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Orencia (Abatacept) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



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 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 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 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 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 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 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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