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Cytarabine (Cytarabine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cytarabine and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (1969)
Death (619)
Life Threatening Events (270)
Disability (42)

Reports by Reaction Type

Sepsis (184)Pyrexia (179)Febrile Neutropenia (153)Neutropenia (138)Pneumonia (108)Thrombocytopenia (107)Respiratory Failure (96)Death (92)Hypotension (88)Blood Bilirubin Increased (83)Nausea (82)Pancytopenia (81)

Below are a few examples of reports where side effects / adverse reactions may be related to Cytarabine. For a complete list or a specific selection of reports, please use the links above.

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 10 year old male

Reported by a physician from United States on 2012-08-27

Patient: 10 year old male, weighing 76.1 kg (167.4 pounds)

Reactions: Hypersensitivity, Hyperglycaemia, Peripheral Motor Neuropathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1000mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Cytarabine
    Dosage: 75mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Mercaptopurine
    Dosage: 60mgm2 cyclic
    Administration route: Oral
    Indication: T-Cell Type Acute Leukaemia

Methotrexate
    Indication: T-Cell Type Acute Leukaemia
    Start date: 2012-06-06

Nelarabine
    Dosage: 650mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia
    Start date: 2012-05-22

PEG-Asparaginase
    Indication: T-Cell Type Acute Leukaemia
    Start date: 2012-06-13

Vincristine
    Dosage: 1.5mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia
    Start date: 2012-06-13

Other drugs received by patient: Radiation



Possible Cytarabine side effects in male

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

Patient: male, weighing 87.0 kg (191.4 pounds)

Reactions: Hepatic Function Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Start date: 2012-05-16

Cytarabine
    Start date: 2012-05-16

Daunorubicin HCL
    Start date: 2012-05-16

Daunorubicin HCL
    Start date: 2012-05-16

Revlimid
    Administration route: Oral
    Start date: 2012-05-16
    End date: 2012-05-31

Other drugs received by patient: Fluconazole; Ciprofloxacin HCL



Possible Cytarabine side effects in female

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

Patient: female, weighing 67.6 kg (148.7 pounds)

Reactions: Nodule, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clofarabine
    Dosage: 90 mg, unk, 1 hr infusion on d2,d4,d6,d8,d10
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-01

Cytarabine
    Dosage: 1.80 g, unk,continuous infusion d1 to d10
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-30

Idarubicin HCL
    Dosage: 48 mg, unk, on d1,d3,d5
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-30

Other drugs received by patient: Fluconazole; Valaciclovir; Ceftazidime; Oxazepam; Leucoplenin



Possible Cytarabine side effects in 29 year old female

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

Patient: 29 year old female

Reactions: Histiocytosis Haematophagic, Cytomegalovirus Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Bleomycin
    Dosage: 8 cycles
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Carboplatin
    Dosage: 2 cycles
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Cisplatin
    Dosage: 2 cycles
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Cytarabine
    Dosage: 2 cycles
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Dacarbazine
    Dosage: 8 cycles
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Dexamethasone Sodium Phosphate
    Dosage: 2 cycles
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Doxorubicin HCL
    Dosage: 8 cycles
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Doxorubicin HCL
    Dosage: unk
    Indication: Hodgkin's Disease

Etoposide
    Dosage: 2 cycles
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Etoposide
    Dosage: unk
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2007-01-01

Gemcitabine Hydrochloride
    Dosage: unk
    Indication: Hodgkin's Disease
    Start date: 2007-01-01

Ifosfamide
    Dosage: unk
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2007-01-01

Ifosfamide
    Dosage: 2 cycles
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Rituximab
    Dosage: unk
    Indication: Hodgkin's Disease
    Start date: 2007-01-01

Vinblastine
    Dosage: 8 cycles
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Vinorelbine
    Dosage: unk
    Indication: Hodgkin's Disease
    Start date: 2007-01-01



Possible Cytarabine side effects in

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-24

Patient:

Reactions: Radiculopathy

Drug(s) suspected as cause:
Cisplatin
    Indication: Diffuse Large B-Cell Lymphoma

Cytarabine
    Indication: Diffuse Large B-Cell Lymphoma

Dexamethasone
    Indication: Diffuse Large B-Cell Lymphoma

Mabthera
    Indication: Diffuse Large B-Cell Lymphoma



Possible Cytarabine side effects in male

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

Patient: male, weighing 48.0 kg (105.6 pounds)

