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Cytarabine (Cytarabine) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (270)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Cytarabine life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 270   Next >>

Possible Cytarabine side effects in female

Reported by a physician from Japan on 2012-08-27

Patient: female, weighing 45.8 kg (100.8 pounds)

Reactions: Cerebral Haemorrhage

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Cisplatin
    Dosage: 100mgm2 every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-06-11

Cytarabine
    Dosage: 4gm2 every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-06-12

Dexamethasone
    Dosage: 40mg every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-06-11

Ofatumumab
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-06-08

Other drugs received by patient: Granisetron; Maglax; Primperan TAB; Rabeprazole Sodium; Orgadrone



Possible Cytarabine side effects in male

Reported by a physician from Netherlands on 2012-08-24

Patient: male, weighing 94.0 kg (206.8 pounds)

Reactions: Subdural Haemorrhage

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Cytarabine
    Dosage: 430 milligram
    Start date: 2012-08-14
    End date: 2012-08-19

Daunorubicin HCL
    Start date: 2012-08-14
    End date: 2012-08-16

Revlimid
    Dosage: 20 milligram
    Administration route: Oral
    Start date: 2012-08-14
    End date: 2012-08-19

Other drugs received by patient: Fraxiparine



Possible Cytarabine side effects in 14 year old male

Reported by a physician from Norway on 2012-08-21

Patient: 14 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Mucosal Inflammation, Listless, Fatigue, Febrile Neutropenia, Sinusitis, Decreased Appetite

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Celecoxib
    Dosage: 400 mg, 2x/day
    Indication: Medulloblastoma

Cytarabine
    Dosage: 50 mg, cyclic, every other month

Cytarabine
    Dosage: 50 mg, cyclic, every other week then monthly
    Indication: Medulloblastoma

Etoposide
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Medulloblastoma

Thalidomide
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Indication: Medulloblastoma

Other drugs received by patient: Prednisolone Succinate



Possible Cytarabine side effects in male

Reported by a consumer/non-health professional from Netherlands on 2012-08-20

Patient: male, weighing 76.0 kg (167.2 pounds)

Reactions: Hepatic Function Abnormal, Splenic Embolism, Encephalopathy, Febrile Neutropenia, Pneumonia Cytomegaloviral, Mucosal Inflammation, Enterococcal Sepsis, Pericarditis, Cerebral Artery Embolism, Respiratory Failure, Ventricular Tachycardia, Acute Respiratory Distress Syndrome, Renal Failure Acute, Candidiasis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Clofarabine
    Dosage: 19.6 mg, unk
    Indication: Acute Leukaemia
    Start date: 2012-03-28
    End date: 2012-04-01

Cytarabine
    Dosage: 391 mg, unk
    Indication: Acute Leukaemia
    Start date: 2012-03-28
    End date: 2012-04-03

Idarubicin HCL
    Dosage: 23.5 mg, unk
    Indication: Acute Leukaemia
    Start date: 2012-03-28
    End date: 2012-03-30



Possible Cytarabine side effects in female

Reported by a physician from United States on 2012-08-20

Patient: female, weighing 70.8 kg (155.8 pounds)

Reactions: Abdominal Pain, Hyperpyrexia, Anaphylactic Reaction, Chills, Pain, Hepatic Failure, Transaminases Increased, Splenic Infarction, Loss of Consciousness, Aortic Thrombosis, Off Label Use, Malaise, C-Reactive Protein Increased, Myositis, Dyspnoea, Hypotension, Arrhythmia, Lung Consolidation, Hypophosphataemia, Zygomycosis, Bacteraemia, Ventricular Tachycardia, Hyperammonaemia, Neutropenia, Hepatic Infarction, Shock, Infusion Related Reaction

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Cytarabine
    Dosage: day 1,8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23

Decadron Phosphate
    Dosage: day 1
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23

Doxil
    Dosage: day 1
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23
    End date: 2007-10-23

Methotrexate
    Dosage: day 1
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2005-01-01
    End date: 2007-01-01

PEG-Asparaginase
    Dosage: day 2, 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-25
    End date: 2007-10-25

Velcade
    Dosage: day 1, 4, 8 and 11
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23
    End date: 2007-10-23

Vincristine
    Dosage: day 1,8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23
    End date: 2007-10-23



Possible Cytarabine side effects in 14 year old male

Reported by a physician from United States on 2012-08-20

Patient: 14 year old male, weighing 71.4 kg (157.1 pounds)

Reactions: Dyspnoea, Hypotension, Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 100 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-08-09
    End date: 2012-08-10

