Index of reports
> Life Threatening Events (513)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Humira (Adalimumab) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 513 Next >>
Possible Humira side effects in 53 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27
Patient: 53 year old male
Reactions: Aesthesioneuroblastoma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Enbrel
Dosage: 50 mg, weekly
Indication: Ankylosing Spondylitis
Start date: 2005-11-01
End date: 2006-05-01
Humira
Dosage: 40 mg, every other week
Indication: Ankylosing Spondylitis
Start date: 2006-10-01
End date: 2011-02-18
Remicade
Dosage: 3 mg/kg, single
Indication: Ankylosing Spondylitis
Start date: 2011-03-23
End date: 2011-04-07
Possible Humira side effects in 53 year old female
Reported by a physician from France on 2012-08-24
Patient: 53 year old female
Reactions: Cardiac Tamponade, Pericarditis, Progressive Multifocal Leukoencephalopathy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Start date: 2009-01-01
Orencia
Dosage: 250 mg powder concentrate for solution for infusion
Start date: 2012-03-01
End date: 2012-06-30
Prednisone TAB
Dosage: 20 mg (prednisone) 1/d or 1.5/d
End date: 2012-07-01
Other drugs received by patient: Atorvastatin; Fosavance; Metformin HCL; Nexium
Possible Humira side effects in female
Reported by a physician from Austria on 2012-08-24
Patient: female, weighing 44.0 kg (96.8 pounds)
Reactions: Fistula, Sepsis, Abscess
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Indication: Crohn's Disease
Start date: 2008-03-11
End date: 2011-10-18
Humira
Start date: 2012-01-10
Other drugs received by patient: Budesonide; Mesalamine
Possible Humira side effects in 56 year old female
Reported by a physician from United States on 2012-08-22
Patient: 56 year old female, weighing 81.0 kg (178.2 pounds)
Reactions: Fluid Overload, Gastroenteritis Viral
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Indication: Uveitis
Start date: 2011-09-14
End date: 2012-02-08
Humira
Start date: 2012-02-29
Prednisone TAB
Dosage: 40 mg
Administration route: Oral
Start date: 2011-10-05
End date: 2011-10-11
Prednisone TAB
Dosage: 15 nr
Administration route: Oral
Start date: 2011-10-26
End date: 2011-11-01
Prednisone TAB
Dosage: 4 mg
Administration route: Oral
Start date: 2011-12-01
End date: 2011-12-07
Prednisone TAB
Dosage: 50 mg
Administration route: Oral
Start date: 2011-09-28
End date: 2011-10-04
Prednisone TAB
Dosage: 20 mg
Administration route: Oral
Start date: 2011-10-19
End date: 2011-10-25
Prednisone TAB
Dosage: 3 mg
Administration route: Oral
Start date: 2011-12-08
End date: 2011-12-14
Prednisone TAB
Dosage: 2 mg
Administration route: Oral
Start date: 2011-12-15
End date: 2011-12-21
Prednisone TAB
Dosage: 12.5 mg
Administration route: Oral
Start date: 2011-11-02
End date: 2011-11-08
Prednisone TAB
Dosage: 60 mg
Administration route: Oral
Indication: Uveitis
Start date: 2011-09-14
End date: 2011-09-27
Prednisone TAB
Dosage: 30 mg
Administration route: Oral
Start date: 2011-10-12
End date: 2011-10-18
Prednisone TAB
Dosage: 10 mg
Administration route: Oral
Start date: 2011-11-09
End date: 2011-11-16
Prednisone TAB
Dosage: 7.5 mg
Administration route: Oral
Start date: 2011-11-17
End date: 2011-11-23
Prednisone TAB
Dosage: 5 mg
Administration route: Oral
Start date: 2011-11-24
End date: 2011-11-30
Prednisone TAB
Dosage: 1 mg
Administration route: Oral
Start date: 2011-12-22
End date: 2011-12-28
Other drugs received by patient: Mycophenolate Mefetil; Promethazine; Sertraline Hydrochloride; Vicodin; Lisinopril; Rosuvastatin; Lorazepam; Amlodipine Maleate; Calcium with D; Cefixime; Furosemide; Tramadol HCL; Cyclobenzaprine HCL; Pantoprazole Sodium Sesquihydrate; Mycophenolate Mefetil; Ketorolac Tromethamine; Loratadine; Estradiol; Folic Acid; Furosemide; Metoprolol Tartrate; Amlodipine Maleate; Mycophenolate Mefetil; Gabapentin; Diclofenac Sodium; Bupropion Hydrochloride
