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Cytarabine (Cytarabine) - Serious Reactions - Suspected Cause - Side Effect Reports

 
 



Index of reports > Serious Reactions (917)

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

 Reports 1 - 30 of 917   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 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

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

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 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 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

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 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 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 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 17 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: 17 year old female, weighing 42.7 kg (93.9 pounds)

Reactions: Flushing, Oral Pain, Skin Exfoliation, Pain of Skin, Peripheral Sensory Neuropathy

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Cytarabine
    Dosage: 100 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-09
    End date: 2012-07-17

Daunorubicin HCL
    Dosage: unk
    Indication: Acute Myeloid Leukaemia

Doxorubicin Hydrochloride
    Dosage: 50 mg/m2, cyclic
    Start date: 2012-06-09
    End date: 2012-07-14

Etoposide
    Dosage: 100 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-09
    End date: 2012-07-14

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-09
    End date: 2012-07-17



Possible Cytarabine side effects in

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

Patient:

Reactions: Off Label Use, Zygomycosis

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

Asparaginase
    Dosage: 2500 units/m2/dose as 4 weekly doses
    Indication: Acute Lymphocytic Leukaemia

Asparaginase
    Dosage: 2500 units/m2/dose as 4 weekly doses

Asparaginase
    Dosage: 2500 units/m2/dose as 4 weekly doses

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

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

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

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

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

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

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

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

Dexamethasone
    Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
    Administration route: Oral

Dexamethasone
    Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
    Administration route: Oral

Dexamethasone
    Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
    Administration route: Oral

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

Doxorubicin Hydrochloride
    Dosage: given over 15-30 minutes on day 1

Doxorubicin Hydrochloride
    Dosage: given over 15-30 minutes on day 1

Doxorubicin Hydrochloride
    Dosage: given over 15-30 minutes on day 1

Hydrocortisone
    Dosage: on days 8, 15 and 22

Hydrocortisone
    Dosage: on days 8, 15 and 22

Hydrocortisone
    Dosage: on days 8, 15 and 22

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

Methotrexate
    Dosage: 1 dose on day 15 for no cns invlovement and on days 8, 15, 22 for cns invlovement

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

Methotrexate
    Dosage: 1 dose on day 15 for no cns invlovement and on days 8, 15, 22 for cns invlovement

Methotrexate
    Dosage: 1 dose on day 15 for no cns invlovement and on days 8, 15, 22 for cns invlovement

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

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

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

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



Possible Cytarabine side effects in

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

Patient:

Reactions: Gastrointestinal Haemorrhage, Coagulopathy, Escherichia Sepsis

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

Methotrexate
    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



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

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



Possible Cytarabine side effects in

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

Patient:

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



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 44 year old female

Reported by a physician from France on 2012-08-17

Patient: 44 year old female

Reactions: Lung Disorder, Gastrointestinal Haemorrhage, Mesenteric Panniculitis, Sepsis, Febrile Bone Marrow Aplasia

Drug(s) suspected as cause:
Cytarabine
    Dosage: 348 mg, 1x/day
    Indication: Acute Leukaemia
    Start date: 2008-07-22
    End date: 2008-07-28

Daunorubicin HCL
    Dosage: 104.4 mg, 1x/day
    Indication: Acute Leukaemia
    Start date: 2008-07-22
    End date: 2008-07-24

Mylotarg
    Dosage: 10.4 mg, 1x/day
    Indication: Acute Leukaemia
    Start date: 2008-07-25
    End date: 2008-07-25



Possible Cytarabine side effects in male

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-17

Patient: male, weighing 68.0 kg (149.6 pounds)

Reactions: Dyspnoea, Vomiting, Nausea, Hyperreflexia, Encephalopathy, Extensor Plantar Response, Endophthalmitis, Lung Consolidation, Respiratory Failure, Emotional Disorder, CSF Pressure Increased, Reflexes Abnormal, Lethargy

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Amsacrine
    Dosage: 220 mg, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-28

