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Review Cytarabine Safety Reports submitted to FDA

Total Cytarabine reports: 445.
Cytarabine FDA safety alerts: No.
Reported deaths: 87    Reported hospitalizations: 287.
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FDA Reported Cytarabine Side Effects: febrile neutropenia, haemoglobin decreased, platelet count decreased, blood culture positive, disease progression, hypotension, sepsis, white blood cell count decreased, diarrhoea haemorrhagic, pyrexia, haematocrit decreased.
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Cytarabine Side Effects Report #5568173-5
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Dec 18, 2007. Female patient, weighting 213.0 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute monocytic leukaemia, acute respiratory distress syndrome, back pain, bradycardia, central nervous system leukaemia, cerebral disorder, complex partial seizures, enterococcal infection, fungal infection. CYTARABINE dosage: 16160 MG. During the same period patient was treated with MYLOTARG. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5569581-9
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Dec 04, 2007. Female patient, 52 years of age, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, splenic rupture. CYTARABINE dosage: 100 MG/M2 DAILY IV. During the same period patient was treated with DAUNORUBICIN. Patient died.

Cytarabine Side Effects Report #5569620-5
Consumer or non-health professional from UKRAINE reported CYTARABINE problem on Dec 04, 2007. Female patient, 53 years of age, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: neutropenia. CYTARABINE dosage: 2 MG/M2 FREQ IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, NEUPOGEN. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5570301-2
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 19, 2007. Male patient, weighting 134.5 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, bone marrow failure, leukaemia, lung infiltration, pericardial effusion, pleural effusion, refusal of treatment by relative, respiratory failure, sepsis. CYTARABINE dosage: 1260 MG. During the same period patient was treated with DAUNORUBICIN, ETOPOSIDE. Patient was hospitalized. Patient died on 11/28/2007.

Cytarabine Side Effects Report #5570306-1
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Dec 19, 2007. Male patient, weighting 208.8 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: pneumonia bacterial, pneumonia fungal, respiratory disorder, therapeutic agent toxicity. CYTARABINE dosage: 1456 MG. During the same period patient was treated with DAUNORUBICIN, ETOPOSIDE. Patient recovered.

Cytarabine Side Effects Report #5570308-5
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 19, 2007. Female patient, weighting 260.8 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: catheter site cellulitis. CYTARABINE dosage: unknown. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5570737-X
Consumer or non-health professional from JAPAN reported CYTARABINE problem on Dec 11, 2007. Female patient, 22 years of age, was diagnosed with bone marrow transplant and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, cardiomyopathy, cardiotoxicity, haemodialysis, nephropathy, renal transplant. CYTARABINE dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, METHOTREXATE, NEORAL, IRRADIATION. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5573455-7
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 20, 2007. Male patient, weighting 123.3 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: cholecystitis acute, cholelithiasis, gastrointestinal obstruction, murphy's sign positive. CYTARABINE dosage: 1456 MG. During the same period patient was treated with DAUNORUBICIN, ETOPOSIDE. Patient recovered.

