Index of reports
> Life Threatening Events (178)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Actemra (Tocilizumab) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 178 Next >>
Possible Actemra side effects in male
Reported by a physician from Japan on 2012-08-25
Patient: male, weighing 56.0 kg (123.2 pounds)
Reactions: Dermatitis Allergic, Pruritus, Erythema, Fall, Death, Arthralgia, Injury, White Blood Cell Count Increased, Infection
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Prednisolone; Precipitated Calcium Carbonate; Levothyroxine Sodium; Allegra; Lasix; Sulfamethoxazole and Trimethoprim; Micardis; Vildagliptin; Bisoprolol Fumarate
Possible Actemra side effects in female
Reported by a physician from United Kingdom on 2012-08-22
Patient: female, weighing 67.5 kg (148.5 pounds)
Reactions: Small Intestinal Obstruction, Abdominal Adhesions
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Dosage: wk 52 only
Indication: Rheumatoid Arthritis
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2010-06-30
Placebo
Indication: Rheumatoid Arthritis
Other drugs received by patient: Alendronate Sodium; Symbicort; Prednisolone; Tiotropium; Lansoprazole; Prednisolone; Celecoxib; Albuterol Sulate; Theophylline; Simvastatin
Possible Actemra side effects in 47 year old female
Reported by a physician from Colombia on 2012-08-20
Patient: 47 year old female, weighing 59.8 kg (131.6 pounds)
Reactions: Pneumonia, Pyrexia
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Dosage: date of most recent dose prior to sae :22/feb/2012
Indication: Rheumatoid Arthritis
Start date: 2011-09-21
Roactemra
Dosage: date of last dose prior to sae : 13/jun/2012
Indication: Rheumatoid Arthritis
Start date: 2012-03-07
Other drugs received by patient: Omeprazole; Diclofenac; Folic Acid; Chloroquine; Acetaminophen; Prednisolone; Naproxen; Methotrexate
Possible Actemra side effects in 47 year old female
Reported by a physician from Colombia on 2012-08-17
Patient: 47 year old female, weighing 59.8 kg (131.6 pounds)
Reactions: Pneumonia, Pyrexia
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Dosage: date of most recent dose prior to sae :22/feb/2012
Indication: Rheumatoid Arthritis
Start date: 2011-09-21
Actemra
Dosage: date of last dose prior to sae : 13/jun/2012
Indication: Rheumatoid Arthritis
Start date: 2012-03-07
Other drugs received by patient: Acetaminophen; Prednisolone; Naproxen; Diclofenac; Methotrexate; Folic Acid; Omeprazole; Chloroquine
Possible Actemra side effects in male
Reported by a physician from Japan on 2012-08-17
Patient: male, weighing 158.0 kg (347.6 pounds)
Reactions: Dermatitis Allergic, Pruritus, Arthralgia, Injury, Fall, Erythema, White Blood Cell Count Increased, Infection
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Sulfamethoxazole and Trimethoprim; Bisoprolol Fumarate; Allegra; Lasix; Levothyroxine Sodium; Vildagliptin; Micardis; Prednisolone; Precipitated Calcium Carbonate
Possible Actemra side effects in 51 year old female
Reported by a physician from Brazil on 2012-08-15
Patient: 51 year old female, weighing 48.0 kg (105.6 pounds)
Reactions: Pleural Effusion, Septic Shock, Lower Respiratory Tract Infection
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Folic Acid; Methotrexate; Prednisone TAB; Golimumab; Acetaminophen
Possible Actemra side effects in female
Reported by a physician from India on 2012-08-14
Patient: female
Reactions: Muscle Spasms
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Actemra
Possible Actemra side effects in 49 year old female
Reported by a physician from France on 2012-08-14
Patient: 49 year old female
