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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 Humira (Adalimumab) where reactions include septic shock. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of Next >>
Possible Humira side effects in male
Reported by a physician from Slovenia on 2012-08-27
Patient: male, weighing 101.0 kg (222.2 pounds)
Reactions: Multi-Organ Failure, Pneumonia Legionella, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Septic Shock
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Infliximetan
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-14
End date: 2011-06-12
Humira
Indication: Ankylosing Spondylitis
Start date: 2010-10-14
End date: 2012-07-25
Other drugs received by patient: Arcoxia
Possible Humira side effects in male
Reported by a physician from United States on 2012-08-22
Patient: male, weighing 86.3 kg (189.8 pounds)
Reactions: Chills, Hypotension, Urine Flow Decreased, Fall, Nephrolithiasis, Diverticulum, Urosepsis, Septic Shock, Arthritis, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Alendronate Sodium; Hydroxychloroquine Sulfate; Aspirin; Colchicine; Prednisone TAB; Metoprolol Tartrate; Prednisone TAB; Advil; Amlodipine; Mirtazapine; Plaquenil; Zetia
Possible Humira side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-09
Patient: female, weighing 49.9 kg (109.9 pounds)
Reactions: Liver Injury, Listeriosis, Pneumonia, Pyrexia, Hyperhidrosis, Arrhythmia, Death, Renal Impairment, Septic Shock, Cardiac Failure Congestive, Infection
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2011-10-21
End date: 2012-07-13
Tylenol
Indication: Pain
Tylenol W / Codeine NO. 2
Administration route: Oral
Indication: Pain
Other drugs received by patient: Meprolol; Toloxin; Warfarin Sodium; Methotrexate; Folic Acid; Rabeprazole Sodium; Oxeze; Furosemide; Vitamin B-12; Calcium; Mirtazapine; Methotrexate; Euro-FER; Vitamin D
Possible Humira side effects in 53 year old female
Reported by a physician from Brazil on 2012-08-08
Patient: 53 year old female
Reactions: Weight Decreased, Abdominal Pain, Liver Injury, Hypotension, Pyrexia, Heart Rate Increased, Pancreatitis, Liver Abscess, Asthenia, Septic Shock, Hepatic Infection, Immunosuppression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Possible Humira side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-03
Patient: female, weighing 49.9 kg (109.9 pounds)
Reactions: Liver Injury, Listeriosis, Pneumonia, Pyrexia, Hyperhidrosis, Arrhythmia, Renal Impairment, Septic Shock, Cardiac Failure Congestive, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tylenol (Caplet)
Indication: Pain
Humira
Indication: Rheumatoid Arthritis
Start date: 2011-10-21
End date: 2012-07-13
Tylenol W / Codeine NO. 2
Administration route: Oral
Indication: Pain
Other drugs received by patient: Methotrexate; Vitamin B-12; Rabeprazole Sodium; Oxeze; Euro-FER; Toloxin; Methotrexate; Furosemide; Warfarin Sodium; Vitamin D; Meprolol; Folic Acid; Mirtazapine; Calcium
Possible Humira side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: female, weighing 56.8 kg (124.9 pounds)
Reactions: Liver Injury, Malaise, Arthralgia, Arthritis Infective, Septic Shock, Cardiac Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2003-01-01
End date: 2011-11-01
Humira
Other drugs received by patient: Arava; Levothyroxine Sodium; Prednisone
Possible Humira side effects in 53 year old female
Reported by a physician from Brazil on 2012-08-01
Patient: 53 year old female
Reactions: Weight Decreased, Liver Injury, Abdominal Pain, Hypotension, Pyrexia, Heart Rate Increased, Pancreatitis, Liver Abscess, Asthenia, Septic Shock, Hepatic Infection, Immunosuppression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Possible Humira side effects in male