Cytarabine Side Effects Report #5573456-9
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Dec 20, 2007. Male patient, weighting 174.8 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: clostridial infection, febrile neutropenia, hypotension. CYTARABINE dosage: 27300 MG. During the same period patient was treated with ETOPOSIDE, RITUXIMAB. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5573466-1
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 20, 2007. Female patient, weighting 212.5 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, aspergillosis, atelectasis, bone marrow failure, chronic obstructive pulmonary disease, condition aggravated, leukocytosis, lung neoplasm, neutropenia. CYTARABINE dosage: 1491 MG. During the same period patient was treated with DAUNORUBICIN, LEUKINE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5574794-6
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Dec 26, 2007. Female patient, weighting 213.0 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute monocytic leukaemia, acute respiratory distress syndrome, bradycardia, complex partial seizures, computerised tomogram abnormal, enterococcal infection, fungal infection, hypotension. CYTARABINE dosage: 16160 MG. During the same period patient was treated with MYLOTARG, NEUPOGEN, FLUDARABINE PHOSPHATE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5576005-4
CYTARABINE problem was reported by a Health Professional from AUSTRALIA on Dec 18, 2007. Female patient, 53 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: liver function test abnormal, neutropenia, neutropenic colitis, oedema peripheral, thrombocytopenia. CYTARABINE dosage: unknown. During the same period patient was treated with IDARUBICIN, HEMATOPOETIC PROGENITOR CELLS, FLUDARABINE PHOSPHATE, CYCLOPHOSPHAMIDE, IMATINIB. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5578519-X
Consumer or non-health professional from NETHERLANDS reported CYTARABINE problem on Dec 13, 2007. Male patient, 65 years of age, weighting 209.4 lb, was diagnosed with acute myeloid leukaemia, epilepsy and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: atelectasis, blood sodium decreased, coma, convulsion, encephalopathy, enterococcal bacteraemia, enterococcal infection, febrile neutropenia. CYTARABINE dosage: 200 MG/M2. During the same period patient was treated with KEPPRA, AVASTIN, FRISIUM, FUNGIZONE, METOPROLOL SUCCINAAT, KONAKION, HALDOL, FLUCONAZOLE. Patient recovered.

Cytarabine Side Effects Report #5578520-6
CYTARABINE problem was reported by a Consumer or non-health professional from NETHERLANDS on Dec 13, 2007. Male patient, 65 years of age, weighting 209.4 lb, was diagnosed with acute myeloid leukaemia, epilepsy and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: atelectasis, bedridden, blood lactate dehydrogenase increased, blood sodium decreased, cardiac pacemaker insertion, central nervous system infection, coma, convulsion. CYTARABINE dosage: 200 MG/M2. During the same period patient was treated with KEPPRA, AVASTIN, FRISIUM, FUNGIZONE, METOPROLOL SUCCINAAT, KONAKION, FLUCONAZOLE, LANOXIN. Patient recovered.

Cytarabine Side Effects Report #5578617-0
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Dec 28, 2007. Female patient, weighting 121.3 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute haemorrhagic leukoencephalitis, adrenal insufficiency, alpha haemolytic streptococcal infection, blood amylase increased, caecitis, clostridial infection, depressed level of consciousness, encephalopathy, hypoxia. CYTARABINE dosage: 28620 MG. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5578976-9
CYTARABINE problem was reported by a Health Professional from UNITED STATES on Dec 20, 2007. Male patient, 47 years of age, weighting 144.6 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, ascites, aspergillosis, cardiac failure congestive, clostridial infection, hepatic function abnormal, malignant neoplasm progression, mastocytosis, pancytopenia. CYTARABINE dosage: unknown. During the same period patient was treated with FLUDARABINE, PENTOSTATIN, NEUPOGEN, GLEEVEC. Patient died on 11/30/2007.

Cytarabine Side Effects Report #5580079-4
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Dec 27, 2007. Male patient, weighting 147.5 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: neutropenia, pyrexia. CYTARABINE dosage: 41600 MG. During the same period patient was treated with ELSPAR. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5580085-X
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 27, 2007. Male patient, weighting 222.7 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: electrolyte imbalance, haemodialysis, headache, hypoxia, leukostasis, oliguria, renal failure acute, tachycardia, tachypnoea. CYTARABINE dosage: 1456 MG. During the same period patient was treated with DAUNORUBICIN, ETOPOSIDE. Patient recovered.

Cytarabine Side Effects Report #5580361-0
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Dec 21, 2007. Female patient, 65 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: condition aggravated, febrile neutropenia, lymphadenopathy, mouth ulceration, oral candidiasis, pharyngitis, septic shock, tonsillitis. CYTARABINE dosage: 28 MG PER_CYCLE SC. During the same period patient was treated with RIFATAR, ETHAMBUTOL HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE, NYSTATIN, SENNOSIDE B, METFORMIN, INDOMETHACIN, ISONIAZID. Patient was hospitalized. Patient died on 08/23/2007.

