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Index of reports
> Cases with Antinuclear Antibody Positive ()
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Vioxx (Rofecoxib) where reactions include antinuclear antibody positive. 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
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