Cytarabine
    Dosage: 70 mg, cyclic
    Start date: 2012-08-09
    End date: 2012-08-09

Daunorubicin HCL
    Dosage: 50 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-08-09
    End date: 2012-08-09

Etoposide
    Dosage: 100 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-08-09
    End date: 2012-08-09

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-08-09
    End date: 2012-08-09



Possible Cytarabine side effects in 66 year old male

Reported by a physician from United Kingdom on 2012-08-17

Patient: 66 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Multi-Organ Failure, Neutropenic Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22

Daunorubicin HCL
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22

Mylotarg
    Dosage: 5.3 mg (total dose)
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22



Possible Cytarabine side effects in female

Reported by a physician from Netherlands on 2012-08-16

Patient: female, weighing 7.4 kg (16.3 pounds)

Reactions: Capillary Leak Syndrome, Hepatic Function Abnormal, Respiratory Failure, Disease Progression, Ascites

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Clofarabine
    Dosage: 11 mg (40 mg/m2), qdx5
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2010-07-23
    End date: 2010-07-27

Cyclophosphamide
    Dosage: 80 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2010-07-23
    End date: 2010-07-27

Cytarabine
    Dosage: 15 mg, od
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2010-07-28
    End date: 2010-07-28

Cytarabine
    Indication: Chemotherapy

Etoposide
    Dosage: 28 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2010-07-23
    End date: 2010-07-27

Methotrexate
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: 6 mgr, od
    Indication: Chemotherapy
    Start date: 2010-07-28
    End date: 2010-07-28

Prednisolone
    Indication: Chemotherapy

Prednisolone
    Dosage: 6 mgr, od
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2010-07-28
    End date: 2010-07-28

Other drugs received by patient: Itraconazole; Vancomycin; Dexamethasone; Filgrastim; Teicoplanin; Ciprofloxacin HCL; Ciprofloxacin HCL; Tramadol HCL; Vancomycin; Ceftazidime; Zofran; Vancomycin; Furosemide; Cotrim; Vancomycin; Vitamin K TAB; Cotrim; Itraconazole; Vancomycin; Vancomycin; Omeprazole; Acetaminophen; Ciprofloxacin; Furosemide; Ceftazidime; Furosemide; Omeprazole



Possible Cytarabine side effects in 4 year old female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 4 year old female, weighing 13.7 kg (30.1 pounds)

Reactions: Blood Bilirubin Increased, Hyponatraemia, Hypernatraemia, Caecitis, Hypokalaemia, Hypophosphataemia, Left Ventricular Dysfunction, Cardiac Failure, Ileus, Diarrhoea, Venoocclusive Liver Disease, Hypocalcaemia, Acute Respiratory Distress Syndrome

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk, cyclic

Cytarabine
    Dosage: 100 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-20
    End date: 2012-07-05

Daunorubicin HCL
    Dosage: 50 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-20
    End date: 2012-06-24

Etoposide
    Dosage: 100 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-20
    End date: 2012-06-24

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-20
    End date: 2012-06-25



Possible Cytarabine side effects in female

Reported by a physician from Netherlands on 2012-08-14

Patient: female, weighing 61.9 kg (136.2 pounds)

Reactions: Pancytopenia, Ascites

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Clofarabine
    Dosage: 17 mg at day 2, 4, 6, 8, 10, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-07-01
    End date: 2012-07-09

Cytarabine

Cytarabine
    Dosage: 170 mg, 1 in 1 day
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-30
    End date: 2012-07-09

Idarubicin HCL
    Dosage: 17 mg at day 1, 3, 5
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-30
    End date: 2012-07-04



Possible Cytarabine side effects in 66 year old male

Reported by a physician from United States on 2012-08-14

Patient: 66 year old male

Reactions: Sepsis, Melaena, Decreased Appetite, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 3360 mg, (total)
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-25

Daunorubicin HCL
    Dosage: 435 mg, (total)
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-25

Sprycel
    Dosage: 1200 mg, (total)
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-25
    End date: 2012-06-12



Possible Cytarabine side effects in 70 year old male

Reported by a physician from Austria on 2012-08-14

Patient: 70 year old male, weighing 94.0 kg (206.8 pounds)

Reactions: Respiratory Failure

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Atracurium Besylate
    Dosage: 120 mg, 1x/day
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-07-18

Cytarabine
    Dosage: 205 mg, 1x/day
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-07-13

Etoposide
    Dosage: 205 mg, 1x/day
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-07-13

