Busulfan and acute graft versus host disease Patient Reports February 09, 2010

Busulfan Side Effects Report #5586026-3
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 21, 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 side effects: acute graft versus host disease, anorexia, blister, diabetes mellitus, diarrhoea, febrile neutropenia, haematochezia, hepatic function abnormal, malaise. Busulfan dosage: 12 ML; IV, 16 ML; IV, 4 ML; IV. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5585758-0
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 21, 2007. Male patient, 64 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease, acute myeloid leukaemia recurrent, anorexia, atrial tachycardia, atrioventricular block, bone marrow transplant , cytomegalovirus antigen positive, dysgeusia, hepatic function abnormal. Busulfan dosage: unknown. During the same period patient was treated with PHENYTOIN, NARTOGRASTIM, METHOTREXATE, TACROLIMUS, CYLOCIDE, NOVANTRONE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5586040-8
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 21, 2007. Female patient, 64 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease, acute respiratory distress syndrome, bone marrow transplant , candidiasis, convulsion, disseminated intravascular coagulation, neutropenia, pancreatitis acute. Busulfan dosage: 10 ML; IV, 20 ML; IV. Patient died.

Busulfan Side Effects Report #5422205-3
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN 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 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 #5506440-1
Busulfan side effect 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 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 #5586043-3
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 21, 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 side effects: acute graft versus host disease, anorexia, aplasia pure red cell, blood creatinine increased, cytomegalovirus antigen positive, hyperkalaemia, nausea , stomatitis. Busulfan dosage: 29.08 ML; X1; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5468653-7
Busulfan side effect 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 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 Report #5570101-3
Busulfan side effect was reported by a Health Professional from JAPAN 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 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 #5466146-4
Busulfan side effect 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 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 #5585755-5
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 21, 2007. Male patient, 56 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease, adenoviral haemorrhagic cystitis, anorexia, cytomegalovirus viraemia, diarrhoea, enterococcal infection, hepatic function abnormal, malaise, nausea . Busulfan dosage: 36 ML; QD; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, PHENYTOIN. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5447577-5
Busulfan side effect was reported by a Health Professional from JAPAN 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 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 #5497678-0
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN 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 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 #5573171-1
Busulfan side effect was reported by a Health Professional from JAPAN 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 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 #5586027-5
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 21, 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 side effects: acute graft versus host disease, cytomegalovirus viraemia, diarrhoea, hepatic function abnormal, malaise, nausea , stomatitis. Busulfan dosage: 25.2 ML; X1; IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, PHENYTOIN. Patient was hospitalized. Patient recovered.


Busulfan Side Effects Report #5391671-4
Busulfan side effect 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 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 #5466200-7
Busulfan side effect 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 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 #5284362-1
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Mar 16, 2007. Male patient, 46 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease. Busulfan dosage: 8 ML;QID;IV. During the same period patient was treated with CYCLOPHOSPHAMIDE, FILGRASTIM, PHENYTOIN, METHOTREXATE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5663404-5
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Feb 22, 2008. Male patient, 46 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease, acute myeloid leukaemia recurrent, anorexia, convulsion, diarrhoea, nausea , staphylococcal sepsis, stomatitis. Busulfan dosage: 27 ML; 36 ML; 9 ML. Patient was hospitalized. Patient died.

Busulfan Side Effects Report #5468654-9
Busulfan side effect was reported by a Health Professional from JAPAN on Sept 11, 2007. Male patient, 43 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease, haemodialysis, meningitis viral, renal impairment, sepsis , stem cell transplant. Busulfan dosage: 36 ML;QD;IV. During the same period patient was treated with NEUPOGEN, FLUDARABINE PHOSPHATE, VALPROATE, TACROLIMUS. Patient died on 06/03/2007.


Busulfan Side Effects Report #5308979-0
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Apr 17, 2007. Male patient, 40 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease, peritonitis, tumour lysis syndrome, venoocclusive liver disease. Busulfan dosage: 216 MG; QD; IV. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5369892-6
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on June 07, 2007. Male patient, 40 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease, bone marrow transplant rejection, peritonitis, tumour lysis syndrome, venoocclusive liver disease. Busulfan dosage: 216 MG; QD; IV. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5397301-X
Busulfan side effect 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 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 #5586034-2
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 21, 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 side effects: acinetobacter infection, acute graft versus host disease, bacterial sepsis, cystitis haemorrhagic, cytomegalovirus viraemia, liver disorder, pseudomembranous colitis, staphylococcal sepsis, stomatitis. Busulfan dosage: 31.2 ML; X1; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, PHENYTOIN. Patient was hospitalized and became disabled. Patient recovered.

