FLUDARA Side Effects

6668618-3 | Pyrexia, Renal Failure Acute
on Mar 19, 2010 Male patient from UNITED STATES , 64 years of age, weighting 198.4 lb, was diagnosed with chronic lymphocytic leukaemia, pyrexia and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: pyrexia, renal failure acute. Fludara dosage: . During the same period patient was treated with TAZOCIN (4x4.5 G) (View Tazocin Review and Tazocin Label ), TRITACE (View Tritace Review and Tritace Label ), HERPLEX (View Herplex Review and Herplex Label ), SINERSUL (View Sinersul Review and Sinersul Label ), AMONEX (View Amonex Review and Amonex Label ). Patient was hospitalized.

6668617-1 | Cardiac Enzymes Increased, Chest Pain, Dyspnoea, Electrocardiogram Change, Metabolic Acidosis, Multi-organ Failure, Pericarditis, Platelet Count Decreased, Renal Impairment
Patient was taking Fludara (View Usage). Patient had the following side effects: cardiac enzymes increased, chest pain (What is chest pain?), dyspnoea, electrocardiogram change, metabolic acidosis, multi-organ failure, pericarditis, platelet count decreased, renal impairment on Mar 22, 2010 from UNITED KINGDOM Additional patient health information: Female patient , 43 years of age, weighting 194.0 lb, was diagnosed with acute myeloid leukaemia and. Fludara dosage: 4 Cycles. During the same period patient was treated with NEUPOGEN (Starting With Cycle 3) (View Neupogen Review and Neupogen Label ), ARA C (4 Cycles) (View Ara-c Review and Ara-c Label ), EVOLTRA (4 Cycles) (View Evoltra Review and Evoltra Label ), MYLOTARG (View Mylotarg Review and Mylotarg Label ), ZAVEDOS (1 In Days) (View Zavedos Review and Zavedos Label ), AMPHOTERICIN B (View Amphotericin B Review and Amphotericin B Label ), RASBURICASE (View Rasburicase Review and Rasburicase Label ), VALACYCLOVIR (View Valacyclovir Review and Valacyclovir Label ). Patient was hospitalized.

6668555-4 | Disseminated Intravascular Coagulation, Hepatic Failure, Thrombotic Microangiopathy
Adverse event was reported on Mar 19, 2010 by a Male patient taking Fludara (View Usage) (Dosage: ) was diagnosed with acute myeloid leukaemia, stem cell transplant, prophylaxis against graft versus host disease and. Location: JAPAN , 49 years of age, After Fludara was administered, patient had the following side effects: disseminated intravascular coagulation, hepatic failure, thrombotic microangiopathy. During the same period patient was treated with BUSULFEX (View Busulfex Review and Busulfex Label ), CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6667482-6 | Brain Stem Haemorrhage, Encephalopathy, Pyrexia, Rash, Thrombotic Microangiopathy
on Mar 19, 2010 Male patient from JAPAN , child 12 years of age, was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: brain stem haemorrhage, encephalopathy, pyrexia, rash (What is rash?), thrombotic microangiopathy. Fludara dosage: . During the same period patient was treated with BUSULFEX (View Busulfex Review and Busulfex Label ).


6667431-0 | Autoimmune Thrombocytopenia, Myelodysplastic Syndrome, Pneumonia
on Mar 17, 2010 Male patient from JAPAN , 72 years of age, was diagnosed with follicle centre lymphoma, follicular grade i, ii, iii and was treated with Fludara (View Usage). Patient had the following side effects: autoimmune thrombocytopenia, myelodysplastic syndrome, pneumonia (What is pneumonia?). Fludara dosage: . During the same period patient was treated with CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), RITUXAN (View Rituxan Review and Rituxan Label ). Patient was hospitalized and became disabled.

6663407-8 | Disseminated Intravascular Coagulation, Thrombotic Microangiopathy
Patient was taking Fludara (View Usage). After Fludara was administered, patient had the following side effects: disseminated intravascular coagulation, thrombotic microangiopathy on Mar 19, 2010 from JAPAN Additional patient health information: Male patient , 49 years of age, was diagnosed with acute myeloid leukaemia, stem cell transplant, prophylaxis against graft versus host disease and. Fludara dosage: . During the same period patient was treated with BUSULFEX (View Busulfex Review and Busulfex Label ), CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6663367-X | Pyrexia, Renal Failure Acute
Adverse event was reported on Mar 19, 2010 by a Male patient taking Fludara (View Usage) (Dosage: ) was diagnosed with chronic lymphocytic leukaemia, pyrexia and. Location: UNITED STATES , 64 years of age, weighting 198.4 lb, Patient experienced the following unwanted or unexpected effects: pyrexia, renal failure acute. During the same period patient was treated with TAZOCIN (4x4.5 G) (View Tazocin Review and Tazocin Label ), TRITACE (View Tritace Review and Tritace Label ), HERPLEX (View Herplex Review and Herplex Label ), SINERSUL (View Sinersul Review and Sinersul Label ), AMONEX (View Amonex Review and Amonex Label ). Patient was hospitalized.

