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

 
 



Index of reports > Cases with Somnolence (9)

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

Possible Vioxx side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-10

Patient: female, weighing 81.6 kg (179.6 pounds)

Reactions: Cyst, Rheumatoid Arthritis, Upper Respiratory Tract Infection, Peroneal Nerve Palsy, Temperature Intolerance, Back Pain, Abscess Oral, Bursitis, Antinuclear Antibody Positive, Myeloma Recurrence, Chondromalacia, Intervertebral Disc Space Narrowing, Staphylococcal Infection, Swelling, Abscess, Spinal Cord Oedema, FAT Tissue Increased, Somnolence, Foot Fracture, Depression, Acquired Oesophageal WEB, Exostosis, Ligament Sprain, Renal Failure Acute, Musculoskeletal Pain, Muscular Weakness, Arthralgia, Asthma, Night Sweats, Tongue Discolouration, Urinary Incontinence, Deafness, Clostridium Difficile Colitis, Osteomyelitis, Arthropathy, Oral Candidiasis, Ecchymosis, Uterine Leiomyoma, Nodule, Fibrosis, Oral Pustule, Multiple Sclerosis, Epistaxis, Muscle Spasms, Intervertebral Disc Protrusion, Stomatitis, Dysphagia, Pneumonia, Hiatus Hernia, Cellulitis, Pain in Extremity, Anaemia, Hypoaesthesia, Cholelithiasis, Epicondylitis, Mastication Disorder, Spinal Column Stenosis, Colitis Ulcerative, Eye Irritation, Mouth Ulceration, Myofascitis, Laryngitis, Myalgia, Neck Pain, Skin Lesion, Bone Marrow Failure, Gastrooesophageal Reflux Disease, Sinusitis, Pain in JAW, Bone Lesion, Urinary Tract Infection, Neck Mass, Renal Failure Chronic, Amnesia, Dental Discomfort, Osteoarthritis, Renal Impairment, Osteonecrosis of JAW, Diarrhoea, Spinal Osteoarthritis, Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vioxx
    Dosage: 50 mg, unk
    Indication: Rheumatoid Arthritis
    Start date: 2004-01-01
    End date: 2004-01-01

Aredia
    Dosage: 90 mg, qmo
    Start date: 2001-04-26

Zometa
    Dosage: 4 mg, qmo
    Indication: Multiple Myeloma
    Start date: 2001-01-01
    End date: 2005-06-03

Other drugs received by patient: Celebrex; Ambien; Fentanyl Citrate; Neurontin; Chemotherapeutics NOS; Prozac; Quinine Sulfate; Elavil; Augmentin '125'; Clindamycin; Prempro; Levaquin; Diflucan; Magnesium Oxide; Flexeril; Plaquenil; Vitamin D; Pepcid; Ceftriaxone; Bactrim; Skelaxin; Hydromorphone HCL; Radiation Therapy; Clonidine; Nasonex; Protonix; Periogard; Flagyl; Cefazolin; Duragesic-100; Folate Sodium; Multi-Vitamins; Amoxicillin; Nexium; Clarinex / DEN /; Minerals NOS; Keflex; PEN-VEE K; Reglan; Cipro; Combivent; Zithromax; Phenergan; Lactulose



Possible Vioxx side effects in female

Reported by a physician from United States on 2012-02-21

Patient: female, weighing 81.6 kg (179.6 pounds)

Reactions: Cyst, Rheumatoid Arthritis, Upper Respiratory Tract Infection, Peroneal Nerve Palsy, Temperature Intolerance, Back Pain, Abscess Oral, Bursitis, Antinuclear Antibody Positive, Myeloma Recurrence, Intervertebral Disc Space Narrowing, Chondromalacia, Staphylococcal Infection, Swelling, Abscess, Spinal Cord Oedema, FAT Tissue Increased, Somnolence, Foot Fracture, Acquired Oesophageal WEB, Depression, Exostosis, Ligament Sprain, Renal Failure Acute, Musculoskeletal Pain, Muscular Weakness, Arthralgia, Asthma, Night Sweats, Tongue Discolouration, Urinary Incontinence, Osteomyelitis, Clostridium Difficile Colitis, Arthropathy, Oral Candidiasis, Uterine Leiomyoma, Ecchymosis, Nodule, Fibrosis, Oral Pustule, Multiple Sclerosis, Muscle Spasms, Intervertebral Disc Protrusion, Cellulitis, Stomatitis, Dysphagia, Hiatus Hernia, Pneumonia, Pain in Extremity, Anaemia, Hypoaesthesia, Cholelithiasis, Epicondylitis, Mastication Disorder, Spinal Column Stenosis, Eye Irritation, Mouth Ulceration, Myofascitis, Laryngitis, Myalgia, Neck Pain, Skin Lesion, Bone Marrow Failure, Sinusitis, Gastrooesophageal Reflux Disease, Pain in JAW, Bone Lesion, Urinary Tract Infection, Neck Mass, Renal Failure Chronic, Dental Discomfort, Osteoarthritis, Renal Impairment, Diarrhoea, Osteonecrosis of JAW, Spinal Osteoarthritis, Bronchitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aredia
    Dosage: 90 mg, qmo
    Start date: 2001-04-26

Vioxx
    Dosage: 50 mg, unk
    Indication: Rheumatoid Arthritis
    Start date: 2004-01-01
    End date: 2004-01-01

