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Enbrel (Etanercept) - Septic Shock - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Septic Shock ()

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

Possible Enbrel side effects in 55 year old female

Reported by a consumer/non-health professional from Canada on 2012-08-24

Patient: 55 year old female

Reactions: Postoperative Wound Infection, Staphylococcal Infection, Aspiration Pleural Cavity, Sepsis, Rheumatoid Lung, Cerebrovascular Accident, Septic Shock, Splenic Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 55 year old female

Reported by a physician from Canada on 2012-08-03

Patient: 55 year old female

Reactions: Postoperative Wound Infection, Staphylococcal Infection, Aspiration Pleural Cavity, Rheumatoid Lung, Cerebrovascular Accident, Septic Shock, Splenic Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel



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

Enbrel
    Dosage: 50 mg, weekly
    Indication: Psoriatic Arthropathy
    Start date: 2004-01-01
    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:
Methotrexate
    Dosage: 20 mg, weekly
    Administration route: Oral
    Start date: 2010-10-01

Enbrel
    Dosage: 50 mg, unk
    Indication: Rheumatoid Arthritis
    Start date: 2011-01-31
    End date: 2012-01-25

Other drugs received by patient: Folic Acid; Hydrocortisone



Possible Enbrel side effects in

Reported by a physician from Brazil on 2012-07-02

Patient:

Reactions: Death, Septic Shock, Cardiac Arrest, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel



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

Micardis

Basen

Januvia
    Administration route: Oral

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



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

Enbrel
    Dosage: 50 mg, unk
    Indication: Rheumatoid Arthritis
    Start date: 2011-01-31
    End date: 2012-01-25

Other drugs received by patient: Folic Acid; Hydrocortisone



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:
Januvia
    Administration route: Oral

Basen

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

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

Enbrel
    Dosage: 50 mg, weekly
    Indication: Psoriatic Arthropathy
    Start date: 2004-01-01
    End date: 2011-09-01



Possible Enbrel side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-22

Patient: 73 year old female

Reactions: Epiduritis, Intervertebral Discitis, Septic Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketoprofen
    Dosage: 150 mg, 2x/week

Enbrel
    Dosage: unk
    Indication: Rheumatoid Arthritis
    Start date: 2006-01-01
    End date: 2009-12-01

Humira
    Dosage: 40 mg, one in 2 weeks
    Indication: Rheumatoid Arthritis
    Start date: 2009-12-26
    End date: 2010-05-01

Other drugs received by patient: Valsartan and Hydrochlorothiazide; Orocal Vitamin D; Pantoprazole Sodium; Propoxyphene HCL and Acetaminophen; Felodipine; Acetaminophen



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:
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

Basen
    Dosage: 0.3 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 70 year old female

Reported by a individual with unspecified qualification from Japan on 2012-02-20

Patient: 70 year old female, weighing 46.0 kg (101.2 pounds)

Reactions: Respiratory Failure, Pneumonia Staphylococcal, Septic Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Isalon; Loxoprofen Sodium



Possible Enbrel side effects in 70 year old female

Reported by a individual with unspecified qualification from Japan on 2012-02-16

Patient: 70 year old female, weighing 46.0 kg (101.2 pounds)

Reactions: Respiratory Failure, Pneumonia Staphylococcal, Septic Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Isalon; Loxoprofen Sodium



Possible Enbrel side effects in 78 year old male

Reported by a physician from Japan on 2012-01-23

Patient: 78 year old male

Reactions: Disseminated Intravascular Coagulation, Portal Vein Thrombosis, Septic Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, weekly
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-05-01

Azulfidine
    Dosage: unk
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Tacrolimus
    Dosage: unk
    Indication: Rheumatoid Arthritis

Prednisolone
    Dosage: 15 mg, unk
    Indication: Rheumatoid Arthritis



Possible Enbrel side effects in 78 year old male

Reported by a physician from Japan on 2012-01-17

Patient: 78 year old male

Reactions: Disseminated Intravascular Coagulation, Portal Vein Thrombosis, Septic Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, weekly
    Indication: Rheumatoid Arthritis
    Start date: 2010-05-01

Azulfidine
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Prednisolone
    Dosage: 15 mg, unk
    Indication: Rheumatoid Arthritis

Tacrolimus
    Indication: Rheumatoid Arthritis



Possible Enbrel side effects in female

Reported by a physician from Czech Republic on 2012-01-03

Patient: female

Reactions: Vomiting, Pyrexia, Loss of Consciousness, Diarrhoea, Septic Shock, Meningococcal Sepsis, Shock, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Calcichew-D3; Micardis HCT; Bonviva / 01304701 /; Medrol; Atorvastatin; Meloxicam; Betaxolol; Indomethacin