Clofarabine
    Dosage: 18 mg, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-25

Cytarabine
    Dosage: 3600 mg, unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-25

Other drugs received by patient: Valaciclovir



Possible Cytarabine side effects in

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

Patient:

Reactions: Off Label Use, Zygomycosis

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

Asparaginase
    Dosage: 2500 units/m2/dose as 4 weekly doses

Asparaginase
    Dosage: 2500 units/m2/dose as 4 weekly doses
    Indication: Acute Lymphocytic Leukaemia

Asparaginase
    Dosage: 2500 units/m2/dose as 4 weekly doses

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

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

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

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

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

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

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

Dexamethasone
    Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
    Administration route: Oral

Dexamethasone
    Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
    Administration route: Oral

Dexamethasone
    Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
    Administration route: Oral

Doxorubicin Hydrochloride
    Dosage: given over 15-30 minutes on day 1

Doxorubicin Hydrochloride
    Dosage: given over 15-30 minutes on day 1

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

Doxorubicin Hydrochloride
    Dosage: given over 15-30 minutes on day 1

Hydrocortisone
    Dosage: on days 8, 15 and 22

Hydrocortisone
    Dosage: on days 8, 15 and 22

Hydrocortisone
    Dosage: on days 8, 15 and 22

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

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

Methotrexate
    Dosage: 1 dose on day 15 for no cns invlovement and on days 8, 15, 22 for cns invlovement

Methotrexate
    Dosage: 1 dose on day 15 for no cns invlovement and on days 8, 15, 22 for cns invlovement

Methotrexate
    Dosage: 1 dose on day 15 for no cns invlovement and on days 8, 15, 22 for cns invlovement

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

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

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

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



Possible Cytarabine side effects in 63 year old female

Reported by a physician from Germany on 2012-08-17

Patient: 63 year old female, weighing 49.0 kg (107.8 pounds)

Reactions: Pneumonia Cryptococcal, Cardiac Failure, Mitral Valve Incompetence, Bone Marrow Failure, Acute Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: sequential high dose, sham regimen, within amlcg-2008 study
    Indication: Acute Myeloid Leukaemia

Mitoxantrone
    Dosage: sequential high dose, sham regimen, within amlcg-2008 study
    Indication: Acute Myeloid Leukaemia



Possible Cytarabine side effects in 44 year old male

Reported by a physician from Germany on 2012-08-17

Patient: 44 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 200 mg, daily
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-06
    End date: 2012-06-12

Etoposide
    Dosage: 200 mg, daily
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-06
    End date: 2012-06-08

Gemtuzumab Ozogamicin
    Dosage: 6 mg, 1x/day
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-06
    End date: 2012-06-06

Idarubicin HCL
    Dosage: 24 mg, daily
    Start date: 2012-06-08
    End date: 2012-06-08

Idarubicin HCL
    Dosage: 24 mg, daily
    Start date: 2012-06-10
    End date: 2012-06-10

Idarubicin HCL
    Dosage: 24 mg, daily
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-06
    End date: 2012-06-06

Tretinoin
    Dosage: 90 mg, daily
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-06-11
    End date: 2012-06-12

Tretinoin
    Dosage: 30 mg, daily
    Start date: 2012-06-13
    End date: 2012-06-16

Tretinoin
    Dosage: 30 mg, daily
    Start date: 2012-06-21
    End date: 2012-06-21



Possible Cytarabine side effects in

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

Patient:

Reactions: Off Label Use, Hypoxia, Bacterial Sepsis

Drug(s) suspected as cause:
Bortezomib
    Dosage: push on days 1, 4, 8, and 11
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Dosage: day 1 with no cns involvement + on days 8, 15 + 22 with cns involvement
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: divided into 2 doses for 14 consecutive days from day 1
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

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

Methotrexate
    Dosage: who had no cns involvement- day 15;
    Indication: Acute Lymphocytic Leukaemia