6663329-2 | Brain Stem Haemorrhage, Encephalopathy, Pyrexia, Rash, Thrombotic Microangiopathy
on Mar 19, 2010 Male patient from JAPAN , child 12 years of age, was treated with Fludara (View Usage). Patient had the following side effects: brain stem haemorrhage, encephalopathy, pyrexia, rash (What is rash?), thrombotic microangiopathy. Fludara dosage: . During the same period patient was treated with BUSULFEX (View Busulfex Review and Busulfex Label ).

6646326-2 | Engraftment Syndrome, Histiocytosis Haematophagic, Venoocclusive Liver Disease
on Mar 11, 2010 Female patient from JAPAN , 22 years of age, was diagnosed with stem cell transplant, prophylaxis against graft versus host disease and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: engraftment syndrome, histiocytosis haematophagic, venoocclusive liver disease. Fludara dosage: 6 Days. During the same period patient was treated with CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ).

6646316-X | Acute Graft Versus Host Disease, C-reactive Protein Increased, Cytomegalovirus Infection, Engraft Failure, Febrile Neutropenia, Hepatic Encephalopathy, Hepatic Failure, Histiocytosis Haematophagic, Platelet Count Decreased
Patient was taking Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: acute graft versus host disease, c-reactive protein increased, cytomegalovirus infection (What is cytomegalovirus infection?), engraft failure, febrile neutropenia, hepatic encephalopathy, hepatic failure, histiocytosis haematophagic, platelet count decreased on Mar 09, 2010 from JAPAN Additional patient health information: Female patient , 16 years of age, was diagnosed with bone marrow transplant (What is bone marrow transplant?), prophylaxis against graft versus host disease and. Fludara dosage: . During the same period patient was treated with L PAM (View L-pam Review and L-pam Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6646314-6 | Blood Creatinine Increased, Conjunctivitis, Corneal Epithelium Defect, Cytomegalovirus Chorioretinitis, Graft Versus Host Disease, Pulmonary Alveolar Haemorrhage, Retinal Detachment
Adverse event was reported on Mar 10, 2010 by a Female patient taking Fludara (View Usage) (Dosage: ) was diagnosed with stem cell transplant, cytomegalovirus chorioretinitis and. Location: JAPAN , 27 years of age, Patient had the following side effects: blood creatinine increased, conjunctivitis, corneal epithelium defect, cytomegalovirus chorioretinitis, graft versus host disease, pulmonary alveolar haemorrhage, retinal detachment. During the same period patient was treated with CYTARABINE (View Cytarabine Review and Cytarabine Label ), METHYLPREDNISOLONE (View Methylprednisolone Review and Methylprednisolone Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), HOSCARNET (View Hoscarnet Review and Hoscarnet Label ), GANCICLOVIR (View Ganciclovir Review and Ganciclovir Label ).

6646297-9 | Asthenia, Balance Disorder, Drop Attacks, Vestibular Disorder
on Mar 03, 2010 Female patient from UNITED KINGDOM , 76 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: asthenia, balance disorder, drop attacks, vestibular disorder. Fludara dosage: .

6646286-4 | Febrile Neutropenia, Nausea, Neutrophil Count Decreased, Oropharyngeal Pain, Stomatitis
on Mar 08, 2010 Male patient from JAPAN , 39 years of age, weighting 156.5 lb, was diagnosed with diffuse large b-cell lymphoma stage iii, prophylaxis against graft versus host disease, infection prophylaxis and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: febrile neutropenia, nausea (What is nausea?), neutrophil count decreased, oropharyngeal pain, stomatitis. Fludara dosage: As Used: 44 Mg Unit Dose: 500 Mg. During the same period patient was treated with ALKERAN (As Used: 120 Mg) (View Alkeran Review and Alkeran Label ), PROGRAF (As Used: 1.3 Mg) (View Prograf Review and Prograf Label ), METHOTREXATE (As Used: 17 Mg) (View Methotrexate Review and Methotrexate Label ), FUNGUARD (View Funguard Review and Funguard Label ), VICCLOX (As Used: 750 Mg) (View Vicclox Review and Vicclox Label ), CRAVIT (As Used: 300 Mg Unit Dose: 100 G) (View Cravit Review and Cravit Label ).