Reactions: Memory Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amphotericin B
    Dosage: 6x60 mg/d
    Administration route: Oral
    Start date: 2012-06-24

Cytarabine
    Dosage: 110 mg, per day
    Start date: 2012-08-08
    End date: 2012-08-11

Cytarabine
    Dosage: 110 mg, per day
    Start date: 2012-08-16

Furosemide
    Dosage: 2x10mg/d
    Start date: 2012-08-09
    End date: 2012-08-11

Granisetron
    Dosage: 3 mg, per day
    Start date: 2012-08-08
    End date: 2012-08-11

Granisetron
    Dosage: 3 mg, per day
    Start date: 2012-08-16

Imatinib Mesylate
    Dosage: 450 mg, per day
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-13

Mercaptopurine
    Dosage: 1x87.5mg/d average
    Administration route: Oral
    Start date: 2012-08-06

Pantoprazole
    Dosage: 40 mg, per day
    Administration route: Oral
    Start date: 2012-06-24
    End date: 2012-08-15

Sulfamethoxazole and Trimethoprim
    Dosage: 2x120mg every sat, sun and mon
    Administration route: Oral



Possible Cytarabine side effects in 29 year old female

Reported by a health professional (non-physician/pharmacist) from Hungary on 2012-08-24

Patient: 29 year old female

Reactions: Histiocytosis Haematophagic, Neoplasm Malignant, Cytomegalovirus Infection, Pancytopenia, Immunosuppression

Adverse event resulted in: death

Drug(s) suspected as cause:
Bleomycin Sulfate
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Carboplatin
    Indication: Hodgkin's Disease

Cisplatin
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Cytarabine
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Dacarbazine
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Doxorubicin Hydrochloride
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Etoposide
    Indication: Hodgkin's Disease

Gemcitabine Hydrochloride
    Indication: Hodgkin's Disease

Ifosfamide
    Indication: Hodgkin's Disease

Rituximab
    Indication: Hodgkin's Disease

Vinblastine Sulfate
    Indication: Hodgkin's Disease
    Start date: 2006-01-01

Vinorelbine
    Indication: Hodgkin's Disease

Other drugs received by patient: Dexamethasone



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 male

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

Patient: male, weighing 95.8 kg (210.8 pounds)

Reactions: Abdominal Pain, Hypotension, Pancytopenia, Ascites, Faecaloma, Diarrhoea, Sepsis, Colitis, Septic Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clofarabine
    Dosage: 25 mg/m2, unk
    Start date: 2012-07-31
    End date: 2012-08-04

Clofarabine
    Dosage: 25 mg/m2, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-29
    End date: 2012-07-03

Cytarabine
    Dosage: 750 mg/m2, unk
    Start date: 2012-07-31
    End date: 2012-08-04

Cytarabine
    Dosage: 750 mg/m2, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-29
    End date: 2012-07-03

Idarubicin HCL
    Dosage: 7.5 mg/m2, unk
    Start date: 2012-07-31
    End date: 2012-08-02

Idarubicin HCL
    Dosage: 7.5 mg/m2, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-29
    End date: 2012-07-01

Other drugs received by patient: Vancomycin; Metronidazole; Piritramide; Enoxaparin Sodium; Zofran; Clonazepam; Sodium Chloride; Ciprofloxacin; Acyclovir; Ringer; Levothyroxine Sodium; Potassium Chloride; Ceftazidime; Noxafil



Possible Cytarabine side effects in 29 year old female

Reported by a physician from Hungary on 2012-08-23

Patient: 29 year old female

Reactions: Histiocytosis Haematophagic, Pancytopenia, Cytomegalovirus Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Bleomycin Sulfate
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Carboplatin
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Cisplatin
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Cytarabine
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Dacarbazine
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Dexamethasone
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Doxorubicin Hydrochloride
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Etoposide
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Etoposide
    Start date: 2007-01-01

Gemcitabine Hydrochloride
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2007-01-01

Ifosfamide
    Start date: 2007-01-01

Ifosfamide
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Rituximab
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2007-01-01

Vinblastine Sulfate
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Vinorelbine
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2007-01-01



