Index of reports
> Cases with Venoocclusive Liver Disease (14)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Busulfex (Busulfan) where reactions include venoocclusive liver disease. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Busulfex side effects in 61 year old male
Reported by a physician from United States on 2012-08-07
Patient: 61 year old male
Reactions: Portal Hypertension, Hepatic Necrosis, Hepatic Failure, Ataxia, Lymphoproliferative Disorder, Hepatic Haemorrhage, Venoocclusive Liver Disease, Lethargy
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Fludarabine Phosphate; Alemtuzumab (Alemtuzumab)
Possible Busulfex side effects in 57 year old male
Reported by a physician from United States on 2012-08-07
Patient: 57 year old male
Reactions: Renal Failure, Hepatic Necrosis, Bacteraemia, Venoocclusive Liver Disease, Disturbance in Attention, Mental Status Changes, Hepatic Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Fludarabrne (Fludarabine Phosphate); Alemtuzumab (Alemtuzumab)
Possible Busulfex side effects in 61 year old male
Reported by a physician from United States on 2012-08-07
Patient: 61 year old male
Reactions: Weight Increased, Venoocclusive Liver Disease, Pneumonia Cytomegaloviral
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Alemtuzumab (Alemtuzumab); Fludarabine Phosphate
Possible Busulfex side effects in 65 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-31
Patient: 65 year old male
Reactions: Blood Bilirubin Increased, Venoocclusive Liver Disease, Abdominal Distension, Thrombotic Microangiopathy, Blood Pressure Decreased, Melaena, Ileus Paralytic
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Dosage: 45 mg milligram(s), intravenous ; 45 mg milligram(s), qid, intravenous
Indication: Stem Cell Transplant
Start date: 2008-11-04
End date: 2008-11-07
Sandimmune
Dosage: 100 mg milligram(s), bid, intravenous
Indication: Immunosuppression
Start date: 2007-11-08
End date: 2007-11-08
Other drugs received by patient: Fludara; Cellcept; Maxipime; Omegacin (Biapenem); Urso 250; G-CSF-Priming-ARA-C (G-CSF-Priming-ARA-C); Hibon (Riboflavin Tetrabutyrate); Filgrastim (Filgrastin); Famotidine; Epadel (Elcosapentaenoic Acid Ethyl Ester); Neutrogin (Lenograstim); Soldactone (Potassium Canrenoate); Diflucan; Zovirax; Neuquinon (Ubidecarenone)
Possible Busulfex side effects in 65 year old male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-27
Patient: 65 year old male
Reactions: Venoocclusive Liver Disease, Thrombotic Microangiopathy
Adverse event resulted in: death
Drug(s) suspected as cause:
Sandimmune
Dosage: 100 mg milligram(s), bid, intravenous
Indication: Immunosuppression
Start date: 2007-11-08
End date: 2007-12-05
Busulfex
Dosage: 45 mg milligram(s), intravenous, 45 mg milligram(s), qid, intravenous
Indication: Stem Cell Transplant
Start date: 2008-11-04
End date: 2008-11-07
Other drugs received by patient: Filgrastim (Filgrastim); Cellcept; Urso 250; G-CSF-Priming-ARA-C (G-CSF-Priming-ARA-C); Maxipime; Epadel (Eicosapentaenoic Acid Ethyl Ester); Fludara; Famotidine; Soldactone (Potassium Canrenoate); Zovirax; Diflucan; Hibon (Riboflavin Tetrabutyrate); Omegacin (Biapenem); Neutrogin (Lenograstim); Neuquinon (Ubidecarenone)
Possible Busulfex side effects in 23 year old male
Reported by a physician from United States on 2012-07-20
Patient: 23 year old male
Reactions: Hepatic Artery Thrombosis, Renal Failure, Post Procedural Bile Leak, Venoocclusive Liver Disease, Cytomegalovirus Infection, Encephalopathy, General Physical Health Deterioration, Liver Abscess, Liver Transplant
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Cyclophosphamide; Valganciclovir HCL; Methotrexate Sodium; Tacrolimus
Possible Busulfex side effects in 49 year old
Reported by a physician from Germany on 2012-05-14
Patient: 49 year old