Cytarabine Side Effects Report #5580362-2
CYTARABINE problem was reported by a Consumer or non-health professional from TAIWAN, PROVINCE OF CHINA on Dec 21, 2007. Female patient, 65 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: condition aggravated, febrile neutropenia, haematocrit decreased, haemoglobin decreased, lymphadenopathy, mouth ulceration, oral candidiasis, parapharyngeal abscess, pharyngitis. CYTARABINE dosage: 20 MG/M2 DAILY SC. During the same period patient was treated with NYSTATIN, RIFATAR, ETHAMBUTOL HYDROCHLORIDE, VITAMIN B6, DOMPERIDONE, PYRIDOXINE HYDROCHLORIDE, SENNOSIDE B. Patient was hospitalized. Patient died on 08/23/2007.

Cytarabine Side Effects Report #5580480-9
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Dec 31, 2007. Female patient, weighting 197.3 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, myocardial infarction, pulmonary embolism. CYTARABINE dosage: 20300 MG. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5580701-2
CYTARABINE problem was reported by a Consumer or non-health professional from TAIWAN, PROVINCE OF CHINA on Dec 21, 2007. Female patient, 65 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: condition aggravated, febrile neutropenia, lung infection, lymphadenopathy, mass, oral candidiasis, pharyngitis, septic shock, tonsillitis. CYTARABINE dosage: 28 MG PER_CYCLE SC. During the same period patient was treated with RIFATAR, ETHAMBUTOL HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE, NYSTATIN, SENNOSIDE B, METFORMIN, INDOMETHACIN, ISONIAZID. Patient was hospitalized. Patient died on 08/23/2007.

Cytarabine Side Effects Report #5582799-4
Physician from SPAIN reported CYTARABINE problem on Dec 21, 2007. Female patient, 65 years of age, weighting 231.5 lb, was diagnosed with non-hodgkin's lymphoma recurrent and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: cerebral ventricle dilatation, pneumocystis jiroveci pneumonia. CYTARABINE dosage: 50 MG;QOW;INTH. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5506304-3
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 02, 2007. Female patient, weighting 97.89 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: bladder distension, bladder perforation, flatulence. CYTARABINE dosage: 70 MG. During the same period patient was treated with DEXAMETHASONE, METHOTREXATE, VINCRISTINE SULPHATE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5507581-5
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Nov 05, 2007. Male patient, weighting 75.40 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: bacteraemia, caecitis, enterococcal infection, escherichia infection, multi-organ failure, pancytopenia, septic shock. CYTARABINE dosage: 1280 MG. During the same period patient was treated with MYLOTARG, MITOXANTRONE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5509751-9
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 07, 2007. Female patient, weighting 176.4 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: cardiac failure, cardiogenic shock, cardiomyopathy, fungaemia, fusarium infection, no therapeutic response, pulmonary oedema. CYTARABINE dosage: 1190 MG. During the same period patient was treated with DAUNORUBICIN, LEUKINE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5509873-2
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Nov 07, 2007. Female patient, weighting 176.4 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: blood culture positive, cardiac failure, cardiogenic shock, cardiomyopathy, dyspnoea, fungaemia, fusarium infection, no therapeutic response, pulmonary oedema. CYTARABINE dosage: 1190 MG. During the same period patient was treated with DAUNORUBICIN. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5518196-7
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 13, 2007. Male patient, weighting 138.9 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acidosis, anuria, asthenia, back pain, bronchopulmonary aspergillosis, central line infection, depressed level of consciousness, dialysis, eye pain. CYTARABINE dosage: 14640 MG. During the same period patient was treated with MITOXANTRONE, BACITRACIN, GABAPENTIN, MOXIFLOXACIN, PROTONIX, RANITIDINE, SULFAMETHOXAZOLE, AMPHOTERICIN B. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5518480-7
Pharmacist from UNITED STATES reported CYTARABINE problem on Nov 13, 2007. Female patient, 67 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute respiratory distress syndrome, pulmonary alveolar haemorrhage, respiratory failure. CYTARABINE dosage: 160 MG DAILY IV. During the same period patient was treated with ALBUTEROL, PROTROPIN, MAGIC MOUTHWASH, PROTONIX, LASIX, ACETYLCYSTEINE, MOXIFLOXACIN, ZOLOFT. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5520692-3
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 15, 2007. Female patient, weighting 203.3 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: septic shock. CYTARABINE dosage: 30080 MG. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5523129-3
Physician from UNITED KINGDOM reported CYTARABINE problem on Nov 08, 2007. Male patient, 47 years of age, was diagnosed with acute myelomonocytic leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: haemodialysis, hyperphosphataemia, renal failure acute, tumour lysis syndrome. CYTARABINE dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE, IDARUBICIN, PARENTERAL, ALLOPURINOL, RASBURICASE. Patient recovered.

