Index of reports
> Cases with Sepsis (71)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Actemra (Tocilizumab) where reactions include sepsis. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 71 Next >>
Possible Actemra side effects in
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-13
Patient:
Reactions: Disseminated Intravascular Coagulation, Diverticulitis, Cardiac Disorder, Herpes Zoster, Gastric Cancer, Pleural Mesothelioma, Pneumocystis Jiroveci Pneumonia, Spinal Compression Fracture, Pneumothorax, Pyelonephritis, Gastrointestinal Perforation, Breast Cancer, Cellulitis, Pneumonia, Tuberculosis, Atypical Mycobacterial Infection, Large Intestine Carcinoma, Organising Pneumonia, Hepatobiliary Disease, Cerebral Infarction, Lymphoma, Septic Shock, Bile Duct Cancer, Interstitial Lung Disease, Bladder Neoplasm, Basal Cell Carcinoma, Acute Myocardial Infarction, Cervix Carcinoma, B-Cell Lymphoma, Lung Neoplasm, Uterine Cancer, Arthritis Infective, Sepsis, Gastroenteritis, Bronchitis, Meningioma, Infection
Drug(s) suspected as cause:
Actemra
Possible Actemra side effects in 60 year old male
Reported by a physician from Japan on 2012-08-10
Patient: 60 year old male, weighing 73.0 kg (160.6 pounds)
Reactions: Death, Sepsis
Adverse event resulted in: death
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Lansoprazole; Folic Acid; Prednisolone; Methotrexate
Possible Actemra side effects in male
Reported by a physician from Japan on 2012-08-01
Patient: male, weighing 55.0 kg (121.0 pounds)
Reactions: Hydronephrosis, Cholecystitis Acute, Disseminated Intravascular Coagulation, Gastric Ulcer, Haemorrhage Subcutaneous, Spinal Compression Fracture, Sepsis, Platelet Count Decreased, Cholecystitis, Pyelonephritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tacrolimus
Indication: Product Used FOR Unknown Indication
Actemra
Start date: 2009-03-05
End date: 2009-03-05
Prednisolone
Administration route: Oral
Indication: Rheumatoid Arthritis
Actemra
Indication: Rheumatoid Arthritis
Start date: 2009-02-05
End date: 2009-02-05
Other drugs received by patient: Crestor; Zantac; Lasix; Loxonin; Methotrexate; Alfarol; Glakay; Alendronate Sodium; Flivas; Amoban; Tamsulosin HCL; Methotrexate; Isoniazid; Vitamin B12; Folic Acid; Allopurinol
Possible Actemra side effects in 60 year old male
Reported by a physician from Japan on 2012-07-31
Patient: 60 year old male, weighing 73.0 kg (160.6 pounds)
Reactions: Drowning, Embolism, Sepsis, Myocardial Infarction
Adverse event resulted in: death
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Folic Acid; Prednisolone; Lansoprazole; Methotrexate
Possible Actemra side effects in female
Reported by a physician from United Kingdom on 2012-07-23
Patient: female
Reactions: Sepsis, Wound Decomposition
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Prednisone; Methotrexate
Possible Actemra side effects in 66 year old male
Reported by a physician from United Kingdom on 2012-07-23
Patient: 66 year old male
Reactions: Multi-Organ Failure, Death, Sepsis, Acute Respiratory Distress Syndrome, Pulmonary Fibrosis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Actemra
Possible Actemra side effects in female
Reported by a pharmacist from United States on 2012-07-17
Patient: female, weighing 77.8 kg (171.2 pounds)
Reactions: Cardiac Murmur, Urinary Tract Infection, General Physical Health Deterioration, Acidosis, Candida Test Positive, Escherichia Test Positive, Respiratory Failure, Sepsis, Pathogen Resistance, Aortic Valve Disease
Adverse event resulted in: death
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Citalopram Hydrobromide; Leflunomide; Gabapentin; Potassium Chloride; Oxybutynin; Omeprazole; Bisoprolol Fumarate; Zolpidem Tartrate
Possible Actemra side effects in 60 year old male
Reported by a physician from Japan on 2012-07-16
Patient: 60 year old male
Reactions: Drowning, Sepsis
Adverse event resulted in: death
Drug(s) suspected as cause:
Actemra
Possible Actemra side effects in female
