Index of reports
> Cases with Device Failure (31)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Simponi (Golimumab) where reactions include device failure. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 31 Next >>
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-29
Patient: female, weighing 94.3 kg (207.6 pounds)
Reactions: Pain, Muscular Weakness, Underdose, Exercise Tolerance Decreased, Device Failure, Therapeutic Response Decreased, Weight Increased, Swelling
Drug(s) suspected as cause:
Prednisone TAB
Start date: 2012-06-15
Simponi
Indication: Rheumatoid Arthritis
Start date: 2011-01-01
End date: 2012-03-01
Prednisone TAB
Start date: 2012-01-18
Prednisone TAB
Start date: 2010-06-30
Prednisone TAB
Indication: Rheumatoid Arthritis
Start date: 2012-04-16
Prednisone TAB
Start date: 2010-12-21
End date: 2011-06-08
Other drugs received by patient: Methotrexate; Aspirin; Ibuprofen; Ibuprofen; Ibuprofen; Aspirin; Ibuprofen; Aspirin; Ibuprofen; Aspirin; Aspirin
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-10
Patient: female, weighing 88.5 kg (194.6 pounds)
Reactions: Device Failure, Drug Dose Omission, Lymphadenopathy, Urinary Tract Infection, Injection Site Reaction, Hypertension, Sinusitis
Drug(s) suspected as cause:
Simponi
Start date: 2010-08-01
End date: 2010-08-01
Simponi
Indication: Arthritis
Start date: 2012-03-01
Other drugs received by patient: Wellbutrin; Sulfasalazine; Prevacid; Gabapentin; Zyrtec
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-03
Patient: female, weighing 82.1 kg (180.6 pounds)
Reactions: Drug Dose Omission, Device Failure, Type 2 Diabetes Mellitus
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Methotrexate
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-26
Patient: female, weighing 88.5 kg (194.6 pounds)
Reactions: Drug Dose Omission, Device Failure, Lymphadenopathy, Injection Site Reaction, Hypertension
Drug(s) suspected as cause:
Simponi
Indication: Arthritis
Start date: 2012-03-01
Simponi
Start date: 2010-08-01
End date: 2010-08-01
Other drugs received by patient: Prevacid; Zyrtec; Wellbutrin; Sulfasalazine; Gabapentin
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-25
Patient: female, weighing 84.4 kg (185.6 pounds)
Reactions: Drug Dose Omission, Device Failure, Nephrolithiasis, Urinary Tract Infection
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Methotrexate
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-04
Patient: female, weighing 72.6 kg (159.7 pounds)
Reactions: Device Failure, Drug Dose Omission, Confusional State, Road Traffic Accident, Chest Pain, Stress AT Work, Cyst, Lower Limb Fracture
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Unknown Medication
Indication: Pain
Simponi
Indication: Rheumatoid Arthritis
Start date: 2009-01-01
Other drugs received by patient: Crestor; Premarin; Methotrexate; Metoprolol Tartrate; Omeprazole; Unknown Medication
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-21
Patient: female
Reactions: Pain, Muscular Weakness, Underdose, Exercise Tolerance Decreased, Therapeutic Response Decreased, Device Failure, Weight Increased, Swelling
Drug(s) suspected as cause:
Simponi
Indication: Rheumatoid Arthritis
Start date: 2011-01-01
End date: 2012-01-01
Prednisone
Indication: Rheumatoid Arthritis
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-12
Patient: female, weighing 59.4 kg (130.7 pounds)
Reactions: Device Failure, Drug Dose Omission, Pain, Coma, Fall, Cerebral Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Boniva; Medrol; Vitamin D; Levothyroxine Sodium; Nexium
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-23
Patient: female, weighing 61.7 kg (135.7 pounds)
Reactions: Vitamin D Deficiency, Drug Dose Omission, RED Blood Cell Count Increased, Injection Site Haemorrhage, Injection Site Pruritus, Device Failure, Injection Site Erythema, Liver Function Test Abnormal, Dysuria, Blood Cholesterol Increased
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Calcium and Vitamin D; Fluticasone Propionate; Synthroid; Levothyroxine Sodium; Lovastatin
Possible Simponi side effects in female
Reported by a consumer/non-health professional from Germany on 2012-02-14
Patient: female
