosis, dry mouth, duodenal ulcer, duodenitis, eructation, esophagitis, fecal incontinence, gastric ulcer, gastritis, gastroenteritis, gastroesophageal reflux, hematemesis, hematochezia, hemorrhoids, hemorrhoids 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
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
Skin and appendages: Acne, alopecia, dermatitis, dermatitis fungal, eczema, photosensitivity allergic reaction, pruritus, rash erythematous, rash maculopapular, rash psoriaform, skin dry, skin hypertrophy, skin ulceration, sweating increased, urticaria
Special senses: Taste perversion
Other serious adverse events that were reported rarely (estimated <0.1%) in clinical trials, regardless of causality, in patients taking BEXTRA:
Cardiovascular: Abnormal ECG, aortic stenosis, atrial fibrillation, carotid stenosis, coronary thrombosis, heart block, heart valve disorders, mitral insufficiency, myocardial infarction, myocardial ischemia, pericarditis, syncope, thrombophlebitis, unstable angina, ventricular fibrillation
Central, peripheral nervous system: Convulsions
Female reproductive: Cervical dysplasia
Liver and biliary system: Cholelithiasis
Musculoskeletal: Pathological fracture, osteomyelitis
Renal: Acute renal failure
Resistance mechanism disorders: Sepsis
Vision: Retinal detachment
The following reactions have been identified during postmarketing use of BEXTRA. These reactions have been chosen for inclusion either due to their seriousness, reporting frequency, possible causal relationship to BEXTRA, or a combination of these factors. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General: Hypersensitivity reactions (including anaphylactic reactions and angioedema)
Read the entire FDA prescribing information for Bextra (Valdecoxib)