Idarubicin HCL
    Dosage: 24 mg, 1x/day
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-07-13

Other drugs received by patient: Colidimin; Tazonam; Vfend



Possible Cytarabine side effects in female

Reported by a physician from United States on 2012-08-14

Patient: female, weighing 70.8 kg (155.8 pounds)

Reactions: Abdominal Pain, Rhabdomyolysis, Hyperpyrexia, Chills, Anaphylactic Reaction, Bone Pain, Hepatic Failure, Transaminases Increased, Loss of Consciousness, Aortic Thrombosis, Splenic Infarction, Hypokalaemia, Malaise, C-Reactive Protein Increased, Dyspnoea, Hypotension, Hypophosphataemia, Zygomycosis, Bacteraemia, Hyperammonaemia, Neutropenia, Hepatic Infarction, Lung Infiltration, Shock, Infusion Related Reaction

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 70 mg, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2005-01-01
    End date: 2007-10-23

Decadron Phosphate
    Dosage: 9 mg, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23
    End date: 2007-10-23

Doxorubicin HCL
    Dosage: 107 mg, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23
    End date: 2007-10-23

Methotrexate Sodium
    Dosage: unk, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2005-01-01
    End date: 2007-01-01

Pegaspargase
    Dosage: unk, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-25

Velcade
    Dosage: 1.3 mg/m2, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23
    End date: 2007-10-23

Vincristine
    Dosage: 2 mg, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2007-10-23
    End date: 2007-10-23



Possible Cytarabine side effects in male

Reported by a consumer/non-health professional from Belgium on 2012-08-10

Patient: male, weighing 76.0 kg (167.2 pounds)

Reactions: Hepatic Function Abnormal, Splenic Embolism, Encephalopathy, Febrile Neutropenia, Pneumonia Cytomegaloviral, Mucosal Inflammation, Enterococcal Sepsis, Respiratory Failure, Pericarditis, Cerebral Artery Embolism, Sepsis, Ventricular Tachycardia, Acute Respiratory Distress Syndrome, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Clofarabine
    Dosage: 19.6 mg, unk
    Indication: Acute Leukaemia
    Start date: 2012-03-28
    End date: 2012-04-01

Cytarabine
    Dosage: 391 mg, unk
    Indication: Acute Leukaemia
    Start date: 2012-03-28
    End date: 2012-04-03

Floxacillin Sodium

Idarubicin HCL
    Dosage: 23.5 mg, unk
    Indication: Acute Leukaemia
    Start date: 2012-03-28
    End date: 2012-03-30



Possible Cytarabine side effects in male

Reported by a physician from Netherlands on 2012-08-09

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Pneumonia, Respiratory Failure

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Cytarabine
    Start date: 2012-06-15

Daunorubicin HCL
    Start date: 2012-06-15

Revlimid
    Administration route: Oral
    Start date: 2012-06-15
    End date: 2012-06-29

Other drugs received by patient: Ciprofloxacin HCL; Temazepam; Lisinopril; Fluconazole; Colistin



Possible Cytarabine side effects in male

Reported by a physician from United States on 2012-08-09

Patient: male, weighing 31.8 kg (70.0 pounds)

Reactions: Abdominal Pain, Atelectasis, Disseminated Intravascular Coagulation, Acidosis, Pericardial Effusion, Activated Partial Thromboplastin Time Prolonged, Multi-Organ Failure, Left Ventricular Dysfunction, Pulmonary Oedema, Mediastinal Haemorrhage, Blood Creatinine Increased, Renal Failure Acute, Dyspnoea, Angina Pectoris, Alanine Aminotransferase Increased, Hypotension, Hypercalcaemia, Respiratory Failure, Embolism, Cardiac Failure, Aspartate Aminotransferase Increased, Ventricular Tachycardia, Ejection Fraction Decreased, Hypoalbuminaemia, Ventricular Fibrillation, Sinus Tachycardia

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Ativan
    Indication: Product Used FOR Unknown Indication

Cytarabine
    Dosage: 100 mg/kg, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-01
    End date: 2012-06-11

Daunorubicin HCL
    Dosage: 50 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-01
    End date: 2012-06-05

Etoposide
    Dosage: 100 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-01
    End date: 2012-06-05

Fentanyl
    Indication: Product Used FOR Unknown Indication

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-01
    End date: 2012-06-01



Possible Cytarabine side effects in male

Reported by a consumer/non-health professional from Netherlands on 2012-08-07

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Multi-Organ Failure, Rhabdomyolysis, Blood Creatine Phosphokinase Increased, Sepsis, Lung Infection

