Busulfan and venoocclusive liver disease Patient Reports February 12, 2012

Busulfan Side Effects Report #5356577-5
Busulfan side effect was reported by a Health Professional from JAPAN on May 29, 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: cardiac disorder, nausea , oedema, pneumonia , sepsis , venoocclusive liver disease. Busulfan dosage: unknown. During the same period patient was treated with FLUDARABINE PHOSPHATE. Patient recovered.

Busulfan Side Effects Report #5269623-4
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Mar 08, 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, graft versus host disease, thrombotic microangiopathy, venoocclusive liver disease, weight increased. Busulfan dosage: unknown. During the same period patient was treated with CYCLOPHOSPHAMIDE, CYCLOSPORINE, VALPROATE. Patient died on 12/19/2006.

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 #5192749-0
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Nov 27, 2006. 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: abdominal pain upper, liver function test abnormal, venoocclusive liver disease, weight increased. Busulfan dosage: 3.2 MG/KG;. During the same period patient was treated with CYCLOSPORINE. Patient died on 11/28/2006.


Busulfan Side Effects Report #5341131-1
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Jan 08, 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: venoocclusive liver disease. Busulfan dosage: 40 MG; QID; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE. 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 #5269621-0
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Mar 01, 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 side effects: blood stem cell transplant failure, haemodialysis, renal failure acute, sepsis , venoocclusive liver disease. Busulfan dosage: 208 MG;. Patient was hospitalized. Patient died on 02/09/2007.

Busulfan Side Effects Report #5406731-9
Busulfan side effect 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 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 #5503592-4
Busulfan side effect 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 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 #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 #5341116-5
Busulfan side effect was reported by a Consumer or non-health professional from FRANCE on Apr 20, 2006. Male patient, 42 years of age, weighting 160.9 lb, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: venoocclusive liver disease. Busulfan dosage: 0.8 MG/KG/Q6H;IV. During the same period patient was treated with CYCLOPHOSPHAMIDE. Patient recovered.

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 #5607473-7
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Jan 11, 2008. Female patient, 19 years of age, was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: bronchopulmonary aspergillosis, cytomegalovirus viraemia, venoocclusive liver disease, viral haemorrhagic cystitis. Busulfan dosage: 24 ML; X1; IV. During the same period patient was treated with FLUDARABINE PHOSPHATE, VALPROATE. 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 #5447576-3
Busulfan side effect 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 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 #5313523-8
Busulfan side effect was reported by a Consumer or non-health professional from FRANCE on Apr 17, 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 side effects: anuria, ascites, dialysis , hyperbilirubinaemia, stem cell transplant, venoocclusive liver disease, weight increased. Busulfan dosage: unknown. During the same period patient was treated with ALKERAN, CYCLOPHOSPHAMIDE. Patient was hospitalized. Patient recovered.

Busulfan Side Effects Report #5608394-6
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Jan 11, 2008. 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 side effects: gallbladder enlargement, hepatic failure, hypopnoea, pulmonary haemorrhage, renal failure, venoocclusive liver disease. Busulfan dosage: 4.4 MG; QID; IV. During the same period patient was treated with THIOTEPA. Patient died on 11/18/2007.

Busulfan Side Effects Report #5341130-X
Busulfan side effect was reported by a Consumer or non-health professional from JAPAN on Jan 08, 2007. Male patient was diagnosed with stem cell transplant and was treated with Busulfan. After drug was administered, patient experienced the following side effects: venoocclusive liver disease. Busulfan dosage: 5.2 ML; IV. Patient was hospitalized. Patient recovered.