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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 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
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
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