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Busulfan Side Effects submitted to FDA
Total Busulfan reports: 188.Busulfan FDA safety alerts: No.
Reported deaths: 73 Reported hospitalizations: 79.
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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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Busulfan Side Effects Report #5570101-3Health Professional from JAPAN reported BUSULFAN problem on Dec 03, 2007. Male patient, 58 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, acute graft versus host disease in skin, anorexia, ascites, bk virus infection, blister, blood bilirubin increased, cystitis haemorrhagic, diarrhoea. BUSULFAN dosage: 31.72 ML;QD;IV. During the same period patient was treated with FLUDARABINE PHOSPHATE. Patient died on 09/11/2007.
Busulfan Side Effects Report #5573170-X
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Dec 06, 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, jaundice, mitral valve incompetence, nausea, oedema, pneumonia, renal disorder. BUSULFAN dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE. Patient recovered.
Busulfan Side Effects Report #5573171-1
Health Professional from JAPAN reported BUSULFAN problem on Dec 06, 2007. Male patient, 53 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, anorexia, gamma-glutamyltransferase increased, malaise, pneumonia, venoocclusive liver disease. BUSULFAN dosage: 40 MG; QID; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, PHENYTOIN, FILGRASTIM, METHOTREXATE, CYCLOSPORINE. Patient was hospitalized and became disabled. Patient recovered.
Busulfan Side Effects Report #5506440-1
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Oct 23, 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, diarrhoea, febrile neutropenia, haemodialysis, haemorrhagic cerebral infarction, intestinal functional disorder, liver disorder. BUSULFAN dosage: unknown. Patient was hospitalized and became disabled. Patient died.

Busulfan Side Effects Report #5506837-X
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Oct 24, 2007. Male patient, 60 years of age, was diagnosed with prophylaxis against graft versus host disease, antibiotic prophylaxis, antiviral prophylaxis, antifungal prophylaxis and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: hypovolaemic shock, immune system disorder, pulmonary alveolar haemorrhage, thrombocytopenia. BUSULFAN dosage: 4 MG/KG, DAY-6 TO -5. During the same period patient was treated with TACROLIMUS, FLUDARA, CIPROFLOXACIN, ACYCLOVIR, ITRACONAZOLE. Patient died on 01/01/2005.
Busulfan Side Effects Report #5509985-3
BUSULFAN problem was reported by a Health Professional from UNITED STATES on Nov 07, 2007. Female patient, weighting 196.4 lb, was diagnosed with myeloid leukaemia and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, alanine aminotransferase abnormal, ammonia increased, anorexia, ascites, aspartate aminotransferase abnormal, blood bilirubin increased, confusional state, gastritis. BUSULFAN dosage: .08 MG/KG -56.5 MG- Q 8 H FPR 16 DOSES IV BOLUS. During the same period patient was treated with CLOFARABINE. Patient was hospitalized. Patient recovered.
Busulfan Side Effects Report #5523798-8
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Nov 05, 2007. Male patient, 21 years of age, was diagnosed with stem cell transplant, hyperbilirubinaemia and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: diarrhoea, hyperbilirubinaemia, staphylococcal sepsis, streptococcal sepsis. BUSULFAN dosage: 33.2 ML; QD; IV. During the same period patient was treated with MICAFUNGIN, CYCLOPHOSPHAMIDE, VALPROATE, NEUPOGEN, METHOTREXATE, CYCLOSPORINE. Patient recovered.
Busulfan Side Effects Report #5523800-3
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Nov 05, 2007. Male patient, child 4 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 recurrent, graft versus host disease, sepsis, stomatitis. BUSULFAN dosage: 9.63 ML; QD; IV, 12.84 ML; QD; IV, 3.21 ML; QD; IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, CYTARABINE, CLONAZEPAM, NEUPOGEN, METHOTREXATE. Patient was hospitalized. Patient died on 07/26/2007.
Busulfan Side Effects Report #5523802-7
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Nov 05, 2007. Female patient, 18 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, malaise, nausea, nystagmus, staphylococcal sepsis, vertigo, vomiting. BUSULFAN dosage: 20 ML; QD; IV. During the same period patient was treated with PHENYTOIN, CYCLOPHOSPHAMIDE, NEUPOGEN, METHOTREXATE, TACROLIMUS. Patient recovered.

Busulfan Side Effects Report #5523815-5
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Nov 05, 2007. Male patient, 60 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, nausea, nystagmus, staphylococcal sepsis, vertigo, vomiting. BUSULFAN dosage: 3.2 ML; QD; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, NEUPOGEN, METHOTREXATE, TACROLIMUS. Patient was hospitalized. Patient recovered.
