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Bextra (Valdecoxib) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 DiclofenacIbuprofenNaproxen
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
Hypertension0.61.62.12.52.41.7
Body as a Whole
Back pain1.61.62.72.81.41.0
Edema peripheral0.72.43.03.22.92.1
Influenza-like symptoms2.22.02.23.12.92.0
Injury accidental2.84.03.73.93.93.0
Central and Peripheral Nervous System Disorders
Dizziness2.12.62.74.23.42.7
Headache7.14.88.56.64.35.5
Gastrointestinal System Disorders
Abdominal fullness2.02.11.93.02.92.5
Abdominal pain6.37.08.217.08.210.1
Diarrhea4.25.46.010.83.94.7
Dyspepsia6.37.98.713.415.012.9
Flatulence4.12.93.53.17.75.4
Nausea5.97.06.38.47.78.7
Musculoskeletal System Disorders
Myalgia1.62.01.92.42.41.4
Respiratory System Disorders
Sinusitis2.22.61.81.13.43.4
Upper respiratory tract infection6.06.75.76.34.36.4
Skin and Appendages Disorders
Rash1.01.42.11.50.51.4

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



REPORTS OF SUSPECTED BEXTRA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Bextra. The information is not vetted and should not be considered as verified clinical evidence.

Possible Bextra side effects / adverse reactions in 70 year old female

Reported by a individual with unspecified qualification from United States on 2011-10-31

Patient: 70 year old female weighing 80.3 kg (176.7 pounds)

Reactions: Anxiety, Fatigue, Upper Limb Fracture, Drug Ineffective, Bone Pain, Hypotension, Gastrooesophageal Reflux Disease, Herpes Zoster

Suspect drug(s):
Bextra
    Administration route: Oral
    Indication: Back Disorder
    Start date: 1997-01-01

Nexium
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Other drugs received by patient: Lisinopril



Possible Bextra side effects / adverse reactions in 58 year old male

Reported by a consumer/non-health professional from United States on 2012-02-15

Patient: 58 year old male weighing 72.6 kg (159.7 pounds)

Reactions: Cerebrovascular Accident, Cardiac Disorder

Adverse event resulted in: death

Suspect drug(s):
Bextra



Possible Bextra side effects / adverse reactions in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 61 year old female weighing 77.1 kg (169.6 pounds)

Reactions: Nerve Injury, Diabetes Mellitus, Drug Ineffective, Chills, Constipation, Fall, Blood Creatinine Increased, Vomiting, Renal Disorder, Nausea, Mental Impairment, Renal Impairment, Panic Attack, Kidney Small, Blood Potassium Decreased, Arthralgia, Swelling, Dehydration, Memory Impairment, Gait Disturbance, Feeling Abnormal

Suspect drug(s):
Bextra
    Dosage: unk
    Administration route: Oral
    Indication: Arthritis
    End date: 2005-01-01

Celebrex
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Indication: Arthritis
    Start date: 1999-01-01
    End date: 2002-01-01

Cymbalta
    Administration route: Oral
    Indication: Neuralgia

Gabitril
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Indication: Neuralgia

Maxzide
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension

Morphine Sulfate
    Dosage: unk

Neurontin
    Dosage: 100 mg, daily
    Administration route: Oral
    Indication: Nerve Injury

Neurontin
    Dosage: 100 mg, 2x/day

Neurontin
    Dosage: 600 mg, 3x/day
    Indication: Pain

Neurontin
    Dosage: 300 mg, 2x/day

Potassium Chloride
    Dosage: unk
    Indication: Blood Potassium Decreased
    Start date: 2012-01-01

Topamax
    Dosage: unk
    Administration route: Oral
    Indication: Neuralgia

Toprol-XL
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension

Zyrtec
    Dosage: 10 mg, daily
    Indication: House Dust Allergy

Other drugs received by patient: Toprol-XL; Lyrica; Lipitor; Aspirin; Norvasc



See index of all Bextra side effect reports >>

Drug label data at the top of this Page last updated: 2006-02-06

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