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Orencia (Abatacept) - Sepsis - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Sepsis ()

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Orencia (Abatacept) where reactions include sepsis. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Orencia side effects in 65 year old female

Reported by a consumer/non-health professional from Japan on 2012-08-09

Patient: 65 year old female, weighing 35.0 kg (77.0 pounds)

Reactions: Sepsis, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orencia

Other drugs received by patient: Lipitor; Sucralfate; Azulfidine; Glufast; Lansoprazole; Alendronate Sodium; Prednisolone; Isoniazid



Possible Orencia side effects in 51 year old female

Reported by a physician from Japan on 2012-08-03

Patient: 51 year old female, weighing 73.0 kg (160.6 pounds)

Reactions: Urinary Tract Infection, Sepsis, Cholecystitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Orencia

Other drugs received by patient: Prednisolone; Clonazepam; Bactrim; Indomethacin; Diclofenac Sodium; Merislon; Tramadol Hydrochloride / Acetaminophen; Diflunisal; Doral; Rozerem; Cyanocobalamin; PL Granules; Forteo; Tacrolimus; Lansoprazole; Lyrica



Possible Orencia side effects in 80 year old male

Reported by a consumer/non-health professional from Japan on 2012-08-02

Patient: 80 year old male

Reactions: Sepsis, Urinary Tract Infection, Renal Failure Acute

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Bredinin
    Administration route: Oral

Orencia
    Dosage: no of infusions :2
    Indication: Rheumatoid Arthritis
    Start date: 2012-06-28
    End date: 2012-01-01

Prograf
    Administration route: Oral



Possible Orencia side effects in 65 year old female

Reported by a consumer/non-health professional from Japan on 2012-08-01

Patient: 65 year old female, weighing 35.0 kg (77.0 pounds)

Reactions: Sepsis, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orencia

Other drugs received by patient: Lipitor; Lansoprazole; Azulfidine; Glufast; Alendronate Sodium; Prednisolone; Sucralfate; Isoniazid



Possible Orencia side effects in 80 year old male

Reported by a consumer/non-health professional from Japan on 2012-07-31

Patient: 80 year old male

Reactions: Urinary Tract Infection, Sepsis, Renal Failure Acute

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Bredinin
    Administration route: Oral

Orencia
    Dosage: no of infusions :2
    Indication: Rheumatoid Arthritis
    Start date: 2012-06-28
    End date: 2012-01-01

Prograf
    Administration route: Oral



Possible Orencia side effects in 80 year old male

Reported by a physician from Japan on 2012-07-23

Patient: 80 year old male

Reactions: Urinary Tract Infection, Sepsis, Renal Failure Acute

Drug(s) suspected as cause:
Bredinin
    Administration route: Oral

Orencia
    Dosage: no of infusions :2
    Indication: Rheumatoid Arthritis
    Start date: 2012-06-28
    End date: 2012-01-01

Prograf
    Administration route: Oral



Possible Orencia side effects in 51 year old female

Reported by a physician from Japan on 2012-07-02

Patient: 51 year old female, weighing 73.0 kg (160.6 pounds)

Reactions: Sepsis, Urinary Tract Infection, Cholecystitis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Orencia

Other drugs received by patient: Prednisolone; PL Granules; Diflunisal; Diclofenac Sodium; Tacrolimus; Lyrica; Clonazepam; Bactrim; Forteo; Lansoprazole; Doral; Rozerem; Cyanocobalamin; Merislon; Indomethacin; Tramadol Hydrochloride / Acetaminophen



Possible Orencia side effects in 72 year old female

Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-02-26

Patient: 72 year old female

Reactions: Sepsis, Pleural Effusion, Infectious Pleural Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orencia



Possible Orencia side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-10

Patient: female

Reactions: Drug Ineffective, Sepsis

Drug(s) suspected as cause:
Orencia

Remicade
    Dosage: lyophilized powder



Possible Orencia side effects in 73 year old male

Reported by a consumer/non-health professional from Sweden on 2012-02-10

Patient: 73 year old male

Reactions: Sepsis, Urosepsis, Benign Prostatic Hyperplasia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orencia

Other drugs received by patient: Tramadol HCL; Furosemide; Cozaar; Warfarin Sodium; Atenolol; Kalcipos-D; Alendronic Acid; Alvedon Forte; Alfuzosin HCL



Possible Orencia side effects in 72 year old female

Reported by a physician from Sweden on 2012-02-09

Patient: 72 year old female

Reactions: Sepsis, Pleural Effusion, Infectious Pleural Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orencia