Reactions: Duodenal Ulcer, Perforated Ulcer, Peritonitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Start date: 2009-01-01
End date: 2011-06-01
Actemra
Start date: 2011-06-01
End date: 2012-03-01
Prednisone TAB
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Lyrica; Nexium; Atorvastatin
Possible Actemra side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13
Patient: female, weighing 63.1 kg (138.8 pounds)
Reactions: Pain in Extremity, Oedema Peripheral, Haematoma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Start date: 2011-11-11
End date: 2011-11-25
Actemra
Dosage: dose - 8
Start date: 2011-11-25
Other drugs received by patient: Bactrim DS; Azathioprine Sodium; Trazodone HCL; Trazodone HCL; Insulin S; Methylprednisolone; Tramadol HCL; Methylprednisolone; Prednisolone; Atenolol; Lisinopril
Possible Actemra side effects in female
Reported by a physician from Japan on 2012-08-13
Patient: female
Reactions: Thrombosis, Epigastric Discomfort, Dehydration, Oedema Peripheral, Drug Interaction, Superior Vena Cava Syndrome, Cardiomyopathy, Shock, Inferior Vena Caval Occlusion
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Actemra
Other drugs received by patient possibly interacting with the suspect drug: Actemra
Start date: 2010-07-16
End date: 2010-08-20
Actemra
Start date: 2010-09-17
End date: 2010-11-26
Actemra
Start date: 2010-12-07
Actemra
Start date: 2010-05-14
End date: 2010-06-18
Actemra
Start date: 2009-11-20
End date: 2010-04-09
Warfarin Sodium
Administration route: Oral
Start date: 2011-02-18
End date: 2011-04-27
Warfarin Sodium
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2010-12-01
Warfarin Sodium
Administration route: Oral
Start date: 2011-04-28
End date: 2011-08-13
Warfarin Sodium
Administration route: Oral
Start date: 2010-12-02
End date: 2011-02-17
Warfarin Sodium
Administration route: Oral
Start date: 2011-08-14
Other drugs received by patient: Prednisolone; Prednisolone; Prednisolone; Prednisolone; Prednisolone; Prednisolone; Lasix; Prednisolone; Prednisolone; Prednisolone; Neoral; Levothyroxine Sodium; Acetaminophen; Alfarol; Prednisolone; Lasix; Sulfamethoxazole and Trimethoprim; Aspirin; Alfarol; Loxonin; Prednisolone; Levothyroxine Sodium; Prednisolone; Prednisolone; Prednisolone; Prednisolone; Prednisolone; Prednisolone; Lasix; Alendronate Sodium; Prednisolone; Prednisolone; Prednisolone; Lasix; Mucosta; Sulfamethoxazole and Trimethoprim; Neoral; Neoral; Prednisolone; Omeprazole; Etodolac; Alfarol; Prednisolone; Lasix; Kadian; Levothyroxine Sodium; Fluconazole
Possible Actemra side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-08-08
Patient: female, weighing 49.0 kg (107.8 pounds)
Reactions: Weight Decreased, Nasopharyngitis, Cataract, Contusion, Hypovitaminosis, Dental Caries, Anaemia, Immunodeficiency, Platelet Count Decreased, Arthritis, Influenza
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Actemra
Dosage: dose:unknown, route :endovenous
Indication: Rheumatoid Arthritis
Start date: 2009-06-26
Actemra
Start date: 2009-10-01
Actemra
Start date: 2009-06-01
Actemra
Start date: 2009-09-01
Actemra
Start date: 2009-12-01
Actemra
Start date: 2009-05-01
Actemra
Start date: 2009-11-01
Actemra
Start date: 2009-08-28
Actemra
Start date: 2009-06-29
Actemra
Start date: 2009-01-01
Actemra
Start date: 2009-02-01
Actemra
Start date: 2009-03-01
Actemra
Start date: 2009-04-01
Other drugs received by patient: Calcium / Vitamin D; Captopril; Clonazepam; Citoneurin; Folic Acid; Amlodipine Besylate; Ascorbic Acid; Dipyrone INJ; Prednisolone
Possible Actemra side effects in female
Reported by a physician from Argentina on 2012-08-07
