Busulfan and hepatic function abnormal Patient Reports February 12, 2012

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 #5585753-1
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 21, 2007. Male 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 side effects: coagulopathy, gastritis, haemosiderosis, hepatic function abnormal, hyperbilirubinaemia, hypoproteinaemia, neutropenia, pneumocystis jiroveci pneumonia, renal impairment. Busulfan dosage: 6 ML; ; IV. Patient was hospitalized. Patient died.

Busulfan Side Effects Report #5608393-4
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Jan 11, 2008. Male 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 side effects: anorexia, coagulopathy, continuous haemodiafiltration, febrile neutropenia, gastritis, haemosiderosis, hepatic function abnormal, hyperbilirubinaemia, hypoproteinaemia. Busulfan dosage: 6 ML; IV. Patient was hospitalized. Patient died on 11/29/2007.

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 #5299878-1
Busulfan side effect was reported by a Health Professional from JAPAN on Mar 27, 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 side effects: cystitis haemorrhagic, diarrhoea, graft versus host disease, hepatic function abnormal, pyrexia, thrombotic microangiopathy, venoocclusive liver 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 #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 #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 #5341137-2
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Jan 23, 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: hepatic function abnormal. Busulfan dosage: unknown. Patient recovered.

Busulfan Side Effects Report #5363113-6
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on June 01, 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 , blood bilirubin increased, bone marrow transplant , cardiac failure, engraftment syndrome, haematemesis, hepatic function abnormal, infusion related reaction, interstitial lung disease. 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 #5570090-1
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Dec 04, 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: anorexia, bacterial sepsis, cytomegalovirus viraemia, diarrhoea, febrile neutropenia, hepatic function abnormal, hyperglycaemia, nausea , platelet count decreased. Busulfan dosage: 18.9 ML; 25.2 ML; 6.3 ML; QD; IV. During the same period patient was treated with VALPROATE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5832346-4
Busulfan side effect was reported by a Consumer or non-health professional from UNITED STATES on July 23, 2008. Male patient, 25 years of age, was diagnosed with bone marrow transplant  and was treated with Busulfan. After drug was administered, patient experienced the following side effects: ascites, biliary tract disorder, cytomegalovirus infection , diarrhoea, encephalopathy, enterococcal sepsis, hepatic enzyme increased, hepatic function abnormal, hepatic vein thrombosis. Busulfan dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient died.

Busulfan Side Effects Report #5235918-3
Busulfan side effect was reported by a Health Professional from GERMANY on Jan 30, 2007. Female patient was diagnosed with bone marrow conditioning regimen, bone marrow transplant  and was treated with Busulfan. After drug was administered, patient experienced the following side effects: blood bilirubin increased, hepatic function abnormal, renal impairment, venoocclusive disease. Busulfan dosage: 16 MG/KG/D. During the same period patient was treated with CYCLOPHOSPHAMIDE, ATGAM, METHOTREXATE, DEFIBROTIDE, CYCLOSPORINE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5235928-6
Busulfan side effect was reported by a Health Professional from GERMANY on Jan 30, 2007. Female patient was diagnosed with bone marrow conditioning regimen, bone marrow transplant  and was treated with Busulfan. After drug was administered, patient experienced the following side effects: blood bilirubin increased, disseminated intravascular coagulation, hepatic function abnormal, life support, oliguria, renal failure, respiratory failure, thrombocytopenic purpura, venoocclusive disease. Busulfan dosage: 16 MG/KG/D. During the same period patient was treated with CYCLOPHOSPHAMIDE, ATGAM, METHOTREXATE, CYCLOSPORINE. Patient was hospitalized. Patient recovered.


Busulfan Side Effects Report #5977591-2
Busulfan side effect was reported by a Consumer or non-health professional from UNITED STATES on Dec 01, 2008. Female patient, weighting 157.0 lb, was diagnosed with acute myeloid leukaemia and was treated with Busulfan. After drug was administered, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, chest discomfort, continuous haemodiafiltration, hepatic function abnormal, hypoxia, renal failure acute. Busulfan dosage: 50 MG 16X Q6HR IV. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient died on 11/27/2008.