6646265-7 | Autoimmune Thrombocytopenia, Pneumonia
Patient was taking Fludara (View Usage). Patient had the following side effects: autoimmune thrombocytopenia, pneumonia (What is pneumonia?) on Mar 17, 2010 from JAPAN Additional patient health information: Male patient , 72 years of age, was diagnosed with follicle centre lymphoma, follicular grade i, ii, iii and. Fludara dosage: . During the same period patient was treated with ENDOXAN (View Endoxan Review and Endoxan Label ), RITUXAN (View Rituxan Review and Rituxan Label ). Patient was hospitalized.

6645626-X | Asthenia, Balance Disorder, Drop Attacks, Vestibular Disorder
Adverse event was reported on Mar 03, 2010 by a Female patient taking Fludara (View Usage) (Dosage: ) was diagnosed with chronic lymphocytic leukaemia and. Location: UNITED KINGDOM , 76 years of age, After Fludara was administered, patient had the following side effects: asthenia, balance disorder, drop attacks, vestibular disorder.

6642474-1 | Haemolytic Anaemia
on Mar 01, 2010 Male patient from UNITED STATES , 62 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: haemolytic anaemia. Fludara dosage: Total Daily Dose: 50 Mg.

6642267-5 | Acute Graft Versus Host Disease, Cytomegalovirus Enteritis, Cytomegalovirus Test Positive, Lung Infection Pseudomonal, Pneumatosis Intestinalis, Small Intestinal Haemorrhage
on Mar 11, 2010 Male patient from JAPAN , 60 years of age, was diagnosed with prophylaxis against graft versus host disease and was treated with Fludara (View Usage). Patient had the following side effects: acute graft versus host disease, cytomegalovirus enteritis, cytomegalovirus test positive, lung infection pseudomonal, pneumatosis intestinalis, small intestinal haemorrhage. Fludara dosage: . During the same period patient was treated with MELPHALAN HYDROCHLORIDE (View Melphalan Hydrochloride Review and Melphalan Hydrochloride Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6642204-3 | Chronic Myeloid Leukaemia Transformation, Focal Segmental Glomerulosclerosis, Leukaemic Infiltration
Patient was taking Fludara (View Usage). After Fludara was administered, patient had the following side effects: chronic myeloid leukaemia transformation, focal segmental glomerulosclerosis, leukaemic infiltration on Mar 10, 2010 from JAPAN Additional patient health information: Female patient , 68 years of age, was diagnosed with chronic lymphocytic leukaemia and. Fludara dosage: . During the same period patient was treated with RITUXIMAB(GENETICAL RECOMBINATION) (View Rituximab(genetical Recombination) Review and Rituximab(genetical Recombination) Label ).

6640302-1 | Asthenia, Balance Disorder, Drop Attacks, Vestibular Disorder
Adverse event was reported on Mar 03, 2010 by a Female patient taking Fludara (View Usage) (Dosage: ) was diagnosed with chronic lymphocytic leukaemia and. Location: UNITED KINGDOM , 76 years of age, Patient experienced the following unwanted or unexpected effects: asthenia, balance disorder, drop attacks, vestibular disorder.

6635940-6 | Haemolytic Anaemia
on Mar 01, 2010 Male patient from UNITED STATES , 62 years of age, was diagnosed with chronic lymphocytic leukaemia and was treated with Fludara (View Usage). Patient had the following side effects: haemolytic anaemia. Fludara dosage: Total Daily Dose: 50 Mg.

6618003-5 | Engraft Failure, Epstein-barr Virus Associated Lymphoproliferative Disorder, Epstein-barr Virus Infection
on Mar 01, 2010 Male patient from JAPAN , child 7 years of age, was diagnosed with aplastic anaemia, stem cell transplant, prophylaxis against graft versus host disease and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: engraft failure, epstein-barr virus associated lymphoproliferative disorder, epstein-barr virus infection. Fludara dosage: . During the same period patient was treated with CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), ANTI HUMAN THYMOCYTE IMMUNOGLOBULIN (View Anti-human Thymocyte Immunoglobulin Review and Anti-human Thymocyte Immunoglobulin Label ), CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ).

