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Enbrel (Etanercept) - Multi-Organ Failure - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Multi-Organ Failure ()

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Enbrel (Etanercept) where reactions include multi-organ failure. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Enbrel side effects in 17 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-08

Patient: 17 year old female

Reactions: Hypotension, Disease Progression, Delusion, Psoas Abscess, Pneumocystis Jiroveci Pneumonia, Multi-Organ Failure, Dehydration, Acute Respiratory Distress Syndrome, Bacterial Sepsis, Muscle Abscess, Autoimmune Thrombocytopenia, Jugular Vein Thrombosis, Vascular Complication Associated With Device, Epistaxis, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Aspirin
    Dosage: unk unk, unk
    Administration route: Oral
    Start date: 2010-05-02
    End date: 2010-05-09

Enbrel
    Dosage: 25 mg, 2 times/wk
    Start date: 2009-01-01

Enbrel
    Dosage: 25 mg, 2 times/wk
    Indication: Juvenile Arthritis
    Start date: 2000-01-01
    End date: 2008-01-01

Ibuprofen
    Dosage: unk unk, unk
    Administration route: Oral
    Start date: 2010-05-02
    End date: 2010-05-09

Other drugs received by patient: Acetaminophen



Possible Enbrel side effects in 17 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-07

Patient: 17 year old female

Reactions: Hypotension, Delusion, Disease Progression, Multi-Organ Failure, Pneumocystis Jiroveci Pneumonia, Psoas Abscess, Dehydration, Bacterial Sepsis, Acute Respiratory Distress Syndrome, Muscle Abscess, Autoimmune Thrombocytopenia, Jugular Vein Thrombosis, Vascular Complication Associated With Device, Renal Failure Acute, Epistaxis

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
    Dosage: unk unk, unk
    Administration route: Oral
    Start date: 2010-05-02
    End date: 2010-05-09

Enbrel
    Dosage: 25 mg, 2 times/wk
    Indication: Juvenile Arthritis
    Start date: 2000-01-01
    End date: 2008-01-01

Enbrel
    Dosage: 25 mg, 2 times/wk
    Start date: 2009-01-01

Ibuprofen
    Dosage: unk unk, unk
    Administration route: Oral
    Start date: 2010-05-02
    End date: 2010-05-09

Other drugs received by patient: Acetaminophen



Possible Enbrel side effects in 55 year old male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 55 year old male

Reactions: Multi-Organ Failure, Pancreatitis Acute, Pancreatic Necrosis, Rash Macular

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, 2 times/wk
    Indication: Ankylosing Spondylitis
    Start date: 2006-07-31

Enbrel
    Indication: Psoriasis



Possible Enbrel side effects in 17 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-03

Patient: 17 year old female

Reactions: Hypotension, Disease Progression, Delusion, Multi-Organ Failure, Pneumocystis Jiroveci Pneumonia, Psoas Abscess, Dehydration, Bacterial Sepsis, Acute Respiratory Distress Syndrome, Muscle Abscess, Jugular Vein Thrombosis, Autoimmune Thrombocytopenia, Renal Failure Acute, Epistaxis, Vascular Complication Associated With Device

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Aspegic 1000
    Dosage: unknown
    Administration route: Oral
    Start date: 2010-05-02
    End date: 2010-05-09

Enbrel
    Dosage: 25.0 mg, 2x/week
    Start date: 2009-01-01
    End date: 2010-06-02

Enbrel
    Dosage: 25 mg, 2x/week
    Indication: Juvenile Arthritis
    Start date: 2000-01-01
    End date: 2008-01-01

Ibuprofen (Advil)
    Dosage: unknown
    Administration route: Oral
    Start date: 2010-05-02
    End date: 2010-05-09

Other drugs received by patient: Acetaminophen



Possible Enbrel side effects in 17 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-24

Patient: 17 year old female

Reactions: Hypotension, Delusion, Disease Progression, Psoas Abscess, Pneumocystis Jiroveci Pneumonia, Multi-Organ Failure, Dehydration, Acute Respiratory Distress Syndrome, Bacterial Sepsis, Muscle Abscess, Jugular Vein Thrombosis, Autoimmune Thrombocytopenia, Epistaxis, Vascular Complication Associated With Device, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Advil
    Dosage: unknown
    Administration route: Oral
    Start date: 2010-05-02
    End date: 2010-05-09

Aspegic 1000
    Dosage: unknown
    Administration route: Oral
    Start date: 2010-05-02
    End date: 2010-05-09

Enbrel
    Dosage: 25.0 mg, 2x/week
    Start date: 2009-01-01
    End date: 2010-06-02

Enbrel
    Dosage: 25 mg, 2x/week
    Indication: Juvenile Arthritis
    Start date: 2000-01-01
    End date: 2008-01-01

