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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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