Index of reports
> Life Threatening Events (53)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Orencia (Abatacept) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 53 Next >>
Possible Orencia side effects in 53 year old female
Reported by a physician from France on 2012-08-24
Patient: 53 year old female
Reactions: Cardiac Tamponade, Pericarditis, Progressive Multifocal Leukoencephalopathy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Start date: 2009-01-01
Orencia
Dosage: 250 mg powder concentrate for solution for infusion
Start date: 2012-03-01
End date: 2012-06-30
Prednisone TAB
Dosage: 20 mg (prednisone) 1/d or 1.5/d
End date: 2012-07-01
Other drugs received by patient: Atorvastatin; Fosavance; Metformin HCL; Nexium
Possible Orencia side effects in 72 year old male
Reported by a consumer/non-health professional from Canada on 2012-08-17
Patient: 72 year old male
Reactions: Colon Cancer, Septic Shock, Immobile
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methotrexate
Orencia
Indication: Rheumatoid Arthritis
Start date: 2010-01-01
End date: 2012-04-02
Prednisone TAB
Other drugs received by patient: Metformin HCL; Folic Acid; Verapamil; Glyburide; Vitamin B-12; Rivasa; Avalide; Coumadin; Lipitor
Possible Orencia side effects in 41 year old male
Reported by a consumer/non-health professional from Japan on 2012-08-16
Patient: 41 year old male, weighing 68.0 kg (149.6 pounds)
Reactions: Blood Pressure Increased, Aortic Dissection
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Prednisolone; Methotrexate; Folic Acid; Rabeprazole Sodium; Celecoxib
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 female
Reported by a consumer/non-health professional from Japan on 2012-08-01
Patient: female
Reactions: Interstitial Lung Disease
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Orencia
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 70 year old male
Reported by a physician from Japan on 2012-07-31
Patient: 70 year old male, weighing 60.0 kg (132.0 pounds)
Reactions: Coronary Artery Stenosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Orencia
Indication: Rheumatoid Arthritis
Start date: 2012-05-29
Prednisolone
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2012-05-17
Other drugs received by patient: Rheumatrex
Possible Orencia side effects in 84 year old female
Reported by a consumer/non-health professional from Japan on 2012-07-31
Patient: 84 year old female, weighing 36.0 kg (79.2 pounds)
Reactions: Cardiac Failure, Diarrhoea, Hyponatraemia, Altered State of Consciousness
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Candesartan Cilexetil
Dosage: tab
Administration route: Oral
End date: 2012-07-09
Orencia
Dosage: 6may,20may,1jul,28jul,19aug.16sep,13oct11
Indication: Rheumatoid Arthritis
Start date: 2011-04-22
End date: 2012-07-09
Prograf
Indication: Rheumatoid Arthritis
End date: 2012-06-06
Other drugs received by patient: Celecoxib; Lasix; Sulfamethoxazole and Trimethoprim; Aspirin; Sulfasalazine; Prednisolone; Mucosta; Lyrica; Prednisolone; Ketoprofen; Basen; Maglax; Alendronate Sodium; Bucillamine; Lipitor; Loxonin; Depas; Actarit; Estazolam; Lansoprazole
Possible Orencia side effects in 84 year old female
Reported by a physician from Japan on 2012-07-27
Patient: 84 year old female, weighing 36.0 kg (79.2 pounds)
Reactions: Diarrhoea, Cardiac Failure, Hyponatraemia, Altered State of Consciousness
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Candesartan Cilexetil
Dosage: tab
Administration route: Oral
End date: 2012-07-09
Orencia
Dosage: 6may,20may,1jul,28jul,19aug.16sep,13oct11
Indication: Rheumatoid Arthritis
