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Vioxx (Rofecoxib) - Nausea - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Nausea (14)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Vioxx (Rofecoxib) where reactions include nausea. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Vioxx side effects in 46 year old male

Reported by a physician from United States on 2012-06-28

Patient: 46 year old male, weighing 73.0 kg (160.6 pounds)

Reactions: Abdominal Pain, Pruritus, Seborrhoeic Dermatitis, Hyperhidrosis, Rheumatoid Arthritis, DRY Mouth, Osteopenia, Lumbar Vertebral Fracture, Nephritis, Tonsillar Disorder, Staphylococcal Infection, Dysphonia, Compression Fracture, Gastrointestinal Disorder, Pancreatitis, Arthritis Bacterial, Polyarthritis, Anosmia, Pseudarthrosis, Adverse Drug Reaction, Change of Bowel Habit, Fall, Muscle Strain, Urosepsis, Bone Disorder, Depression, Postoperative Fever, Light Chain Analysis Increased, Renal Failure Acute, Emphysema, Dyspnoea, Vomiting, Arthritis Infective, Impaired Healing, Sinus Disorder, Sepsis, Blood Disorder, Asthenia, Weight Decreased, Femur Fracture, Enterococcal Infection, Osteomyelitis, Thirst, Headache, Pyrexia, Herpes Zoster, Duodenitis, Arthropathy, Dyspepsia, Irritable Bowel Syndrome, Joint Effusion, Device Malfunction, Ankylosing Spondylitis, Pain in Extremity, Hyperglycaemia, Anaemia, Bone Formation Decreased, Prostatic Disorder, Fungal Infection, Dehydration, Septic Shock, Drug Ineffective, Wrist Fracture, Pain, Fracture Nonunion, Fatigue, Road Traffic Accident, Neck Pain, Wound Drainage, Sinusitis, Autoimmune Arthritis, Nausea, Dental Caries, Synovitis, Rash, Diarrhoea, Steroid Therapy, Lipase Increased, Spinal Disorder, Arthritis, Iritis, Infection

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Fosamax
    Administration route: Oral
    Start date: 2002-01-01
    End date: 2003-02-01

Fosamax
    Administration route: Oral
    Start date: 2004-06-01
    End date: 2006-01-01

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Indication: Ankylosing Spondylitis
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Indication: Arthritis
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Fosamax
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 1998-01-01

Other drugs received by patient: Prednisone; Vitamin E; Vitamins (Unspecified); Oxycontin; Protonix; Clonopin; Ascorbic Acid



Possible Vioxx side effects in 46 year old male

Reported by a physician from United States on 2012-05-07

Patient: 46 year old male, weighing 73.0 kg (160.6 pounds)

Reactions: Abdominal Pain, Seborrhoeic Dermatitis, Hyperhidrosis, Rheumatoid Arthritis, DRY Mouth, Lumbar Vertebral Fracture, Osteopenia, Nephritis, Tonsillar Disorder, Dysphonia, Staphylococcal Infection, Compression Fracture, Gastrointestinal Disorder, Arthritis Bacterial, Pancreatitis, Polyarthritis, Anosmia, Pseudarthrosis, Adverse Drug Reaction, Fall, Change of Bowel Habit, Muscle Strain, Urosepsis, Depression, Postoperative Fever, Bone Disorder, Renal Failure Acute, Light Chain Analysis Increased, Emphysema, Vomiting, Dyspnoea, Impaired Healing, Sinus Disorder, Sepsis, Blood Disorder, Asthenia, Weight Decreased, Femur Fracture, Enterococcal Infection, Osteomyelitis, Headache, Thirst, Pyrexia, Herpes Zoster, Duodenitis, Arthropathy, Dyspepsia, Irritable Bowel Syndrome, Joint Effusion, Device Malfunction, Ankylosing Spondylitis, Hyperglycaemia, Anaemia, Bone Formation Decreased, Prostatic Disorder, Fungal Infection, Dehydration, Septic Shock, Wrist Fracture, Drug Ineffective, Pain, Road Traffic Accident, Fatigue, Neck Pain, Sinusitis, Wound Drainage, Autoimmune Arthritis, Nausea, Synovitis, Rash, Steroid Therapy, Diarrhoea, Spinal Disorder, Lipase Increased, Hypertension, Arthritis, Iritis, Infection

