This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Busulfex (Busulfan) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (120)
Death (68)
Life Threatening Events (11)
Reports by Reaction Type
Venoocclusive Liver Disease (14),
Acute Graft Versus Host Disease (13),
Chronic Graft Versus Host Disease (13),
Renal Failure (13),
Thrombotic Microangiopathy (12),
Acute Respiratory Distress Syndrome (8),
Pleural Effusion (8),
Mucosal Inflammation (8),
Cytomegalovirus Infection (8),
Graft Versus Host Disease (7),
Cardiac Failure (7),
Recurrent Cancer (6)
Below are a few examples of reports where side effects / adverse reactions may be related to Busulfex (Busulfan). For a complete list or a specific selection of reports, please use the links above.
Possible Busulfex side effects in 49 year old female
Reported by a physician from United States on 2012-08-07
Patient: 49 year old female
Reactions: Pulmonary Haemorrhage, Hepatic Necrosis, Venoocclusive Disease
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 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 48 year old female
Reported by a physician from Japan on 2012-08-06
Patient: 48 year old female
Reactions: Fatigue, Acute Graft Versus Host Disease, Cystitis Haemorrhagic, Brain Abscess, Recurrent Cancer, Pancytopenia, Liver Disorder
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Tacrolimus; Dasatinib (Dasatinib); Cyclophosphamide; Niotinib Hydrochloride (Niotinib Hydrochloride); Mycophenolate Mofetil; Fludara; Cytarabine; Imatinib Mesylate
Possible Busulfex side effects in 3 year old male
Reported by a health professional (non-physician/pharmacist) from Poland on 2012-08-01
Patient: 3 year old male
Reactions: Viral Infection, Cystitis Haemorrhagic, Toxicity To Various Agents, Mucosal Inflammation, Post Transplant Lymphoproliferative Disorder, Agranulocytosis, Refusal of Treatment by Relative, BK Virus Infection, Adenovirus Infection, Leukopenia
Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
Dosage: 3 x 20 mg/kg., intravenous (not otherwise specified)
Indication: Bone Marrow Conditioning Regimen
Busulfex
Dosage: 2x1 mg/kg
Indication: Bone Marrow Conditioning Regimen
Cyclosporine
Indication: Prophylaxis Against Graft Versus Host Disease
Fludarabine Phosphate
Dosage: 5x30 mg/m2, intravenous (not otherwise specified)
Indication: Bone Marrow Conditioning Regimen
Methylprednisolone Sodium Succinate
Indication: Prophylaxis Against Graft Versus Host Disease
Muromonab-CD3 (Muromonab-Cd3)
Indication: Prophylaxis Against Graft Versus Host Disease
Possible Busulfex side effects in 54 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient: 54 year old male
Reactions: Hypotension, Tachycardia, Mental Status Changes, Multiple Myeloma, Renal Failure, Fatigue, Sepsis, Tachypnoea, Pleural Effusion, Lung Infiltration, Asthenia, Deep Vein Thrombosis
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Possible Busulfex side effects in 63 year old female
Reported by a physician from United States on 2012-08-01
Patient: 63 year old female
Reactions: Pulmonary Oedema, Infection
Adverse event resulted in: death
Drug(s) suspected as cause:
Alemtuzumab (Alemtuzumab)
Dosage: 100 mg milligram(s), daily dose
Indication: Stem Cell Transplant
Busulfex
Dosage: 3.2 mg/kg, daily dose
Indication: Stem Cell Transplant
Fludarabine Phosphate
Dosage: 30 mg/m2/d
Indication: Stem Cell Transplant
Other drugs received by patient: Clofarabine
Possible Busulfex side effects in 37 year old female
Reported by a physician from Japan on 2012-08-01
Patient: 37 year old female
Reactions: Autoimmune Pancreatitis, Diarrhoea, Chronic Graft Versus Host Disease in Skin, Chronic Graft Versus Host Disease, Acute Myeloid Leukaemia Recurrent
Adverse event resulted in: death
Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
Dosage: 15 mg/kg, daily dose, day -2 and day -1
Indication: Bone Marrow Conditioning Regimen
Busulfex
Dosage: 3.2 mg/kg, daily dose, -7 to day -4, intravenous
Indication: Bone Marrow Conditioning Regimen
Cyclophosphamide
Dosage: 60 mg/kg, daily dose, day -3
Indication: Bone Marrow Conditioning Regimen
Other drugs received by patient: Gabexate Mesilate (Gabexate Mesilate); Gemtuzumab Ozogamicin (Gemtuzumab Ozogamicin); Prednisolone
Possible Busulfex side effects in 52 year old female
Reported by a physician from United States on 2012-08-01
Patient: 52 year old female
Reactions: Aspergillosis