Reported by a individual with unspecified qualification from Japan on 2012-07-06
Patient: female, weighing 59.0 kg (129.8 pounds)
Reactions: Pneumonia Bacterial, RED Blood Cell Count Decreased, Skin Ulcer, Cerebral Infarction, Sepsis, Arthritis Bacterial, Endocarditis, Platelet Count Decreased, Abscess Limb
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Start date: 2009-01-29
End date: 2009-01-29
Prednisolone and Prednisolone Acetate and Prednisolone Sodium Succinat
Administration route: Oral
Indication: Rheumatoid Arthritis
Vancomycin
Indication: Rheumatoid Arthritis
Actemra
Start date: 2009-03-24
End date: 2009-03-24
Actemra
Start date: 2009-02-24
End date: 2009-02-24
Prednisolone and Prednisolone Acetate and Prednisolone Sodium Succinat
Administration route: Oral
Other drugs received by patient: Rheumatrex; Rimatil; Cytotec; Celecoxib; Methotrexate
Possible Actemra side effects in female
Reported by a physician from Japan on 2012-07-06
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Sepsis, Disseminated Intravascular Coagulation, Pelvic Abscess
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Start date: 2009-12-15
End date: 2011-12-22
Methotrexate Sodium
Administration route: Oral
Indication: Rheumatoid Arthritis
Prednisolone
Indication: Rheumatoid Arthritis
Other drugs received by patient: Diclofenac Sodium; Azulfidine
Possible Actemra side effects in
Reported by a individual with unspecified qualification from United Kingdom on 2012-07-03
Patient:
Reactions: Pneumonia, Nausea, NO Therapeutic Response, Sepsis, Arthritis Bacterial, Neutropenia, Hypogammaglobulinaemia, Infusion Related Reaction
Adverse event resulted in: death
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Actemra
Indication: Spondyloarthropathy
Actemra
Indication: Arthritis
Actemra
Indication: Juvenile Arthritis
Actemra
Indication: Still's Disease Adult Onset
Possible Actemra side effects in female
Reported by a physician from Japan on 2012-07-03
Patient: female, weighing 35.0 kg (77.0 pounds)
Reactions: Disseminated Intravascular Coagulation, Sepsis, Gastritis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Dosage: once every 4-6 weeks
Indication: Rheumatoid Arthritis
Actemra
Dosage: once every 4-6 weeks, last dose prior to sae : 25/jan/2011
Actemra
Dosage: injection
Start date: 2008-10-28
End date: 2009-12-24
Other drugs received by patient: Ferrous Citrate; Glycyron; Clarithromycin; Livalo; Actonel; Rabeprazole Sodium; Calfina; Acetaminophen; Prednisolone; Prednisolone; Ganaton; Antihypertensive Medication NOS; Urso 250; Celecoxib; Promacta; Levothyroxine Sodium; Magnesium Oxide
Possible Actemra side effects in female
Reported by a physician from Thailand on 2012-07-02
Patient: female, weighing 30.0 kg (66.0 pounds)
Reactions: Histiocytosis Haematophagic, Sepsis, Infection
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Methotrexate
Possible Actemra side effects in male
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-06-29
Patient: male
Reactions: Pneumonia, Staphylococcal Infection, Cardiac Failure, Sepsis
Adverse event resulted in: death
Drug(s) suspected as cause:
Prednisolone
Indication: Rheumatoid Arthritis
Start date: 2002-04-04
Methotrexate
Indication: Rheumatoid Arthritis
Start date: 2002-04-04
Actemra
Dosage: 560 mg hver 4. uge
Indication: Rheumatoid Arthritis
Start date: 2010-08-01
End date: 2012-02-23
Possible Actemra side effects in 64 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-28
Patient: 64 year old male
Reactions: Death, Sepsis, Cholangitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Aspirin; Nicorandil; Valsartan; Temazepam; Simvastatin; Diazepam; Methotrexate; Omeprazole; Montelukast; Isosorbide Mononitrate; Acetaminophen and Codeine Phosphate; Folic Acid; Naproxen; Zemtard
Possible Actemra side effects in female
Reported by a physician from United States on 2012-06-27
Patient: female
Reactions: Cardiopulmonary Failure, Sepsis, Pulmonary Oedema, Cardiac Failure Congestive
Adverse event resulted in: death
