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Index of reports
> Cases with Device Malfunction (71)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Simponi (Golimumab) where reactions include device malfunction. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 71 Next >>
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: female, weighing 58.1 kg (127.7 pounds)
Reactions: Asthma, Drug Dose Omission, Bronchopneumonia, Device Malfunction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simponi
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: female, weighing 82.1 kg (180.6 pounds)
Reactions: Drug Ineffective, Underdose, Incorrect Storage of Drug, Arthralgia, Bronchitis, Device Malfunction, Infection, Influenza
Drug(s) suspected as cause:
Simponi
Start date: 2012-05-01
Simponi
Indication: Rheumatoid Arthritis
Start date: 2012-06-08
Enbrel
Indication: Rheumatoid Arthritis
Start date: 2012-03-01
End date: 2012-04-01
Simponi
Start date: 2011-01-01
End date: 2012-02-01
Other drugs received by patient: Cymbalta; Methotrexate
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-08
Patient: female, weighing 92.1 kg (202.6 pounds)
Reactions: Weight Decreased, Drug Dose Omission, Device Malfunction
Drug(s) suspected as cause:
Simponi
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-07
Patient: female, weighing 56.7 kg (124.7 pounds)
Reactions: Cataract, Underdose, Device Malfunction
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Methotrexate; Prednisone; Forteo
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: female
Reactions: Drug Dose Omission, Bone Density Decreased, Gait Disturbance, Device Malfunction
Drug(s) suspected as cause:
Simponi
Start date: 2011-01-01
Simponi
Indication: Rheumatoid Arthritis
Start date: 2012-03-01
End date: 2012-06-01
Other drugs received by patient: Methotrexate; Levothyroxine Sodium; Folic Acid
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-25
Patient: female, weighing 72.6 kg (159.7 pounds)
Reactions: Injection Site Haemorrhage, Underdose, Osteoarthritis, Throat Irritation, Gastrooesophageal Reflux Disease, Sjogren's Syndrome, Hypertension, Device Malfunction, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Leucovorin Calcium; Synthroid; Methotrexate; Prednisone
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: female, weighing 77.1 kg (169.6 pounds)
Reactions: Drug Dose Omission, Uterine Leiomyoma, Device Malfunction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Celebrex; Sulfasalazine
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-17
Patient: female, weighing 62.6 kg (137.7 pounds)
Reactions: Weight Increased, Drug Dose Omission, Body Height Decreased, Decubitus Ulcer, Memory Impairment, Device Malfunction
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Ranitidine; Crestor; Premarin; Diovan; Nabumetone; Aspirin; Prednisone; Amoxicillin
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-10
Patient: female, weighing 92.1 kg (202.6 pounds)
Reactions: Weight Decreased, Drug Dose Omission, Device Malfunction
Drug(s) suspected as cause:
Simponi
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient: female, weighing 93.0 kg (204.6 pounds)
Reactions: Localised Infection, Drug Dose Omission, Device Malfunction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simponi
Indication: Psoriatic Arthropathy
Start date: 2011-11-01
End date: 2011-12-01
Simponi
Start date: 2012-04-01
Simponi
Start date: 2012-02-15
Other drugs received by patient: Caduet; Cenestin; Cymbalta; Toprol-XL; Lyrica; Ambien; Caduet; Nexium; Methotrexate
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-22
Patient: female, weighing 68.0 kg (149.7 pounds)
Reactions: Transplant Failure, Drug Dose Omission, Corneal Transplant, Rheumatoid Factor Increased, Device Malfunction
Drug(s) suspected as cause:
Simponi
Start date: 2010-04-01
End date: 2011-04-01
Simponi
Indication: Rheumatoid Arthritis
Start date: 2012-03-01
Other drugs received by patient: Toprol-XL
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: female, weighing 61.2 kg (134.7 pounds)
Reactions: Drug Dose Omission, Movement Disorder, Pain, Swelling, Rash Erythematous, Erythema, Device Malfunction
Drug(s) suspected as cause:
Simponi
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: female, weighing 70.3 kg (154.7 pounds)
Reactions: Dyspepsia, Irritable Bowel Syndrome, Injection Site Pain, Device Malfunction, Bradyphrenia, Convulsion
Drug(s) suspected as cause:
Simponi
Indication: Rheumatoid Arthritis
Start date: 2010-01-01
Paxil
Administration route: Oral
Indication: Depression
End date: 2012-04-01
Other drugs received by patient: Prilosec
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-14
Patient: female, weighing 76.7 kg (168.7 pounds)
Reactions: Drug Dose Omission, Hypothyroidism, Device Malfunction
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Carvedilol; Singulair; Requip; Furosemide; ALL Other Therapeutic Products; Leflunomide
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-14
Patient: female, weighing 72.6 kg (159.7 pounds)
Reactions: Injection Site Haemorrhage, Underdose, Osteoarthritis, Throat Irritation, Sjogren's Syndrome, Gastrooesophageal Reflux Disease, Hypertension, Device Malfunction, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Synthroid; Prednisone TAB; Leucovorin Calcium; Methotrexate
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-12
Patient: female, weighing 93.0 kg (204.6 pounds)