Start date: 2011-04-22
End date: 2012-07-09
Prograf
Indication: Rheumatoid Arthritis
End date: 2012-06-06
Other drugs received by patient: Ketoprofen; Lansoprazole; Actarit; Sulfamethoxazole and Trimethoprim; Prednisolone; Mucosta; Aspirin; Lyrica; Bucillamine; Prednisolone; Loxonin; Maglax; Lipitor; Sulfasalazine; Estazolam; Celecoxib; Depas; Basen; Lasix; Alendronate Sodium
Possible Orencia side effects in 75 year old female
Reported by a consumer/non-health professional from Japan on 2012-07-19
Patient: 75 year old female
Reactions: Duodenal Ulcer Perforation, RED Blood Cell Count Decreased, Interstitial Lung Disease, Post Procedural Complication, Post Procedural Infection, Peritonitis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Methotrexate
Dosage: 10 mg, qw
Indication: Rheumatoid Arthritis
Start date: 2000-04-01
End date: 2011-04-05
Methotrexate
Dosage: 4 mg, qw
Start date: 2011-07-15
End date: 2011-08-08
Methotrexate
Dosage: 4 mg, qw
Start date: 2011-11-26
End date: 2012-02-08
Methotrexate
Dosage: 6 mg/ week
Start date: 2012-02-08
End date: 2012-05-09
Methotrexate
Dosage: 6 mg, qw
Start date: 2011-08-08
End date: 2011-11-26
Orencia
Dosage: 500 mg, unk
Indication: Rheumatoid Arthritis
Start date: 2011-01-07
Orencia
Dosage: 500 mg, unk
Start date: 2011-02-03
Orencia
Dosage: 500 mg, unk
Start date: 2011-03-04
Orencia
Dosage: 500 mg, unk
Start date: 2011-05-14
Voltaren
Indication: Rheumatoid Arthritis
Other drugs received by patient: Fosamax; Prednisolone; Warfarin Potassium; Mucosta; Betamethasone; Sulfamethoxazole and Trimethoprim
Possible Orencia side effects in 72 year old female
Reported by a physician from Japan on 2012-07-12
Patient: 72 year old female, weighing 49.0 kg (107.8 pounds)
Reactions: Infectious Pleural Effusion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Orencia
Dosage: route of adm:iv
Indication: Rheumatoid Arthritis
Start date: 2010-11-01
End date: 2012-03-19
Rheumatrex
Dosage: resumed on 15may12 6mg
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2003-05-22
End date: 2012-03-19
Other drugs received by patient: Alendronate Sodium; Amlodipine
Possible Orencia side effects in 75 year old female
Reported by a physician from United States on 2012-07-11
Patient: 75 year old female
Reactions: Adverse Event
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Orencia
Possible Orencia side effects in 62 year old male
Reported by a physician from Japan on 2012-07-09
Patient: 62 year old male
Reactions: Spinal Compression Fracture, Interstitial Lung Disease, Staphylococcal Bacteraemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methotrexate
Dosage: restarted from 15sep
Orencia
Indication: Rheumatoid Arthritis
Start date: 2010-12-21
Prednisolone
Dosage: also 15mg dose increased to 40mg/d on 14jan11 dose reduced to 30mg/d on 21jan11
Indication: Rheumatoid Vasculitis
Other drugs received by patient: Bactrim; Imuran; Kenalog; Onealfa; Tacrolimus
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 75 year old female
Reported by a consumer/non-health professional from United States on 2012-06-26
Patient: 75 year old female
Reactions: Adverse Event
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Orencia
Possible Orencia side effects in 84 year old male
Reported by a consumer/non-health professional from Japan on 2012-06-18
Patient: 84 year old male
Reactions: Hepatitis B DNA Increased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Orencia
Dosage: no of course-2
Indication: Rheumatoid Arthritis
Start date: 2011-05-30
Prednisolone
Administration route: Oral
Indication: Rheumatoid Arthritis
Possible Orencia side effects in 68 year old male