Possible Humira side effects in 53 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-22
Patient: 53 year old male
Reactions: Aesthesioneuroblastoma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Enbrel
Indication: Ankylosing Spondylitis
Start date: 2005-11-01
End date: 2006-05-01
Humira
Dosage: treated for four years
Indication: Ankylosing Spondylitis
Start date: 2006-10-01
End date: 2011-02-01
Remicade
Indication: Ankylosing Spondylitis
Start date: 2011-03-23
Remicade
Start date: 2011-04-07
End date: 2011-04-07
Possible Humira side effects in female
Reported by a physician from Canada on 2012-08-22
Patient: female, weighing 84.4 kg (185.8 pounds)
Reactions: Intestinal Polyp, Weight Decreased, Fistula, Malnutrition, Gastrointestinal Inflammation, Pulmonary Embolism, Diarrhoea, Impaired Healing, Deep Vein Thrombosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Ferrous Sulfate TAB; Warfarin Sodium; APO-Trifluoperazine; Synthroid; Vitamin B-12; Perindopril Erbumine; Esomeprazole Sodium; Remicade; Furosemide; Slow-K; Imuran; Omeprazole; Vitamin D; Prednisone TAB
Possible Humira side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: female
Reactions: Lung Neoplasm
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Humira
Start date: 2012-04-19
End date: 2012-07-23
Humira
Indication: Product Used FOR Unknown Indication
Start date: 2005-01-01
End date: 2010-01-01
Possible Humira side effects in male
Reported by a physician from United States on 2012-08-21
Patient: male
Reactions: Drug Ineffective, Hepatosplenic T-Cell Lymphoma, Anaemia, Sepsis, Thrombocytopenia, Leukopenia
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Azathioprine Sodium
Administration route: Oral
Indication: Crohn's Disease
Start date: 1996-01-01
End date: 2004-05-01
Azathioprine Sodium
Dosage: variable and lower doses
Administration route: Oral
Start date: 2004-01-01
End date: 2007-04-01
Humira
Indication: Crohn's Disease
Start date: 2007-01-01
End date: 2007-11-01
Humira
Start date: 2005-05-04
End date: 2005-11-10
Remicade
Indication: Crohn's Disease
Start date: 2004-04-15
End date: 2004-06-10
Possible Humira side effects in female
Reported by a physician from Canada on 2012-08-21
Patient: female, weighing 84.4 kg (185.8 pounds)
Reactions: Intestinal Polyp, Weight Decreased, Fistula, Diarrhoea, Impaired Healing, Malnutrition, Gastrointestinal Inflammation, Pulmonary Embolism, Deep Vein Thrombosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Ferrous Sulfate TAB; Imuran; Warfarin Sodium; Vitamin D; Perindopril Erbumine; Furosemide; Esomeprazole Sodium; Slow-K; Prednisone; Remicade; Omeprazole; Vitamin B-12; Synthroid; APO-Trifluoperazine
Possible Humira side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient: male, weighing 69.0 kg (151.8 pounds)
Reactions: Hepatosplenic T-Cell Lymphoma
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Indication: Colitis Ulcerative
Start date: 2007-06-15
Humira
Start date: 2007-06-15
Humira
Start date: 2006-11-01
Humira
Indication: Irritable Bowel Syndrome
Start date: 2006-11-01
Purinethol
Dosage: also reported with start date of 01-oct-1999
Start date: 1999-06-02
Purinethol
Dosage: also reported with start date of 01-oct-1999
Start date: 1999-06-02
Purinethol
Indication: Inflammatory Bowel Disease
End date: 2007-04-01
Purinethol
Indication: Colitis Ulcerative
End date: 2007-04-01
Remicade
Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
Indication: Inflammatory Bowel Disease
Start date: 2002-07-10
End date: 2006-03-07
Remicade
Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
Indication: Colitis Ulcerative
Start date: 2002-07-10
End date: 2006-03-07
Remicade
Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
Indication: Crohn's Disease
Start date: 2002-07-10
End date: 2006-03-07
Other drugs received by patient: Prednisone TAB; Asacol; Prednisone TAB; Asacol
Possible Humira side effects in
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient:
