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Actemra (Tocilizumab) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



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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