Reported by a physician from Japan on 2012-06-12
Patient: 68 year old male
Reactions: Carotid Aneurysm Rupture
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Prednisolone; Selbex; Lorcam; Loxonin; Bucillamine; Risedronate Sodium; Voltaren
Possible Orencia side effects in 57 year old female
Reported by a consumer/non-health professional from Japan on 2012-06-07
Patient: 57 year old female, weighing 40.0 kg (88.0 pounds)
Reactions: Coronary Artery Stenosis, Arrhythmia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methotrexate
Orencia
Dosage: 19jan11,02feb,02mar,06apr11,5th infusion
Start date: 2011-01-05
End date: 2011-04-06
Other drugs received by patient: Tacrolimus; Acetaminophen; Actemra; Cytotec; Actonel; Talion; Prednisolone; Naboal
Possible Orencia side effects in 76 year old female
Reported by a physician from Japan on 2012-05-21
Patient: 76 year old female
Reactions: Hepatic Function Abnormal
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Bucillamine
Orencia
Dosage: 3 treatments
Indication: Rheumatoid Arthritis
Start date: 2011-03-03
Other drugs received by patient: Urea; Omeprazole; Indomethacin; Alfarol; Celecoxib; Mucodyne; Alendronate Sodium
Possible Orencia side effects in 72 year old male
Reported by a consumer/non-health professional from Japan on 2012-05-13
Patient: 72 year old male, weighing 55.0 kg (121.0 pounds)
Reactions: Interstitial Lung Disease, NO Therapeutic Response
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2002-09-01
End date: 2012-02-07
Orencia
Dosage: 500mg twice in the first month (dec11) and once in jan12, from 6dec11
Indication: Rheumatoid Arthritis
Start date: 2011-12-06
End date: 2012-02-01
Other drugs received by patient: Limaprost; Rebamipide; Risedronate Sodium; Amlodipine Besylate; Prednisolone; Foliamin; Bredinin
Possible Orencia side effects in 70 year old
Reported by a physician from United States on 2012-05-08
Patient: 70 year old
Reactions: Mycobacterium Avium Complex Infection
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Orencia
Indication: Rheumatoid Arthritis
Remicade
Indication: Rheumatoid Arthritis
Possible Orencia side effects in 71 year old female
Reported by a consumer/non-health professional from Canada on 2012-05-02
Patient: 71 year old female
Reactions: Cholelithiasis, Infection
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methotrexate
Dosage: injection
Orencia
Indication: Rheumatoid Arthritis
Start date: 2010-07-29
Other drugs received by patient: Acidophilus; Vitamin D; Oxybutynin; Gabapentin; Prednisone TAB; Vitamin B-50; Folic Acid; Symbicort; Oxycontin
Possible Orencia side effects in 62 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-04-11
Patient: 62 year old male
Reactions: Spinal Compression Fracture, Interstitial Lung Disease, Acute Respiratory Distress Syndrome, Staphylococcal Bacteraemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methotrexate
Dosage: restarted from 15sep
Orencia
Indication: Rheumatoid Arthritis
Start date: 2010-12-21
Prednisolone
Dosage: also 15mg dose increased to 40mg/d on 14jan11 dose reduced to 30mg/d on 21jan11
Indication: Rheumatoid Vasculitis
Other drugs received by patient: Bactrim; Kenalog; Tacrolimus; Imuran; Onealfa
Possible Orencia side effects in 57 year old female
Reported by a consumer/non-health professional from United States on 2012-04-05
Patient: 57 year old female, weighing 66.0 kg (145.2 pounds)
Reactions: Guillain-Barre Syndrome
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Insulin; Sertraline Hydrochloride; Vitamin B-12; Vitamin D; Levothyroxine Sodium; Montelukast; Carvedilol; Ibuprofen; Aspirin; Gabapentin