Busulfan Side Effects Report #5523818-0
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Nov 05, 2007. Female patient, child 1 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: obliterative bronchiolitis, respiratory failure, thrombotic microangiopathy. BUSULFAN dosage: 2.8 ML; QD; IV, 4.0 ML; QD; IV. During the same period patient was treated with ETOPOSIDE, CYCLOPHOSPHAMIDE, CLONAEPAM, METHOTREXATE, TARCOLIMUS, CYCLOSPORINE. Patient died on 06/25/2007.
Busulfan Side Effects Report #5523819-2
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Nov 05, 2007. Male patient, 25 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: perianal abscess, pharyngitis, pneumonia staphylococcal, stomatitis. BUSULFAN dosage: 29.2 ML; QD; IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, VALPROATE, NEUPOGEN, METHOTREXATE, CYCLOSPORINE. Patient recovered.
Busulfan Side Effects Report #5523822-2
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Nov 05, 2007. Female patient, 14 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, cytomegalovirus hepatitis, klebsiella sepsis, venoocclusive liver disease. BUSULFAN dosage: 21.6 ML; QD; IV, 30.8 ML; QD; IV, 7.2 ML;QD;IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, MELPHALAN, PHENYTOIN, LENOGRASTIM, METHOTREXATE, TACROLIMUS. Patient died on 08/21/2007.
Busulfan Side Effects Report #5523823-4
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Nov 05, 2007. Female 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: blood bilirubin increased, bronchopulmonary aspergillosis, diarrhoea, hepatic function abnormal, hypokalaemia, pancytopenia, stomatitis, streptococcal sepsis. BUSULFAN dosage: 24.4 ML;QD;IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, PHENYTOIN, NEUPOGEN, LENOGRASTIM, METHOTREXATE, TACROLIMUS. Patient recovered.

Busulfan Side Effects Report #5526439-9
Health Professional from UNITED STATES reported BUSULFAN problem on Nov 21, 2007. Male patient, weighting 175.7 lb, was diagnosed with acute myeloid leukaemia and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: agitation, anxiety, confusional state, mood altered, nervous system disorder. BUSULFAN dosage: 78MG QD. During the same period patient was treated with CYTOXAN, ATGAM, ACYCLOVIR, DAPSONE, ACTIGALL, NEORAL, BUDESONIDE. Patient was hospitalized. Patient recovered.
Busulfan Side Effects Report #5527709-0
BUSULFAN problem was reported by a Physician from JAPAN on Nov 09, 2007. Male patient, child 4 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. BUSULFAN dosage: 4.8 MG/KG;QD;IV. During the same period patient was treated with DALTEPARIN. Patient recovered.
Busulfan Side Effects Report #5528069-1
Health Professional from JAPAN reported BUSULFAN problem on Nov 09, 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: ascites, continuous haemodiafiltration, dyspnoea, gallbladder enlargement, haematemesis, hepatic failure, hepatomegaly, hypopnoea, multi-organ failure. BUSULFAN dosage: 6.6 MG;QID;IV. Patient recovered.
Busulfan Side Effects Report #5528071-X
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Nov 09, 2007. Female patient, 17 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, white blood cell count decreased. BUSULFAN dosage: 28.4 ML;QV;IV. Patient recovered.
Busulfan Side Effects Report #5496979-X
Health Professional from JAPAN reported BUSULFAN problem on Oct 09, 2007. Male patient, child .8 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, bone marrow transplant, cholecystitis, diarrhoea, hypoalbuminaemia, oral intake reduced, platelet count decreased, sepsis. BUSULFAN dosage: 0.45 ML; X1; IV, 5.08 ML; X1; IV. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5496980-6
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Oct 09, 2007. Female patient, 52 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, diarrhoea, enterococcal sepsis, nausea, pathogen resistance, respiratory failure, staphylococcal sepsis, stomatitis. BUSULFAN dosage: 26.8 ML; X1; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE. Patient was hospitalized and became disabled. Patient died on 08/11/2007.
Busulfan Side Effects Report #5496982-X
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Oct 09, 2007. Female patient, child 4 years of age, weighting 35.27 lb, was diagnosed with stem cell transplant and was treated with BUSULFAN. After drug was administered, patient experienced the following problems/side effects: anorexia, coagulopathy, diarrhoea, disseminated intravascular coagulation, febrile neutropenia, haematemesis, malaise, multi-organ failure, shock. BUSULFAN dosage: 4.4 MG/KG; QD; IV. Patient was hospitalized. Patient died.
Busulfan Side Effects Report #5497620-2
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Oct 09, 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, bone marrow transplant, diarrhoea, enteritis, enterococcal sepsis, gamma-glutamyltransferase increased. BUSULFAN dosage: 26.8 MG;QD;IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, PHENYTOIN, NEUPOGEN, METHOTREXATE, TACROLIMUS. Patient recovered.
