Busulfan and stomatitis Patient Reports February 12, 2012

Busulfan Side Effects Report #5663403-3
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Feb 22, 2008. Male patient, 62 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: diarrhoea, malaise, pneumonia staphylococcal, stomatitis, viraemia. Busulfan dosage: 32 ML. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5313465-8
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Apr 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 side effects: blood bilirubin increased, blood glucose increased, mouth haemorrhage, sepsis , stem cell transplant, stomatitis. Busulfan dosage: unknown. Patient recovered.

Busulfan Side Effects Report #5324436-X
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Apr 25, 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: blood bilirubin increased, blood glucose increased, mouth haemorrhage, staphylococcal sepsis, stomatitis. Busulfan dosage: unknown. During the same period patient was treated with CYTARABINE, VALPROATE, FILGRASTIM, ETOPOSIDE. Patient recovered.

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 #5259878-4
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Feb 28, 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 side effects: cardiac failure, oedema mouth, pyrexia, renal failure, stomatitis. Busulfan dosage: unknown. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5570086-X
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 03, 2007. Female 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: anorexia, aspergillosis, diarrhoea, gastrointestinal haemorrhage, infection , malaise, nausea , stomatitis. Busulfan dosage: 24.4 ML;QD;IV 18.3 ML;QD;IV. Patient died on 04/11/2007.

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 #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 #5523823-4
Busulfan side effect 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 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 #5663405-7
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Feb 22, 2008. 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 side effects: anorexia, bone marrow transplant rejection, diarrhoea, malaise, nausea , stomatitis. Busulfan dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, VALPROATE, FILGRASTIM, METHOTREXATE, CYCLOSPORINE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5608395-8
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Jan 11, 2008. 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: anorexia, malaise, nausea , off label use, pneumonia , staphylococcal sepsis, stomatitis. Busulfan dosage: 7.5 MG;X1;IV. During the same period patient was treated with VALPROATE, FLUDARABINE PHOSPHATE. Patient died on 08/15/2007.

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 #5391697-0
Busulfan side effect was reported by a Health Professional from JAPAN 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 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 #5352384-8
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on May 24, 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 side effects: cardiac failure, liver disorder, renal disorder, staphylococcal sepsis, stomatitis. Busulfan dosage: 4 ML; QID; IV. During the same period patient was treated with MELPHALAN, CLADRIBINE, PHENYTOIN, LENOGRASTIM, CYCLOSPORINE. Patient recovered.


Busulfan Side Effects Report #5391627-1
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN 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 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 #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 #5059934-X
Busulfan side effect was reported by a Consumer or non-health professional from FRANCE on July 04, 2006. Male patient, 44 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: aplasia, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, incorrect dose administered, mucosal inflammation, overdose, stomatitis, transaminases increased. Busulfan dosage: 208 MG; QD; IV. During the same period patient was treated with ALKERAN. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5586032-9
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 21, 2007. Female 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: altered state of consciousness, febrile neutropenia, grand mal convulsion, pruritus, stomatitis, thrombotic microangiopathy, venoocclusive liver disease. Busulfan dosage: 26.68 ML; IV. 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 #5523800-3
Busulfan side effect 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 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 #5503590-0
Busulfan side effect 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 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 #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 #5523819-2
Busulfan side effect 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 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 #5503594-8
Busulfan side effect 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 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 #5570087-1
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 03, 2007. Male patient, 17 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: blood pressure decreased, hepatic failure, metabolic acidosis, staphylococcal sepsis, stomatitis, thrombotic microangiopathy, venoocclusive disease. Busulfan dosage: 172 MG;QD;IV. During the same period patient was treated with FLUDARABINE PHOSPAHATE. Patient died on 09/13/2007.

Busulfan Side Effects Report #5663691-3
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Feb 22, 2008. Female patient, 16 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: anorexia, bone marrow transplant , malaise, nausea , nystagmus, staphylococcal sepsis, stomatitis, vertigo. Busulfan dosage: 20 ML;QD;IV. During the same period patient was treated with PHENYTOIN, CYCLOPHOSPHAMIDE, FILGRASTIM, METHOTREXATE, TRACOLIMUS. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5564610-0
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 03, 2007. Male patient, 13 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: anorexia, bone marrow transplant , malaise, nausea , sepsis , stomatitis. Busulfan dosage: 24.8 ML; QD; IV. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #4622348-8
Busulfan side effect was reported by a Consumer or non-health professional from on Mar 25, 2005. Male patient, weighting 337.3 lb, was treated with Busulfan. After drug was administered, patient experienced the following side effects: dyspnoea at rest, oropharyngeal swelling, pharyngeal haemorrhage, stomatitis. Busulfan dosage: 1 MG/KG PO Q6H X 16 DOSES ON DAYS -7 TO -4.. During the same period patient was treated with ETOPOSIDE. Patient recovered.