Reported by a consumer/non-health professional from Australia on 2012-08-01
Patient: male
Reactions: Pneumonia Legionella, Cardiac Arrest, Septic Shock, Renal Failure Acute
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Humira
Indication: Product Used FOR Unknown Indication
Start date: 2011-05-15
End date: 2011-07-15
Methotrexate
Indication: Product Used FOR Unknown Indication
End date: 2011-07-15
Other drugs received by patient: Cartia XT; Lipitor; Metoprolol Succinate
Possible Humira side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-03
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Urinary Tract Infection, Portal Vein Thrombosis, Upper Gastrointestinal Haemorrhage, Septic Shock
Adverse event resulted in: death
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Methotrexate
Possible Humira side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-15
Patient: female, weighing 75.8 kg (166.8 pounds)
Reactions: Device Related Sepsis, Femur Fracture, Upper Limb Fracture, Cystitis, Fall, Rheumatoid Arthritis, Staphylococcal Infection, Impaired Healing, Skin Ulcer, Septic Shock
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Start date: 2012-05-01
Humira
Start date: 2009-01-01
End date: 2010-01-01
Humira
Indication: Product Used FOR Unknown Indication
Possible Humira side effects in 53 year old female
Reported by a physician from Brazil on 2012-06-15
Patient: 53 year old female
Reactions: Liver Injury, Pancreatitis, Pyrexia, Hepatic Infection, Septic Shock
Drug(s) suspected as cause:
Humira
Possible Humira side effects in male
Reported by a physician from United States on 2012-06-15
Patient: male, weighing 47.8 kg (105.2 pounds)
Reactions: Multi-Organ Failure, Transfusion Reaction, Myeloid Leukaemia, Septic Shock, Acute Monocytic Leukaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Infliximab
Indication: Crohn's Disease
Start date: 2009-04-29
End date: 2009-04-29
Humira
Start date: 2009-11-16
Infliximab
Dosage: prior to registry
Start date: 2005-11-03
Methotrexate
Indication: Crohn's Disease
Humira
Indication: Crohn's Disease
Start date: 2009-05-12
Prednisone TAB
Indication: Crohn's Disease
Humira
Start date: 2010-03-31
End date: 2010-03-31
Other drugs received by patient: Cotrim; Chlorhexidine Gluconate; Augmentin '125'; Cytarabine; Oxycodone HCL; Antibiotics; Scopolamine; Zofran; Aluminum Hydroxide; Peptamen; Imodium; Morphine; Zosyn; Cholecalciferol; Miralax; Fluconazole; Rifaximin; Vancomycin; Ativan; Benadryl; Iron; Leucovorin Calcium; Zantac; Nalbuphine; Calcium Carbonate; Omeprazole
Possible Humira side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-13
Patient: male, weighing 128.9 kg (283.7 pounds)
Reactions: Confusional State, Pneumonia, Cellulitis, Hypotension, Condition Aggravated, Dyspnoea Exertional, Staphylococcal Infection, Oedema Peripheral, Septic Shock, Myocardial Infarction, Cardiac Failure Congestive
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Indication: Psoriatic Arthropathy
Remicade
Indication: Psoriatic Arthropathy
Other drugs received by patient: Muscle Relaxant; Multiple Medications; Muscle Relaxant; Unknown Medication
Possible Humira side effects in female
Reported by a physician from Brazil on 2012-06-04
Patient: female, weighing 54.0 kg (118.8 pounds)
Reactions: Interstitial Lung Disease, Urinary Tract Infection, Unevaluable Event, Septic Shock, Herpes Zoster
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
End date: 2012-01-27
Humira
Dosage: induction dose
Humira
Dosage: induction dose
Indication: Rheumatoid Arthritis
Start date: 2011-04-01
End date: 2011-04-01
Other drugs received by patient: Nimesulide; Moduretic 5-50; Prednisone TAB; Cholecalciferol; Risedronate Sodium; Methotrexate; Losartan
Possible Humira side effects in male