Reactions: Device Failure, Drug Dose Omission, Inappropriate Schedule of Drug Administration, Pneumonia, Pain
Drug(s) suspected as cause:
Simponi
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-03
Patient: female, weighing 61.7 kg (135.7 pounds)
Reactions: Vitamin D Deficiency, Drug Dose Omission, RED Blood Cell Count Increased, Injection Site Haemorrhage, Injection Site Pruritus, Device Failure, Injection Site Erythema, Dysuria, Liver Function Test Abnormal, Blood Cholesterol Increased
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Calcium and Vitamin D; Synthroid
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-02
Patient: female, weighing 59.4 kg (130.7 pounds)
Reactions: Device Failure, Drug Dose Omission, Pain, Coma, Fall, Cerebral Haemorrhage
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 2012-01-26
Patient: female
Reactions: Device Failure, Meniscus Lesion, Ligament Rupture, Drug Dose Omission, Fall
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Gabapentin; Gabapentin; Tizanidine HCL; Tizanidine HCL; Celebrex; Celebrex
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-25
Patient: female, weighing 111.1 kg (244.5 pounds)
Reactions: Uterine Prolapse, Device Failure, Anxiety, Bladder Prolapse, Insomnia
Drug(s) suspected as cause:
Simponi
Start date: 2010-10-01
End date: 2011-11-01
Simponi
Indication: Rheumatoid Arthritis
Start date: 2012-01-20
Other drugs received by patient: Diovan; Alprazolam; Methotrexate; Toprol-XL
Possible Simponi side effects in male
Reported by a consumer/non-health professional from United States on 2012-01-20
Patient: male, weighing 65.8 kg (144.7 pounds)
Reactions: Weight Decreased, Type 2 Diabetes Mellitus, RED Blood Cell Abnormality, Hypotension, Injury Associated With Device, Device Failure, Upper Respiratory Tract Infection, Dehydration, Sinusitis, Accidental Exposure
Drug(s) suspected as cause:
Simponi
Indication: Rheumatoid Arthritis
Start date: 2010-08-01
End date: 2010-09-01
Prednisone
Administration route: Oral
Start date: 2011-01-01
Methotrexate
Indication: Arthritis
Start date: 2011-01-01
End date: 2011-12-01
Simponi
Start date: 2011-01-01
Methotrexate
End date: 2010-09-01
Prednisone
Administration route: Oral
Indication: Arthritis
End date: 2010-09-01
Other drugs received by patient: Lisinopril; Atenolol; Singulair; Flomax; Crestor; ALL Other Therapeutic Products; Nortriptyline HCL; Neurontin; Nexium; Vitamins NOS
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2011-12-22
Patient: female, weighing 90.7 kg (199.6 pounds)
Reactions: Drug Dose Omission, Device Failure, Sleep Disorder, Ovarian Mass, Blood Cholesterol Increased, Hypertension
Drug(s) suspected as cause:
Simponi
Start date: 2011-11-01
Simponi
Indication: Product Used FOR Unknown Indication
Start date: 2011-07-01
End date: 2011-08-01
Other drugs received by patient: Vitamin D; Zonegran; Xanax; Enalapril Maleate; Lipitor; Tizanidine HCL; Fish OIL; Neurontin; Cymbalta; Ambien CR
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2011-12-21
Patient: female, weighing 61.7 kg (135.7 pounds)
Reactions: Vitamin D Deficiency, Drug Dose Omission, Injection Site Haemorrhage, RED Blood Cell Count Increased, Injection Site Pruritus, Device Failure, Injection Site Erythema, Dysuria, Liver Function Test Abnormal, Blood Cholesterol Increased
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Synthroid; Calcium and Vitamin D
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2011-12-08
Patient: female, weighing 90.7 kg (199.6 pounds)
Reactions: Drug Dose Omission, Device Failure, Product Quality Issue, Ovarian Mass, Sleep Disorder, Blood Cholesterol Increased, Hypertension
Drug(s) suspected as cause:
Simponi
Indication: Product Used FOR Unknown Indication
Start date: 2011-07-01
End date: 2011-08-01
Simponi
Start date: 2011-11-01
Other drugs received by patient: Neurontin; Tizanidine HCL; Fish OIL; Enalapril Maleate; Lipitor; Ambien CR; Cymbalta; Vitamin D; Xanax; Zonegran
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2011-12-01
Patient: female, weighing 59.0 kg (129.7 pounds)
Reactions: Drug Dose Omission, Device Failure, Therapeutic Response Decreased, Anaemia, Liver Disorder
Drug(s) suspected as cause:
Simponi
Indication: Rheumatoid Arthritis