Possible Cytarabine side effects in 17 year old male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: 17 year old male, weighing 89.9 kg (197.8 pounds)

Reactions: Pharyngeal Inflammation, Hypoxia, Caecitis, Rash Maculo-Papular, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cefepime
    Indication: Acute Myeloid Leukaemia

Cytarabine
    Dosage: 100 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-18
    End date: 2012-05-28

Cytarabine
    Dosage: unk
    Start date: 2012-05-18
    End date: 2012-05-18

Daunorubicin HCL
    Dosage: 50 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-18
    End date: 2012-05-22

Etoposide
    Dosage: 100 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-18
    End date: 2012-05-22

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



Possible Cytarabine side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male, weighing 90.0 kg (198.0 pounds)

Reactions: Dyspnoea, Tachycardia, Atrial Fibrillation, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 1470 mg
    Start date: 2012-08-10

Daunorubicin HCL
    Dosage: 570 mg
    End date: 2012-08-06



Possible Cytarabine side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient:

Reactions: Cardio-Respiratory Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Cytarabine
    Dosage: 200 mg, once
    Start date: 2012-02-22
    End date: 2012-02-22

Emend
    Dosage: 125 mg, once
    Administration route: Oral
    Start date: 2012-02-21
    End date: 2012-02-21

Emend
    Dosage: 80 mg, once
    Administration route: Oral
    Start date: 2012-02-22
    End date: 2012-02-22

Etoposide
    Dosage: 200 mg, once
    Start date: 2012-02-22
    End date: 2012-02-22

Methylprednisolone
    Dosage: 160 mg, once
    Start date: 2012-02-22
    End date: 2012-02-22

Methylprednisolone
    Dosage: 60 mg, once
    Start date: 2012-02-21
    End date: 2012-02-21

Ondansetron
    Dosage: 8 mg, once
    Start date: 2012-02-21
    End date: 2012-02-21

Ondansetron
    Dosage: 8 mg, once
    Start date: 2012-02-22
    End date: 2012-02-22

Other drugs received by patient: Bicnu; Diamicron; Pravastatin Sodium; Amlodipine; Valium; Nexium; Tramadol HCL; Acetaminophen



Possible Cytarabine side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female

Reactions: Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-21

Cytarabine
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-17
    End date: 2012-07-20

Dasatinib
    Dosage: 40 milligram daily;
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-29

Mercaptopurine
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-13
    End date: 2012-07-21

Other drugs received by patient: Zofran; Miralax



Possible Cytarabine side effects in 29 year old female

Reported by a physician from Hungary on 2012-08-23

Patient: 29 year old female

Reactions: Histiocytosis Haematophagic, Pancytopenia, Cytomegalovirus Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Bleomycin Sulfate
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Carboplatin
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Cisplatin
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Cytarabine
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Dacarbazine
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Dexamethasone
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Doxorubicin Hydrochloride
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Etoposide
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Etoposide
    Start date: 2007-01-01

Gemcitabine Hydrochloride
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2007-01-01

Ifosfamide
    Start date: 2007-01-01

Ifosfamide
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Rituximab
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2007-01-01

Vinblastine Sulfate
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Vinorelbine
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2007-01-01



Possible Cytarabine side effects in

Reported by a physician from United States on 2012-08-22

Patient:

Reactions: Abdominal Pain, Thrombosis, Hyperkalaemia, Coagulopathy, Hypoglycaemia, Hypocalcaemia, Hypoxia, Hiccups, Alanine Aminotransferase Abnormal, Pneumonitis, Cough, Pain in Extremity, Hypotension, Hyperglycaemia, External Ear Pain, Haematotoxicity, Dehydration, Lower Gastrointestinal Haemorrhage, Hypofibrinogenaemia, Aspartate Aminotransferase Abnormal, Hypokalaemia, Blood Bilirubin Abnormal, Pleural Effusion, Decreased Appetite, Gamma-Glutamyltransferase Abnormal, Hyponatraemia, Hypercalcaemia, Hypophosphataemia, Diarrhoea, Hypoalbuminaemia, Hypertension, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Asparaginase
    Dosage: 2500 units/m2/dose as 4 weekly doses
    Indication: Acute Lymphocytic Leukaemia

