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Humira (Adalimumab) - Sepsis - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Sepsis ()

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Humira (Adalimumab) where reactions include sepsis. 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 consumer/non-health professional from Germany on 2012-08-27

Patient: male

Reactions: Multi-Organ Failure, Intestinal Operation, Sepsis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Humira



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 male

Reported by a physician from Japan on 2012-08-23

Patient: male, weighing 61.2 kg (134.6 pounds)

Reactions: White Blood Cell Count Decreased, Haematochezia, Anaemia, Sepsis, Platelet Count Decreased, Pyrexia, Abdominal Adhesions

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Start date: 2012-05-29
    End date: 2012-05-29

Humira
    Indication: Crohn's Disease
    Start date: 2012-05-15
    End date: 2012-05-15

Humira
    Start date: 2012-06-15

Other drugs received by patient: Clostridium Butyricum; TPN; Mesalamine; Mesalamine



Possible Humira side effects in male

Reported by a physician from United States on 2012-08-22

Patient: male, weighing 104.9 kg (230.7 pounds)

Reactions: Rhabdomyolysis, Tachycardia, Haematuria, Pain, Urinary Tract Infection, International Normalised Ratio Increased, Synovitis, Discomfort, Joint Swelling, Sepsis, Platelet Count Decreased, Bronchitis, Blood Creatinine Increased, Asthenia, Psoriatic Arthropathy

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Alprazolam; Aspirin; Norco; Hydrochlorothiazide; Aspirin; Rapaflo; Neurontin; Norvasc; Prednisone TAB; Zetia; Metoprolol Tartrate; Lasix



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 male

Reported by a physician from United States on 2012-08-10

Patient: male, weighing 104.9 kg (230.7 pounds)

Reactions: Rhabdomyolysis, International Normalised Ratio Increased, Tachycardia, Haematuria, Urinary Tract Infection, Pain, Synovitis, Discomfort, Joint Swelling, Sepsis, Platelet Count Decreased, Bronchitis, Asthenia, Arthritis, Blood Creatinine Increased, Psoriatic Arthropathy

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Norvasc; Prednisone TAB; Zetia; Neurontin; Aspirin; Alprazolam; Hydrochlorothiazide; Aspirin; Lasix; Metoprolol Tartrate; Norco; Rapaflo



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 United States on 2012-08-02

Patient: female, weighing 61.3 kg (134.8 pounds)

Reactions: Pyrexia, Toxic Shock Syndrome, Exercise Tolerance Decreased, Renal Failure, Alopecia, Sepsis, Ejection Fraction Abnormal, Cardiac Failure Congestive, Lethargy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    End date: 2012-03-27

Humira
    Dosage: initial dose of 80mg
    Indication: Psoriasis
    Start date: 2011-12-16
    End date: 2011-12-16

Other drugs received by patient: Oral Contraception



Possible Humira side effects in male

Reported by a physician from United States on 2012-07-27

Patient: male, weighing 136.2 kg (299.6 pounds)

Reactions: Pneumonia, Haematuria, Sepsis, Hyponatraemia, Pleural Effusion, Obstructive Uropathy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Atenolol; Enalapril Maleate and Hydrochlorothiazide; Vytorin; Metformin Hydrochloride



Possible Humira side effects in 78 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-25

Patient: 78 year old female

Reactions: Klebsiella Infection, Syncope, Hydronephrosis, Urinary Tract Infection, Sepsis, Unevaluable Event

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Simvastatin; Amitriptyline Hydrochloride; Furosemide; Methotrexate; Folic Acid; Acetaminophen; Cephradine; Lansoprazole; Pregabalin; Oramorph SR; Sulfasalazine



Possible Humira side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-24

Patient:

Reactions: Trisomy 21, Congenital Hydronephrosis, Foetal Exposure During Pregnancy, Sepsis

