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Busulfex (Busulfan) - Side Effect Reports to FDA

 
 



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)Pleural Effusion (8)Acute Respiratory Distress Syndrome (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 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 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 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 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 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

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 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 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 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 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 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 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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