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Pneumonia, Acute Respiratory Failure
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Hydroxychloroquine Sulfate; Methotrexate; Folic Acid; Naproxen; Prednisone
Possible Actemra side effects in female
Reported by a consumer/non-health professional from Australia on 2012-08-07
Patient: female
Reactions: Pancreatic Carcinoma, Pulmonary Thrombosis, Neck Mass, Gastric Cancer
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Actemra
Possible Actemra side effects in female
Reported by a physician from Thailand on 2012-08-03
Patient: female, weighing 53.0 kg (116.6 pounds)
Reactions: Pneumonia, Ischaemic Stroke, Atrial Fibrillation, Acute Myocardial Infarction, Ischaemic Cerebral Infarction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Start date: 2011-07-12
Actemra
Dosage: last dose prior to the event: 06/dec/2011
Indication: Rheumatoid Arthritis
Start date: 2009-12-24
Actemra
Start date: 2011-10-10
Actemra
Start date: 2011-11-07
Actemra
Start date: 2011-12-06
Placebo
Indication: Rheumatoid Arthritis
Other drugs received by patient: Meropenem; Digoxin; Prednisolone; Sulfasalazine; Amiodarone HCL; Meropenem; Amiodarone HCL; Carvedilol; Amlodipine
Possible Actemra side effects in female
Reported by a physician from Argentina on 2012-08-03
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Pneumonia, Acute Respiratory Failure
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Prednisone; Naproxen; Hydroxychloroquine Sulfate; Methotrexate; Folic Acid
Possible Actemra side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-08-03
Patient: female, weighing 58.0 kg (127.6 pounds)
Reactions: Asthma, Cardio-Respiratory Arrest, Lung Disorder, Drug Ineffective, Pulmonary Embolism, Psoriasis, Laryngeal Oedema, Thyroid Neoplasm
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Start date: 2012-06-13
Actemra
Start date: 2012-07-10
Other drugs received by patient: Prednisone; Arava; Omeprazole; Codeine; Enbrel; Humira; Remicade; Cymbalta; Orencia; Methotrexate; Naprosyn
Possible Actemra side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-01
Patient: female, weighing 54.0 kg (118.8 pounds)
Reactions: Weight Decreased, Lymphadenopathy, Diverticulitis, Pulmonary Embolism, Cytomegalovirus Colitis, Intestinal Perforation, Basal Cell Carcinoma, Neck Pain, Hepatocellular Injury, Immunosuppression, Anaemia, Lymphopenia, Peritonitis, Arthralgia, Abscess, Lymphoma, Diffuse Large B-Cell Lymphoma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Dosage: monthly dose 432 mg
Indication: Rheumatoid Arthritis
Start date: 2010-08-03
End date: 2010-11-26
Etanercept
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
End date: 2008-01-01
Mabthera
Start date: 2012-01-01
Mabthera
Indication: Rheumatoid Arthritis
Start date: 2009-01-27
End date: 2009-02-12
Mabthera
Start date: 2010-01-05
End date: 2010-01-19
Methotrexate Sodium
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-01-01
End date: 2010-12-16
Methotrexate Sodium
Start date: 2008-01-01
Methotrexate Sodium
Administration route: Oral
Start date: 1995-01-01
End date: 2010-12-16
Other drugs received by patient: Piroxicam; Folic Acid; Acetaminophen; Aluminum Hydroxide and Magnesium Trisilicate; Indapamide; Feldene; Vitamin D; Protelos; Ferrous Sulfate TAB; Imodium; Omeprazole; Arixtra; Prednisone TAB; Calcium Carbonate
Possible Actemra side effects in female
Reported by a physician from France on 2012-08-01
Patient: female, weighing 54.0 kg (118.8 pounds)
Reactions: Diverticulitis, Lymphopenia, Pulmonary Embolism, Cytomegalovirus Colitis, Peritonitis, Intestinal Perforation, Diffuse Large B-Cell Lymphoma, Lymphoma