Reactions: Localised Infection, Drug Dose Omission, Device Malfunction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simponi
Indication: Psoriatic Arthropathy
Start date: 2011-11-01
End date: 2011-12-01
Simponi
Start date: 2012-04-01
Other drugs received by patient: Caduet; Cymbalta; Lyrica; Nexium; Caduet; Methotrexate; Cenestin
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-24
Patient: female, weighing 82.1 kg (180.6 pounds)
Reactions: Drug Ineffective, Underdose, Incorrect Storage of Drug, Arthralgia, Bronchitis, Device Malfunction, Infection, Influenza
Drug(s) suspected as cause:
Simponi
Indication: Rheumatoid Arthritis
Start date: 2012-05-01
Enbrel
Indication: Rheumatoid Arthritis
Start date: 2012-03-01
End date: 2012-04-01
Simponi
Start date: 2011-01-01
End date: 2012-02-01
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-24
Patient: female, weighing 53.5 kg (117.7 pounds)
Reactions: Drug Dose Omission, Arthralgia, Bone Disorder, Device Malfunction
Drug(s) suspected as cause:
Simponi
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: female, weighing 59.4 kg (130.7 pounds)
Reactions: Drug Dose Omission, Drug Ineffective, Pyrexia, Spinal Fusion Surgery, Rheumatoid Arthritis, Staphylococcal Infection, Device Malfunction, Spinal Column Stenosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simponi
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: female, weighing 51.7 kg (113.8 pounds)
Reactions: Drug Dose Omission, Onychomadesis, Tinea Pedis, Feeling Cold, Abnormal Loss of Weight, Device Malfunction, Sinusitis, Cough
Drug(s) suspected as cause:
Simponi
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Drug Dose Omission, Nephrolithiasis, Drug Effect Decreased, Arthralgia, Device Malfunction, Nervousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Prednisone; Activelle (Estradiol and Norethindrone)
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-17
Patient: female, weighing 93.0 kg (204.6 pounds)
Reactions: Drug Dose Omission, Mammoplasty, Thyroid Cancer, Device Malfunction
Drug(s) suspected as cause:
Simponi
Indication: Psoriatic Arthropathy
Start date: 2009-12-01
Simponi
Start date: 2010-01-01
Other drugs received by patient: Victoza; Corgard; Naproxen (Aleve); Naproxen (Aleve); Amitiza; Elavil; Levothyroxine Sodium; MS Contin; Estratest
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-17
Patient: female, weighing 90.7 kg (199.6 pounds)
Reactions: Drug Dose Omission, Body Height Decreased, Rheumatoid Arthritis, Dyspepsia, Drug Ineffective, Hypertension, Device Malfunction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simponi
Start date: 2009-12-01
Simponi
Indication: Rheumatoid Arthritis
Start date: 2012-03-25
Other drugs received by patient: Naprosyn; Prednisone; Folic Acid; Multi-Vitamins; Calcium
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-16
Patient: female, weighing 89.4 kg (196.6 pounds)
Reactions: Drug Dose Omission, Arthralgia, Insomnia, Abnormal Loss of Weight, Psoriasis, Device Malfunction, Psoriatic Arthropathy
Drug(s) suspected as cause:
Simponi
Start date: 2011-04-01
Simponi
Indication: Psoriatic Arthropathy
Start date: 2012-03-01
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-16
Patient: female, weighing 93.0 kg (204.6 pounds)
Reactions: Localised Infection, Drug Dose Omission, Device Malfunction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simponi
Indication: Psoriatic Arthropathy
Start date: 2011-11-01
End date: 2011-12-01
Simponi
Start date: 2012-04-01
Other drugs received by patient: Cymbalta; Methotrexate; Cenestin; Caduet; Lyrica; Nexium; Caduet
Possible Simponi side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-03
Patient: female, weighing 108.9 kg (239.5 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Drug Dose Omission, Pain, Underdose, Device Malfunction
Drug(s) suspected as cause:
Simponi
Start date: 2012-04-01
Simponi
Indication: Ankylosing Spondylitis
Start date: 2012-04-01
Simponi
Start date: 2012-03-05
Simponi
Indication: Rheumatoid Arthritis
Start date: 2012-03-05
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-25
Patient: female, weighing 76.7 kg (168.7 pounds)
Reactions: Drug Dose Omission, Hypothyroidism, Device Malfunction
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Furosemide; Singulair; Requip; Carvedilol; ALL Other Therapeutic Products; Leflunomide
Possible Simponi side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-25
Patient: male, weighing 70.3 kg (154.7 pounds)
Reactions: Drug Dose Omission, Malignant Tumour Excision, Device Malfunction
Drug(s) suspected as cause:
Simponi
Indication: Psoriatic Arthropathy
Start date: 2011-12-01
Simponi
Indication: Rheumatoid Arthritis
Start date: 2011-12-01
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-24
Patient: female, weighing 66.2 kg (145.7 pounds)
Reactions: Myocardial Infarction, Device Malfunction, Sjogren's Syndrome
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Aspirin; Leflunomide; Arimidex; Clarinex; Toprol-XL; Clarinex; Epipen; ALL Other Therapeutic Agents; Levothyroxine Sodium; Norvasc
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-05
Patient: female, weighing 77.1 kg (169.6 pounds)
Reactions: Drug Dose Omission, Contusion, Injection Site Haematoma, Ear Infection, Sinusitis, Device Malfunction, Herpes Virus Infection
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Levothyroxine Sodium; Fluticasone Furoate; Spironolactone; Zyrtec; Folic Acid; Zetia; Methotrexate; Tizanidine HCL
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