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Busulfex (Busulfan) - Venoocclusive Liver Disease - Suspected Cause - Side Effect Reports

 
 



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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