6617568-7 | Gastrointestinal Haemorrhage, Histiocytosis Haematophagic, Thrombotic Microangiopathy
Patient was taking Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: gastrointestinal haemorrhage, histiocytosis haematophagic, thrombotic microangiopathy on Feb 17, 2010 from JAPAN Additional patient health information: Male patient , 18 years of age, was diagnosed with stem cell transplant, bone marrow transplant (What is bone marrow transplant?), prophylaxis against graft versus host disease and. Fludara dosage: Total Daily Dose: 30 Mg/m2 Unit Dose: 50 Mg. During the same period patient was treated with MELPHALAN (Total Daily Dose: 90 Mg/m2) (View Melphalan Review and Melphalan Label ), ANTI HUMAN THYMOCYTE IMMUNOGLOBULIN,RABBIT (Total Daily Dose: 15 Mg/m2) (View Anti-human Thymocyte Immunoglobulin,rabbit Review and Anti-human Thymocyte Immunoglobulin,rabbit Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6617567-5 | Gastrointestinal Haemorrhage, Histiocytosis Haematophagic, Thrombotic Microangiopathy
Adverse event was reported on Feb 17, 2010 by a Male patient taking Fludara (View Usage) (Dosage: Total Daily Dose: 30 Mg/m2) was diagnosed with stem cell transplant, bone marrow transplant (What is bone marrow transplant?), prophylaxis against graft versus host disease and. Location: JAPAN , child 4 years of age, Patient had the following side effects: gastrointestinal haemorrhage, histiocytosis haematophagic, thrombotic microangiopathy. During the same period patient was treated with MELPHALAN (Total Daily Dose: 90 Mg/m2) (View Melphalan Review and Melphalan Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6617518-3 | Acute Graft Versus Host Disease, Arrhythmia, Cardiac Failure, Human Herpes Virus 6 Serology Positive, Infection, Pneumonia, Renal Failure Acute, Reversible Posterior Leukoencephalopathy Syndrome
on Mar 01, 2010 Female patient from JAPAN , 39 years of age, was diagnosed with bone marrow conditioning regimen, prophylaxis against graft versus host disease and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: acute graft versus host disease, arrhythmia (What is arrhythmia?), cardiac failure, human herpes virus 6 serology positive, infection (What is infection?), pneumonia (What is pneumonia?), renal failure acute, reversible posterior leukoencephalopathy syndrome. Fludara dosage: Total Daily Dose: 30 Mg/m2. During the same period patient was treated with CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), LYMPHOGLOBULINE (View Lymphoglobuline Review and Lymphoglobuline Label ), CYCLOSPORINE (1.5mg/kg?2fr) (View Cyclosporine Review and Cyclosporine Label ), METHOTREXATE (Day1,3,6) (View Methotrexate Review and Methotrexate Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ).

6617517-1 | Histiocytosis Haematophagic, Infection, Thrombotic Microangiopathy
on Feb 17, 2010 Male patient from JAPAN , 59 years of age, was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: histiocytosis haematophagic, infection (What is infection?), thrombotic microangiopathy. Fludara dosage: Hla: Matched Related Donor. During the same period patient was treated with BUSULFEX (Hla: Matched Related Donor) (View Busulfex Review and Busulfex Label ), IMATINIB MESILATE (View Imatinib Mesilate Review and Imatinib Mesilate Label ), DASATINIB HYDRATE (View Dasatinib Hydrate Review and Dasatinib Hydrate Label ).

6617516-X | Epstein-barr Virus Associated Lymphoproliferative Disorder, Graft Versus Host Disease
Patient was taking Fludara (View Usage). Patient had the following side effects: epstein-barr virus associated lymphoproliferative disorder, graft versus host disease on Feb 17, 2010 from JAPAN Additional patient health information: Female patient , 39 years of age, was diagnosed with acute lymphocytic leukaemia, prophylaxis against graft versus host disease and. Fludara dosage: . During the same period patient was treated with MELPHALAN (View Melphalan Review and Melphalan Label ), ANTI THYMOCYTE GLOBULIN NOS (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ).

6617360-3 | Dyspnoea, Metabolic Acidosis, Multi-organ Failure, Pericarditis, Renal Impairment, Septic Shock
Adverse event was reported on Feb 15, 2010 by a Female patient taking Fludara (View Usage) (Dosage: Cycle 3, 30 Mg/m2 X 5/7) was diagnosed with acute myeloid leukaemia and. Location: UNITED KINGDOM , 43 years of age, weighting 194.0 lb, After Fludara was administered, patient had the following side effects: dyspnoea, metabolic acidosis, multi-organ failure, pericarditis, renal impairment, septic shock. During the same period patient was treated with ARA C (Cycle 4) (View Ara-c Review and Ara-c Label ), ARA C (Cycle 3, 2 G/m2 X 5/7) (View Ara-c Review and Ara-c Label ), ARA C (Cycle 2) (View Ara-c Review and Ara-c Label ), ARA C (Cycle 1 Standard Aml Protocol) (View Ara-c Review and Ara-c Label ), NEUPOGEN (30 Mu/day Till Count Recovery) (View Neupogen Review and Neupogen Label ), ZAVEDOS (Day 1-3) (View Zavedos Review and Zavedos Label ), EVOLTRA (Cycle 4) (View Evoltra Review and Evoltra Label ).