Busulfan Side Effects Report #5391694-5
Busulfan side effect 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 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 #5497620-2
Busulfan side effect 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 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 #5585735-X
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 21, 2007. Female patient, 32 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease, acute graft versus host disease in intestine, brain abscess, cytomegalovirus viraemia, diarrhoea, haemodynamic instability, no therapeutic response, stomatitis. Busulfan dosage: 19.2 ML; XL; IV, 25.6 ML; X1; IV, 6.4 ML; X1; IV. During the same period patient was treated with MELPHALAN, FLUDARABINE PHOSPHATE, VALPROATE, ATGAM, IMMUNOGLOBULIN. Patient died on 08/20/2007.

Busulfan Side Effects Report #5385508-7
Busulfan side effect 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 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 #5663693-7
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Feb 22, 2008. 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 side effects: acute graft versus host disease, adenoviral haemorrhagic cystitis, bacterial infection , bone marrow transplant , complications of transplant surgery, cytomegalovirus antigen positive, renal failure, staphylococcal sepsis, stomatitis. Busulfan dosage: 34.0 ML;QD;IV. During the same period patient was treated with TACROLIMUS HYDRATE, CYCLOPHOSPHAMIDE, PHENYTOIN, FILGRASTIM, METHOTREXATE. Patient was hospitalized. Patient died.

Busulfan Side Effects Report #5564485-X
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 03, 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 side effects: acute graft versus host disease, anorexia, bone marrow failure, bone marrow transplant , cystitis haemorrhagic, cytomegalovirus infection , diarrhoea, malaise, nausea . Busulfan dosage: 16 ML; QD;IV, 32 ML; QD; IV. Patient recovered.


Busulfan Side Effects Report #5585760-9
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 21, 2007. Male patient, 24 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease, anorexia, bone marrow transplant rejection, cytomegalovirus infection , febrile neutropenia, liver disorder, nausea , pancytopenia, stomatitis. Busulfan dosage: 8.13 ML; ; IV. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5324444-9
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Apr 24, 2007. Male patient, 23 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease, continuous haemodiafiltration, convulsion, diarrhoea, encephalitis viral, engraftment syndrome, haemorrhage, human herpesvirus 6 infection, liver disorder. Busulfan dosage: 9.4 ML; QID; IV. During the same period patient was treated with VALPROATE, FLUDARABINE PHOSPHATE, CYCLOPHOSPHAMIDE. Patient recovered.

Busulfan Side Effects Report #5663692-5
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Feb 22, 2008. 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 side effects: acute graft versus host disease, anorexia, cystitis haemorrhagic, diarrhoea, hepatitis b , hepatitis post transfusion, nausea , pneumonia , sepsis . Busulfan dosage: 27.48 MGL;QD;IV. During the same period patient was treated with FLUDARABINE, PHENYTOIN, FILGASTRIM, TRACROLIMUS. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5523822-2
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN 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 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 #5496979-X
Busulfan side effect was reported by a Health Professional from JAPAN 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 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 #5663402-1
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on June 18, 2007. Male patient, child .5 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease, anaemia, anorexia, cytomegalovirus viraemia, diarrhoea, gastric haemorrhage, lymphocyte count decreased, malaise, nausea . Busulfan dosage: 1.05 ML; 2.0 ML; 2.4 ML; 0.6 ML. Patient recovered.

Busulfan Side Effects Report #5607486-5
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Jan 11, 2008. Male patient was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease, anorexia, cellulitis , diarrhoea, escherichia sepsis, ileus, malaise, nausea , pneumonia . Busulfan dosage: 27 ML; X1; IV, 6 ML; X1; IV, 9 ML; X1, IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5663696-2
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Feb 22, 2008. Male patient was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease, alanine aminotransferase increased, altered state of consciousness, blood bilirubin increased, gamma-glutamyltransferase increased, hyperglycaemia, pleural effusion, pneumonia , renal failure. Busulfan dosage: 28 ML; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE, TACROLIMUS. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5469880-5
Busulfan side effect was reported by a Physician from RUSSIAN FEDERATION on Sept 18, 2007. Female patient was diagnosed with bone marrow conditioning regimen and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease. Busulfan dosage: 8 MG/KG, OTHER. During the same period patient was treated with FLUDARA, CYCLOSPORINE. Patient recovered.

Busulfan Side Effects Report #5469881-7
Busulfan side effect was reported by a Physician from RUSSIAN FEDERATION on Sept 18, 2007. Female patient was diagnosed with bone marrow conditioning regimen and was treated with Busulfan. After drug was administered, patient experienced the following side effects: acute graft versus host disease. Busulfan dosage: 8 MG/KG, UNK. During the same period patient was treated with FLUDARA, CYCLOSPORINE. Patient died.