Cytarabine Side Effects Report #5523546-1
CYTARABINE problem was reported by a Physician from GERMANY on Nov 06, 2007. Male patient, 24 years of age, was diagnosed with acute lymphocytic leukaemia, graft versus host disease and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease in intestine, acute graft versus host disease in skin, bk virus infection, complications of transplant surgery, cystitis haemorrhagic, hepatotoxicity. CYTARABINE dosage: unknown. During the same period patient was treated with CYCLOSPORINE, PURINE ANALOGUES. Patient recovered.

Cytarabine Side Effects Report #5525314-3
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Nov 20, 2007. Male patient, weighting 232.4 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: thrombocytopenia. CYTARABINE dosage: 20700 MG. Patient recovered.

Cytarabine Side Effects Report #5525333-7
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 20, 2007. Female patient, weighting 207.9 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: status epilepticus. CYTARABINE dosage: 3070 MG. During the same period patient was treated with DAUNORUBICIN, ETOPOSIDE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5526584-8
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Nov 21, 2007. Female patient, weighting 198.4 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: hyperglycaemia, hyponatraemia. CYTARABINE dosage: 16740 MG. Patient recovered.

Cytarabine Side Effects Report #5527446-2
CYTARABINE problem was reported by a Health Professional from UNITED STATES on Nov 13, 2007. Female patient, 33 years of age, was diagnosed with chronic myeloid leukaemia, prophylaxis against graft versus host disease, stem cell transplant and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease in skin, lip and/or oral cavity cancer. CYTARABINE dosage: unknown. During the same period patient was treated with METHOTREXATE, AZATHIOPRINE, PREDNISONE, CYCLOPHOSPHAMIDE, IRRADIATION. Patient recovered.

Cytarabine Side Effects Report #5527639-4
Consumer or non-health professional from RUSSIAN FEDERATION reported CYTARABINE problem on Nov 09, 2007. Female patient, 68 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: anaemia, autoimmune disorder, blood bilirubin unconjugated increased, disseminated intravascular coagulation, free haemoglobin present, haemodialysis, haemoglobinuria, hyperthermia, multi-organ failure. CYTARABINE dosage: 37 MG QD SC. During the same period patient was treated with CEFTAZIDIME, AMPHOTERICIN, METOCLOPRAMIDE, POTASSIUM CHLORIDE. Patient died on 03/30/2007.

Cytarabine Side Effects Report #5532122-6
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 30, 2007. Male patient, weighting 249.1 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: tumour lysis syndrome. CYTARABINE dosage: 484 MG. During the same period patient was treated with DAUNORUBICIN, ETOPOSIDE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5532184-6
Health Professional from UNITED STATES reported CYTARABINE problem on Sept 20, 2007. Female patient, 82 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, decreased appetite, diarrhoea, fatigue, hypotension, lethargy, leukaemia recurrent, loss of consciousness, malaise. CYTARABINE dosage: 20 MG/M2 PER_CYCLE SC. During the same period patient was treated with GLYCOPYRROLATE, MAXOLON, PHOSPHATE, ATORVASTATIN, PANADEINE CO, ALLOPURINOL, AMIODARONE HYDROCHLORINE, BETAGAN. Patient was hospitalized. Patient died on 02/23/2007.