Bortezomib
    Dosage: 1.3 mg/sq.m/dose on days 1, 4, 8 and 11 combined with vxld
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Dosage: on day 1 for all patients and on days 8, 15, 22 for cns invlovment
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: 10 mg/m2/day divided in to 2 doses for 14 consecutive days
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin HCL
    Dosage: given over 15-30 minutes on day 1
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Dosage: on days 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

Methotrexate Sodium
    Dosage: 1 dose on day 15 for no cns involvement and on days 8, 15, 22 for cns involvement
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2/dose, max. 2 mg, by push on days 1, 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

Other drugs received by patient: Vancomycin; Posaconazole; Voriconazole; Levofloxacin



Possible Cytarabine side effects in male

Reported by a physician from Netherlands on 2012-08-22

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Confusional State, Hepatic Enzyme Abnormal, Disorientation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clofarabine
    Dosage: 57 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-06

Cytarabine
    Dosage: 360 mg, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-28

Etoposide
    Dosage: 212 mg, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-28

Methotrexate
    Dosage: 900 mg, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-31

Methotrexate
    Dosage: 15 mg, unk
    Start date: 2012-08-06

Prednisolone
    Dosage: 55 mg, bid
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-06

Other drugs received by patient: Esomeprazole Sodium; Oxazepam; Fluconazole



Possible Cytarabine side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-08-22

Patient: 54 year old female

Reactions: Osteomyelitis, Febrile Neutropenia, Osteonecrosis, Bacterial Disease Carrier, Face Oedema, Osteonecrosis of JAW, Endocarditis Enterococcal, Bone Marrow Failure, Candidiasis, Purulent Discharge, Pain in JAW

Drug(s) suspected as cause:
Cytarabine
    Dosage: 200 mg/m2, unk
    Indication: Acute Myeloid Leukaemia

Cytarabine
    Dosage: 3 g/m2 every 12 hours for 4 days

Daunorubicin HCL
    Dosage: 45 mg/m2, unk
    Indication: Acute Myeloid Leukaemia

Idarubicin HCL
    Dosage: 12 mg/m2, unk
    Indication: Acute Myeloid Leukaemia



Possible Cytarabine side effects in male

Reported by a physician from United States on 2012-08-22

Patient: male, weighing 78.0 kg (171.6 pounds)

Reactions: Pain in Extremity, Hypotension, Splenic Infarction, Paraesthesia, Septic Embolus, Fungal Test Positive, Hypoxia, Circulatory Collapse, Asthenia, Cough

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 70 mg, intrathecal
    End date: 2012-07-12

Daunorubicin HCL
    Dosage: 200 mg
    End date: 2012-08-02

Methotrexate
    Dosage: 30 m, intrathecal
    End date: 2012-08-09

PEG-L-Asparaginase (Pegaspargase, Oncospar)
    Dosage: 4900 iu, intravenous
    End date: 2012-07-15

Prednisone
    Dosage: 3360 mg, oral
    Administration route: Oral
    End date: 2012-08-08



Possible Cytarabine side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female, weighing 23.6 kg (51.9 pounds)

Reactions: Activated Partial Thromboplastin Time Prolonged, Blood Fibrinogen Decreased, RED Blood Cell Schistocytes Present, Fibrin D Dimer Increased, International Normalised Ratio Increased, Coagulopathy, Prothrombin Time Prolonged

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 70 mg

Daunorubicin HCL
    Dosage: 46 mg

Dexamethasone
    Dosage: 115 mg

Methotrexate
    Dosage: 12 mg

PEG-L Asparaginase (Pegaspargase, Oncospar)

Vincristine Sulfate
    Dosage: 2.8 mg



Possible Cytarabine side effects in 29 year old female

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

Patient: 29 year old female

Reactions: Histiocytosis Haematophagic, Cytomegalovirus Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Bleomycin
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Carboplatin
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Cisplatin
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Cytarabine
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Dacarbazine
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Dexamethasone
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Doxorubicin HCL
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Doxorubicin HCL

Etoposide
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Etoposide
    Start date: 2007-01-01

Gemcitabine Hydrochloride
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2007-01-01

Ifosfamide
    Start date: 2007-01-01

Ifosfamide
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Rituximab
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2007-01-01

Vinblastine Sulfate
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2006-01-01

