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Review Busulfan Safety Reports submitted to FDA

Total Busulfan reports: 135.
Busulfan FDA safety alerts: No.
Reported deaths: 55    Reported hospitalizations: 61.
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FDA Reported Busulfan Side Effects: diarrhoea, sepsis, anorexia, acute graft versus host disease, venoocclusive liver disease, malaise, graft versus host disease, stomatitis, stem cell transplant, nausea, liver disorder.
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Showing 1-100 of 135 Next >

Busulfan Side Effects Report #5474509-6
Consumer or non-health professional from UNITED STATES reported BUSULFAN problem on Sept 28, 2007. Female patient, weighting 201.1 lb, was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: atelectasis, febrile neutropenia, haemoglobin decreased, mucosal inflammation, platelet count decreased, white blood cell count decreased, white blood cell count increased. BUSULFAN dosage: 864 MG. During the same period patient was treated with ETOPOSIDE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5406731-9
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on July 20, 2007. Female patient, 52 years of age, weighting 132.3 lb, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: blood stem cell transplant failure, bone marrow transplant rejection, haemodialysis, renal failure, sepsis, venoocclusive liver disease, weight increased. BUSULFAN dosage: 208 MG. Patient was hospitalized. Patient died on 02/09/2007.

Busulfan Side Effects Report #5406807-6
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Aug 01, 2007. Male patient, child 3 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: anorexia, bone marrow transplant rejection, diarrhoea, hyponatraemia, malaise, nausea, vomiting. BUSULFAN dosage: 12 ML;QD;IV. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5408208-3
BUSULFAN problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 06, 2007. Female patient, weighting 127.9 lb, was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: clostridium difficile colitis, enterocutaneous fistula, febrile neutropenia, metabolic disorder, sepsis, stem cell transplant. BUSULFAN dosage: 640 MG. During the same period patient was treated with CYTARABINE, ETOPOSIDE. Patient died on 07/14/2007.

Busulfan Side Effects Report #5413016-3
Consumer or non-health professional from JAPAN reported BUSULFAN problem on July 26, 2007. Male patient, 30 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: anorexia, cerebellar ataxia, cytomegalovirus antigen positive, diarrhoea, gastrointestinal candidiasis, graft versus host disease, herpes zoster, malaise, small intestinal haemorrhage. BUSULFAN dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, METHOTREXATE. Patient recovered.

Busulfan Side Effects Report #5422196-5
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Aug 03, 2007. Female patient, child 7 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: bone marrow transplant rejection, bronchopulmonary aspergillosis, cystitis haemorrhagic, erythema, flushing, pigmentation disorder, staphylococcal sepsis, swelling, venoocclusive liver disease. BUSULFAN dosage: 20 MG/KG; QD; IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, ETOPOSIDE, VALPROATE, METHOTREXATE, TACROLIMUS. Patient recovered.

Busulfan Side Effects Report #5422205-3
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Aug 03, 2007. Male patient, 63 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, blood lactate dehydrogenase increased, bone marrow transplant, diarrhoea, febrile neutropenia, gastrointestinal disorder, haemodialysis, haemorrhagic cerebral infarction, liver disorder. BUSULFAN dosage: unknown. Patient recovered.

Busulfan Side Effects Report #5385414-8
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on June 26, 2007. Male patient, 55 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: cardiac failure congestive, cerebral haemorrhage, convulsion, mitral valve incompetence, oedema, pneumonia, renal disorder, sepsis, venoocclusive liver disease. BUSULFAN dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE. Patient recovered.

Busulfan Side Effects Report #5385416-1
Consumer or non-health professional from JAPAN reported BUSULFAN problem on June 26, 2007. Male patient, 54 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, ascites, blood bilirubin increased, blood lactate dehydrogenase increased, cystitis haemorrhagic, cytomegalovirus antibody positive, cytomegalovirus infection, diarrhoea, graft versus host disease. BUSULFAN dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, CYCLOSPORINE, VALPROATE. Patient died on 12/19/2006.

Busulfan Side Effects Report #5385508-7
BUSULFAN problem was reported by a Health Professional from JAPAN on June 26, 2007. Male patient, 31 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, blood bilirubin increased, blood lactate dehydrogenase increased, cystitis haemorrhagic, thrombotic microangiopathy, viraemia. BUSULFAN dosage: unknown. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5391627-1
Consumer or non-health professional from JAPAN reported BUSULFAN problem on July 02, 2007. Male patient, 47 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: cardiac failure, liver disorder, renal disorder, staphylococcal sepsis, stomatitis, transplant failure. BUSULFAN dosage: 4 ML; QID; IV. During the same period patient was treated with MELPHALAN, CLADRIBINE, PHENYTOIN, LENOGRASTIM, CYCLOSPORINE, METHOTREXATE. Patient recovered.

Busulfan Side Effects Report #5391671-4
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on July 03, 2007. Female patient, 48 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, acute graft versus host disease, anorexia, blood bilirubin increased, bone marrow transplant, cardiac failure, diarrhoea, engraftment syndrome, gastrointestinal haemorrhage. BUSULFAN dosage: 5.3 ML;QID;IV. During the same period patient was treated with HEPARIN, CYCLOPHOSPHAMIDE, PHENYTOIN. Patient recovered.