Busulfan Side Effects Report #5497643-3
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Oct 09, 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, central line infection, cytomegalovirus infection, diarrhoea, gamma-glutamyltransferase increased, hyperbilirubinaemia, malaise, pain in extremity. BUSULFAN dosage: 40 ML;QD;IV. During the same period patient was treated with NARTOGRASTIM, TRIMETHYLCETYLAMMONIUM PENTACHLOROPHENATE, CLADRIBINE, PHENYTOIN, LENOGRASTIM, NEUPOGEN, TACROLIMUS, MYCOPHENOLATE MOFETIL. Patient was hospitalized and became disabled. Patient recovered.
Busulfan Side Effects Report #5497644-5
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Oct 09, 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, blood potassium decreased, bone marrow transplant rejection, cytomegalovirus infection, gamma-glutamyltransferase increased, ill-defined disorder, mucous membrane disorder, nausea, neutropenia. BUSULFAN dosage: 26.4 ML;QD;IV. During the same period patient was treated with METHOTREXATE, FLUDARABINE PHOSPHATE, PHENYTOIN, NEUPOGEN. Patient was hospitalized and became disabled. Patient recovered.
Busulfan Side Effects Report #5497678-0
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Oct 09, 2007. Female 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: acute graft versus host disease, anorexia, arthritis bacterial, cardiac failure, cytomegalovirus viraemia, diarrhoea, febrile neutropenia, hyponatraemia. BUSULFAN dosage: 10.6 ML;X1;IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, CYCLOSPORINE. Patient was hospitalized. Patient recovered.
Busulfan Side Effects Report #5503590-0
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Oct 15, 2007. Male patient, 35 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: enterococcal sepsis, hyperkalaemia, renal failure, stenotrophomonas sepsis, stomatitis, ventricular fibrillation. BUSULFAN dosage: 34 ML; QD; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE, CYCLOSPORINE, NEUPOGEN. Patient died on 06/15/2007.
Busulfan Side Effects Report #5503591-2
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Oct 15, 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: azotaemia, capillary leak syndrome, cardiac arrest, cardiac failure, disseminated intravascular coagulation, gastroenteritis staphylococcal, gastrointestinal haemorrhage. 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 #5503592-4
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Oct 15, 2007. Male 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: staphylococcal sepsis, supraventricular tachycardia, venoocclusive liver disease. BUSULFAN dosage: 30 ML;QD;IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, VALPROATE, NEUPOGEN, METHOTREXATE, TACROLIMUS. Patient recovered.
Busulfan Side Effects Report #5503593-6
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Oct 15, 2007. Male patient, 15 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, cystitis, cystitis haemorrhagic, diarrhoea, graft versus host disease, nausea, pneumonia, sepsis, stomatitis haemorrhagic. BUSULFAN dosage: 27.48 ML;QD;IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, PHENYTOIN, NEUPOGEN, TACROLIMUS. Patient recovered.
Busulfan Side Effects Report #5503594-8
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Oct 15, 2007. Female patient, 21 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, candida sepsis, cardiogenic shock, pneumonia, staphylococcal sepsis, stomatitis. BUSULFAN dosage: 26 ML;QD;IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE, NEUPOGEN, METHOTREXATE, TACROLIMUS. Patient recovered.
Busulfan Side Effects Report #5503595-X
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Oct 15, 2007. Male patient, 65 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, idiopathic pneumonia syndrome, stem cell transplant. BUSULFAN dosage: 32 ML; QD; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, MELPHALAN, VALPROATE, NEUPOGEN, TACROLIMUS, MYCOPHENOLATE MOFETIL. Patient died on 08/13/2007.
Busulfan Side Effects Report #5447576-3
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Aug 22, 2007. Male patient, child 10 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: multi-organ failure, performance status decreased, venoocclusive liver disease. BUSULFAN dosage: 0.8 MG/KG;1X;. Patient died on 05/27/2007.
Busulfan Side Effects Report #5447577-5
Health Professional from JAPAN reported BUSULFAN problem on Aug 22, 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: acute graft versus host disease, anorexia, cytomegalovirus infection, diarrhoea, malaise, nausea, sepsis, stomatitis. BUSULFAN dosage: 32.8 ML;. During the same period patient was treated with METHOTREXATE, CYCLOSPORINE. Patient was hospitalized. Patient recovered.