Cytarabine Side Effects Report #5533144-1
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 29, 2007. Female patient, weighting 110.0 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, blood amylase increased, blood bilirubin increased, chills, diarrhoea, epigastric discomfort, faeces discoloured, ill-defined disorder, pyrexia. CYTARABINE dosage: 572 MG. During the same period patient was treated with DAUNORUBICIN, ETOPOSIDE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5533206-9
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Nov 30, 2007. Male patient, weighting 138.9 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: abasia, acidosis, anuria, asthenia, back pain, bronchopulmonary aspergillosis, chest x-ray abnormal, condition aggravated, depressed level of consciousness. CYTARABINE dosage: 14640 MG. During the same period patient was treated with MITOXANTRONE, BACITRACIN, GABAPENTIN, MOXIFLOXACIN, PROTONIX, RANITIDINE, SULFAMETHOXAZOLE, AMPHOTERICIN B. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5533228-8
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 30, 2007. Male patient, weighting 196.7 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: diarrhoea, erythema, leukaemia, pyrexia, rash maculo-papular, rash pruritic, rash pustular, skin haemorrhage. CYTARABINE dosage: 1400 MG. During the same period patient was treated with DAUNORUBICIN, MYLOTARG, ALLOPOURINOL, CEFTAZIDIME, FLUCONAZOLE, TAZOCIN, VANCOMYCIN. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5533264-1
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Nov 30, 2007. Female patient, weighting 207.9 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: agitation, cerebral infarction, disorientation, headache, status epilepticus, vision blurred. CYTARABINE dosage: 3070 MG. During the same period patient was treated with DAUNORUBICIN, ETOPOSIDE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5533453-6
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 14, 2007. Female patient, 33 years of age, was diagnosed with acute myeloid leukaemia, prophylaxis against graft versus host disease and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease in skin, lip and/or oral cavity cancer, refusal of treatment by patient. CYTARABINE dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, METHOTREXATE, AZATHIOPRINE, PREDNISONE. Patient died.

Cytarabine Side Effects Report #5534135-7
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Nov 29, 2007. Male patient, weighting 158.7 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: central line infection, pseudomonas infection, staphylococcal infection. CYTARABINE dosage: 28800 MG. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5534137-0
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 29, 2007. Male patient, weighting 158.7 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: central line infection, pseudomonas infection, staphylococcal infection. CYTARABINE dosage: 28800 MG. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5534146-1
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Nov 29, 2007. Male patient, weighting 182.3 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: blood culture positive, haemoptysis, hypoxia, pseudomonas infection. CYTARABINE dosage: unknown. During the same period patient was treated with DAUNORUBICIN, ETOPOSIDE, CLOFARABINE. Patient was hospitalized. Patient died on 10/13/2007.

Cytarabine Side Effects Report #5422309-5
CYTARABINE problem was reported by a Physician from TAIWAN, PROVINCE OF CHINA on Aug 08, 2007. Male patient, 72 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, empyema, haematocrit decreased, haemoglobin decreased, malignant neoplasm progression, pleural effusion, pneumonia klebsiella, refusal of treatment by patient. CYTARABINE dosage: 20 MG/M2 DAILY SC. During the same period patient was treated with ACETAMINOPHEN, FENTANYL, MAGNESIUM SULPHATE, DIGOXIN. Patient was hospitalized. Patient died on 11/16/2006.