Drug(s) suspected as cause:
Actemra
Start date: 2012-01-07
End date: 2012-01-07
Actemra
Indication: Rheumatoid Arthritis
Start date: 2011-10-12
End date: 2011-10-12
Other drugs received by patient: Methotrexate
Possible Actemra side effects in male
Reported by a physician from Denmark on 2012-06-25
Patient: male
Reactions: Pneumonia, Staphylococcal Infection, Cardiac Failure, Sepsis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Prednisolone
Dosage: behandling stoppet pga. mors
Indication: Rheumatoid Arthritis
Start date: 2002-04-04
Actemra
Dosage: dosis: 560 mg hver 4. uge
Indication: Rheumatoid Arthritis
Start date: 2010-08-01
End date: 2012-02-23
Methotrexate
Dosage: behandling stoppet pga. mors, drug reported as emthexate
Indication: Rheumatoid Arthritis
Start date: 2002-04-04
Possible Actemra side effects in female
Reported by a individual with unspecified qualification from Japan on 2012-06-14
Patient: female, weighing 53.0 kg (116.6 pounds)
Reactions: Cellulitis, Sepsis, Anaemia, Bacterial Sepsis, Endocarditis, Pancytopenia, Upper Respiratory Tract Inflammation, Pyelonephritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Actemra
Tacrolimus
Actemra
Start date: 2010-01-21
End date: 2010-09-02
Actemra
Indication: Rheumatoid Arthritis
Start date: 2008-12-25
End date: 2008-12-25
Actemra
Start date: 2009-04-02
End date: 2009-04-02
Tacrolimus
Start date: 2008-10-26
End date: 2008-12-24
Actemra
Start date: 2009-01-23
End date: 2009-01-23
Actemra
Start date: 2009-04-30
End date: 2009-04-30
Actemra
Start date: 2009-06-18
End date: 2009-06-18
Actemra
Start date: 2009-05-21
End date: 2009-05-21
Actemra
Start date: 2010-01-07
End date: 2011-01-01
Tacrolimus
Indication: Rheumatoid Arthritis
Start date: 2008-09-18
End date: 2008-10-25
Other drugs received by patient: Prednisolone; Prednisolone; Warfarin Potassium; Loxonin; Prednisolone; Prednisolone; Lansoprazole; Prednisolone; Warfarin Potassium; Foliamin; Prednisolone; Isoniazid; Mecobalamin; Prednisolone; Prednisolone; Zolpidem
Possible Actemra side effects in female
Reported by a physician from Japan on 2012-06-05
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Pneumonia, Cellulitis, Respiratory Failure, Liver Function Test Abnormal, Sepsis, Meningitis, Thermal Burn
Adverse event resulted in: death
Drug(s) suspected as cause:
Rheumatrex
Administration route: Oral
Indication: Rheumatoid Arthritis
End date: 2011-08-26
Actemra
Dosage: dosage is uncertain.
Indication: Rheumatoid Arthritis
Start date: 2010-10-26
End date: 2012-04-03
Other drugs received by patient: Diflunisal; Ranitidine HCL; Aspirin; Celebrex; Talion (Japan); Lipitor; Alfacalcidol; Humulin R; Prednisolone; Alendronate Sodium
Possible Actemra side effects in female
Reported by a individual with unspecified qualification from Japan on 2012-05-17
Patient: female
Reactions: Disseminated Intravascular Coagulation, Sepsis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prednisolone and Prednisolone Acetate and Prednisolone Sodium Succinat
Administration route: Oral
Actemra
Indication: Rheumatoid Arthritis
Start date: 2009-05-15
End date: 2011-12-22
Prednisolone and Prednisolone Acetate and Prednisolone Sodium Succinat
Administration route: Oral
Indication: Rheumatoid Arthritis
Methotrexate Sodium
Administration route: Oral
Indication: Rheumatoid Arthritis
Other drugs received by patient: Azulfidine
Possible Actemra side effects in 52 year old male
Reported by a physician from Finland on 2012-05-15
Patient: 52 year old male
Reactions: Death, Vomiting, Flank Pain, Sepsis, Hypotonia, Oropharyngeal Pain
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Actemra
Indication: Juvenile Arthritis
End date: 2012-03-01
Prednisolone
Administration route: Oral
Indication: Juvenile Arthritis
Other drugs received by patient: Methotrexate
Possible Actemra side effects in female
Reported by a individual with unspecified qualification from Japan on 2012-05-04
Patient: female, weighing 37.0 kg (81.4 pounds)
