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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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