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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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