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

 
 



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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