Reactions: Respiratory Disorder, Crohn's Disease
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Humira
Possible Humira side effects in male
Reported by a consumer/non-health professional from Germany on 2012-08-14
Patient: male
Reactions: Intestinal Perforation, Medical Induction of Coma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Indication: Crohn's Disease
Humira
Indication: Ankylosing Spondylitis
Start date: 2012-07-25
Possible Humira side effects in 79 year old male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-10
Patient: 79 year old male, weighing 68.0 kg (149.6 pounds)
Reactions: Metastatic Neoplasm, Weight Decreased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Enbrel
Dosage: unk
Indication: Product Used FOR Unknown Indication
Start date: 2007-06-01
End date: 2011-11-01
Humira
Dosage: unk
Start date: 2008-03-01
End date: 2008-08-01
Other drugs received by patient: Stelara
Possible Humira side effects in female
Reported by a physician from Germany on 2012-08-10
Patient: female
Reactions: Cellulitis, C-Reactive Protein Increased, Necrosis, Lymphangitis, Aplastic Anaemia, Skin Necrosis, Empyema, Thermal Burn, White Blood Cell Count Increased
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2005-12-01
End date: 2006-12-01
Hydrocortisone
Indication: Rheumatoid Arthritis
Methotrexate
Administration route: Oral
Start date: 2007-06-19
Methotrexate
Indication: Rheumatoid Arthritis
Start date: 2005-12-01
End date: 2006-12-01
Other drugs received by patient: Prednisolone; Etanercept
Possible Humira side effects in female
Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-08-10
Patient: female
Reactions: Pyrexia, Leukopenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Arheuma; Methotrexate
Possible Humira side effects in female
Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-08-10
Patient: female
Reactions: Haemoglobin Decreased, Cardiac Failure, Bone Marrow Failure, Leukopenia
Adverse event resulted in: 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 physician from United States on 2012-08-10
Patient: female, weighing 71.0 kg (156.2 pounds)
Reactions: Suicide Attempt
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Escitalopram; Topamax; Sulfasalazine; Tramadol HCL; Diclofenac; Depo-Provera; Sulfasalazine; Topamax
Possible Humira side effects in male
Reported by a physician from Japan on 2012-08-10
Patient: male, weighing 90.0 kg (198.0 pounds)
Reactions: Gastrointestinal Amyloidosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Dosage: 40 mg on an irregular basis
End date: 2011-09-30
Humira
Indication: Psoriatic Arthropathy
Start date: 2010-10-21
End date: 2010-10-21
Other drugs received by patient: Lomoxicam; Maxacalcitol; Clobetasol Propionate; Rebamipide
Possible Humira side effects in female
Reported by a physician from Germany on 2012-08-10
Patient: female
Reactions: Procalcitonin Increased, C-Reactive Protein Increased, Bacteraemia, Escherichia Urinary Tract Infection, Urinary Tract Infection, Systemic Inflammatory Response Syndrome, Bronchitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Humira
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-30
End date: 2012-06-27
Possible Humira side effects in 64 year old female
Reported by a physician from Germany on 2012-08-09
Patient: 64 year old female
Reactions: Pneumonia, Sepsis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Etanercept; Methotrexate
Possible Humira side effects in female
Reported by a physician from Belgium on 2012-08-09
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Weight Decreased, Rheumatoid Arthritis, Vasculitis Gastrointestinal, Prerenal Failure, Enterococcal Sepsis, Decubitus Ulcer, Small Intestinal Ulcer Haemorrhage, Oedema Peripheral, Pulmonary Oedema, Small Intestinal Haemorrhage, Melaena, Aphthous Stomatitis, Pneumonia, Urinary Tract Infection, Malnutrition, Congestive Cardiomyopathy, Rheumatic Heart Disease, Dehydration