Cytarabine Side Effects Report #5475679-6
Health Professional from UNITED STATES reported CYTARABINE problem on Sept 19, 2007. Male patient, 78 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: anaemia, aortic valve incompetence, arthralgia, arthropathy, back pain, bacteraemia, blood culture positive, blood pressure systolic increased, bone marrow disorder. CYTARABINE dosage: 20 MG/M2 QD SC. During the same period patient was treated with PROSCAR, MICRO, VITAMIN B, ATENOLOL, CENTRUM SILVER, PREDTE, ACULAR, MIRALAX. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5479423-8
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 03, 2007. Male patient, weighting 49.38 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: blood culture positive, blood pressure abnormal, caecitis, capillary leak syndrome, cardio-respiratory arrest, clostridium difficile toxin test positive, hypotension, pseudomonas infection, respiratory failure. CYTARABINE dosage: 70 MG GIVEN INTRATHECALLY. During the same period patient was treated with DEXAMETHASONE, METHOTREXATE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5480157-4
Consumer or non-health professional from UNITED KINGDOM reported CYTARABINE problem on Aug 27, 2007. Female patient, 42 years of age, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: herpes zoster, hyperkeratosis, pancytopenia, rash papular, skin necrosis, stem cell transplant. CYTARABINE dosage: unknown. During the same period patient was treated with ETOPOSIDE, CAMPATH, CARMUSTINE, MELPHALAN, ACYCLOVIR. Patient recovered.

Cytarabine Side Effects Report #5480286-5
CYTARABINE problem was reported by a Health Professional from UNITED STATES on Sept 27, 2007. Female patient, 68 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: cardiomyopathy, left ventricular dysfunction, nausea, pneumonia, toxic shock syndrome. CYTARABINE dosage: 20 MG/M2 SC. During the same period patient was treated with AMPHOTERICIN B, ENDAMETHASONE, ERYTHROMYCIN, CEFOTAXIME, BROMHEXINE, LASIX, VERAPAMIL. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5480374-3
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Oct 04, 2007. Male patient, weighting 206.1 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: disease recurrence, neutropenia, rectal abscess. CYTARABINE dosage: unknown. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5483538-8
CYTARABINE problem was reported by a Health Professional from UNITED STATES on Sept 27, 2007. Male patient, 78 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: anaemia, aortic stenosis, arthralgia, bacteraemia, blood pressure systolic increased, contusion, left ventricular hypertrophy, lip haemorrhage. CYTARABINE dosage: 20 MG/M2 QD SC. During the same period patient was treated with PROSCAR, MICRO, VITAMIN B, ATENOLOL, CENTRUM SILVER, PREDTE, ACULAR, MIRALAX. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5483903-9
Consumer or non-health professional from AUSTRALIA reported CYTARABINE problem on Sept 27, 2007. Female patient, 82 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: abasia, chondrocalcinosis, chondrocalcinosis pyrophosphate, joint effusion, pain in extremity. CYTARABINE dosage: 20 MG/M2 QD; SC. During the same period patient was treated with SERTRALINE, VITAMIN B, ERGOCALCIFEROL, GABAPENTIN, MONOPRIL, LIPITOR, FOSAMAX, THIAMINE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5485548-3
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 11, 2007. Male patient, weighting 138.9 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: aspergillosis, lung consolidation, mass, pneumonia klebsiella, septic shock, tachycardia, urine output decreased. CYTARABINE dosage: 3600 MG. During the same period patient was treated with DAUNORUBICIN, ETOPOSIDE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5485995-X
Health Professional from POLAND reported CYTARABINE problem on Oct 03, 2007. Female patient, 72 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase decreased, blood alkaline phosphatase increased, blood glucose increased, c-reactive protein increased, chest pain, hypotension. CYTARABINE dosage: 20 MG/M2 QD SC. During the same period patient was treated with EPIRUBICIN HYDROCHLORIDE, AMOXICILLIN, CHLORIDE, ALLOPURINOL, ONDANSETRON, NATRIUM BICARBONATE, ELECTROLYTE COMPOUND SOLUTION. Patient was hospitalized and became disabled. Patient recovered.