Other drugs received by patient: Paracetamol



Possible Enbrel side effects in 45 year old male

Reported by a physician from Italy on 2012-07-13

Patient: 45 year old male

Reactions: Myelitis, Shock Haemorrhagic, Dyskinesia, Urinary Tract Infection, Sciatica, Groin Pain, Multi-Organ Failure, Paraplegia, Malignant Atrophic Papulosis, Joint Effusion, Vasculitis, Gait Disturbance, Septic Shock, Sleep Apnoea Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, weekly
    Indication: Psoriatic Arthropathy
    Start date: 2004-01-01
    End date: 2011-09-01

Methotrexate Sodium
    Dosage: 10 mg, weekly
    Indication: Psoriatic Arthropathy
    Start date: 2011-04-01
    End date: 2011-09-01



Possible Enbrel side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-05

Patient: 36 year old female

Reactions: Rhabdomyolysis, Disseminated Intravascular Coagulation, Arterial Thrombosis Limb, Tonsillitis, Rheumatoid Arthritis, Multi-Organ Failure, Intracardiac Thrombus, Septic Shock, Influenza

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, unk
    Indication: Rheumatoid Arthritis
    Start date: 2011-01-31
    End date: 2012-01-25

Methotrexate
    Dosage: 20 mg, weekly
    Administration route: Oral
    Start date: 2010-10-01

Other drugs received by patient: Folic Acid; Hydrocortisone



Possible Enbrel side effects in 33 year old female

Reported by a health professional (non-physician/pharmacist) from Colombia on 2012-06-27

Patient: 33 year old female

Reactions: Multi-Organ Failure, Stevens-Johnson Syndrome, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Calcium; Methotrexate; Prednisolone; Prednisolone; Jadelle; Methotrexate; Prednisolone; Acetaminophen; Folic Acid; Methotrexate; Chloroquine



Possible Enbrel side effects in 60 year old female

Reported by a pharmacist from Japan on 2012-06-20

Patient: 60 year old female

Reactions: Nasopharyngitis, Pyrexia, Multi-Organ Failure, Malaise, Septic Shock, Decreased Appetite, Blood Pressure Diastolic Decreased, Immunosuppression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Basen

Enbrel
    Indication: Rheumatoid Arthritis
    Start date: 2010-10-15
    End date: 2012-02-01

Januvia
    Administration route: Oral

Micardis

Other drugs received by patient: Voltaren-XR; Lansoprazole; Voltaren; Bonoteo; Lipitor; Lansoprazole



Possible Enbrel side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient: 71 year old female

Reactions: Multi-Organ Failure, Cerebrovascular Accident, Convulsion

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-15

Patient: 36 year old female

Reactions: Rhabdomyolysis, Disseminated Intravascular Coagulation, Arterial Thrombosis Limb, Tonsillitis, Rheumatoid Arthritis, Multi-Organ Failure, Septic Shock, Intracardiac Thrombus, Influenza

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, unk
    Indication: Rheumatoid Arthritis
    Start date: 2011-01-31
    End date: 2012-01-25

Methotrexate
    Dosage: 20 mg, weekly
    Administration route: Oral
    Start date: 2010-10-01

Other drugs received by patient: Folic Acid; Hydrocortisone



Possible Enbrel side effects in

Reported by a physician from United States on 2012-05-02

Patient:

Reactions: Multi-Organ Failure, Death, Viral Myocarditis, Cardiomyopathy, Pericardial Effusion

Adverse event resulted in: death

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 33 year old female

Reported by a physician from Colombia on 2012-04-27

Patient: 33 year old female

Reactions: Multi-Organ Failure, Stevens-Johnson Syndrome, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Jadelle; Methotrexate; Prednisolone; Chloroquine Phosphate; Prednisolone; Acetaminophen; Folic Acid; Methotrexate; Calcium; Methotrexate; Prednisolone



Possible Enbrel side effects in

Reported by a physician from United States on 2012-04-20

Patient:

Reactions: Multi-Organ Failure, Death, Cardiomyopathy, Pericardial Effusion

Adverse event resulted in: death

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 60 year old female

Reported by a pharmacist from Japan on 2012-04-17

Patient: 60 year old female

Reactions: Nasopharyngitis, Pyrexia, Multi-Organ Failure, Malaise, Septic Shock, Decreased Appetite, Immunosuppression, Blood Pressure Diastolic Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Basen

Enbrel
    Indication: Rheumatoid Arthritis
    Start date: 2010-10-15
    End date: 2012-02-01

Januvia
    Administration route: Oral

Micardis

Other drugs received by patient: Lipitor; Bonoteo; Voltaren-XR; Voltaren; Lansoprazole; Lansoprazole