Busulfan Side Effects Report #5447579-9
BUSULFAN problem was reported by a Health Professional from JAPAN on Aug 22, 2007. Female patient, 21 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: cystitis haemorrhagic, diarrhoea, disseminated intravascular coagulation, malaise, multi-organ failure, nausea, neutropenia, staphylococcal sepsis, stem cell transplant. BUSULFAN dosage: 6.2 ML;BID;IV; 6.2 ML;QID;IV; 6.2 ML;X1;IV. During the same period patient was treated with PHENYTOIN, CYCLOPHOSPHAMIDE, METHOTREXATE, CYCLOSPORINE. Patient died on 05/05/2007.
Busulfan Side Effects Report #5466145-2
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Sept 10, 2007. Male patient, 45 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, diarrhoea, enterococcal sepsis, pneumonia parainfluenzae viral. BUSULFAN dosage: 28 ML; QD; IV. During the same period patient was treated with VALPROATE, FLUDARABINE PHOSPHATE, LENOGRASTIM, TACROLIMUS, MELPHALAN. Patient was hospitalized. Patient recovered.
Busulfan Side Effects Report #5466146-4
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Sept 10, 2007. Female patient, 56 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, haemodialysis, pneumonia, renal failure acute, sepsis, stomatitis. BUSULFAN dosage: 26.4 ML; QD; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, NEUPOGEN, VALPROATE, METHOTREXATE, TACROLIMUS, CYCLOSPORINE. Patient died on 06/15/2007.
Busulfan Side Effects Report #5466154-3
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Sept 10, 2007. Male patient, 20 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: altered state of consciousness, diarrhoea, gastrointestinal perforation, stress ulcer, thrombotic microangiopathy, upper gastrointestinal haemorrhage. BUSULFAN dosage: 31.2 ML;QD;IV; 41.6 ML;QD;IV; 10.4 ML;QD;IV. During the same period patient was treated with NEUPOGEN, VALPROATE, CYCLOPHOSPHAMIDE, METHOTREXATE, TACROLIMUS. Patient was hospitalized. Patient recovered.
Busulfan Side Effects Report #5466200-7
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Sept 10, 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: acute graft versus host disease, blood bilirubin increased, bone marrow transplant, cardiac failure, engraftment syndrome, gastrointestinal haemorrhage, hepatic function abnormal, hypernatraemia, interstitial lung disease. BUSULFAN dosage: 5.3 ML;QID;IV. During the same period patient was treated with HEPARIN, CYCLOPHOSPHAMIDE, PHENYTOIN. Patient was hospitalized. Patient died.
Busulfan Side Effects Report #5466201-9
Consumer or non-health professional from JAPAN reported BUSULFAN problem on Sept 10, 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: enterococcal infection, histiocytosis haematophagic, sepsis, transplant failure. BUSULFAN dosage: 24 ML;QD;IV; ;IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE, NEUPOGEN, TACROLIMUS. Patient died on 06/12/2007.
Busulfan Side Effects Report #5466208-1
BUSULFAN problem was reported by a Consumer or non-health professional from JAPAN on Sept 10, 2007. Male patient, 21 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: lower gastrointestinal haemorrhage, thrombocytopenia. BUSULFAN dosage: 25.8 MG; QD; IV; 34.4 ML; QD; IV; 6 ML; QD; IV. During the same period patient was treated with NEUPOGEN, VALPROATE, CYCLOPHOSPHAMIDE, METHOTREXATE, CYCLOSPORINE. Patient recovered.
Busulfan Side Effects Report #5468640-9
Health Professional from JAPAN reported BUSULFAN problem on Sept 11, 2007. Male patient, 60 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: blood creatinine increased, blood culture positive, blood sodium increased, bone marrow transplant, decreased appetite, diarrhoea, escherichia infection, febrile neutropenia, haemodialysis. BUSULFAN dosage: 27 ML; QD; IV; 36 ML; QD; IV; 9 ML; QD; IV. During the same period patient was treated with NEUPOGEN, FLUDARABINE PHOSPHATE, CYTARABINE, VALPROATE, METHOTREXATE, TACROLIMUS. Patient died.
Busulfan Side Effects Report #5468653-7
BUSULFAN problem was reported by a Health Professional from JAPAN on Sept 11, 2007. Female patient, child 6 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: acute graft versus host disease, anorexia, cytomegalovirus antigen positive, diabetes mellitus, diarrhoea, febrile neutropenia, malaise, oedema mouth, pharyngolaryngeal pain. BUSULFAN dosage: 10.2 ML; QD; IV; 13.6 ML; QD; IV; 3.4 ML; QD; IV. During the same period patient was treated with MELPHALAN, TACROLIMUS, PHENYTOIN, LENOGRASTIM, METHOTREXATE. Patient was hospitalized. Patient recovered.
Busulfan Side Effects


