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Simponi (Golimumab) - Device Failure - Suspected Cause - Side Effect Reports

 
 



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, 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 2011-11-16

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 2011-11-11

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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