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Amsacrine
    Dosage: 220 mg, unk
    Indication: Haematological Malignancy
    Start date: 2012-01-21
    End date: 2012-01-23

Clofarabine
    Dosage: 18 mg (10mg/m2), unk
    Start date: 2012-01-18
    End date: 2012-01-22

Clofarabine
    Dosage: 19.5 mg x 1, day 1-5
    Indication: Haematological Malignancy
    Start date: 2011-11-16
    End date: 2011-11-20

Cytarabine
    Dosage: 390 mg x 1, day 1-7
    Indication: Haematological Malignancy
    Start date: 2011-11-16
    End date: 2011-11-22

Cytarabine
    Dosage: 1800 mg x2
    Start date: 2012-01-18
    End date: 2012-01-23

Idarubicin HCL
    Dosage: 24 mg x 1, day 1-3
    Indication: Haematological Malignancy
    Start date: 2011-11-16
    End date: 2011-11-18

Other drugs received by patient: Valaciclovir; Propofol; Amphotericin B; Valaciclovir



Possible Cytarabine side effects in 66 year old male

Reported by a physician from France on 2012-08-07

Patient: 66 year old male, weighing 82.0 kg (180.4 pounds)

Reactions: Stenotrophomonas Infection, Coma, Device Related Infection, Pyrexia, Hypernatraemia, Loss of Consciousness, Malaise, Meningeal Disorder, Oedema Peripheral, Eye Movement Disorder, Blood Creatinine Increased, Cough, Hyperphosphataemia, Pleurisy, Pancytopenia, General Physical Health Deterioration, Aplasia, Convulsion, Nephrogenic Diabetes Insipidus, Neutropenia, Citrobacter Infection, Generalised Oedema, Hyperuricaemia, Myalgia, Weight Increased, Pleural Effusion, Crepitations, Thrombocytopenia, Jugular Vein Thrombosis, Candidiasis, Renal Failure Acute, Dyspnoea, Mucosal Inflammation, Diarrhoea, Monoparesis, Inflammation

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Cytarabine
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2012-02-28
    End date: 2012-03-02

Etoposide
    Dosage: 400 mg/m2 daily; uid/qd
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2012-02-28
    End date: 2012-03-02

Melphalan Hydrochloride
    Dosage: 250 mg total dose
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2012-03-03

Treanda
    Dosage: 180 mg/m2 daily; 358.5 mg on day 1 + 2 of each cycle
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2012-02-27
    End date: 2012-02-28

Treanda
    Indication: non-Hodgkin's Lymphoma



Possible Cytarabine side effects in male

Reported by a physician from Belgium on 2012-08-06

Patient: male, weighing 76.0 kg (167.2 pounds)

Reactions: Hepatic Function Abnormal, Splenic Embolism, Encephalopathy, Febrile Neutropenia, Pneumonia Cytomegaloviral, Mucosal Inflammation, Enterococcal Sepsis, Respiratory Failure, Cerebral Artery Embolism, Pericarditis, Sepsis, Ventricular Tachycardia, Acute Respiratory Distress Syndrome, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Clofarabine
    Dosage: 19.6 mg, unk
    Indication: Acute Leukaemia
    Start date: 2012-03-28
    End date: 2012-04-01

Cytarabine
    Dosage: 391 mg, unk
    Indication: Acute Leukaemia
    Start date: 2012-03-28
    End date: 2012-04-03

Floxacillin Sodium

Idarubicin HCL
    Dosage: 23.5 mg, unk
    Indication: Acute Leukaemia
    Start date: 2012-03-28
    End date: 2012-03-30



Possible Cytarabine side effects in 65 year old male

Reported by a physician from France on 2012-08-06

Patient: 65 year old male, weighing 74.0 kg (162.8 pounds)

Reactions: Oedema Peripheral, Pancytopenia, Blood Creatinine Increased, Generalised Oedema, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Cytarabine
    Dosage: continuous infusion w/syringe driver 775 mg/day-day 2 to 5
    Indication: Bone Marrow Conditioning Regimen

Etoposide
    Dosage: 380 mg from day 2 to day 5
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2012-03-06

Rituximab
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2012-03-06

Treanda
    Dosage: 200 mg/kg daily; day 1 and 2 of each cycle
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2012-03-05

Other drugs received by patient: Melphalan Hydrochloride



Possible Cytarabine side effects in female

Reported by a physician from Netherlands on 2012-08-06

Patient: female, weighing 61.9 kg (136.2 pounds)