Start date: 2011-02-01
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2011-05-01
Other drugs received by patient: Zofran; Vitamin D; Calcium; Omeprazole; Prednisone TAB; Forteo
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-18
Patient: female, weighing 59.0 kg (129.7 pounds)
Reactions: Drug Dose Omission, Therapeutic Response Decreased, Device Failure, Anaemia, Liver Disorder
Drug(s) suspected as cause:
Simponi
Indication: Rheumatoid Arthritis
Start date: 2011-02-01
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2011-05-01
Other drugs received by patient: Omeprazole; Zofran; Prednisone TAB; Calcium; Vitamin D; Forteo
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-17
Patient: female, weighing 54.4 kg (119.7 pounds)
Reactions: Device Failure, Drug Dose Omission
Drug(s) suspected as cause:
Simponi
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-16
Patient: female
Reactions: Drug Dose Omission, Device Failure, Cardiac Valve Disease, Chest Pain, Heart Rate Irregular
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Synthroid; Lisinopril; Plaquenil
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-16
Patient: female, weighing 83.9 kg (184.6 pounds)
Reactions: Drug Dose Omission, Dyspnoea, Chest X-RAY Abnormal, Seasonal Allergy, Device Failure, Sinus Disorder, Oesophageal Disorder, Gastrooesophageal Reflux Disease, Pharyngitis
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Ambien; Ambien; Prednisone; Methotrexate; Lunesta
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-11
Patient: female, weighing 74.8 kg (164.6 pounds)
Reactions: Drug Dose Omission, Product Quality Issue, Psoriasis, Pyrexia, Device Failure, Palpitations, Disease Recurrence, Bronchitis
Drug(s) suspected as cause:
Simponi
Possible Simponi side effects in male
Reported by a consumer/non-health professional from United States on 2011-11-11
Patient: male, weighing 85.7 kg (188.6 pounds)
Reactions: Device Failure, Drug Dose Omission, Blood Cholesterol Increased, Osteopenia
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Testosterone; Tizanidine HCL; Inderal; Pravastatin; Hydrochlorothiazide
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-01
Patient: female, weighing 94.8 kg (208.6 pounds)
Reactions: Device Failure, Drug Dose Omission, Pituitary-Dependent Cushing's Syndrome, Depression
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Cytomel; Amitiza; Synthroid; Hydrochlorothiazide; Methotrexate; Nexium; Folic Acid; Creon; Celebrex
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2011-10-20
Patient: female, weighing 60.8 kg (133.7 pounds)
Reactions: Rectal Prolapse, Drug Dose Omission, Nausea, Anaemia, Faecal Incontinence, Oesophageal Obstruction, Device Failure, Gastrooesophageal Reflux Disease, Cough
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Elavil; Coreg; Albuterol; Lasix; Cymbalta; Ativan; Percocet; Prednisone; Prednisone; Symbicort; E Vitamin; Nexium; Symbicort; Cyclobenzaprine; Vitamin D; Ferrous Sulfate TAB; Arava
Possible Simponi side effects in male
Reported by a consumer/non-health professional from United States on 2011-10-13
Patient: male, weighing 85.7 kg (188.6 pounds)
Reactions: Drug Dose Omission, Device Failure, Blood Cholesterol Increased, Osteopenia
Drug(s) suspected as cause:
Simponi
Other drugs received by patient: Testosterone; Hydrochlorothiazide; Pravastatin; Inderal; Tizanidine HCL
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2011-10-13
Patient: female, weighing 74.8 kg (164.6 pounds)
Reactions: Device Failure, Drug Dose Omission, Palpitations, Psoriasis, Bronchitis
Drug(s) suspected as cause:
Simponi
Possible Simponi side effects in female
Reported by a consumer/non-health professional from United States on 2011-10-13
Patient: female, weighing 78.5 kg (172.6 pounds)
Reactions: Nephrolithiasis, Drug Dose Omission, Device Failure, Endometriosis, Urinary Tract Infection, Ovarian Cyst, Fall
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Methotrexate
Indication: Rheumatoid Arthritis
Start date: 2007-01-01
Simponi
Indication: Rheumatoid Arthritis
Other drugs received by patient: Gabapentin; Plaquenil; Mobic; Folic Acid; Vicodin
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