6617246-4 | Bacterial Infection, Gastrointestinal Haemorrhage, Septic Shock, Systemic Candida
on Sep 28, 2009 Male patient from JAPAN , 22 years of age, weighting 110.2 lb, was diagnosed with acute myeloid leukaemia, packed red blood cell transfusion, platelet transfusion, blood product transfusion and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: bacterial infection (What is bacterial infection?), gastrointestinal haemorrhage, septic shock, systemic candida. Fludara dosage: As Used: 20 Mg/m2 Unit Dose: 50 Mg. During the same period patient was treated with ALKERAN (As Used: 40 Mg/m2) (View Alkeran Review and Alkeran Label ), CONCENTRATED RED CELLS (View Concentrated Red Cells Review and Concentrated Red Cells Label ), PLATELETS (View Platelets Review and Platelets Label ), FRESH FROZEN PLASMA (View Fresh Frozen Plasma Review and Fresh Frozen Plasma Label ).

6615675-6 | Acute Graft Versus Host Disease, Arrhythmia, Cardiac Failure, Human Herpes Virus 6 Serology Positive, Infection, Pneumonia, Renal Failure Acute, Reversible Posterior Leukoencephalopathy Syndrome
on Feb 17, 2010 Female patient from JAPAN , 39 years of age, was diagnosed with bone marrow conditioning regimen, prophylaxis against graft versus host disease and was treated with Fludara (View Usage). Patient had the following side effects: acute graft versus host disease, arrhythmia (What is arrhythmia?), cardiac failure, human herpes virus 6 serology positive, infection (What is infection?), pneumonia (What is pneumonia?), renal failure acute, reversible posterior leukoencephalopathy syndrome. Fludara dosage: Total Daily Dose: 30 Mg/m2. During the same period patient was treated with CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), LYMPHOGLOBULINE (View Lymphoglobuline Review and Lymphoglobuline Label ), CYCLOSPORINE (1.5mg/kg?2fr) (View Cyclosporine Review and Cyclosporine Label ), METHOTREXATE (Day1,3,6) (View Methotrexate Review and Methotrexate Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), MYCOPHENOLATE MOFETIL (View Mycophenolate Mofetil Review and Mycophenolate Mofetil Label ).

6615667-7 | Brain Herniation, Hyperammonaemia, Hyperammonaemic Encephalopathy
Patient was taking Fludara (View Usage). After Fludara was administered, patient had the following side effects: brain herniation, hyperammonaemia, hyperammonaemic encephalopathy on Feb 16, 2010 from JAPAN Additional patient health information: Male patient , 33 years of age, was diagnosed with stem cell transplant and. Fludara dosage: . During the same period patient was treated with SANDIMMUNE (Total Daily Dose: 160 Mg) (View Sandimmune Review and Sandimmune Label ), GRAN (Total Daily Dose: 450 ?g) (View Gran Review and Gran Label ), TARGOCID (Total Daily Dose: 400 Mg) (View Targocid Review and Targocid Label ), BROACT (Total Daily Dose: 4 G Unit Dose: 1 G) (View Broact Review and Broact Label ).

6615580-5 | Histiocytosis Haematophagic, Infection, Thrombotic Microangiopathy
Adverse event was reported on Feb 17, 2010 by a Male patient taking Fludara (View Usage) (Dosage: Hla: Matched Related Donor) . Location: JAPAN , 59 years of age, Patient experienced the following unwanted or unexpected effects: histiocytosis haematophagic, infection (What is infection?), thrombotic microangiopathy. During the same period patient was treated with BUSULFEX (Hla: Matched Related Donor) (View Busulfex Review and Busulfex Label ), IMATINIB MESILATE (View Imatinib Mesilate Review and Imatinib Mesilate Label ), DASATINIB HYDRATE (View Dasatinib Hydrate Review and Dasatinib Hydrate Label ).

6615573-8 | Epstein-barr Virus Associated Lymphoproliferative Disorder, Graft Versus Host Disease
on Feb 17, 2010 Female patient from JAPAN , 39 years of age, was diagnosed with acute lymphocytic leukaemia, prophylaxis against graft versus host disease and was treated with Fludara (View Usage). Patient had the following side effects: epstein-barr virus associated lymphoproliferative disorder, graft versus host disease. Fludara dosage: . During the same period patient was treated with MELPHALAN (View Melphalan Review and Melphalan Label ), ANTI THYMOCYTE GLOBULIN NOS (View Anti-thymocyte Globulin Nos Review and Anti-thymocyte Globulin Nos Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ).