Cytarabine Side Effects Report #5490453-2
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 17, 2007. Female patient, weighting 126.8 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: dialysis, klebsiella infection, lower respiratory tract infection fungal, necrotising fasciitis, nervous system disorder, neutropenia, renal failure, septic shock, staphylococcal infection. CYTARABINE dosage: 70 MG. During the same period patient was treated with DAUNORUBICIN, DEXAMETHASONE, METHOTREXATE, VINCRISTINE SULPHATE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5490490-8
Pharmacist from UNITED STATES reported CYTARABINE problem on Oct 17, 2007. Female patient, 24 years of age, weighting 109.3 lb, was diagnosed with meningeal disorder and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: arachnoiditis, headache, nausea, pleocytosis, vomiting. CYTARABINE dosage: 50MG EVERY TWO WEEKS INTH. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5496159-8
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 23, 2007. Female patient, weighting 97.89 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: bladder perforation. CYTARABINE dosage: 70 MG. During the same period patient was treated with DEXAMETHASONE, METHOTREXATE, VINCRISTINE SULPHATE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5498635-0
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Oct 24, 2007. Female patient, weighting 114.4 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, depressed level of consciousness. CYTARABINE dosage: 70 MG. During the same period patient was treated with DAUNORUBICIN, LEUCOVORIN CALCIUM, METHOTREXATE, PREDNISONE, VINCRISTINE SULPHATE, LANTUS, NOVOLOG. Patient recovered.

Cytarabine Side Effects Report #5500375-6
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 25, 2007. Male patient, weighting 130.5 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: multi-organ failure. CYTARABINE dosage: 825 MG. During the same period patient was treated with DAUNORUBICIN, ETOPOSIDE. Patient was hospitalized. Patient died on 10/20/2007.

Cytarabine Side Effects Report #5500754-7
Pharmacist from UNITED STATES reported CYTARABINE problem on Feb 01, 2007. Male patient, 54 years of age, weighting 235.9 lb, was diagnosed with mantle cell lymphoma and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: chills. CYTARABINE dosage: unknown. During the same period patient was treated with METHOTREXATE. Patient recovered.

Cytarabine Side Effects Report #5501462-9
CYTARABINE problem was reported by a Pharmacist from UNITED STATES on Aug 08, 2006. Female patient, 15 years of age, weighting 176.4 lb, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: neurological symptom. CYTARABINE dosage: unknown. Patient recovered.

Cytarabine Side Effects Report #5501463-0
Health Professional from UNITED STATES reported CYTARABINE problem on Aug 09, 2006. Male patient, 46 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: pyrexia. CYTARABINE dosage: unknown. During the same period patient was treated with BACTRIM DS, VALCYTE, PROTONIX, OXALIPLATIN, RITUXAN, FLUDARABINE PHOSPHATE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5501464-2
CYTARABINE problem was reported by a Physician from UNITED STATES on Aug 09, 2006. Female patient, 78 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: cellulitis, febrile neutropenia. CYTARABINE dosage: unknown. During the same period patient was treated with KEFLEX, DILTIAZEM, LEVOTHYROXINE, VALTREX, MIACALCIN SPRAY, CYMBALTA, CARTIA XT. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5501466-6
Health Professional from UNITED STATES reported CYTARABINE problem on Sept 19, 2006. Male patient, 78 years of age, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: infection, neutropenia, thrombocytopenia. CYTARABINE dosage: unknown. During the same period patient was treated with CHLORPHENIRAMINE, VITAMIN B, FINASTERIDE, ATENOLOL, PANTOPRAZOLE, POTASSIUM CHLORIDE, ALLOPURINOL, PRENISOLONE ACETATE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5501467-8
CYTARABINE problem was reported by a Health Professional from UNITED STATES on Sept 21, 2006. Male patient, 55 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia. CYTARABINE dosage: unknown. During the same period patient was treated with VORICONAZOLE, DAPSONE, EFFEXOR, ATROPINE, MORPHINE SULPHATE, PREDNISOLONE, QUININE SULPHATE, TIMOLOL MALEATE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5501468-X
Health Professional from UNITED STATES reported CYTARABINE problem on Sept 21, 2006. Female patient, 76 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia. CYTARABINE dosage: unknown. During the same period patient was treated with OXALIPLATIN, FLUDARABINE PHOSPHATE, AMBIEN, BACTRIM, FAMVIR, FENTANYL. Patient was hospitalized. Patient died on 09/02/2006.