Possible Enbrel side effects in 78 year old male

Reported by a physician from Japan on 2011-12-27

Patient: 78 year old male

Reactions: Portal Vein Thrombosis, Disseminated Intravascular Coagulation, Septic Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sulfasalazine
    Dosage: unk
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Enbrel
    Dosage: 50 mg, weekly
    Indication: Rheumatoid Arthritis
    Start date: 2010-05-01

Prednisolone
    Dosage: 15 mg, unk
    Indication: Rheumatoid Arthritis

Tacrolimus
    Dosage: unk
    Indication: Rheumatoid Arthritis



Possible Enbrel side effects in female

Reported by a physician from Czech Republic on 2011-12-08

Patient: female

Reactions: Vomiting, Pyrexia, Loss of Consciousness, Diarrhoea, Meningococcal Sepsis, Septic Shock, Shock, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Calcichew-D3; Medrol; Betaxolol; Micardis HCT; Bonviva / 01304701 /; Meloxicam; Atorvastatin; Indomethacin



Possible Enbrel side effects in 43 year old female

Reported by a physician from United States on 2011-12-06

Patient: 43 year old female

Reactions: Hepatic Failure, Sunburn, Herpes Zoster, Renal Failure, Staphylococcal Infection, Septic Shock, Intestinal Infarction, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel



Possible Enbrel side effects in 42 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-29

Patient: 42 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Disseminated Intravascular Coagulation, Acute Respiratory Distress Syndrome, Septic Shock, Renal Failure Acute, Pneumonia Pneumococcal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Prednisolone; Prednisolone; Methotrexate; Methotrexate



Possible Enbrel side effects in 73 year old male

Reported by a physician from Taiwan, Province of China on 2011-11-25

Patient: 73 year old male

Reactions: Abdominal Pain, Dyspnoea, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Septic Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: unk unk, 2 times/wk
    Indication: Rheumatoid Arthritis
    Start date: 2010-01-26
    End date: 2010-07-05

Enbrel
    Dosage: unk unk, qwk
    Start date: 2010-07-06



Possible Enbrel side effects in female

Reported by a physician from Czech Republic on 2011-11-14

Patient: female

Reactions: Vomiting, Diarrhoea, Pyrexia, Meningococcal Sepsis, Septic Shock, Shock, Leukopenia, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Calcium Carbonate; Indomethacin; Medrol; Betaxolol; Bonviva / 01304701 /; Micardis HCT; Meloxicam; Atorvastatin



Possible Enbrel side effects in 71 year old female

Reported by a physician from NEW Zealand on 2011-11-09

Patient: 71 year old female

Reactions: Back Pain, Muscular Weakness, Campylobacter Sepsis, Septic Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel
    Indication: Rheumatoid Arthritis

Enbrel
    Dosage: 50 mg, weekly
    Indication: Psoriatic Arthropathy
    Start date: 2010-11-01
    End date: 2011-01-01

Other drugs received by patient: Sulfasalazine; Prednefrin Forte / 00330801 /; Methotrexate; Prednisone; Omeprazole; Fosamax Plus D; Candesartan Cilexetil; Folic Acid



Possible Enbrel side effects in female

Reported by a physician from Czech Republic on 2011-10-25

Patient: female

Reactions: Vomiting, Diarrhoea, Pyrexia, Septic Shock, Meningococcal Sepsis, Loss of Consciousness, Shock, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Enbrel

Other drugs received by patient: Meloxicam; Medrol; Betaxolol; Atorvastatin; Calcium Carbonate; Bonviva / 01304701 /; Indomethacin; Micardis HCT



Possible Enbrel side effects in female

Reported by a physician from Japan on 2011-10-14

Patient: female, weighing 45.0 kg (99.0 pounds)

Reactions: Cellulitis, Disseminated Intravascular Coagulation, Septic Shock, Pneumococcal Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Actemra
    Indication: Rheumatoid Arthritis
    Start date: 2011-04-22
    End date: 2011-05-01

Enbrel
    Indication: Rheumatoid Arthritis
    Start date: 2010-10-18
    End date: 2011-04-22

Other drugs received by patient: Ethambutol Hydrochloride; Alendronate Sodium; Acecol; Amlodipine; Alendronate Sodium

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