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Etanercept
Indication: Rheumatoid Arthritis
Mabthera
Indication: Rheumatoid Arthritis
Methotrexate
Indication: Rheumatoid Arthritis
Piroxicam
Indication: Rheumatoid Arthritis
Other drugs received by patient: Omeprazole; Ferrous Sulfate TAB; Vitamin D; Indapamide; Protelos; Aluminum Hydroxide and Magnesium Trisilicate; Calcium Carbonate; Prednisone TAB; Imodium; Folic Acid; Arixtra; Acetaminophen
Possible Actemra side effects in female
Reported by a physician from Thailand on 2012-07-31
Patient: female, weighing 53.0 kg (116.6 pounds)
Reactions: Pneumonia, Ischaemic Stroke, Atrial Fibrillation, Acute Myocardial Infarction, Ischaemic Cerebral Infarction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Start date: 2011-10-10
Actemra
Start date: 2011-12-06
Actemra
Dosage: last dose prior to the event: 06/dec/2011
Indication: Rheumatoid Arthritis
Start date: 2009-12-24
Actemra
Start date: 2011-07-12
Actemra
Start date: 2011-11-07
Placebo
Indication: Rheumatoid Arthritis
Other drugs received by patient: Amlodipine; Sulfasalazine; Amiodarone HCL; Amiodarone HCL; Digoxin; Prednisolone; Meropenem; Carvedilol; Meropenem
Possible Actemra side effects in male
Reported by a physician from Hungary on 2012-07-30
Patient: male, weighing 85.0 kg (187.0 pounds)
Reactions: Abdominal Strangulated Hernia, Peritonitis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Start date: 2011-05-18
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2007-01-01
Other drugs received by patient: Silymarin; Methylprednisolone; Allopurinol; Metoprolol Tartrate; Betahistine; Amlodipine Besilate / Lisinopril; Famotidine; Infliximab
Possible Actemra side effects in female
Reported by a physician from Japan on 2012-07-27
Patient: female, weighing 69.2 kg (152.2 pounds)
Reactions: Death, Hyperlipidaemia, Renal Cell Carcinoma, Hepatic Function Abnormal, Joint Effusion
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Actemra
Dosage: dosage is uncertain
Indication: Rheumatoid Arthritis
Start date: 2008-08-26
End date: 2008-08-26
Infliximab
Indication: Rheumatoid Arthritis
Start date: 2007-09-19
End date: 2008-07-31
Methotrexate Sodium
Dosage: divided into 2 doses.
Administration route: Oral
Start date: 2009-02-11
End date: 2010-09-01
Methotrexate Sodium
Administration route: Oral
Start date: 2009-01-14
End date: 2009-02-10
Methotrexate Sodium
Dosage: divided into 2 doses
Administration route: Oral
Indication: Rheumatoid Arthritis
Other drugs received by patient: Norvasc; Dexamethasone; Prednisolone; Folic Acid; Prednisolone; Norvasc; Protecadin; Folic Acid; Prednisolone; Prednisolone; Prednisolone; Prednisolone; Alendronate Sodium; Amlodipine; Rimatil; Prednisolone; Voltaren
Possible Actemra side effects in female
Reported by a physician from Argentina on 2012-07-25
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Pneumonia, Acute Respiratory Failure
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Ceftriaxone; Clarithromycin; Hydrocortisone; Hydrocortisone
Possible Actemra side effects in female
Reported by a physician from Thailand on 2012-07-23
Patient: female, weighing 53.0 kg (116.6 pounds)
Reactions: Pneumonia, Ischaemic Stroke, Atrial Fibrillation, Acute Myocardial Infarction, Ischaemic Cerebral Infarction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Start date: 2011-12-06
Actemra
Start date: 2011-10-10
Actemra
Start date: 2011-07-12
Actemra
Start date: 2011-11-07
Actemra
Dosage: last dose prior to the event: 06/dec/2011
Indication: Rheumatoid Arthritis
Start date: 2009-12-24
Placebo
Indication: Rheumatoid Arthritis