Zometa
    Dosage: 4 mg, qmo
    Indication: Multiple Myeloma
    Start date: 2001-01-01
    End date: 2005-06-03

Other drugs received by patient: Multi-Vitamins; Elavil; Keflex; Amoxicillin; Periogard; Folate Sodium; Protonix; Plaquenil; Augmentin '125'; Cefazolin; Neurontin; Levaquin; Clonidine; Nasonex; Phenergan; Ceftriaxone; Flexeril; Quinine Sulfate; Skelaxin; Radiation Therapy; Duragesic-100; Magnesium Oxide; Lactulose; Clindamycin; Nexium; Vitamin D; Chemotherapeutics NOS; Prempro; PEN-VEE K; Bactrim; Combivent; Celebrex; Fentanyl; Flagyl; Clarinex / DEN /; Pepcid; Prozac; Ambien; Cipro; Hydromorphone HCL; Zithromax; Minerals NOS; Reglan; Armodafinil



Possible Vioxx side effects in female

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

Patient: female, weighing 81.6 kg (179.6 pounds)

Reactions: Cyst, Rheumatoid Arthritis, Peroneal Nerve Palsy, Temperature Intolerance, Back Pain, Abscess Oral, Bursitis, Antinuclear Antibody Positive, Myeloma Recurrence, Intervertebral Disc Space Narrowing, Chondromalacia, Staphylococcal Infection, Swelling, Abscess, Spinal Cord Oedema, FAT Tissue Increased, Somnolence, Foot Fracture, Depression, Acquired Oesophageal WEB, Exostosis, Renal Failure Acute, Ligament Sprain, Musculoskeletal Pain, Muscular Weakness, Arthralgia, Asthma, Night Sweats, Tongue Discolouration, Urinary Incontinence, Clostridium Difficile Colitis, Osteomyelitis, Arthropathy, Oral Candidiasis, Ecchymosis, Uterine Leiomyoma, Nodule, Fibrosis, Multiple Sclerosis, Oral Pustule, Muscle Spasms, Intervertebral Disc Protrusion, Cellulitis, Stomatitis, Hiatus Hernia, Dysphagia, Pneumonia, Pain in Extremity, Anaemia, Hypoaesthesia, Cholelithiasis, Epicondylitis, Mastication Disorder, Spinal Column Stenosis, Mouth Ulceration, Myofascitis, Myalgia, Neck Pain, Skin Lesion, Bone Marrow Failure, Sinusitis, Gastrooesophageal Reflux Disease, Pain in JAW, Bone Lesion, Urinary Tract Infection, Neck Mass, Renal Failure Chronic, Dental Discomfort, Osteoarthritis, Renal Impairment, Osteonecrosis of JAW, Diarrhoea, Bronchitis, Spinal Osteoarthritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vioxx
    Dosage: 50 mg, unk
    Indication: Rheumatoid Arthritis
    Start date: 2004-01-01
    End date: 2004-01-01

Zometa
    Dosage: 4 mg, qmo
    Indication: Multiple Myeloma
    Start date: 2001-01-01
    End date: 2005-06-03

Aredia
    Dosage: 90 mg, qmo
    Start date: 2001-04-26

Other drugs received by patient: Levaquin; Clarinex / DEN /; Duragesic-100; Ambien; Clonidine; Folate Sodium; Elavil; Celebrex; Keflex; PEN-VEE K; Flagyl; Vitamin D; Hydromorphone HCL; Radiation Therapy; Combivent; Clindamycin; Periogard; Neurontin; Prempro; Magnesium Oxide; Augmentin '125'; Cipro; Chemotherapeutics NOS; Nasonex; Minerals NOS; Amoxicillin; Reglan; Zithromax; Phenergan; Quinine; Protonix; Fentanyl Citrate; Bactrim; Skelaxin; Cefazolin; Pepcid; Prozac; Ceftriaxone; Multi-Vitamins; Plaquenil; Nexium; Armodafinil; Lactulose; Flexeril



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 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 female

Reported by a consumer/non-health professional from United States on 2011-10-06

Patient: female

Reactions: Amnesia, Somnolence, Therapeutic Response Decreased, Fatigue, Diarrhoea, Dizziness, Abnormal Loss of Weight, Adverse Event, Asthenia, Decreased Appetite

Drug(s) suspected as cause:
Topamax
    Dosage: at night
    Administration route: Oral
    Indication: Depression

Vioxx
    Dosage: at night
    Indication: Product Used FOR Unknown Indication

Topamax
    Dosage: at night
    Administration route: Oral

Elavil
    Dosage: at bed time
    Indication: Product Used FOR Unknown Indication

Topamax
    Administration route: Oral

Topamax
    Administration route: Oral



Possible Vioxx side effects in female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: female

Reactions: Amnesia, Somnolence, Therapeutic Response Decreased, Fatigue, Diarrhoea, Abnormal Loss of Weight, Dizziness, Adverse Event, Asthenia, Decreased Appetite

Drug(s) suspected as cause:
Topamax
    Administration route: Oral

Topamax
    Dosage: at night
    Administration route: Oral
    Indication: Depression

Topamax
    Administration route: Oral

Elavil
    Dosage: at bed time
    Indication: Product Used FOR Unknown Indication

Vioxx
    Dosage: at night
    Indication: Product Used FOR Unknown Indication

Topamax
    Dosage: at night
    Administration route: Oral

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