Busulfan Side Effects Report #5391672-6
Consumer or non-health professional from JAPAN reported BUSULFAN problem on July 02, 2007. Male patient, 59 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: anorexia, capillary leak syndrome, cardiac failure, diarrhoea, disseminated intravascular coagulation, gastroenteritis staphylococcal, haemolysis, haemorrhoids, liver disorder. BUSULFAN dosage: 46 MG;QID;IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, HEPARIN. Patient was hospitalized. Patient died on 03/01/2007.

Busulfan Side Effects Report #5391694-5
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on July 03, 2007. Female patient, 34 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, alanine aminotransferase increased, anorexia, aspartate aminotransferase increased, diarrhoea, enterococcal sepsis, liver disorder, malaise, nausea. BUSULFAN dosage: 26.8 MG;QD;IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, PHENYTOIN, FILGRASTIM, METHOTREXATE, TACROLIMUS. Patient recovered.

Busulfan Side Effects Report #5391695-7
Consumer or non-health professional from JAPAN reported BUSULFAN problem on July 03, 2007. Male patient, 49 years of age, was diagnosed with stem cell transplant, graft versus host disease and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: anorexia, bone marrow transplant rejection, cytomegalovirus infection, diarrhoea, graft complication, hyperbilirubinaemia, malaise, pain in extremity, pseudomembranous colitis. BUSULFAN dosage: 40 ML; QD; IV. During the same period patient was treated with NARTOGRASTIM, TRIMETHYLCETYLAMMONIUM PENTACHLOROPHENATE, CLADRIBINE, PHENYTOIN, LENOGRASTIM, FILGRASTIM, TACROLIMUS, MYCOPHENOLATE MOFETIL. Patient recovered.

Busulfan Side Effects Report #5391696-9
BUSULFAN problem was reported by a Health Professional from JAPAN on July 03, 2007. Female patient, 51 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, blood pressure decreased, bone marrow transplant rejection, cardiac arrest, condition aggravated, diarrhoea, respiratory arrest, sepsis. BUSULFAN dosage: 26.68 ML;QD;IV. During the same period patient was treated with VALPROATE, CYCLOPHOSPHAMIDE, METHOTREXATE, CYCLOSPORINE. Patient was hospitalized. Patient died on 04/09/2007.

Busulfan Side Effects Report #5391697-0
Health Professional from JAPAN reported BUSULFAN problem on July 03, 2007. Female patient, 50 years of age, was diagnosed with stem cell transplant, prophylaxis against graft versus host disease and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: anorexia, cytomegalovirus infection, diarrhoea, malaise, nausea, pseudomembranous colitis, sepsis, stomatitis. BUSULFAN dosage: 26.4 ML;QD; IV. During the same period patient was treated with METHOTREXATE, FLUDARABINE PHOSPHATE, PHENYTOIN, NEUPOGEN. Patient recovered.

Busulfan Side Effects Report #5392149-4
BUSULFAN problem was reported by a Consumer or non-health professional from UNITED STATES on July 18, 2007. Male patient, weighting 145.5 lb, was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, septic shock. BUSULFAN dosage: 1024 MG. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5393398-1
Consumer or non-health professional from UNITED STATES reported BUSULFAN problem on July 17, 2007. Male patient, weighting 145.5 lb, was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, septic shock. BUSULFAN dosage: 1024 MG. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient was hospitalized. Patient died on 07/11/2007.

Busulfan Side Effects Report #5397301-X
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on July 06, 2007. Female patient, 40 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, diarrhoea, pharyngeal erythema, sepsis, stomatitis. BUSULFAN dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, METHOTREXATE, VALPROATE, FILGRASTIM, CYCLOSPORINE. Patient recovered.

Busulfan Side Effects Report #5400046-0
Consumer or non-health professional from UNITED KINGDOM reported BUSULFAN problem on July 12, 2007. Female patient was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: thrombotic thrombocytopenic purpura. BUSULFAN dosage: unknown. Patient recovered.

Busulfan Side Effects Report #5385414-8
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on June 26, 2007. Male patient, 55 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: cardiac failure congestive, cerebral haemorrhage, convulsion, mitral valve incompetence, oedema, pneumonia, renal disorder, sepsis, venoocclusive liver disease. BUSULFAN dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE. Patient recovered.

Busulfan Side Effects Report #5385416-1
Consumer or non-health professional from JAPAN reported BUSULFAN problem on June 26, 2007. Male patient, 54 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, ascites, blood bilirubin increased, blood lactate dehydrogenase increased, cystitis haemorrhagic, cytomegalovirus antibody positive, cytomegalovirus infection, diarrhoea, graft versus host disease. BUSULFAN dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, CYCLOSPORINE, VALPROATE. Patient died on 12/19/2006.