Possible Orencia side effects in 76 year old female
Reported by a consumer/non-health professional from Japan on 2012-04-03
Patient: 76 year old female
Reactions: Hepatic Function Abnormal, Hepatitis B Surface Antibody Positive, Hepatitis B Core Antibody Positive
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Bucillamine
Orencia
Dosage: 3 treatments
Indication: Rheumatoid Arthritis
Start date: 2011-03-03
Other drugs received by patient: Urea; Alfarol; Celecoxib; Mucodyne; Alendronate Sodium; Omeprazole; Indomethacin
Possible Orencia side effects in 72 year old male
Reported by a consumer/non-health professional from Japan on 2012-04-03
Patient: 72 year old male, weighing 55.0 kg (121.0 pounds)
Reactions: Interstitial Lung Disease
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2002-09-01
End date: 2012-02-07
Orencia
Dosage: 500mg twice in the first month (dec11) and once in jan12, from 6dec11
Indication: Rheumatoid Arthritis
Start date: 2011-12-06
End date: 2012-02-01
Other drugs received by patient: Prednisolone; Risedronate Sodium; Folic Acid; Bredinin; Limaprost; Amlodipine; Rebamipide
Possible Orencia side effects in 61 year old female
Reported by a consumer/non-health professional from Japan on 2012-03-29
Patient: 61 year old female
Reactions: Cellulitis, Condition Aggravated, Secondary Amyloidosis, Tenosynovitis, Osteonecrosis, Renal Failure, Arthralgia, Interstitial Lung Disease, Cardiac Failure
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Prednisolone; Alosenn; Actemra; Cotrim; Rabeprazole Sodium; Alendronate Sodium; Magnesium Sulfate; Norvasc; Lasix; Urso 250
Possible Orencia side effects in 72 year old male
Reported by a physician from Japan on 2012-03-26
Patient: 72 year old male, weighing 55.0 kg (121.0 pounds)
Reactions: Interstitial Lung Disease, Respiratory Failure
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2002-09-01
End date: 2012-02-07
Orencia
Dosage: 500mg twice in the first month (dec11) and once in jan12, from 6dec11
Indication: Rheumatoid Arthritis
Start date: 2011-12-06
End date: 2012-02-01
Other drugs received by patient: Bredinin; Prednisolone; Folic Acid; Amlodipine; Rebamipide; Risedronate Sodium; Limaprost
Possible Orencia side effects in female
Reported by a physician from Japan on 2012-03-13
Patient: female
Reactions: Metabolic Acidosis, Disseminated Intravascular Coagulation, Hyponatraemia, Generalised Oedema, Candida Test Positive, Pneumocystis Jiroveci Pneumonia, Interstitial Lung Disease, Hepatorenal Syndrome, Hypoalbuminaemia, Enterococcus Test Positive
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Funguard
Dosage: 150 mg, unknown/d
Start date: 2011-09-09
End date: 2011-09-19
Funguard
Dosage: 150 mg, unknown/d
Start date: 2011-09-28
End date: 2011-10-11
Methotrexate
Dosage: 10 mg, weekly
Start date: 2011-03-01
End date: 2011-09-05
Methotrexate
Dosage: 10.5 mg, weekly
Indication: Rheumatoid Arthritis
Start date: 2011-01-21
End date: 2011-02-28
Orencia
Dosage: 500 mg, unknown/d
Indication: Rheumatoid Arthritis
Start date: 2011-05-17
Prograf
Dosage: unk
Indication: Rheumatoid Arthritis
End date: 2011-01-01
Sulfamethoxazole and Trimethoprim
Dosage: 9 df, unknown/d
Administration route: Oral
Start date: 2011-09-07
End date: 2011-09-20
Sulfamethoxazole and Trimethoprim
Dosage: 9 df, unknown/d
Administration route: Oral
Start date: 2011-10-05
Other drugs received by patient: Nabumetone; Amlodipine; Aspirin; Etizolam; Calcium Pantothenate; Valsartan; Mecobalamin; Ascorbic Acid; Sulfasalazine; Isosorbide Mononitrate; Atorvastatin Calcium; Risedronate Sodium; Senna; Folic Acid
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