Bextra

Bextra Side Effects Center

Last reviewed on RxList 7/19/2017

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 Bextra has been withdrawn from the U.S. market.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.

 

Bextra Professional Information

SIDE EFFECTS

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)
		Valdecoxib		Diclofenac	Ibuprofen	Naproxen
Adverse Event Number Treated	Placebo 973	10 mg 1214	20 mg 1358	150 mg 711	2400 mg 207	1000 mg 766
Autonomic Nervous System Disorders
Hypertension	0.6	1.6	2.1	2.5	2.4	1.7
Body as a Whole
Back pain	1.6	1.6	2.7	2.8	1.4	1.0
Edema peripheral	0.7	2.4	3.0	3.2	2.9	2.1
Influenza-like symptoms	2.2	2.0	2.2	3.1	2.9	2.0
Injury accidental	2.8	4.0	3.7	3.9	3.9	3.0
Central and Peripheral Nervous System Disorders
Dizziness	2.1	2.6	2.7	4.2	3.4	2.7
Headache	7.1	4.8	8.5	6.6	4.3	5.5
Gastrointestinal System Disorders
Abdominal fullness	2.0	2.1	1.9	3.0	2.9	2.5
Abdominal pain	6.3	7.0	8.2	17.0	8.2	10.1
Diarrhea	4.2	5.4	6.0	10.8	3.9	4.7
Dyspepsia	6.3	7.9	8.7	13.4	15.0	12.9
Flatulence	4.1	2.9	3.5	3.1	7.7	5.4
Nausea	5.9	7.0	6.3	8.4	7.7	8.7
Musculoskeletal System Disorders
Myalgia	1.6	2.0	1.9	2.4	2.4	1.4
Respiratory System Disorders
Sinusitis	2.2	2.6	1.8	1.1	3.4	3.4
Upper respiratory tract infection	6.0	6.7	5.7	6.3	4.3	6.4
Skin and Appendages Disorders
Rash	1.0	1.4	2.1	1.5	0.5	1.4

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.

Application site disorders: Cellulitis, dermatitis contact

Cardiovascular: Aggravated hypertension, aneurysm, angina pectoris, arrhythmia, cardiomyopathy, congestive heart failure, coronary artery disorder, heart murmur, hypotension

Central, peripheral nervous system: Cerebrovascular disorder, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, tremor, twitching, vertigo

Endocrine: Goiter

Female reproductive: Amenorrhea, dysmenorrhea, leukorrhea, mastitis, menstrual disorder, menorrhagia, menstrual bloating, vaginal hemorrhage

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

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 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

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, conjunctivitis, eye pain, keratitis, vision abnormal

White cell and RES disorders: Eosinophilia, leukopenia, leukocytosis, lymphadenopathy, lymphangitis, lymphopenia

Other serious adverse events that were reported rarely (estimated <0.1%) in clinical trials, regardless of causality, in patients taking BEXTRA:

Autonomic nervous system disorders: Hypertensive encephalopathy, vasospasm

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

Endocrine: Hyperparathyroidism

Female reproductive: Cervical dysplasia

Gastrointestinal: Appendicitis, colitis with bleeding, dysphagia, esophageal perforation, gastrointestinal bleeding, ileus, intestinal obstruction, peritonitis

Hemic: Lymphoma-like disorder, pancytopenia

Liver and biliary system: Cholelithiasis

Metabolic: Dehydration

Musculoskeletal: Pathological fracture, osteomyelitis

Neoplasm: Benign brain neoplasm, bladder carcinoma, carcinoma, gastric carcinoma, prostate carcinoma, pulmonary carcinoma

Platelets (bleeding or clotting): Embolism, pulmonary embolism, thrombosis

Psychiatric: Manic reaction, psychosis

Renal: Acute renal failure

Resistance mechanism disorders: Sepsis

Respiratory: Apnea, pleural effusion, pulmonary edema, pulmonary fibrosis, pulmonary infarction, pulmonary hemorrhage, respiratory insufficiency

Skin: Basal cell carcinoma, malignant melanoma

Urinary system: Pyelonephritis, renal calculus

Vision: Retinal detachment

Postmarketing Experience

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)

Gastrointestinal: Pancreatitis

Skin and appendages: Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis

Read the entire FDA prescribing information for Bextra (Valdecoxib)