Reactions: Venoocclusive Liver Disease, Acute Myeloid Leukaemia Recurrent
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Fludarabine Phosphate
Possible Busulfex side effects in 50 year old
Reported by a physician from Germany on 2012-05-14
Patient: 50 year old
Reactions: Venoocclusive Liver Disease
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Fludarabine Phosphate
Possible Busulfex side effects in 64 year old
Reported by a physician from Germany on 2012-05-14
Patient: 64 year old
Reactions: Venoocclusive Liver Disease
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Fludarabine Phosphate
Possible Busulfex side effects in 15 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-06
Patient: 15 year old female
Reactions: Venoocclusive Liver Disease
Drug(s) suspected as cause:
Busulfex
Dosage: 12.8 mg/kg, daily dose, intravenous ; 16.0 mg/kg, daily dose, intravenous
Cyclophosphamide
Dosage: 60 mg/kg, daily dose, intravenous
Possible Busulfex side effects in 35 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-06
Patient: 35 year old male
Reactions: Venoocclusive Liver Disease
Adverse event resulted in: death
Drug(s) suspected as cause:
Lidocaine
Dosage: transdermal
Indication: Neuropathy Peripheral
Fludarabine Phosphate
Indication: Stem Cell Transplant
Busulfex
Dosage: intravenous
Indication: Stem Cell Transplant
Allopurinol
Other drugs received by patient possibly interacting with the suspect drug: Norfloxacin
Other drugs received by patient: Dapsone; Prednisone; Acyclovir; Amitriptyline Hydrochloride; Ursodiol; Tacrolimus; Pregabalin; Sirolimus; Posaconazole; Hydroxyurea
Possible Busulfex side effects in 1 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-06
Patient: 1 year old female
Reactions: Acute Graft Versus Host Disease, Venoocclusive Liver Disease
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Cyclophosphamide
Possible Busulfex side effects in male
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-18
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Jaundice, Systemic Candida, Hepatic Function Abnormal, Histiocytosis Haematophagic, Neutrophil Count Increased, Cytomegalovirus Test Positive, Hepatic Failure, Thrombotic Microangiopathy, Ascites, Weight Increased, Venoocclusive Liver Disease, Pleural Effusion, Bilirubin Conjugated Increased
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Neoral
Dosage: unk ukn, unk
Busulfex
Dosage: 208 mg, unk
Indication: Bone Marrow Transplant
Start date: 2010-07-07
End date: 2010-07-10
Cyclophosphamide
Dosage: 3900 mg, unk
Indication: Bone Marrow Transplant
Start date: 2010-07-11
End date: 2010-07-12
Sandimmune
Dosage: 150 mg, unk
Indication: Bone Marrow Transplant
Start date: 2010-07-13
End date: 2010-07-29
Other drugs received by patient: Recomodulin; Vfend; Methotrexate; Thrombomodulin Alfa; Solu-Medrol; Funguard
Possible Busulfex side effects in male
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-18
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Systemic Candida, Jaundice, Hepatic Function Abnormal, Histiocytosis Haematophagic, Neutrophil Count Increased, Cytomegalovirus Test Positive, Hepatic Failure, Thrombotic Microangiopathy, Ascites, Weight Increased, Venoocclusive Liver Disease, Pleural Effusion, Bilirubin Conjugated Increased
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: 3900 mg, unk
Indication: Bone Marrow Transplant
Start date: 2010-07-11
End date: 2010-07-12
Busulfex
Dosage: 208 mg, unk
Indication: Bone Marrow Transplant
Start date: 2010-07-07
End date: 2010-07-10
Neoral
Dosage: unk ukn, unk
Sandimmune
Dosage: 150 mg, unk
Indication: Bone Marrow Transplant
Start date: 2010-07-13
End date: 2010-07-29
Other drugs received by patient: Thrombomodulin Alfa; Recomodulin; Funguard; Methotrexate; Vfend; Solu-Medrol
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