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Vioxx
    Administration route: Oral
    Indication: Ankylosing Spondylitis
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Indication: Arthritis
    Start date: 2000-04-01
    End date: 2004-09-30

Fosamax
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 1998-01-01

Fosamax
    Administration route: Oral
    Start date: 2002-01-01
    End date: 2003-02-01

Fosamax
    Administration route: Oral
    Start date: 2004-06-01
    End date: 2006-01-01

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Other drugs received by patient: Prednisone; Oxycontin; Clonopin; Protonix



Possible Vioxx side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-23

Patient: female

Reactions: Nausea, Anaemia, Cerebrovascular Accident, Gastric Ulcer, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Skelaxin

Vioxx

Tobi
    Dosage: 300 mg, 2x/day
    Start date: 2001-01-01

Sulfamethoxazole

Protonix
    Dosage: unk

Other drugs received by patient: Duoneb; Patanol; Vitamin D; Vitamin E; Albuterol; Flexeril; Butalbital and Caffeine and Paracetamol; Astelin; Misoprostol; Aciphex; Ascorbic Acid; Qvar 40; Diphenhydramine; Naproxen; Magnesium; Theophylline; Iron; Acidophilus ^zyma^; Calcium; Xopenex; Ibandronate Sodium; Alpha Lipoic Acid



Possible Vioxx side effects in female

Reported by a physician from United States on 2012-03-13

Patient: female

Reactions: Pruritus, Tinnitus, Nausea, Drug Ineffective, Urticaria, Anaemia, Gastric Ulcer, Cerebrovascular Accident, Insomnia, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tobi
    Dosage: 300 mg, 2x/day
    Start date: 2001-01-01

Vioxx

Sulfamethoxazole

Protonix
    Dosage: unk

Skelaxin

Other drugs received by patient: Duoneb; Calcium; Qvar 40; Xopenex; Diphenhydramine; Misoprostol; Flexeril; Butalbital and Caffeine and Paracetamol; Magnesium; Albuterol; Theophylline; Astelin; Naproxen; Aciphex; Vitamin E; Ascorbic Acid; Iron; Alpha Lipoic Acid; Ibandronate Sodium; Vitamin D; Acidophilus ^zyma^; Patanol



Possible Vioxx side effects in 46 year old male

Reported by a physician from United States on 2012-03-09

Patient: 46 year old male, weighing 73.0 kg (160.6 pounds)

Reactions: Abdominal Pain, Seborrhoeic Dermatitis, Hyperhidrosis, Rheumatoid Arthritis, DRY Mouth, Osteopenia, Lumbar Vertebral Fracture, Nephritis, Tonsillar Disorder, Dysphonia, Staphylococcal Infection, Gastrointestinal Disorder, Compression Fracture, Pancreatitis, Arthritis Bacterial, Polyarthritis, Anosmia, Pseudarthrosis, Adverse Drug Reaction, Fall, Change of Bowel Habit, Muscle Strain, Urosepsis, Depression, Bone Disorder, Postoperative Fever, Renal Failure Acute, Light Chain Analysis Increased, Emphysema, Vomiting, Dyspnoea, Impaired Healing, Sepsis, Sinus Disorder, Blood Disorder, Asthenia, Weight Decreased, Femur Fracture, Enterococcal Infection, Osteomyelitis, Pyrexia, Headache, Thirst, Herpes Zoster, Duodenitis, Arthropathy, Dyspepsia, Irritable Bowel Syndrome, Joint Effusion, Device Malfunction, Ankylosing Spondylitis, Anaemia, Hyperglycaemia, Bone Formation Decreased, Prostatic Disorder, Fungal Infection, Dehydration, Septic Shock, Wrist Fracture, Drug Ineffective, Pain, Road Traffic Accident, Fatigue, Neck Pain, Sinusitis, Wound Drainage, Autoimmune Arthritis, Nausea, Synovitis, Rash, Diarrhoea, Steroid Therapy, Lipase Increased, Spinal Disorder, Hypertension, Arthritis, Iritis, Infection

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Fosamax
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 1998-01-01

Vioxx
    Administration route: Oral
    Indication: Arthritis
    Start date: 2000-04-01
    End date: 2004-09-30

Fosamax
    Administration route: Oral
    Start date: 2002-01-01
    End date: 2003-02-01

Fosamax
    Administration route: Oral
    Start date: 2004-06-01
    End date: 2006-01-01