Possible Orencia side effects in 62 year old male

Reported by a physician from Japan on 2012-01-26

Patient: 62 year old male

Reactions: Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Orencia

Other drugs received by patient: Prelone; Azulfidine; Methycobal; Risedronate Sodium; Clarithromycin



Possible Orencia side effects in 52 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-30

Patient: 52 year old male

Reactions: Psoas Abscess, Extradural Abscess, Intervertebral Discitis, Diabetes Mellitus, Sepsis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2008-08-01
    End date: 2009-06-01

Cimzia
    Dosage: q 15 days
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    End date: 2011-09-01

Cimzia
    Dosage: sc, 400 mg at day 0, 15 and 30, then 200 mg, oral, every 15 days
    Administration route: Oral
    Start date: 2011-07-01

Methotrexate Sodium
    Indication: Rheumatoid Arthritis
    Start date: 2010-08-01

Orencia
    Indication: Rheumatoid Arthritis
    Start date: 2008-01-01
    End date: 2008-08-01

Remicade
    Dosage: 500 mg, then 600 mg, then 700 mg; also noted as 260 mg every 8 weeks
    Indication: Rheumatoid Arthritis
    Start date: 2009-07-01
    End date: 2011-07-01

Other drugs received by patient: Prednisone TAB; Antidepressants; NON Steroidal Anti-Inflammatory Drugs; Bisphosphonates



Possible Orencia side effects in 62 year old female

Reported by a consumer/non-health professional from Canada on 2011-12-27

Patient: 62 year old female

Reactions: Vomiting, Colon Cancer, Nasopharyngitis, Chills, Joint Stiffness, Abdominal Pain Upper, Poor Quality Sleep, Rheumatoid Arthritis, Arthralgia, Sepsis, Cough, Decreased Appetite

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Orencia

Other drugs received by patient: Folic Acid; Prilosec; Methotrexate; Ramipril; Calcium Acetate; Prednisone; Vitamin TAB



Possible Orencia side effects in 58 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2011-12-09

Patient: 58 year old female, weighing 120.0 kg (264.0 pounds)

Reactions: HIP Arthroplasty, Sepsis, Cystitis, Kidney Infection, Lower Respiratory Tract Infection, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orencia

Other drugs received by patient: Prednisone TAB; Nexium; Oxycontin; Methotrexate; Leucovorin Calcium; Ranitidine; Micardis; Mobic; Premarin



Possible Orencia side effects in 73 year old male

Reported by a consumer/non-health professional from Switzerland on 2011-11-28

Patient: 73 year old male

Reactions: Gastric Perforation, Sepsis, Endocrine Neoplasm

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orencia



Possible Orencia side effects in 72 year old male

Reported by a consumer/non-health professional from Spain on 2011-11-23

Patient: 72 year old male

Reactions: Back Pain, Prostatitis, Type 2 Diabetes Mellitus, Haematuria, Sepsis

Drug(s) suspected as cause:
Leflunomide
    Dosage: since 2 years
    Indication: Rheumatoid Arthritis

Orencia
    Indication: Rheumatoid Arthritis
    Start date: 2011-09-06

Prednisone
    Indication: Rheumatoid Arthritis



Possible Orencia side effects in 62 year old female

Reported by a consumer/non-health professional from Canada on 2011-11-22

Patient: 62 year old female

Reactions: Colon Cancer, Vomiting, Nasopharyngitis, Chills, Joint Stiffness, Abdominal Pain Upper, Death, Rheumatoid Arthritis, Poor Quality Sleep, Arthralgia, Sepsis, Decreased Appetite, Cough

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Orencia

Other drugs received by patient: Vitamin TAB; Prednisone TAB; Methotrexate; Prilosec; Ramipril; Folic Acid; Calcium



Possible Orencia side effects in 66 year old female

Reported by a consumer/non-health professional from Canada on 2011-10-14

Patient: 66 year old female

Reactions: Nasopharyngitis, Nausea, Pain, Pyrexia, Disorientation, Rheumatoid Arthritis, Fatigue, Malaise, Dyspepsia, Heart Rate Increased, Insomnia, Sepsis, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Orencia

Other drugs received by patient: Multi-Vitamins; Ativan; Calcium + Vitamin D; Metformin Hydrochloride; Oxycontin; Cenestin; Ventolin; Atrovent; Amitriptyline HCL; Rabeprazole Sodium; Prednisone; Folic Acid; Actonel

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