Drug(s) suspected as cause:
Humira



Possible Humira side effects in female

Reported by a physician from United States on 2012-07-20

Patient: female

Reactions: Localised Infection, Vomiting, Cellulitis, Folliculitis, Hypotension, Urinary Tract Infection, Pyrexia, Secretion Discharge, Diarrhoea, Sepsis, Dehydration, Escherichia Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease
    Start date: 2012-04-01

Humira
    Start date: 2005-01-01

Other drugs received by patient: Zolitriptane; Vitamin D; Multi-Vitamins; Potassium Chloride; Doxycycline; Promethazine; Prozac; Vitamin B Complex CAP; Linezolid; Miconazole Nitrate W / Zinc Oxide; Hydrocodone Bitartrate; Zantac; Vitamin B-12



Possible Humira side effects in female

Reported by a physician from United States on 2012-07-19

Patient: female

Reactions: Localised Infection, Cellulitis, Vomiting, Hypotension, Urinary Tract Infection, Folliculitis, Pyrexia, Secretion Discharge, Diarrhoea, Sepsis, Dehydration, Escherichia Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Linezolid; Promethazine; Vitamin D; Doxycycline; Potassium Chloride; Hydrocodone Bitartrate; Miconazole Nitrate W / Zinc Oxide; Zantac; Prozac; Vitamin B Complex CAP; Vitamin B-12; Multi-Vitamins; Zolitriptane



Possible Humira side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-16

Patient:

Reactions: Trisomy 21, Congenital Hydronephrosis, Sepsis, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Humira



Possible Humira side effects in male

Reported by a physician from United States on 2012-07-16

Patient: male, weighing 136.2 kg (299.6 pounds)

Reactions: Pneumonia, Sepsis, Hypotension, Blood Sodium Decreased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Vytorin; Atenolol; Metformin Hydrochloride; Enalapril Maleate and Hydrochlorothiazide



Possible Humira side effects in male

Reported by a physician from Canada on 2012-07-12

Patient: male, weighing 74.9 kg (164.8 pounds)

Reactions: Abdominal Pain, Fistula, Abdominal Abscess, Sepsis, Abscess, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira



Possible Humira side effects in female

Reported by a physician from United States on 2012-07-06

Patient: female

Reactions: Inappropriate Schedule of Drug Administration, Incoherent, Confusional State, Urinary Tract Infection, Sepsis, Mental Status Changes, Cystitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Rheumatoid Arthritis
    Start date: 2009-04-01

Morphine
    Dosage: once in am and once in evening
    Indication: Product Used FOR Unknown Indication



Possible Humira side effects in male

Reported by a physician from Greece on 2012-07-05

Patient: male, weighing 55.0 kg (121.0 pounds)

Reactions: Multi-Organ Failure, Metabolic Acidosis, Pneumonia, Sepsis, Crohn's Disease, Disseminated Intravascular Coagulation, 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
    Dosage: (week 2)

Humira

Humira
    Start date: 2012-03-30
    End date: 2012-05-08



Possible Humira side effects in male

Reported by a physician from United States on 2012-06-29

Patient: male, weighing 63.6 kg (139.8 pounds)

Reactions: Abdominal Pain, Weight Decreased, Vomiting, Pain, Testicular Malignant Teratoma Stage III, Surgery, Sepsis, Skeletal Injury, Renal Mass

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Unknown Adhd Drug



Possible Humira side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-29

Patient: male, weighing 104.0 kg (228.8 pounds)

Reactions: Bronchopneumonia, Sepsis, Pancreatic Neuroendocrine Tumour Metastatic, Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Humira



Possible Humira side effects in female

Reported by a consumer/non-health professional from United Kingdom on 2012-06-28

Patient: female

Reactions: Confusional State, Pneumonia, Myocardial Ischaemia, Atrial Fibrillation, Pancytopenia, Wound Infection, Pseudomonal Bacteraemia, Rheumatoid Arthritis, Left Ventricular Dysfunction, Cardiac Failure, Sepsis, Leukopenia, Cardiac Failure Congestive, Infected Skin Ulcer, Inflammatory Marker Increased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Methotrexate; Steroids