Possible Enbrel side effects in 45 year old male

Reported by a physician from Italy on 2012-04-10

Patient: 45 year old male

Reactions: Thrombosis, Myelitis, Sciatica, Sensory Loss, Erectile Dysfunction, Cerebral Haemorrhage, Joint Effusion, Axonal Neuropathy, Urinary Retention, Melaena, Ophthalmological Examination Abnormal, Intervertebral Disc Protrusion, Metabolic Acidosis, Anaemia, Pulmonary Haemorrhage, Escherichia Test Positive, NO Therapeutic Response, Ventricular Tachycardia, Enterococcus Test Positive, Pulse Absent, Vasculitis, Septic Shock, Sleep Apnoea Syndrome, Dyskinesia, Shock Haemorrhagic, Gastritis Erosive, Haemodilution, Acinetobacter Test Positive, Spinal Cord Haemorrhage, Groin Pain, Paraplegia, Multi-Organ Failure, Large Intestinal Ulcer, Urinary Tract Infection, Multiple-Drug Resistance, Intestinal Haemorrhage, Gait Disturbance, Ventricular Fibrillation

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, weekly
    Indication: Psoriatic Arthropathy
    Start date: 2004-01-01
    End date: 2011-09-01

Methotrexate Sodium
    Dosage: 10 mg, weekly
    Indication: Psoriatic Arthropathy
    Start date: 2011-04-01
    End date: 2011-09-01



Possible Enbrel side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-05

Patient: male

Reactions: Multi-Organ Failure, Coccidioidomycosis

Adverse event resulted in: death

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 77 year old female

Reported by a physician from Brazil on 2012-04-03

Patient: 77 year old female, weighing 85.0 kg (187.0 pounds)

Reactions: Multi-Organ Failure, Emphysema

Adverse event resulted in: death

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 60 year old female

Reported by a pharmacist from Japan on 2012-03-19

Patient: 60 year old female

Reactions: Multi-Organ Failure, Malaise, Nasopharyngitis, Pyrexia, Septic Shock, Blood Pressure Decreased, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Basen
    Dosage: 0.3 mg, unk

Enbrel
    Dosage: 50 mg, weekly
    Indication: Rheumatoid Arthritis
    Start date: 2010-10-15
    End date: 2012-02-01

Micardis
    Dosage: 40 mg, unk

Sitagliptin Phosphate
    Dosage: 50 mg, unk

Other drugs received by patient: Voltaren; Bonoteo; Voltaren-XR; Lipitor; Lansoprazole; Lansoprazole



Possible Enbrel side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-28

Patient: 36 year old female

Reactions: Multi-Organ Failure, Rheumatoid Arthritis, Rhabdomyolysis, Disseminated Intravascular Coagulation, Tonsillitis, Septic Shock, Influenza

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, unk
    Indication: Rheumatoid Arthritis
    Start date: 2011-01-31
    End date: 2012-01-25

Methotrexate
    Dosage: 20 mg, weekly
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-10-01

Other drugs received by patient: Folic Acid; Hydrocortisone



Possible Enbrel side effects in 73 year old male

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

Patient: 73 year old male

Reactions: Multi-Organ Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 74 year old male

Reported by a consumer/non-health professional from Brazil on 2012-02-07

Patient: 74 year old male

Reactions: Multi-Organ Failure, Pneumonia, Diabetes Mellitus, Hypertension

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-01-24

Patient: 65 year old female

Reactions: Weight Decreased, Bedridden, Tachycardia, Hepatic Failure, Fall, Multi-Organ Failure, HIP Fracture, Syncope, Renal Failure, Decubitus Ulcer, Asthenia, Decreased Appetite

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 64 year old male

Reported by a physician from United States on 2011-12-14

Patient: 64 year old male

Reactions: Multi-Organ Failure, Drug Ineffective, Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 43 year old female

Reported by a physician from Germany on 2011-12-01

Patient: 43 year old female, weighing 76.0 kg (167.2 pounds)

Reactions: Multi-Organ Failure, Breast Abscess, Streptococcal Sepsis, Toxic Shock Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Arava
    Dosage: 20 mg, qd
    Indication: Rheumatoid Arthritis
    End date: 2011-05-01

Enbrel
    Dosage: 50 mg, unk
    Indication: Rheumatoid Arthritis
    Start date: 2011-02-14
    End date: 2011-05-01



Possible Enbrel side effects in 41 year old female

Reported by a physician from Germany on 2011-11-23

Patient: 41 year old female

Reactions: Multi-Organ Failure, Renal Failure, Skin Ulcer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Arava



Possible Enbrel side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-14

Patient: 59 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Multi-Organ Failure, Renal Failure, Cardiac Failure, Respiratory Failure, Breast Cancer Female

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Enbrel

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