Other drugs received by patient: Sulfasalazine; Amlodipine; Prednisolone
Possible Actemra side effects in female
Reported by a physician from Argentina on 2012-07-20
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Pneumonia, Acute Respiratory Failure
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Actemra
Other drugs received by patient: Hydrocortisone; Hydrocortisone; Clarithromycin; Ceftriaxone
Possible Actemra side effects in 78 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-20
Patient: 78 year old female
Reactions: Chronic Lymphocytic Leukaemia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Actemra
Dosage: 8 mg/kg, 1x/day
Indication: Rheumatoid Arthritis
Start date: 2011-02-01
End date: 2012-02-01
Enbrel
Dosage: 50 mg, 1x/day
Indication: Rheumatoid Arthritis
Start date: 2010-06-01
End date: 2011-01-01
Humira
Dosage: 40 mg, unk
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
End date: 2010-01-01
Possible Actemra side effects in female
Reported by a physician from Switzerland on 2012-07-19
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Alveolitis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Actemra
Indication: Temporal Arteritis
Start date: 2012-06-01
End date: 2012-06-01
Methotrexate
Administration route: Oral
Methotrexate
Indication: Temporal Arteritis
Start date: 2012-01-03
End date: 2012-05-29
Methotrexate
Prednisone
Prednisone
Administration route: Oral
Indication: Temporal Arteritis
Start date: 2011-09-01
Prednisone
Possible Actemra side effects in female
Reported by a physician from Honduras on 2012-07-19
Patient: female, weighing 60.0 kg (132.0 pounds)
Reactions: Dyspnoea, Heart Rate Decreased, Anaphylactoid Reaction, Rash
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Start date: 2012-02-19
End date: 2012-04-19
Actemra
Start date: 2012-05-07
Possible Actemra side effects in male
Reported by a physician from Japan on 2012-07-18
Patient: male
Reactions: Lung Adenocarcinoma
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Actemra
Indication: Rheumatoid Arthritis
Start date: 2009-06-19
End date: 2010-08-06
Actemra
Start date: 2010-10-05
End date: 2011-06-03
Actemra
Start date: 2011-07-15
Other drugs received by patient: Isoniazid; Allopurinol
Possible Actemra side effects in female
Reported by a physician from Singapore on 2012-07-18
Patient: female, weighing 56.2 kg (123.6 pounds)
Reactions: Gastrointestinal Inflammation, Gastric Disorder, Autoinflammatory Disease, Liver Disorder, Bacteraemia, Liver Abscess, Meningitis, Inflammation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Actemra
Indication: Autoinflammatory Disease
Start date: 2012-03-03
Anakinra
Indication: Autoinflammatory Disease
Start date: 2011-09-05
End date: 2012-02-19
Other drugs received by patient: Calcium Carbonate; Atorvastatin; Methotrexate; Prednisolone; Lynae Product NOS; Clopidogrel; Alendronate Sodium; Warfarin Sodium
Possible Actemra side effects in female
Reported by a physician from Singapore on 2012-07-16
Patient: female, weighing 56.2 kg (123.6 pounds)
Reactions: Gastrointestinal Inflammation, Gastric Disorder, Autoinflammatory Disease, Liver Disorder, Bacteraemia, Meningitis, Liver Abscess, Inflammation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Actemra
Indication: Autoinflammatory Disease
Start date: 2012-03-03
Anakinra
Indication: Autoinflammatory Disease
Start date: 2011-09-05
End date: 2012-02-19
Other drugs received by patient: Warfarin Sodium; Calcium Carbonate; Methotrexate; Clopidogrel; Alendronate Sodium; Atorvastatin; Prednisolone; Lynae Product NOS
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