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Bextra (Valdecoxib) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Bextra (Valdecoxib) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (27)
Death (5)

Reports by Reaction Type

Drug Ineffective (6)Nausea (5)Death (4)Fatigue (4)Dizziness (4)Depression (4)Heart Rate Irregular (4)Drug Hypersensitivity (4)Anxiety (4)Pain (3)Headache (3)Constipation (3)

Possible Bextra side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Bextra



Possible Bextra side effects 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

Drug(s) suspected as cause:
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



Possible Bextra side effects in female

Reported by a physician from United States on 2012-07-30

Patient: female

Reactions: Drug Hypersensitivity, Rash

Drug(s) suspected as cause:
Bextra



Possible Bextra side effects in

Reported by a physician from United States on 2012-07-30

Patient:

Reactions: Abdominal Discomfort, Pain, Drug Hypersensitivity

Drug(s) suspected as cause:
Amiloride HCL and Hydrochlorothiazide
    Dosage: unk

Bextra
    Dosage: unk

Bupropion HCL
    Dosage: unk

Dicloxacillin
    Dosage: unk

Fluoxetine Hydrochloride
    Dosage: unk

Lexapro
    Dosage: unk

Vicodin
    Dosage: unk



Possible Bextra side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Bextra
    Dosage: unk

Valdecoxib
    Dosage: unk



Possible Bextra side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-31

Patient: male

Reactions: Skin Exfoliation, Drug Hypersensitivity, Rash, Erythema

Drug(s) suspected as cause:
Bactrim
    Dosage: unk

Bextra
    Dosage: unk
    Administration route: Oral



Possible Bextra side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-24

Patient: male

Reactions: Nausea, Suicidal Ideation, Weight Increased, Mood Altered, Heart Rate Increased, Chest Pain, Dizziness, Depression, Heart Rate Irregular, Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bextra
    Dosage: unk
    Indication: Arthritis
    Start date: 2003-11-05
    End date: 2004-10-22

Bextra
    Dosage: 10 mg, 1x/day

Bextra
    Dosage: 20 mg, 1x/day



Possible Bextra side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-14

Patient: female

Reactions: Osteoarthritis, Back Pain, Pain in Extremity, Drug Ineffective, Joint Swelling, Nervous System Disorder

Drug(s) suspected as cause:
Bextra
    Dosage: 20 mg, 1x/day
    Indication: Osteoarthritis
    Start date: 2004-05-01

Bextra
    Dosage: 10 mg, 2x/day
    Start date: 2004-01-01

Lipitor
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Indication: Blood Cholesterol Increased

Other drugs received by patient: Alendronate Sodium



Possible Bextra side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-20

Patient: male

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Bactrim
    Dosage: unk

Bextra
    Dosage: unk



Possible Bextra side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-19

Patient: male

Reactions: Heart Rate Irregular

Drug(s) suspected as cause:
Bextra



Possible Bextra side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-11

Patient: female, weighing 106.0 kg (233.2 pounds)

Reactions: Mydriasis, Ocular Vascular Disorder, Visual Impairment, Vision Blurred

Drug(s) suspected as cause:
Bextra
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Indication: Tendonitis
    Start date: 2004-01-01

Bextra
    Indication: Pain in Extremity

Bextra
    Dosage: unk
    Administration route: Oral
    Indication: Oedema Peripheral
    End date: 2006-01-01

Other drugs received by patient: Cetirizine; Triamterene; Triamterene



Possible Bextra side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-12

Patient: female, weighing 60.8 kg (133.7 pounds)

Reactions: Drug Ineffective, Pain, Headache, Constipation, Somnolence, Myalgia, Fatigue, Neck Pain, Dyspepsia, Fibromyalgia, Animal Bite, Dizziness, Coordination Abnormal, Depression, Cough, Myositis, Back Pain, Localised Infection, Nausea, Anxiety, Osteoarthritis, Sleep Disorder, Diarrhoea, Activities of Daily Living Impaired, DRY Eye, Asthenia

Drug(s) suspected as cause:
Bextra
    Dosage: unk

Lyrica
    Dosage: 50 mg
    Indication: Fibromyalgia

Neurontin
    Dosage: 800 mg, 4x/day
    Administration route: Oral
    Indication: Fibromyalgia

Other drugs received by patient: Nadolol; Vitamin D; Sumatriptan Succinate; Levothroid; Levothyroxine; Bupropion; Dicyclomine; Diazepam; Flonase; Viibryd; Lexapro; Advair Diskus 100 / 50; Acetaminophen and Hydrocodone Bitartrate; Bupropion; Bupropion; Relpax; Vagifem; Nadolol; Diazepam; Gabapentin; Gabapentin; Seroquel; Claritin; Nadolol; Ranitidine; Topiramate; Allegra; Extra Strength Tylenol; Topamax



Possible Bextra side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-27

Patient: female, weighing 102.0 kg (224.4 pounds)

Reactions: Mydriasis, Ocular Vascular Disorder, Visual Impairment, Vision Blurred, Optic Ischaemic Neuropathy

Drug(s) suspected as cause:
Bextra
    Indication: Pain in Extremity

Bextra
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Indication: Tendonitis
    Start date: 2004-01-01
    End date: 2006-01-01

Bextra
    Indication: Oedema Peripheral



Possible Bextra side effects 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

Drug(s) suspected as cause:
Bextra



Possible Bextra side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-14

Patient: female

Reactions: Pneumonia, Coronary Artery Disease, Bundle Branch Block Left, Congestive Cardiomyopathy, Cardiomegaly, Respiratory Failure, Mitral Valve Incompetence, Left Atrial Dilatation, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bextra
    Dosage: 20 mg, 2x/day
    Indication: Antiinflammatory Therapy
    Start date: 2004-03-24