Cytarabine Side Effects Report #5501469-1
CYTARABINE problem was reported by a Physician from UNITED STATES on Sept 29, 2006. Female patient, 64 years of age, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: febrile neutropenia. CYTARABINE dosage: unknown. During the same period patient was treated with ALLOPURINOL, DYAZIDE, VALTREX, BACTRIM DS, OXALIPLATIN, FLUDARABINE PHOSPHATE, RITUXAN. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5501471-X
Health Professional from UNITED STATES reported CYTARABINE problem on Nov 16, 2006. Male patient, 64 years of age, was diagnosed with myeloid leukaemia, pain, prophylaxis and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: hepatic enzyme increased, hyperbilirubinaemia, thrombocytopenia. CYTARABINE dosage: 200MG/IV/DAILY. During the same period patient was treated with DAUNORUBICIN, CEFEPIME, ACETAMINOPHEN, FLUCONAZOLE, ALLOPURINOL, SALBUTAMOL. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5501472-1
CYTARABINE problem was reported by a Pharmacist from UNITED STATES on Aug 08, 2006. Male patient, 16 years of age, weighting 101.4 lb, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: conjunctivitis. CYTARABINE dosage: unknown. During the same period patient was treated with ASPARAGINASE, DEXAMETHASONE, DEX IV, ZOFRAN. Patient recovered.

Cytarabine Side Effects Report #5501473-3
Pharmacist from UNITED STATES reported CYTARABINE problem on Aug 08, 2006. Male patient, 17 years of age, weighting 77.16 lb, was diagnosed with acute myeloid leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: conjunctivitis. CYTARABINE dosage: 3600MG/IV Q 12HR/DAY 1,2 AND. During the same period patient was treated with ASPARAGINASE, DEXAMETHASONE, ZOFRAN, VORICONAZOLE. Patient recovered.

Cytarabine Side Effects Report #5501474-5
CYTARABINE problem was reported by a Pharmacist from UNITED STATES on Feb 01, 2007. Female patient, 60 years of age, was diagnosed with acute lymphocytic leukaemia and was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: ataxia, dysarthria, neurotoxicity. CYTARABINE dosage: unknown. Patient recovered.

Cytarabine Side Effects Report #5503129-X
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Oct 29, 2007. Male patient, weighting 138.7 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: colitis, constipation, faecaloma, gastritis, gastrointestinal necrosis, inappropriate antidiuretic hormone secretion, neutropenia, oesophageal candidiasis, pyrexia. CYTARABINE dosage: 70 MG. During the same period patient was treated with DAUNORUBICIN, METHOTREXATE, PREDNISONE, VINCRISTINE SULPHATE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5503130-6
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 29, 2007. Male patient, weighting 161.8 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: chronic obstructive pulmonary disease, condition aggravated, neutropenia, pneumonia, respiratory failure, staphylococcal bacteraemia. CYTARABINE dosage: 1316 MG. During the same period patient was treated with DAUNORUBICIN. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5503934-X
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Oct 30, 2007. Female patient, weighting 212.7 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: small intestinal obstruction. CYTARABINE dosage: 1400 MG. During the same period patient was treated with DAUNORUBICIN, LEUKINE. Patient was hospitalized. Patient recovered.

Cytarabine Side Effects Report #5444797-0
CYTARABINE problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 04, 2007. Female patient, weighting 115.3 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: dyspnoea, encephalopathy, hepatic congestion, hepatic necrosis, hepatomegaly, urine output decreased, venoocclusive liver disease. CYTARABINE dosage: 4823 MG. During the same period patient was treated with DAUNORUBICIN, MYLOTARG. Patient recovered.

Cytarabine Side Effects Report #5444858-6
Consumer or non-health professional from UNITED STATES reported CYTARABINE problem on Sept 04, 2007. Female patient, weighting 115.3 lb, was treated with CYTARABINE. After drug was administered, patient experienced the following problems/side effects: dyspnoea, encephalopathy, hepatic congestion, hepatic necrosis, urine output decreased, venoocclusive liver disease