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Indication: Ankylosing Spondylitis
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Other drugs received by patient: Oxycontin; Protonix; Prednisone; Clonopin



Possible Vioxx side effects in female

Reported by a physician from United States on 2012-03-05

Patient: female

Reactions: Nausea, Urticaria, Swelling

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

Zoloft
    Dosage: unk

Demerol
    Dosage: unk



Possible Vioxx side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-30

Patient: male, weighing 67.1 kg (147.7 pounds)

Reactions: Abdominal Discomfort, Incorrect Drug Administration Duration, Malaise, Drug Ineffective, Nausea, Hypotension, Somnolence, Loss of Consciousness

Drug(s) suspected as cause:
Voltaren
    Indication: Osteoarthritis

Orudis
    Dosage: unk
    Indication: Spinal Osteoarthritis

ICY HOT
    Dosage: unk
    Indication: Spinal Osteoarthritis

ICY HOT
    Indication: Osteoarthritis

Altace
    Dosage: 5 mg, daily
    Indication: Hypertension

Flector
    Indication: Osteoarthritis

Celebrex
    Dosage: 200 mg, daily
    Administration route: Oral
    Indication: Spinal Osteoarthritis

Celebrex
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Osteoarthritis

Voltaren
    Dosage: unk
    Indication: Spinal Osteoarthritis

Celebrex
    Dosage: 200 mg, daily
    Administration route: Oral

Flector
    Dosage: unk
    Indication: Spinal Osteoarthritis

Vioxx
    Dosage: unk
    Indication: Spinal Osteoarthritis

Vioxx
    Indication: Osteoarthritis

Orudis
    Indication: Osteoarthritis

Other drugs received by patient: Aricept; Aricept; Cortisone; Cymbalta; Cymbalta; Sinemet; Aricept; Tricor



Possible Vioxx side effects in 46 year old male

Reported by a physician from United States on 2012-01-26

Patient: 46 year old male, weighing 73.0 kg (160.6 pounds)

Reactions: Abdominal Pain, Seborrhoeic Dermatitis, Hyperhidrosis, Rheumatoid Arthritis, DRY Mouth, Lumbar Vertebral Fracture, Osteopenia, Nephritis, Tonsillar Disorder, Dysphonia, Staphylococcal Infection, Compression Fracture, Gastrointestinal Disorder, Arthritis Bacterial, Pancreatitis, Anosmia, Polyarthritis, Pseudarthrosis, Adverse Drug Reaction, Fall, Change of Bowel Habit, Muscle Strain, Urosepsis, Bone Disorder, Postoperative Fever, Depression, Light Chain Analysis Increased, Renal Failure Acute, Emphysema, Dyspnoea, Vomiting, Impaired Healing, Sinus Disorder, Sepsis, Blood Disorder, Asthenia, Weight Decreased, Femur Fracture, Enterococcal Infection, Osteomyelitis, Pyrexia, Thirst, Headache, Herpes Zoster, Duodenitis, Arthropathy, Dyspepsia, Irritable Bowel Syndrome, Joint Effusion, Device Malfunction, Ankylosing Spondylitis, Anaemia, Hyperglycaemia, Bone Formation Decreased, Prostatic Disorder, Fungal Infection, Dehydration, Septic Shock, Drug Ineffective, Wrist Fracture, Pain, Fatigue, Road Traffic Accident, Neck Pain, Wound Drainage, Sinusitis, Autoimmune Arthritis, Nausea, Synovitis, Rash, Steroid Therapy, Diarrhoea, Spinal Disorder, Lipase Increased, Hypertension, Arthritis, Iritis, Infection

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Fosamax
    Administration route: Oral
    Start date: 2004-06-01
    End date: 2006-01-01

Fosamax
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 1998-01-01

Vioxx
    Administration route: Oral
    Indication: Arthritis
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Fosamax
    Administration route: Oral
    Start date: 2002-01-01
    End date: 2003-02-01

Vioxx
    Administration route: Oral
    Indication: Ankylosing Spondylitis
    Start date: 2000-04-01
    End date: 2004-09-30

Other drugs received by patient: Clonopin; Protonix; Prednisone; Oxycontin



Possible Vioxx side effects in male

Reported by a individual with unspecified qualification from United States on 2012-01-20

Patient: male, weighing 67.1 kg (147.7 pounds)