Reported by a physician from Netherlands on 2012-06-01
Patient: male, weighing 90.0 kg (198.0 pounds)
Reactions: Histiocytosis Haematophagic, Atrial Fibrillation, Encephalopathy, Epstein-Barr Virus Infection, Multi-Organ Failure, Respiratory Failure, Bacterial Sepsis, Melaena, Septic Shock
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Methotrexate
Possible Humira side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-05-29
Patient: female
Reactions: Aphagia, Resection of Rectum, Colectomy, Gastric Ulcer, Ulcer, Septic Shock
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Alitraq
Possible Humira side effects in 31 year old male
Reported by a individual with unspecified qualification from United States on 2012-05-25
Patient: 31 year old male, weighing 108.9 kg (239.5 pounds)
Reactions: Pneumonia Legionella, Bone Pain, Disseminated Intravascular Coagulation, Fatigue, Malaise, Dialysis, Oedema Peripheral, Abdominal Distension, Dyspnoea, Vomiting, Haemoptysis, General Physical Health Deterioration, Hepatic Steatosis, Organ Failure, Acute Lymphocytic Leukaemia, Platelet Count Decreased, Bronchitis, Septic Shock, Arthritis, Asthenia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Humira
Humira
Dosage: 40 mg. every other week sq
Indication: Psoriasis
Start date: 2011-07-06
End date: 2011-09-22
Humira
Dosage: 40 mg. every other week sq
Indication: Arthritis
Start date: 2011-07-06
End date: 2011-09-22
Possible Humira side effects in female
Reported by a physician from Germany on 2012-05-25
Patient: female
Reactions: Large Intestine Perforation, Septic Shock, Peritonitis
Adverse event resulted in: death
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Prednisolone; Hydroxychloroquine Sulfate
Possible Humira side effects in female
Reported by a consumer/non-health professional from Taiwan, Province of China on 2012-05-15
Patient: female
Reactions: Nasopharyngitis, Cardiac Failure, Septic Shock
Adverse event resulted in: death
Drug(s) suspected as cause:
Humira
Possible Humira side effects in 33 year old female
Reported by a physician from Germany on 2012-04-25
Patient: 33 year old female
Reactions: Aphasia, Paralysis, Multi-Organ Failure, Post Procedural Sepsis, Surgery, Postoperative Wound Infection, Bacterial Infection, Septic Shock
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Methotrexate; Arava; Methotrexate; LEF
Possible Humira side effects in female
Reported by a physician from Japan on 2012-04-24
Patient: female, weighing 52.0 kg (114.4 pounds)
Reactions: Postoperative Wound Infection, Arthralgia, Adrenocortical Insufficiency Acute, Pyrexia, Blood Pressure Decreased, Septic Shock, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Start date: 2010-07-22
End date: 2011-02-02
Humira
Indication: Rheumatoid Arthritis
Start date: 2010-04-23
End date: 2010-06-16
Other drugs received by patient: Steroid; Methotrexate; Prednisolone; Tacrolimus
Possible Humira side effects in 63 year old female
Reported by a consumer/non-health professional from United States on 2012-04-20
Patient: 63 year old female
Reactions: Scratch, Pneumonia, Wrist Fracture, Fungal Sepsis, Fall, Malaise, Staphylococcal Infection, Septic Shock, Renal Failure Acute, Ligament Sprain, Infarction
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Vancomycin
Indication: Product Used FOR Unknown Indication
Tobramycin
Indication: Product Used FOR Unknown Indication
Tigecycline
Indication: Product Used FOR Unknown Indication
Humira
Indication: Crohn's Disease
Other drugs received by patient: Zoloft; Vicodin; Lomotil; Bentyl; Potassium Chloride; Soma; Norvasc; Aciphex; Bupropion HCL; Quinapril and Hydrochlorothiazide; Ambien; Bystolic; Furosemide
Possible Humira side effects in male
Reported by a physician from Japan on 2012-04-06