6615544-1 | Gastrointestinal Haemorrhage, Histiocytosis Haematophagic, Thrombotic Microangiopathy
on Feb 17, 2010 Male patient from JAPAN , child 4 years of age, was diagnosed with stem cell transplant, bone marrow transplant (What is bone marrow transplant?), prophylaxis against graft versus host disease and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: gastrointestinal haemorrhage, histiocytosis haematophagic, thrombotic microangiopathy. Fludara dosage: Total Daily Dose: 30 Mg/m2. During the same period patient was treated with MELPHALAN (Total Daily Dose: 90 Mg/m2) (View Melphalan Review and Melphalan Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6615542-8 | Gastrointestinal Haemorrhage, Histiocytosis Haematophagic, Thrombotic Microangiopathy
Patient was taking Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: gastrointestinal haemorrhage, histiocytosis haematophagic, thrombotic microangiopathy on Feb 17, 2010 from JAPAN Additional patient health information: Male patient , 18 years of age, was diagnosed with stem cell transplant, bone marrow transplant (What is bone marrow transplant?), prophylaxis against graft versus host disease and. Fludara dosage: Total Daily Dose: 30 Mg/m2 Unit Dose: 50 Mg. During the same period patient was treated with MELPHALAN (Total Daily Dose: 90 Mg/m2) (View Melphalan Review and Melphalan Label ), ANTI HUMAN THYMOCYTE IMMUNOGLOBULIN,RABBIT (Total Daily Dose: 15 Mg/m2) (View Anti-human Thymocyte Immunoglobulin,rabbit Review and Anti-human Thymocyte Immunoglobulin,rabbit Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6611668-3 | Febrile Neutropenia, Nausea, Neutrophil Count Decreased, Oropharyngeal Pain, Stomatitis
Adverse event was reported on Feb 24, 2010 by a Male patient taking Fludara (View Usage) (Dosage: As Used: 44 Mg Unit Dose: 500 Mg) was diagnosed with diffuse large b-cell lymphoma stage iii, prophylaxis against graft versus host disease, infection prophylaxis and. Location: JAPAN , 39 years of age, weighting 156.5 lb, Patient had the following side effects: febrile neutropenia, nausea (What is nausea?), neutrophil count decreased, oropharyngeal pain, stomatitis. During the same period patient was treated with ALKERAN (As Used: 120 Mg) (View Alkeran Review and Alkeran Label ), PROGRAF (As Used: 1.3 Mg) (View Prograf Review and Prograf Label ), METHOTREXATE (As Used: 17 Mg) (View Methotrexate Review and Methotrexate Label ), FUNGUARD (View Funguard Review and Funguard Label ), VICCLOX (As Used: 750 Mg) (View Vicclox Review and Vicclox Label ), CRAVIT (As Used: 300 Mg Unit Dose: 100 G) (View Cravit Review and Cravit Label ).

6611361-7 | Engraft Failure, Epstein-barr Virus Associated Lymphoproliferative Disorder, Epstein-barr Virus Infection
on Feb 17, 2010 Male patient from JAPAN , child 7 years of age, was diagnosed with aplastic anaemia, stem cell transplant, prophylaxis against graft versus host disease and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: engraft failure, epstein-barr virus associated lymphoproliferative disorder, epstein-barr virus infection. Fludara dosage: . During the same period patient was treated with CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ), ANTI HUMAN THYMOCYTE IMMUNOGLOBULIN (View Anti-human Thymocyte Immunoglobulin Review and Anti-human Thymocyte Immunoglobulin Label ), CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ).

6611360-5 | Engraftment Syndrome, Histiocytosis Haematophagic, Venoocclusive Liver Disease
on Feb 17, 2010 Female patient from JAPAN , 22 years of age, was diagnosed with stem cell transplant, prophylaxis against graft versus host disease and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: engraftment syndrome, histiocytosis haematophagic, venoocclusive liver disease. Fludara dosage: 6 Days. During the same period patient was treated with CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ), CYCLOPHOSPHAMIDE (View Cyclophosphamide Review and Cyclophosphamide Label ).

6611359-9 | Acute Graft Versus Host Disease, Encephalopathy, Neuropathy Peripheral, Staphylococcal Sepsis
Patient was taking Fludara (View Usage). Patient had the following side effects: acute graft versus host disease, encephalopathy, neuropathy peripheral, staphylococcal sepsis on Feb 17, 2010 from JAPAN Additional patient health information: Female patient , 68 years of age, was diagnosed with prophylaxis against graft versus host disease and. Fludara dosage: Hla: Full Matched. During the same period patient was treated with MELPHALAN (View Melphalan Review and Melphalan Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), CORTICOSTEROID (View Corticosteroid Review and Corticosteroid Label ).