Reactions: Pancytopenia, Ascites

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Clofarabine
    Dosage: 17 mg at day 2, 4, 6, 8, 10, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-07-01
    End date: 2012-07-09

Cytarabine
    Dosage: unk, from day 1 to 10
    Indication: Product Used FOR Unknown Indication

Cytarabine

Idarubicin HCL
    Dosage: 17 mg at day 1, 3, 5
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-30
    End date: 2012-07-04



Possible Cytarabine side effects in female

Reported by a physician from Netherlands on 2012-08-03

Patient: female, weighing 61.9 kg (136.2 pounds)

Reactions: Pancytopenia, Ascites

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Clofarabine
    Dosage: 17 mg at day 2, 4, 6, 8, 10, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-07-01
    End date: 2012-07-09

Cytarabine
    Dosage: unk, from day 1 to 10
    Indication: Product Used FOR Unknown Indication

Cytarabine

Idarubicin HCL
    Dosage: 17 mg at day 1, 3, 5
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-30
    End date: 2012-07-04



Possible Cytarabine side effects in female

Reported by a physician from Netherlands on 2012-08-02

Patient: female, weighing 73.0 kg (160.6 pounds)

Reactions: Bronchopulmonary Aspergillosis, Respiratory Failure, Pancytopenia, Neutropenia, Thrombocytopenia, Cerebral Haemorrhage, Influenza

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Amsacrine
    Dosage: 225 mg, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-10

Clofarabine
    Dosage: 19 mg, qd; day 1 to 5; cycles i and ii
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-07

Cytarabine
    Dosage: 1900 mg, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-07

Other drugs received by patient: Amphotericin B; Meropenem; Vancomycin; Voriconazole



Possible Cytarabine side effects in 33 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient: 33 year old male, weighing 93.0 kg (204.6 pounds)

Reactions: Lactobacillus Infection, Blood PH Increased, Tachycardia, Blood PH Decreased, Device Related Infection, Scleral Haemorrhage, Bacterial Sepsis, Acute Respiratory Distress Syndrome, Bone Marrow Failure, Blood Bicarbonate Increased, Acute Respiratory Failure, Renal Failure Acute, Febrile Neutropenia, Haemodialysis, Alopecia, Treatment Failure, Base Excess Decreased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
(Investigational Drug)
    Dosage: 60 mg, uid/qd, oral ; 60 mg, uid/qd, oral
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-04-17
    End date: 2012-04-23

(Investigational Drug)
    Dosage: 60 mg, uid/qd, oral ; 60 mg, uid/qd, oral
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-04-02
    End date: 2012-04-08

Amphotericin B
    Dosage: 450 mg, uid/qd, intravenous (not otherwise specified)
    Indication: Fungal Infection
    Start date: 2012-05-06
    End date: 2012-05-08

Amphotericin B
    Dosage: 450 mg, uid/qd, intravenous (not otherwise specified)
    Indication: Infection Prophylaxis
    Start date: 2012-05-06
    End date: 2012-05-08

Aztreonam
    Dosage: see image
    Indication: Bacterial Infection
    Start date: 2012-05-06
    End date: 2012-05-07

Aztreonam
    Dosage: see image
    Indication: Bacterial Infection
    Start date: 2012-04-09
    End date: 2012-04-10

Caspofungin Acetate
    Dosage: see image
    Indication: Infection
    Start date: 2012-04-09

Caspofungin Acetate
    Dosage: see image
    Indication: Infection
    Start date: 2012-04-08
    End date: 2012-04-08

Caspofungin Acetate
    Dosage: see image
    Indication: Infection
    Start date: 2012-05-20
    End date: 2012-05-22

Cefepime
    Dosage: 2 g, q8 hours, intravenous (not otherwise specified) ; intravenous (not otherwise specified)
    Indication: Infection
    Start date: 2012-03-29
    End date: 2012-04-10

Cefepime
    Dosage: 2 g, q8 hours, intravenous (not otherwise specified) ; intravenous (not otherwise specified)
    Indication: Infection
    Start date: 2012-06-02
    End date: 2012-06-05

Cytarabine
    Dosage: see image
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-04-14
    End date: 2012-04-20

Cytarabine
    Dosage: see image
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-03-30
    End date: 2012-04-05

Daunorubicin HCL
    Dosage: see image
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-03-30
    End date: 2012-04-01

Daunorubicin HCL
    Dosage: see image
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-04-14
    End date: 2012-04-16