Reactions: Drug Administered AT Inappropriate Site, Drug Ineffective, Nausea, Somnolence, Loss of Consciousness, Abdominal Discomfort, Malaise, Blood Pressure Decreased

Drug(s) suspected as cause:
Orudis
    Dosage: unk, unk
    Indication: Osteoarthritis

Voltaren
    Dosage: unk, unk
    Administration route: Topical
    Indication: Osteoarthritis

Flector
    Dosage: unk, unk
    Indication: Osteoarthritis

Celebrex
    Dosage: 200 mg, qd
    Administration route: Oral
    Indication: Osteoarthritis

Vioxx
    Dosage: unk, unk
    Indication: Osteoarthritis

Celebrex
    Dosage: 200 mg, bid
    Administration route: Oral

Altace
    Dosage: 5 mg, qd
    Indication: Hypertension

ICY HOT
    Indication: Osteoarthritis

Drug Therapy NOS
    Dosage: unk, unk
    Indication: Osteoarthritis

Other drugs received by patient: Sinemet; Cortisone Acetate; Tricor; Aricept; Cymbalta



Possible Vioxx side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-18

Patient: male, weighing 67.1 kg (147.7 pounds)

Reactions: Drug Ineffective, Nausea, Hypotension, Somnolence, Loss of Consciousness, Abdominal Discomfort, Malaise, Incorrect Drug Administration Duration

Drug(s) suspected as cause:
Celebrex
    Dosage: 200 mg, daily
    Administration route: Oral
    Indication: Spinal Osteoarthritis

Flector
    Indication: Osteoarthritis

Voltaren
    Indication: Osteoarthritis

ICY HOT
    Dosage: unk
    Indication: Spinal Osteoarthritis

Voltaren
    Dosage: unk
    Indication: Spinal Osteoarthritis

Orudis
    Indication: Osteoarthritis

Vioxx
    Indication: Osteoarthritis

Celebrex
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Osteoarthritis

Celebrex
    Dosage: 200 mg, daily
    Administration route: Oral

Flector
    Dosage: unk
    Indication: Spinal Osteoarthritis

ICY HOT
    Indication: Osteoarthritis

Orudis
    Dosage: unk
    Indication: Spinal Osteoarthritis

Altace
    Dosage: 5 mg, daily
    Indication: Hypertension

Vioxx
    Dosage: unk
    Indication: Spinal Osteoarthritis

Other drugs received by patient: Cymbalta; Sinemet; Aricept; Cymbalta; Aricept; Cortisone; Aricept; Tricor



Possible Vioxx side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-03

Patient: male, weighing 67.1 kg (147.7 pounds)

Reactions: Nausea, Drug Ineffective, Hypotension, Somnolence, Loss of Consciousness, Abdominal Discomfort, Malaise, Incorrect Drug Administration Duration

Drug(s) suspected as cause:
Celebrex
    Dosage: 200 mg, daily
    Administration route: Oral
    Indication: Spinal Osteoarthritis

Altace
    Dosage: 5 mg, daily
    Indication: Hypertension

Vioxx
    Indication: Osteoarthritis

Celebrex
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Osteoarthritis

Celebrex
    Dosage: 200 mg, daily
    Administration route: Oral

Voltaren
    Dosage: unk
    Indication: Spinal Osteoarthritis

Orudis
    Indication: Osteoarthritis

ICY HOT
    Indication: Osteoarthritis

ICY HOT
    Dosage: unk
    Indication: Spinal Osteoarthritis

Vioxx
    Dosage: unk
    Indication: Spinal Osteoarthritis

Flector
    Dosage: unk
    Indication: Spinal Osteoarthritis

Voltaren
    Indication: Osteoarthritis

Flector
    Indication: Osteoarthritis

Orudis
    Dosage: unk
    Indication: Spinal Osteoarthritis

Other drugs received by patient: Tricor; Aricept; Cortisone; Cymbalta; Aricept; Cymbalta; Sinemet; Aricept



Possible Vioxx side effects in

Reported by a individual with unspecified qualification from United States on 2011-10-07

Patient:

Reactions: Blood Pressure Increased, Vomiting, Chest Discomfort, Nausea, Cardiac Stress Test Abnormal, Muscular Weakness, Hypoaesthesia, Fall, Cardiac Disorder, Hyperventilation, Malaise, Psychotic Disorder, Dizziness, Heart Rate Irregular, Unevaluable Event

