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Humira (Adalimumab) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



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 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 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 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 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 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 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

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 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 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 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 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 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 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 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 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 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 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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