Vinorelbine
    Indication: non-Hodgkin's Lymphoma Stage IV
    Start date: 2007-01-01



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 64 year old male

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

Patient: 64 year old male, weighing 105.5 kg (232.1 pounds)

Reactions: Multi-Organ Failure, Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Clofarabine
    Dosage: 54.53 mg, qd
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-08-08
    End date: 2012-08-11

Cytarabine
    Dosage: unk
    Indication: Acute Myeloid Leukaemia

Other drugs received by patient: Meropenem



Possible Cytarabine side effects in male

Reported by a physician from United Kingdom on 2012-08-21

Patient: male, weighing 80.9 kg (178.0 pounds)

Reactions: Lower Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cisplatin
    Dosage: 100mgm2 every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-08-09

Cytarabine
    Dosage: 4gm2 every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-08-09

Dexamethasone
    Dosage: 40mg every 3 weeks
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-08-08

Ofatumumab
    Dosage: 1000mg cyclic
    Indication: Diffuse Large B-Cell Lymphoma Recurrent
    Start date: 2012-08-08

Other drugs received by patient: Perindopril Erbumine; Aspirin; Persantine



Possible Cytarabine side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female, weighing 108.0 kg (237.6 pounds)

Reactions: Blood Alkaline Phosphatase Increased, Bronchopulmonary Aspergillosis, Haemoptysis, Tinea Cruris, Haemorrhage Intracranial, Transfusion Reaction, Constipation, Mucosal Inflammation, Oesophageal Candidiasis, Respiratory Failure, Diarrhoea, Oral Candidiasis, Sepsis, Blood Creatinine Increased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 1000 mg/m2, qd
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-02-20
    End date: 2012-02-24

Etoposide
    Dosage: 100 mg/m2, qd
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-02-20
    End date: 2012-02-24

Mitoxantrone
    Dosage: 8 mg/m2, qd
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-02-20
    End date: 2012-02-24

Mozobil
    Dosage: 560 mcg/kg, qd
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-02-19
    End date: 2012-02-24

Other drugs received by patient: Omeprazole; Oxycontin; Neupogen; Multi-Vitamin; Biotene; Oxycodone HCL; Platelets; Acyclovir; Albuterol; Allopurinol; Carvedilol; Hydroxyurea; Docusate; Spiriva; Bactrim



Possible Cytarabine side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male, weighing 13.6 kg (29.9 pounds)

Reactions: Contusion, Vomiting, Flatulence, Hypotension, Tachycardia, Gastrointestinal Necrosis, Cardio-Respiratory Arrest, Hypophagia, Abdominal Distension, Bacterial Test Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: it 2-2.99 yrs 50 mg

Dexamethasone TAB
    Dosage: po 3 mg/m2 dose (1.75 bid)
    Administration route: Oral

Methotrexate Sodium
    Dosage: it 2 mg/m2

PEG-L Asparaginase (Pegaspaegase, Oncospar)
    Dosage: iv 2500 units/m2

Vincristine
    Dosage: iv 1.5mg/m2 on day 1 and day 8



Possible Cytarabine side effects in 8 year old female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-21

Patient: 8 year old female

Reactions: Mucoepidermoid Carcinoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin HCL
    Indication: Acute Lymphocytic Leukaemia

Elspar
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Mercaptopurine
    Indication: Acute Lymphocytic Leukaemia

Methotrexate

Methotrexate
    Indication: Acute Lymphocytic Leukaemia

Prednisone TAB
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Indication: Acute Lymphocytic Leukaemia



Possible Cytarabine side effects in 51 year old female

Reported by a health professional (non-physician/pharmacist) from Hong Kong on 2012-08-21

Patient: 51 year old female

Reactions: Granulocytopenia, Palmar-Plantar Erythrodysaesthesia Syndrome, Staphylococcal Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Clofarabine
    Dosage: 40 mg/m2, qd
    Indication: Acute Myeloid Leukaemia Recurrent

Cytarabine
    Dosage: 1 g/m2, qd
    Indication: Acute Myeloid Leukaemia Recurrent



Possible Cytarabine side effects in

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

Patient:

Reactions: Adrenal Insufficiency, Encephalopathy

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: 10 mg/m2, cyclic
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: 60 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

PEG-Asparaginase
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

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