Drug(s) suspected as cause:
Vioxx



Possible Vioxx side effects in 46 year old male

Reported by a physician from United States on 2011-10-04

Patient: 46 year old male, weighing 73.0 kg (160.6 pounds)

Reactions: Abdominal Pain, Hyperhidrosis, Rheumatoid Arthritis, DRY Mouth, Lumbar Vertebral Fracture, Osteopenia, Dysphonia, Compression Fracture, Gastrointestinal Disorder, Polyarthritis, Anosmia, Pseudarthrosis, Adverse Drug Reaction, Fall, Change of Bowel Habit, Muscle Strain, Urosepsis, Bone Disorder, Depression, Renal Failure Acute, Emphysema, Dyspnoea, Vomiting, Impaired Healing, Sepsis, Blood Disorder, Asthenia, Weight Decreased, Femur Fracture, Enterococcal Infection, Osteomyelitis, Headache, Pyrexia, Thirst, Herpes Zoster, Duodenitis, Arthropathy, Dyspepsia, Joint Effusion, Device Malfunction, Ankylosing Spondylitis, Hyperglycaemia, Anaemia, Bone Formation Decreased, Prostatic Disorder, Fungal Infection, Dehydration, Septic Shock, Nephropathy, Wrist Fracture, Pain, Fatigue, Road Traffic Accident, Neck Pain, Wound Drainage, Sinusitis, Nausea, Synovitis, Rash, Steroid Therapy, Diarrhoea, Lipase Increased, Spinal Disorder, Hypertension, Arthritis, Iritis, Infection

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Fosamax
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 1998-01-01
    End date: 2002-03-28

Fosamax
    Administration route: Oral
    Start date: 2004-06-01
    End date: 2006-01-01

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Indication: Ankylosing Spondylitis
    Start date: 2000-04-01
    End date: 2004-09-30

Fosamax
    Administration route: Oral
    Start date: 2002-01-01
    End date: 2003-02-01

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Indication: Arthritis
    Start date: 2000-04-01
    End date: 2004-09-30

Other drugs received by patient: Prednisone; Oxycontin; Protonix; Clonopin



Possible Vioxx side effects in 46 year old male

Reported by a physician from United States on 2011-10-04

Patient: 46 year old male, weighing 73.0 kg (160.6 pounds)

Reactions: Abdominal Pain, Hyperhidrosis, Rheumatoid Arthritis, DRY Mouth, Back Pain, Osteopenia, Lumbar Vertebral Fracture, Dysphonia, Compression Fracture, Gastrointestinal Disorder, Anosmia, Pseudarthrosis, Adverse Drug Reaction, Change of Bowel Habit, Fall, Muscle Strain, Urosepsis, Depression, Bone Disorder, Renal Failure Acute, Emphysema, Dyspnoea, Vomiting, Impaired Healing, Sepsis, Blood Disorder, Asthenia, Weight Decreased, Femur Fracture, Enterococcal Infection, Osteomyelitis, Thirst, Headache, Pyrexia, Herpes Zoster, Duodenitis, Arthropathy, Dyspepsia, Device Malfunction, Ankylosing Spondylitis, Anaemia, Hyperglycaemia, Bone Formation Decreased, Prostatic Disorder, Fungal Infection, Dehydration, Septic Shock, Nephropathy, Wrist Fracture, Pain, Fatigue, Road Traffic Accident, Neck Pain, Sinusitis, Wound Drainage, Nausea, Rash, Steroid Therapy, Diarrhoea, Lipase Increased, Spinal Disorder, Arthritis, Hypertension, Iritis, Infection

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Fosamax
    Administration route: Oral
    Start date: 2002-01-01
    End date: 2003-02-01

Fosamax
    Administration route: Oral
    Start date: 2004-06-01
    End date: 2006-01-01

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Start date: 2000-04-01
    End date: 2004-09-30

Vioxx
    Administration route: Oral
    Indication: Ankylosing Spondylitis
    Start date: 2000-04-01
    End date: 2004-09-30

Fosamax
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 1998-01-01
    End date: 2001-01-01

Vioxx
    Administration route: Oral
    Indication: Arthritis
    Start date: 2000-04-01
    End date: 2004-09-30

Other drugs received by patient: Oxycontin; Protonix; Prednisone; Clonopin

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