6611342-3 | Haemorrhage Intracranial, Histiocytosis Haematophagic
Adverse event was reported on Feb 17, 2010 by a Female patient taking Fludara (View Usage) (Dosage: Hla Matched) was diagnosed with stem cell transplant, prophylaxis against graft versus host disease and. Location: JAPAN , 15 years of age, After Fludara was administered, patient had the following side effects: haemorrhage intracranial, histiocytosis haematophagic. During the same period patient was treated with MELPHALAN (Total Daily Dose: 140 Mg/m2) (View Melphalan Review and Melphalan Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6611334-4 | Acute Graft Versus Host Disease, C-reactive Protein Increased, Cytomegalovirus Infection, Engraft Failure, Febrile Neutropenia, Hepatic Encephalopathy, Hepatic Failure, Histiocytosis Haematophagic, Platelet Count Decreased
on Feb 17, 2010 Female patient from JAPAN , 16 years of age, was diagnosed with bone marrow transplant (What is bone marrow transplant?), prophylaxis against graft versus host disease and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: acute graft versus host disease, c-reactive protein increased, cytomegalovirus infection (What is cytomegalovirus infection?), engraft failure, febrile neutropenia, hepatic encephalopathy, hepatic failure, histiocytosis haematophagic, platelet count decreased. Fludara dosage: . During the same period patient was treated with L PAM (View L-pam Review and L-pam Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6611330-7 | Brain Stem Haemorrhage, Encephalopathy, Pyrexia, Rash, Thrombotic Microangiopathy
on Feb 17, 2010 Male patient from JAPAN , child 12 years of age, was treated with Fludara (View Usage). Patient had the following side effects: brain stem haemorrhage, encephalopathy, pyrexia, rash (What is rash?), thrombotic microangiopathy. Fludara dosage: . During the same period patient was treated with BUSULFEX (View Busulfex Review and Busulfex Label ).

6611272-7 | Brain Herniation, Hyperammonaemia, Hyperammonaemic Encephalopathy
Patient was taking Fludara (View Usage). After Fludara was administered, patient had the following side effects: brain herniation, hyperammonaemia, hyperammonaemic encephalopathy on Feb 16, 2010 from JAPAN Additional patient health information: Male patient , 33 years of age, was diagnosed with stem cell transplant and. Fludara dosage: . During the same period patient was treated with SANDIMMUNE (Total Daily Dose: 160 Mg) (View Sandimmune Review and Sandimmune Label ), GRAN (Total Daily Dose: 450 ?g) (View Gran Review and Gran Label ), TARGOCID (Total Daily Dose: 400 Mg) (View Targocid Review and Targocid Label ), BROACT (Total Daily Dose: 4 G Unit Dose: 1 G) (View Broact Review and Broact Label ).

6601628-0 | Balance Disorder, Drop Attacks, Nervous System Disorder, Vestibular Disorder
Adverse event was reported on Feb 03, 2010 by a Female patient taking Fludara (View Usage) (Dosage: Oral; Oral; Oral) was diagnosed with chronic lymphocytic leukaemia and. Location: UNITED KINGDOM , 76 years of age, Patient experienced the following unwanted or unexpected effects: balance disorder, drop attacks, nervous system disorder, vestibular disorder.

6599379-4 | Disseminated Intravascular Coagulation, Thrombotic Microangiopathy
on Feb 17, 2010 Male patient from JAPAN , 49 years of age, was diagnosed with acute myeloid leukaemia, stem cell transplant, prophylaxis against graft versus host disease and was treated with Fludara (View Usage). Patient had the following side effects: disseminated intravascular coagulation, thrombotic microangiopathy. Fludara dosage: . During the same period patient was treated with BUSULFAN (View Busulfan Review and Busulfan Label ), CYCLOSPORINE (View Cyclosporine Review and Cyclosporine Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6599358-7 | Blood Creatinine Increased, Conjunctivitis, Corneal Epithelium Defect, Cytomegalovirus Chorioretinitis, Graft Versus Host Disease, Pulmonary Alveolar Haemorrhage, Retinal Detachment
on Feb 17, 2010 Female patient from JAPAN , 27 years of age, was diagnosed with stem cell transplant, cytomegalovirus chorioretinitis and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: blood creatinine increased, conjunctivitis, corneal epithelium defect, cytomegalovirus chorioretinitis, graft versus host disease, pulmonary alveolar haemorrhage, retinal detachment. Fludara dosage: . During the same period patient was treated with CYTARABINE (View Cytarabine Review and Cytarabine Label ), METHYLPREDNISOLONE 4MG TAB (View Methylprednisolone 4mg Tab Review and Methylprednisolone 4mg Tab Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), HOSCARNET (View Hoscarnet Review and Hoscarnet Label ), GANCICLOVIR (View Ganciclovir Review and Ganciclovir Label ).