Imipenem and Cilastatin
    Dosage: 1000 mg, q8 hours intravenous (not otherwise specified)
    Indication: Infection
    Start date: 2012-05-07
    End date: 2012-05-28

Penicillin G
    Dosage: 24000000 u, q24 hrs intravenous (not otherwise specified)
    Indication: Infection
    Start date: 2012-05-04
    End date: 2012-05-09

Vancomycin
    Indication: Product Used FOR Unknown Indication

Voriconazole
    Dosage: 522 mg, q12 hours, intravenous (not otherwise specified)
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-08
    End date: 2012-05-08

Other drugs received by patient: Ondansetron; Seroquel; Percocet; Nystatin; Zyloprim; Acetaminophen; Calcium Carbonate; Lorazepam; Xanax; Allopurinol; Calcium Gluconate; Ibuprofen; Hydroxyzine Pamoate; Celexa



Possible Cytarabine side effects in female

Reported by a physician from Netherlands on 2012-08-01

Patient: female, weighing 65.0 kg (143.0 pounds)

Reactions: Malaise, Diarrhoea, Pyrexia, Hypokalaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Amsacrine
    Dosage: 210 mg, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-29

Clofarabine
    Dosage: 18 mg, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-26

Cytarabine
    Dosage: 3600 mg, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-26



Possible Cytarabine side effects in 66 year old male

Reported by a physician from United States on 2012-07-31

Patient: 66 year old male

Reactions: Sepsis, Melaena, Renal Failure Acute, Decreased Appetite

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 3360 mg, (total)
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-24

Daunorubicin HCL
    Dosage: 435 mg, (total)
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-24

Sprycel
    Dosage: 1200 mg, (total)
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-24
    End date: 2012-06-12



Possible Cytarabine side effects in male

Reported by a physician from Netherlands on 2012-07-30

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Pneumonia, Respiratory Failure

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Cytarabine
    Start date: 2012-06-15

Daunorubicin HCL
    Start date: 2012-06-15

Revlimid
    Administration route: Oral
    Start date: 2012-06-15
    End date: 2012-06-29

Other drugs received by patient: Fluconazole; Ciprofloxacin HCL; Temazepam; Lisinopril; Colistin



Possible Cytarabine side effects in female

Reported by a physician from Netherlands on 2012-07-30

Patient: female, weighing 61.9 kg (136.2 pounds)

Reactions: Pancytopenia, Ascites

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Clofarabine
    Dosage: 17 mg at day 2, 4, 6, 8, 10, unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-01

Cytarabine
    Dosage: unk, from day 1 to 10
    Indication: Product Used FOR Unknown Indication

Cytarabine

Idarubicin HCL
    Dosage: 17 mg at day 1, 3, 5
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-30



Possible Cytarabine side effects in female

Reported by a physician from Netherlands on 2012-07-27

Patient: female, weighing 73.0 kg (160.6 pounds)

Reactions: Bronchopulmonary Aspergillosis, Respiratory Failure, Pancytopenia, Thrombocytopenia, Cerebral Haemorrhage, Influenza

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Amsacrine
    Dosage: 225 mg, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-10

Clofarabine
    Dosage: 19 mg, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-07

Cytarabine
    Dosage: 1900 mg, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-07

Other drugs received by patient: Meropenem; Vancomycin; Amphotericin B



Possible Cytarabine side effects in 17 year old male

Reported by a physician from United States on 2012-07-26

Patient: 17 year old male, weighing 84.1 kg (185.0 pounds)

Reactions: Hypotension, Pyrexia, Left Ventricular Dysfunction, Restrictive Cardiomyopathy, Cardiac Failure, Sepsis, Pulmonary Oedema, Acute Respiratory Distress Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 100 mg/m2, cyclic
    Start date: 2012-05-18
    End date: 2012-06-27

Cytarabine
    Dosage: 1000 mg/m2, cyclic
    Start date: 2012-05-18
    End date: 2012-06-27

Cytarabine
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-18
    End date: 2012-06-27

Daunorubicin Hydrochloride
    Dosage: 50 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-18
    End date: 2012-06-23

Daunorubicin Hydrochloride
    Dosage: 150 mg/m2, cyclic
    Start date: 2012-05-18
    End date: 2012-06-23

Etoposide
    Dosage: 150 mg/m2, cyclic
    Start date: 2012-05-18
    End date: 2012-06-23

Etoposide
    Dosage: 100 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-18
    End date: 2012-06-23

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-18
    End date: 2012-06-26



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