Adverse event resulted in: death
Drug(s) suspected as cause:
Alemtuzumab (Alemtuzumab)
Dosage: 20 mg daily dose
Indication: Stem Cell Transplant
Busulfex
Dosage: 3.2 mg/kg, daily dose
Indication: Stem Cell Transplant
Fludarabine Phosphate
Dosage: 30 mg /m2/d
Indication: Stem Cell Transplant
Other drugs received by patient: Clofarabine
Possible Busulfex side effects in 55 year old female
Reported by a physician from United States on 2012-08-01
Patient: 55 year old female
Reactions: Pneumonia Fungal
Adverse event resulted in: death
Drug(s) suspected as cause:
Alemtuzumab (Alemtuzumab)
Dosage: 20 mg daily dose
Indication: Stem Cell Transplant
Busulfex
Dosage: 3.2 mg/kg, daily dose
Indication: Stem Cell Transplant
Fludarabine Phosphate
Dosage: 30 mg/m2/d
Indication: Stem Cell Transplant
Other drugs received by patient: Clofarabine
Possible Busulfex side effects in female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-31
Patient: female
Reactions: Malaise, Urinary Incontinence, Status Epilepticus, Disorientation, Altered State of Consciousness, Somnolence
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Fludara; Nifedipine; Nizatidine; Allopurinol; Antihymocyte Immunoglobulin (Rabbit) (Antithymocyte Immunoglobulin (RA; Methylprednisolone; Biofermin (Bacillus Subtilis, Lactobacillus Acidophilus, Streptococcus; Sulfamethoxazole and Trimethoprim; Depakene; Zovirax; Polymixin B Sulfate (Polymixin B Sulfate)
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 54 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31
Patient: 54 year old male
Reactions: Tachycardia, Hypotension, Mental Status Changes, Multiple Myeloma, Disease Progression, Fatigue, Renal Failure, Sepsis, Tachypnoea, Pleural Effusion, Asthenia, Deep Vein Thrombosis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Busulfex
Possible Busulfex side effects in
Reported by a physician from China on 2012-07-31
Patient:
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Cytarabine; Cyclosporine; Mycophenolate Mofetil; Atgam; Cyclophosphamide
Possible Busulfex side effects in 66 year old male
Reported by a consumer/non-health professional from United States on 2012-07-31
Patient: 66 year old male
Reactions: Pneumonia Haemophilus, Respiratory Failure, Hypotension, Post Procedural Complication, Acute Respiratory Distress Syndrome, Clostridial Infection, Deep Vein Thrombosis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Busulfex
Possible Busulfex side effects in 50 year old female
Reported by a physician from Italy on 2012-07-27
Patient: 50 year old female
Reactions: Leukaemia Recurrent, Acute Graft Versus Host Disease in Intestine
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Fludarabine Phosphate; Atgam; Thiotepa
Possible Busulfex side effects in 54 year old male
Reported by a physician from United States on 2012-07-27
Patient: 54 year old male
Reactions: Graft Versus Host Disease in Skin
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Cyclophosphamide; Alemtuzumab (Alemtuzumab)
Possible Busulfex side effects in
Reported by a physician from China on 2012-07-27
Patient:
Reactions: Gastrointestinal Haemorrhage, Leukaemia Recurrent
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Cyclospori A (Ciclosporin); Mycophenolate Mofetil; Cytarabine; Cyclophosphamide; ATG (Antilymphocyte Immunoglobluin (Horse))
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:
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: 2007-12-05
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 64 year old female
Reported by a physician from United States on 2012-07-27
Patient: 64 year old female
Reactions: Acute Myeloid Leukaemia, Disease Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Alemtuzumab (Alemtuzumab)
Dosage: 20 mg daily dose
Indication: Stem Cell Transplant
Busulfex
Dosage: 3.2 mg/kg, daily dose
Indication: Stem Cell Transplant
Fludarabine Phosphate
Dosage: 30 mg/m2/d
Other drugs received by patient: Clofarabine
Possible Busulfex side effects in 54 year old male
Reported by a physician from United Kingdom on 2012-07-27
Patient: 54 year old male
Reactions: Acute Graft Versus Host Disease
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Campath USA (Alemituzumab); Fludarabine Phosphate
Possible Busulfex side effects in 9 year old female
Reported by a physician from Israel on 2012-07-27
Patient: 9 year old female