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2008-08-01
End date: 2011-11-01
Humira
Start date: 2012-03-01
Possible Humira side effects in female
Reported by a physician from Belgium on 2012-08-08
Patient: female, weighing 56.0 kg (123.2 pounds)
Reactions: Weight Decreased, Vasculitis Gastrointestinal, Rheumatoid Arthritis, Enterococcal Sepsis, Prerenal Failure, Decubitus Ulcer, Oedema Peripheral, Small Intestinal Ulcer Haemorrhage, Pulmonary Oedema, Small Intestinal Haemorrhage, Melaena, Aphthous Stomatitis, Pneumonia, Malnutrition, Urinary Tract Infection, Congestive Cardiomyopathy, Rheumatic Heart Disease, Dehydration
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2008-08-01
End date: 2011-11-01
Humira
Start date: 2012-03-01
Possible Humira side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-08
Patient: female, weighing 90.0 kg (198.0 pounds)
Reactions: Dyspnoea, Dysphagia, Paraesthesia Oral, Anaphylactic Reaction, Dizziness, Feeling Abnormal, Feeling Cold
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Ranitidine; Vallergan; Acetaminophen and Codeine Phosphate; Methotrexate
Possible Humira side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-07
Patient: male, weighing 69.0 kg (151.8 pounds)
Reactions: Subarachnoid Haemorrhage
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Possible Humira side effects in male
Reported by a physician from Greece on 2012-08-06
Patient: male, weighing 55.0 kg (121.0 pounds)
Reactions: Multi-Organ Failure, Pneumonia, Disseminated Intravascular Coagulation, Crohn's Disease, Pneumothorax Traumatic
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Dosage: induction: 160 mg (baseline)
Indication: Crohn's Disease
Start date: 2009-10-20
End date: 2009-10-20
Humira
Humira
Dosage: (week 2)
Humira
Start date: 2012-03-30
End date: 2012-05-08
Possible Humira side effects in male
Reported by a physician from Japan on 2012-08-06
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Pneumocystis Jiroveci Pneumonia, Arthralgia, Joint Swelling, Decreased Appetite
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Humira
Indication: Rheumatoid Arthritis
Start date: 2010-07-13
End date: 2011-01-12
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2009-07-01
End date: 2011-01-21
Other drugs received by patient: Amlodipine Besylate; Prednisolone; Methotrexate; Diclofenac Sodium
Possible Humira side effects in 65 year old male
Reported by a physician from Korea, Republic of on 2012-08-06
Patient: 65 year old male, weighing 68.0 kg (149.6 pounds)
Reactions: Pneumonia, Colitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Lamivudine; Sulfasalazine; Cyclosporine; Hydroxychloroquine Sulfate; Methotrexate; Lamivudine; Bucillamine; Etodolac
Possible Humira side effects in male
Reported by a physician from United States on 2012-08-03
Patient: male
Reactions: Oesophageal Carcinoma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Indication: Psoriasis
Start date: 2008-09-24
End date: 2008-09-24
Humira
Start date: 2011-01-19
End date: 2011-04-01
Other drugs received by patient: Lantus
Possible Humira side effects in female
Reported by a lawyer from United States on 2012-08-03
Patient: female
Reactions: Lymphadenopathy, Mass, Neoplasm Malignant, B-Cell Lymphoma, Tooth Abscess, Central Venous Catheterisation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Humira
Start date: 2010-06-01
End date: 2010-08-01
Humira
Indication: Rheumatoid Arthritis
Start date: 2008-10-14
End date: 2010-02-01
Possible Humira side effects in female
Reported by a physician from United States on 2012-08-02
Patient: female, weighing 65.8 kg (144.8 pounds)
Reactions: Myocardial Infarction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Other drugs received by patient: Fluticasone Propionate; Metoprolol Tartrate; Hydrochlorothiazide; Plavix; Novolog; Singulair; Xanax; Clobetasol Propionate; Omeprazole; Dovonex
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