Possible Humira side effects in female

Reported by a consumer/non-health professional from United Kingdom on 2012-06-25

Patient: female

Reactions: Confusional State, Pneumonia, Myocardial Ischaemia, Atrial Fibrillation, Pancytopenia, Wound Infection, Pseudomonal Bacteraemia, Rheumatoid Arthritis, Left Ventricular Dysfunction, Cardiac Failure, Sepsis, Leukopenia, Cardiac Failure Congestive, Infected Skin Ulcer, Inflammatory Marker Increased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Steroids; Methotrexate



Possible Humira side effects in male

Reported by a physician from United States on 2012-06-15

Patient: male

Reactions: Blood Magnesium Decreased, Short-Bowel Syndrome, Electrolyte Depletion, Gastritis, Duodenitis, Fatigue, Adrenal Insufficiency, Bone Marrow Failure, Intracardiac Thrombus, Blood Glucose Increased, Hypovolaemia, Migraine, Cellulitis, Blood Urea Increased, Fistula, Crohn's Disease, Urine Output Decreased, Anaemia, Intestinal Obstruction, Chronic Myeloid Leukaemia, Small Intestinal Obstruction, Pulmonary Valve Incompetence, Blood Potassium Decreased, Dehydration, Heart Rate Increased, Sepsis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Crohn's Disease
    Start date: 2004-03-16
    End date: 2004-05-12

Sprycel

Other drugs received by patient: Imodium; Allopurinol; Nexium; Multi-Vitamin; Lopid; Fosamax; Neurontin; Remeron; Fish OIL



Possible Humira side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-12

Patient: female, weighing 80.4 kg (176.8 pounds)

Reactions: Weight Decreased, Large Intestine Perforation, Abdominal Pain, Pleurisy, Intestinal Obstruction, Gastrointestinal Infection, Renal Failure, Sepsis, Chest Pain, Asthenia, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira

Other drugs received by patient: COD Liver OIL; Sulfasalazine; Calcium Plus Vitamin D; Multi-Vitamin; Imuran; Sulfasalazine; Flaxseed OIL



Possible Humira side effects in female

Reported by a consumer/non-health professional from Canada on 2012-06-11

Patient: female, weighing 74.9 kg (164.8 pounds)

Reactions: Renal Failure, Sepsis, Post Procedural Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Ankylosing Spondylitis
    Start date: 2011-08-09
    End date: 2011-11-17

Humira
    Start date: 2012-05-29

Other drugs received by patient: Cyclobenzaprine; Avapro; SAS-EC; Gliclazide; Vitamin B-12; Docusate; Amlodipine; APO-Isosorbide Mononitrate; Iron; Synthroid; Pravastatin; Metoprolol Tartrate



Possible Humira side effects in 78 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-08

Patient: 78 year old female

Reactions: Klebsiella Infection, Hydronephrosis, Syncope, Urinary Tract Infection, Sepsis

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 United States on 2012-06-07

Patient: female, weighing 133.0 kg (292.6 pounds)

Reactions: Pneumonia, Sepsis, Cardiac Failure Congestive

Adverse event resulted in: death

Drug(s) suspected as cause:
Humira

Other drugs received by patient: Xanax; Albuterol; Symbicort; Hydrocodone; Ambien; Phenergan; Prednisone; Lasix; Amitriptyline HCL; Cymbalta



Possible Humira side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-07

Patient: male

Reactions: Renal Impairment, Beta Haemolytic Streptococcal Infection, Sepsis

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 United States on 2012-06-07

Patient: male

Reactions: Nephrolithiasis, Surgery, Pneumonia, Sepsis, Cystitis, Kidney Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira

Humira
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-03-18



Possible Humira side effects in male

Reported by a consumer/non-health professional from Canada on 2012-06-07

Patient: male

Reactions: Abdominal Pain, Fistula, Sepsis, Abscess, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira



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