Reactions: Transplant Failure, Post Transplant Lymphoproliferative Disorder, Guillain-Barre Syndrome, Pericarditis, Pleural Effusion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Anti-Thymocyte Globulin Rabbit NOS
Dosage: 2.5 mg/kg/d on days -4 to (10mg/kg); 2.5 mg/kg/d on days - 4 to -2
Indication: Bone Marrow Conditioning Regimen
Busulfex
Dosage: 3.2 mg/kg, daily dose, days 9 to 6, intravenous
Indication: Bone Marrow Conditioning Regimen
Fludarabine Phosphate
Dosage: 30 mg/m2/d on days 0 to -5 (180mg/m^2); 40 mg/d/d on days -5 to -3
Indication: Bone Marrow Conditioning Regimen
Thiotepa
Dosage: 5mg/kg/d on days; 8 mg/kg/d on day - 7
Indication: Bone Marrow Conditioning Regimen
Other drugs received by patient: Azathioprine (Azathioprine0; Treosulfan (Treosulfan); Acyclovir; Hydroxyurea; Cyclosporine
Possible Busulfex side effects in 48 year old female
Reported by a physician from United Kingdom on 2012-07-27
Patient: 48 year old female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Fludarabine Phosphate; Campath USA (Alemtuzumab)
Possible Busulfex side effects in
Reported by a physician from China on 2012-07-27
Patient:
Reactions: Pneumonia, Acute Lymphocytic Leukaemia Recurrent
Adverse event resulted in: death
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: Mycophenolate Mofetil; Cytarabine; ATG (Antilymphocyte Immunoglobulin); Cyclophosphamide; Cyclosporine
Possible Busulfex side effects in 24 year old male
Reported by a physician from United States on 2012-07-25
Patient: 24 year old male
Reactions: Retinal Haemorrhage, Refractoriness To Platelet Transfusion, Mucosal Haemorrhage, Purpura, Scleral Haemorrhage, NO Therapeutic Response, Skin Haemorrhage, Hypoxia, Thrombocytopenia, Lung Infiltration, Epistaxis
Drug(s) suspected as cause:
Busulfex
Other drugs received by patient: IG Vena N (Immunoglobulin Human Normal); Methotrexate Sodium; Filgrastim (Filgrastim); Anti-Thymocyte Globulin NOS; Rituximab (Rituximab); Cyclophosphamide; Tacrolimus
Possible Busulfex side effects in 8 year old male
Reported by a health professional (non-physician/pharmacist) from Saudi Arabia on 2012-07-25
Patient: 8 year old male
Reactions: Gingival Bleeding, Stridor, Graft Versus Host Disease, Kaposi's Sarcoma, Gingival Hypertrophy, Pulmonary Mass, Graft Versus Host Disease in Liver, Oral Mucosal Exfoliation, Rash Macular, Bone Marrow Disorder, Lung Consolidation, Respiratory Failure, Acute Graft Versus Host Disease in Skin, Graft Versus Host Disease in Intestine, Pneumothorax, Lung Infiltration
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Busulfex
Dosage: 16 mg/kg, intravenous
Indication: Bone Marrow Conditioning Regimen
Cyclophosphamide
Dosage: 200 mg/kg, intravenous
Indication: Bone Marrow Conditioning Regimen
Cyclosporine
Indication: Prophylaxis Against Graft Versus Host Disease
Prednisolone
Dosage: 4 mg/kg, daily dose
Indication: Graft Versus Host Disease
Possible Busulfex side effects in 54 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-24
Patient: 54 year old male
Reactions: Hypotension, Tachycardia, Mental Status Changes, Multiple Myeloma, Disease Progression, Renal Failure, Fatigue, Sepsis, Pleural Effusion, Tachypnoea, Asthenia, Deep Vein Thrombosis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Busulfex
Possible Busulfex side effects in 66 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-24
Patient: 66 year old male
Reactions: Pneumonia Haemophilus, Respiratory Failure, Acute Respiratory Distress Syndrome, Clostridial Infection, Deep Vein Thrombosis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Busulfex
Possible Busulfex side effects in 2 year old female
Reported by a physician from United States on 2012-07-23
Patient: 2 year old female
Reactions: Fluid Overload, Thrombotic Microangiopathy, Leukaemia Recurrent, Respirovirus Test Positive, Grand MAL Convulsion, Multi-Organ Failure, Haemoglobin Decreased, Renal Failure, Respiratory Failure, Posterior Reversible Encephalopathy Syndrome, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Anti-Thymocyte Globulin NOS
Dosage: 90 mg/kg, intravenous
Indication: Stem Cell Transplant
Busulfex
Dosage: 16 mg/kg, intravenous
Indication: Stem Cell Transplant
Cyclophosphamide
Dosage: 200 mg/kg, intravenous
Indication: Stem Cell Transplant
Other drugs received by patient: Cyclosporine; Methylprednisolone
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