6599357-5 | Acute Graft Versus Host Disease, Cytomegalovirus Enteritis, Cytomegalovirus Test Positive, Lung Infection Pseudomonal, Pneumatosis Intestinalis, Small Intestinal Haemorrhage
Patient was taking Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: acute graft versus host disease, cytomegalovirus enteritis, cytomegalovirus test positive, lung infection pseudomonal, pneumatosis intestinalis, small intestinal haemorrhage on Feb 17, 2010 from JAPAN Additional patient health information: Male patient , 60 years of age, was diagnosed with prophylaxis against graft versus host disease and. Fludara dosage: . During the same period patient was treated with MELPHALAN (View Melphalan Review and Melphalan Label ), TACROLIMUS HYDRATE (View Tacrolimus Hydrate Review and Tacrolimus Hydrate Label ), METHOTREXATE (View Methotrexate Review and Methotrexate Label ).

6594193-8 | Paraneoplastic Pemphigus, Pneumonia
Adverse event was reported on Feb 17, 2010 by a Male patient taking Fludara (View Usage) (Dosage: Unit Dose: 10 Mg) was diagnosed with follicle centre lymphoma, follicular grade i, ii, iii stage iii, antifungal prophylaxis and. Location: JAPAN , 54 years of age, Patient had the following side effects: paraneoplastic pemphigus, pneumonia (What is pneumonia?). During the same period patient was treated with BAKTAR (View Baktar Review and Baktar Label ). Patient was hospitalized.

6593838-6 | Altered State Of Consciousness, Brain Herniation, Encephalopathy, Hyperammonaemia
on Feb 16, 2010 Male patient from JAPAN , 33 years of age, was diagnosed with stem cell transplant and was treated with Fludara (View Usage). After Fludara was administered, patient had the following side effects: altered state of consciousness, brain herniation, encephalopathy, hyperammonaemia. Fludara dosage: . During the same period patient was treated with SANDIMMUNE (Total Daily Dose: 160 Mg) (View Sandimmune Review and Sandimmune Label ), GRAN (Total Daily Dose: 450 ?g) (View Gran Review and Gran Label ), TARGOCID (Total Daily Dose: 400 Mg) (View Targocid Review and Targocid Label ), BROACT (Total Daily Dose: 4 G Unit Dose: 1 G) (View Broact Review and Broact Label ).

6593786-1 | Dyspnoea, Metabolic Acidosis, Multi-organ Failure, Pericarditis, Renal Impairment, Septic Shock
on Feb 15, 2010 Female patient from UNITED KINGDOM , 43 years of age, weighting 194.0 lb, was diagnosed with acute myeloid leukaemia and was treated with Fludara (View Usage). Patient experienced the following unwanted or unexpected effects: dyspnoea, metabolic acidosis, multi-organ failure, pericarditis, renal impairment, septic shock. Fludara dosage: Cycle 3, 30 Mg/m2 X 5/7. During the same period patient was treated with ARA C (Cycle 1 Standard Aml Protocol) (View Ara-c Review and Ara-c Label ), ARA C (Cycle 4) (View Ara-c Review and Ara-c Label ), ARA C (Cycle 3, 2 G/m2 X 5/7) (View Ara-c Review and Ara-c Label ), ARA C (Cycle 2) (View Ara-c Review and Ara-c Label ), NEUPOGEN (30 Mu/day Till Count Recovery) (View Neupogen Review and Neupogen Label ), ZAVEDOS (Day 1-3) (View Zavedos Review and Zavedos Label ), EVOLTRA (Cycle 2) (View Evoltra Review and Evoltra Label ). Patient was hospitalized.

6593749-6 | Aspartate Aminotransferase Increased, Hepatic Function Abnormal
Patient was taking Fludara (View Usage). Patient had the following side effects: aspartate aminotransferase increased, hepatic function abnormal on Jan 27, 2010 from JAPAN Additional patient health information: Male patient , 59 years of age, was diagnosed with b-cell lymphoma recurrent and. Fludara dosage: Oral, Every Cycle, Time To Onset: 3 Weeks. During the same period patient was treated with RITUXAN (View Rituxan Review and Rituxan Label ).