Busulfan Side Effects Report #5385508-7
BUSULFAN problem was reported by a Health Professional from JAPAN on June 26, 2007. Male patient, 31 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, blood bilirubin increased, blood lactate dehydrogenase increased, cystitis haemorrhagic, thrombotic microangiopathy, viraemia. BUSULFAN dosage: unknown. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5391627-1
Consumer or non-health professional from JAPAN reported BUSULFAN problem on July 02, 2007. Male patient, 47 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: cardiac failure, liver disorder, renal disorder, staphylococcal sepsis, stomatitis, transplant failure. BUSULFAN dosage: 4 ML; QID; IV. During the same period patient was treated with MELPHALAN, CLADRIBINE, PHENYTOIN, LENOGRASTIM, CYCLOSPORINE, METHOTREXATE. Patient recovered.

Busulfan Side Effects Report #5391671-4
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on July 03, 2007. Female patient, 48 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, acute graft versus host disease, anorexia, blood bilirubin increased, bone marrow transplant, cardiac failure, diarrhoea, engraftment syndrome, gastrointestinal haemorrhage. BUSULFAN dosage: 5.3 ML;QID;IV. During the same period patient was treated with HEPARIN, CYCLOPHOSPHAMIDE, PHENYTOIN. Patient recovered.

Busulfan Side Effects Report #5391672-6
Consumer or non-health professional from JAPAN reported BUSULFAN problem on July 02, 2007. Male patient, 59 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: anorexia, capillary leak syndrome, cardiac failure, diarrhoea, disseminated intravascular coagulation, gastroenteritis staphylococcal, haemolysis, haemorrhoids, liver disorder. BUSULFAN dosage: 46 MG;QID;IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, HEPARIN. Patient was hospitalized. Patient died on 03/01/2007.

Busulfan Side Effects Report #5391694-5
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on July 03, 2007. Female patient, 34 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, alanine aminotransferase increased, anorexia, aspartate aminotransferase increased, diarrhoea, enterococcal sepsis, liver disorder, malaise, nausea. BUSULFAN dosage: 26.8 MG;QD;IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, PHENYTOIN, FILGRASTIM, METHOTREXATE, TACROLIMUS. Patient recovered.

Busulfan Side Effects Report #5391695-7
Consumer or non-health professional from JAPAN reported BUSULFAN problem on July 03, 2007. Male patient, 49 years of age, was diagnosed with stem cell transplant, graft versus host disease and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: anorexia, bone marrow transplant rejection, cytomegalovirus infection, diarrhoea, graft complication, hyperbilirubinaemia, malaise, pain in extremity, pseudomembranous colitis. BUSULFAN dosage: 40 ML; QD; IV. During the same period patient was treated with NARTOGRASTIM, TRIMETHYLCETYLAMMONIUM PENTACHLOROPHENATE, CLADRIBINE, PHENYTOIN, LENOGRASTIM, FILGRASTIM, TACROLIMUS, MYCOPHENOLATE MOFETIL. Patient recovered.

Busulfan Side Effects Report #5391696-9
BUSULFAN problem was reported by a Health Professional from JAPAN on July 03, 2007. Female patient, 51 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute myeloid leukaemia, blood pressure decreased, bone marrow transplant rejection, cardiac arrest, condition aggravated, diarrhoea, respiratory arrest, sepsis. BUSULFAN dosage: 26.68 ML;QD;IV. During the same period patient was treated with VALPROATE, CYCLOPHOSPHAMIDE, METHOTREXATE, CYCLOSPORINE. Patient was hospitalized. Patient died on 04/09/2007.

Busulfan Side Effects Report #5391697-0
Health Professional from JAPAN reported BUSULFAN problem on July 03, 2007. Female patient, 50 years of age, was diagnosed with stem cell transplant, prophylaxis against graft versus host disease and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: anorexia, cytomegalovirus infection, diarrhoea, malaise, nausea, pseudomembranous colitis, sepsis, stomatitis. BUSULFAN dosage: 26.4 ML;QD; IV. During the same period patient was treated with METHOTREXATE, FLUDARABINE PHOSPHATE, PHENYTOIN, NEUPOGEN. Patient recovered.

Busulfan Side Effects Report #5392149-4
BUSULFAN problem was reported by a Consumer or non-health professional from UNITED STATES on July 18, 2007. Male patient, weighting 145.5 lb, was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, septic shock. BUSULFAN dosage: 1024 MG. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5393398-1
Consumer or non-health professional from UNITED STATES reported BUSULFAN problem on July 17, 2007. Male patient, weighting 145.5 lb, was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: multi-organ failure, septic shock. BUSULFAN dosage: 1024 MG. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient was hospitalized. Patient died on 07/11/2007.

Busulfan Side Effects Report #5397301-X
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on July 06, 2007. Female patient, 40 years of age, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease, diarrhoea, pharyngeal erythema, sepsis, stomatitis. BUSULFAN dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, METHOTREXATE, VALPROATE, FILGRASTIM, CYCLOSPORINE. Patient recovered.

Busulfan Side Effects Report #5400046-0
Consumer or non-health professional from UNITED KINGDOM reported BUSULFAN problem on July 12, 2007. Female patient was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: thrombotic thrombocytopenic purpura. BUSULFAN dosage: unknown. Patient recovered.

Showing 1-100 of 135 Next >


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