Patient: male, weighing 36.0 kg (79.2 pounds)
Reactions: Weight Decreased, Emphysema, Hepatic Function Abnormal, Disseminated Intravascular Coagulation, Anaemia, Haemorrhagic Disorder, Mucous Stools, Hypokalaemia, Klebsiella Infection, Diarrhoea, Hypophagia, Hypoalbuminaemia, Abdominal Distension, Disuse Syndrome, Septic Shock, Decreased Appetite
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Indication: Crohn's Disease
Start date: 2011-05-12
End date: 2011-05-12
Humira
Start date: 2011-05-26
End date: 2011-05-26
Humira
Start date: 2011-06-09
End date: 2011-10-15
Other drugs received by patient: Prednisolone; Mesalamine; Isoniazid; Ursodiol; Sulfamethoxazole + Trimethoprim
Possible Humira side effects in female
Reported by a physician from Austria on 2012-04-06
Patient: female, weighing 51.0 kg (112.2 pounds)
Reactions: Serratia Infection, Crohn's Disease, Staphylococcal Sepsis, Colonic Stenosis, Sepsis, Bacterial Sepsis, Septic Shock, Multi-Organ Disorder, Erysipelas
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Prednisolone
Indication: Sepsis
Azathioprine
Dosage: 50 mg -100 mg daily
Indication: Sepsis
Start date: 2010-10-01
End date: 2010-12-01
Prednisolone
Dosage: daily
Indication: Bacterial Sepsis
Start date: 2008-05-01
End date: 2010-12-01
Prednisolone
Indication: Serratia Infection
Humira
Indication: Rheumatoid Arthritis
Start date: 2009-10-01
End date: 2010-06-11
Humira
Indication: Crohn's Disease
Possible Humira side effects in 42 year old female
Reported by a physician from Ireland on 2012-04-05
Patient: 42 year old female
Reactions: Thrombosis, Hyperkalaemia, Hepatic Failure, Thoracic Haemorrhage, Multi-Organ Failure, Renal Failure, Aortic Valve Incompetence, Septic Shock, Cardiac Arrest
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Indication: Immunosuppression
Humira
Indication: Psoriatic Arthropathy
End date: 2009-10-01
Methotrexate
Administration route: Oral
Indication: Immunosuppression
End date: 2009-10-01
Other drugs received by patient: Folic Acid; Ramic; Lasix
Possible Humira side effects in male
Reported by a physician from Japan on 2012-04-02
Patient: male, weighing 36.0 kg (79.2 pounds)
Reactions: Weight Decreased, Emphysema, Hepatic Function Abnormal, Disseminated Intravascular Coagulation, Anaemia, Mucous Stools, Haemorrhagic Disorder, Hypokalaemia, Pneumonia Klebsiella, Diarrhoea, Hypophagia, Abdominal Distension, Disuse Syndrome, Hypoalbuminaemia, Septic Shock, Decreased Appetite
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Start date: 2011-06-09
End date: 2011-10-15
Humira
Start date: 2011-05-26
End date: 2011-05-26
Humira
Indication: Crohn's Disease
Start date: 2011-05-12
End date: 2011-05-12
Other drugs received by patient: Isoniazid; Ursodiol; Prednisolone; Mesalamine; Sulfamethoxazole + Trimethoprim
Possible Humira side effects in female
Reported by a physician from Germany on 2012-03-30
Patient: female
Reactions: Enterovesical Fistula, Septic Shock, Infectious Peritonitis
Adverse event resulted in: death
Drug(s) suspected as cause:
Humira
Possible Humira side effects in female
Reported by a physician from Brazil on 2012-03-30
Patient: female
Reactions: Pneumonia, Urinary Tract Infection, Unevaluable Event, Septic Shock, Herpes Zoster
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Risedronate Sodium; Methotrexate; Cholecalciferol; Nimesulide; Moduretic 5-50; Prednisone TAB; Losartan Potassium
Possible Humira 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 Humira side effects in female
Reported by a physician from Germany on 2012-03-15
Patient: female
Reactions: Enterovesical Fistula, Septic Shock, Infectious Peritonitis
Adverse event resulted in: death
Drug(s) suspected as cause:
Humira
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