Reactions: Atelectasis, Pneumonia, Subcutaneous Abscess, Bone Abscess, Disseminated Intravascular Coagulation, Pericardial Effusion, Ascites, Mediastinitis, Sepsis, Pleural Effusion, Arteritis Infective, Abscess Limb
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Start date: 2011-01-20
End date: 2011-02-17
Rheumatrex
Administration route: Oral
Indication: Rheumatoid Arthritis
Other drugs received by patient: Celecoxib; Rabeprazole Sodium
Possible Actemra side effects in 40 year old male
Reported by a physician from Israel on 2012-05-01
Patient: 40 year old male
Reactions: Renal Failure, Sepsis, Amyloidosis
Adverse event resulted in: death
Drug(s) suspected as cause:
Actemra
Possible Actemra side effects in 64 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-13
Patient: 64 year old female
Reactions: Abdominal Pain, Sepsis, Musculoskeletal Pain
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Piperacillin and Tazobactam; Warfarin Sodium; Lansoprazole; Calcium Carbonate; Prednisolone; Furosemide; Candesartan Cilexetil; Ergocalciferol; Ibandronate Sodium; Acetaminophen; Azathioprine; Dihydrocodeine Bitartrate INJ
Possible Actemra side effects in 60 year old female
Reported by a individual with unspecified qualification from Sweden on 2012-04-04
Patient: 60 year old female
Reactions: Sepsis, Circulatory Collapse, Thrombocytopenia, Leukopenia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Methotrexate; Prednisolone
Possible Actemra side effects in 52 year old male
Reported by a physician from Finland on 2012-03-30
Patient: 52 year old male
Reactions: Death, Vomiting, Flank Pain, Hypotonia, Sepsis, Oropharyngeal Pain
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Prednisolone
Administration route: Oral
Indication: Juvenile Arthritis
Actemra
Indication: Juvenile Arthritis
End date: 2012-03-01
Other drugs received by patient: Methotrexate
Possible Actemra side effects in female
Reported by a physician from Japan on 2012-03-30
Patient: female, weighing 37.0 kg (81.4 pounds)
Reactions: Atelectasis, Pneumonia, Subcutaneous Abscess, Bone Abscess, Disseminated Intravascular Coagulation, Ascites, Pericardial Effusion, Sepsis, Mediastinitis, Pleural Effusion, Arteritis Infective, Abscess Limb
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Rheumatrex
Administration route: Oral
Indication: Rheumatoid Arthritis
Actemra
Indication: Rheumatoid Arthritis
Start date: 2011-01-20
End date: 2011-02-17
Other drugs received by patient: Celecoxib; Rabeprazole Sodium
Possible Actemra side effects in female
Reported by a physician from Japan on 2012-03-20
Patient: female, weighing 37.0 kg (81.4 pounds)
Reactions: Atelectasis, Pneumonia, Subcutaneous Abscess, Bone Abscess, Disseminated Intravascular Coagulation, Pericardial Effusion, Ascites, Sepsis, Mediastinitis, Pleural Effusion, Arteritis Infective, Abscess Limb
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Start date: 2011-01-20
End date: 2011-02-17
Rheumatrex
Administration route: Oral
Indication: Rheumatoid Arthritis
Other drugs received by patient: Celecoxib; Rabeprazole Sodium
Possible Actemra side effects in 52 year old female
Reported by a physician from South Africa on 2012-03-20
Patient: 52 year old female
Reactions: Cardiac Tamponade, Purulent Pericarditis, Sepsis, Arthritis Bacterial, Hallucination
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Actemra
Possible Actemra side effects in female
Reported by a individual with unspecified qualification from Japan on 2012-03-13
Patient: female
Reactions: Renal Impairment, Hepatic Function Abnormal, Urinary Tract Infection, Sepsis, Disseminated Intravascular Coagulation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Start date: 2008-10-10
End date: 2011-09-29
Prednisolone
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
End date: 2011-10-09
Other drugs received by patient: Loxonin; Triazolam; Benidipine; Voltaren; Magmitt; Lansoprazole; Doxazosin Mesylate; Coniel; Famotidine; Voltaren; Livalo; Aspirin
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