Bextra
    Dosage: 20 mg, 2x/day
    Indication: Musculoskeletal Pain
    Start date: 2004-05-20

Bextra
    Dosage: 20 mg, 2x/day
    Indication: Back Pain
    Start date: 2004-10-08

Other drugs received by patient: Levoxyl; Glucophage; Amaryl; Neurontin



Possible Bextra side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-13

Patient: male

Reactions: Nausea, Weight Increased, Mood Altered, Heart Rate Increased, Chest Pain, Dizziness, Depression, Heart Rate Irregular, Myocardial Infarction

Drug(s) suspected as cause:
Bextra
    Dosage: unk
    Indication: Arthritis
    Start date: 2003-11-05
    End date: 2004-10-22

Bextra
    Dosage: 10 mg, 1x/day

Bextra
    Dosage: 20 mg, 1x/day



Possible Bextra side effects in female

Reported by a physician from United States on 2012-01-20

Patient: female, weighing 60.8 kg (133.7 pounds)

Reactions: Drug Ineffective, Pain, Headache, Constipation, Myalgia, Fatigue, Dyspepsia, Neck Pain, Fibromyalgia, Dizziness, Coordination Abnormal, Depression, Myositis, Back Pain, Nausea, Osteoarthritis, Anxiety, Activities of Daily Living Impaired, Sleep Disorder, Diarrhoea

Drug(s) suspected as cause:
Bextra
    Dosage: unk

Lyrica
    Dosage: unk
    Indication: Fibromyalgia

Neurontin
    Dosage: 800 mg, 4x/day
    Administration route: Oral
    Indication: Fibromyalgia

Other drugs received by patient: Topiramate; Relpax; Seroquel; Viibryd; Nadolol; Nadolol; Allegra; Flonase; Claritin; Levothroid; Lexapro; Dicyclomine; Levothyroxine; Diazepam; Ranitidine; Gabapentin; Gabapentin; Vagifem; Nadolol; Advair Diskus 100 / 50; Acetaminophen and Hydrocodone Bitartrate; Extra Strength Tylenol; Vitamin D; Sumatriptan Succinate; Bupropion; Bupropion; Bupropion; Diazepam; Topamax



Possible Bextra side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-04

Patient: female, weighing 102.0 kg (224.4 pounds)

Reactions: Ocular Vascular Disorder, Mydriasis, Visual Impairment, Vision Blurred

Drug(s) suspected as cause:
Bextra
    Indication: Pain in Extremity

Bextra
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Indication: Tendonitis
    Start date: 2004-01-01
    End date: 2004-01-01

Bextra
    Indication: Oedema Peripheral



Possible Bextra side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-04

Patient: male, weighing 87.1 kg (191.6 pounds)

Reactions: Myocardial Infarction, Cerebrovascular Accident

Drug(s) suspected as cause:
Bextra
    Dosage: unk

Celebrex
    Dosage: unk
    Administration route: Oral
    Indication: Gastrointestinal Pain

Vioxx
    Dosage: unk

Other drugs received by patient: Amlodipine



Possible Bextra side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-20

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Bextra



Possible Bextra side effects in female

Reported by a consumer/non-health professional from United States on 2011-11-01

Patient: female, weighing 59.4 kg (130.7 pounds)

Reactions: Heart Rate Irregular

Drug(s) suspected as cause:
Bextra
    Dosage: unk
    Indication: Wrist Fracture

Bextra
    Indication: Complex Regional Pain Syndrome

Other drugs received by patient: Cymbalta; Azelastine Hydrochloride; Cymbalta; Premarin; Trazodone; Simvastatin / Niacin; Calcium; Premarin; Magnesium; Fish OIL; Nasonex; Premarin; Vitamin D; Multi-Vitamins



Possible Bextra side effects in

Reported by a consumer/non-health professional from United States on 2011-10-31

Patient:

Reactions: Hypertension, Cardiac Disorder

Drug(s) suspected as cause:
Bextra



Possible Bextra side effects 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

Drug(s) suspected as cause:
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 in female

Reported by a consumer/non-health professional from United States on 2011-10-26

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Bextra



Possible Bextra side effects in male

Reported by a consumer/non-health professional from United States on 2011-10-17

Patient: male, weighing 64.9 kg (142.7 pounds)

Reactions: Abdominal Discomfort, Dyspepsia, Drug Ineffective, Headache, Abdominal Pain Upper

Drug(s) suspected as cause:
Bextra
    Indication: Arthritis

Celebrex
    Administration route: Oral
    Indication: Arthritis
    Start date: 2004-01-01
    End date: 2004-01-01

Other drugs received by patient: Valium; Uroxatral



Possible Bextra side effects in female

Reported by a consumer/non-health professional from United States on 2011-10-05

Patient: female, weighing 80.3 kg (176.6 pounds)

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

Drug(s) suspected as cause:
Bextra
    Dosage: unk
    Administration route: Oral
    Indication: Back Disorder
    Start date: 1997-01-01

Nexium
    Dosage: 40 mg, alternate day
    Indication: Gastrooesophageal Reflux Disease

Other drugs received by patient: Lisinopril



Possible Bextra side effects in female

Reported by a consumer/non-health professional from United States on 2011-10-05

Patient: female, weighing 80.3 kg (176.6 pounds)

Reactions: Wrong Technique in Drug Usage Process, Pneumonia, Pain in Extremity, Expired Drug Administered

Drug(s) suspected as cause:
Bextra

Other drugs received by patient: Lisinopril

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