PEG-Asparaginase
    Dosage: pegylated 2500 units/m2/dose given intravenously as 4 weekly doses
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: by push (2 mg maximum dose) was administered intravenously by push day 1, 8, 15, and 22
    Indication: Acute Lymphocytic Leukaemia



Possible Cytarabine side effects in

Reported by a physician from United States on 2012-08-16

Patient:

Reactions: Off Label Use, Encephalopathy, Cerebral Ischaemia

Drug(s) suspected as cause:
Bortezomib
    Dosage: per dose on days 1, 4, 8 and 11
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Dosage: on day 1 or days 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: divided into 2 doses was given orally for 14 consecutive days
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

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

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

Methotrexate
    Dosage: on day 15 or days 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

PEG-Asparaginase
    Dosage: 2500 units/m2/dose was given intramuscularly as 4 weekly doses
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: per dose (2 mg maximum dose) was administered intravenously by push on day 1, 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia



Possible Cytarabine side effects in female

Reported by a physician from United States on 2012-08-16

Patient: female

Reactions: Pyrexia, Pupils Unequal, Cerebral Ischaemia, Pleural Effusion, Brain Oedema, Intracranial Pressure Increased, Staphylococcal Bacteraemia, Pupil Fixed, Blood Pressure Systolic Decreased, Pupillary Reflex Impaired, Cerebral Artery Stenosis, Brain Stem Haemorrhage, Brain Herniation, Hyperreflexia, Ascites, Convulsion, Venoocclusive Disease, Bacteraemia, Respiratory Failure, Meningitis Bacterial, Mental Disorder, Acute Myeloid Leukaemia Recurrent

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clolar
    Dosage: 52 mg/m2, dose level 3
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2012-07-13
    End date: 2012-07-17

Cytarabine
    Dosage: unk
    Indication: Bone Marrow Conditioning Regimen
    Start date: 2012-07-12



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

Reported by a physician from United States on 2012-08-16

Patient:

Reactions: Off Label Use, Hyperglycaemia, Hypoglycaemia

Drug(s) suspected as cause:
Bortezomib
    Dosage: per dose on days 1, 4, 8 and 11
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Dosage: on day 1 or days 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: per day divided into 2 doses was given orally for 14 consecutive days
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

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

Methotrexate
    Dosage: on day 15 or days 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

PEG-Asparaginase
    Dosage: 2500 units/m2/dose was given intramuscularly as 4 weekly doses
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: per dose (2 mg maximum dose) was administered intravenously by push on day 1, 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia



Possible Cytarabine side effects in

Reported by a physician from United States on 2012-08-16

Patient:

Reactions: Off Label Use, Hypotension, Hypertension

Drug(s) suspected as cause:
Bortezomib
    Dosage: per dose on days 1, 4, 8 and 11
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Dosage: on day 1 or days 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: per day divided into 2 doses was given orally for 14 consecutive days
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

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

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

Methotrexate
    Dosage: on day 15 or days 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

PEG-Asparaginase
    Dosage: 2500 units/m2/dose was given intramuscularly as 4 weekly doses
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: per dose (2 mg maximum dose) was administered intravenously by push on day 1, 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia



Possible Cytarabine side effects in

Reported by a physician from United States on 2012-08-16

Patient:

Reactions: Off Label Use, Peripheral Sensorimotor Neuropathy

Drug(s) suspected as cause:
Bortezomib
    Dosage: by push per dose on days 1, 4, 8 and 11
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Dosage: on day 1 or days 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: per day divided into 2 doses was given orally for 14 consecutive days
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

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

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

Methotrexate
    Dosage: on day 15 or days 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

PEG-Asparaginase
    Dosage: 2500 units/m2/dose was given intramuscularly as 4 weekly doses
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: per dose (2 mg maximum dose) was administered intravenously by push on day 1, 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia



Possible Cytarabine side effects in

Reported by a physician from United States on 2012-08-16

Patient:

Reactions: Off Label Use, Coagulopathy, Lower Gastrointestinal Haemorrhage, Escherichia Sepsis

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 Hydrochloride
    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
    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



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