Drug information for BUSULFEX
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
INJECTABLE; INJECTION
6MG/ML
Prescription
(Reference Drug)
BUSULFAN
Busulfan
OTSUKA PHARM
20954
2011-06-29 Label
2011-06-29 Label
2011-06-29 Letter
2011-06-29 Letter
2007-04-25 Letter
2007-04-20 Label
2004-06-04 Review
2004-03-09 Review
2004-03-09 Review
2003-07-08 Review
2003-03-06 Label
2003-01-13 Letter
2002-12-23 Letter
2002-11-13 Letter
2002-11-13 Label
2002-04-24 Letter
1999-06-14 Review
1999-02-04 Letter
1999-02-04 Label
Drug Adverse Effects information for BUSULFEX
Role code
Indications
Reaction
# Reports
PS
ACUTE MYELOID LEUKAEMIA
ACUTE PULMONARY OEDEMA
1
PS
ACUTE MYELOID LEUKAEMIA
CARDIAC ARREST
1
PS
ACUTE MYELOID LEUKAEMIA
CARDIAC FAILURE
1
PS
ACUTE MYELOID LEUKAEMIA
CLOSTRIDIUM COLITIS
2
PS
ACUTE MYELOID LEUKAEMIA
SEPSIS
2
PS
BONE MARROW CONDITIONING REGIMEN
ACUTE RESPIRATORY DISTRESS SYNDROME
1
PS
BONE MARROW CONDITIONING REGIMEN
BONE MARROW FAILURE
1
PS
BONE MARROW CONDITIONING REGIMEN
CHOLANGITIS
1
PS
BONE MARROW CONDITIONING REGIMEN
CHOLELITHIASIS
1
PS
BONE MARROW CONDITIONING REGIMEN
CONFUSIONAL STATE
1
PS
BONE MARROW CONDITIONING REGIMEN
EJECTION FRACTION DECREASED
1
PS
BONE MARROW CONDITIONING REGIMEN
HYPERBILIRUBINAEMIA
1
PS
BONE MARROW CONDITIONING REGIMEN
LEFT VENTRICULAR DYSFUNCTION
1
PS
BONE MARROW CONDITIONING REGIMEN
MIOSIS
1
PS
BONE MARROW CONDITIONING REGIMEN
MUCOSAL INFLAMMATION
1
PS
BONE MARROW CONDITIONING REGIMEN
MULTI-ORGAN DISORDER
1
PS
BONE MARROW CONDITIONING REGIMEN
MULTIPLE-DRUG RESISTANCE
1
PS
BONE MARROW CONDITIONING REGIMEN
NEUROLOGICAL DECOMPENSATION
1
PS
BONE MARROW CONDITIONING REGIMEN
OVERDOSE
1
PS
BONE MARROW CONDITIONING REGIMEN
PSEUDOMONAS INFECTION
1
PS
BONE MARROW CONDITIONING REGIMEN
REFRACTORINESS TO PLATELET TRANSFUSION
1
PS
BONE MARROW CONDITIONING REGIMEN
RENAL FAILURE
1
PS
BONE MARROW CONDITIONING REGIMEN
SEPSIS
1
PS
BONE MARROW CONDITIONING REGIMEN
SOMNOLENCE
1
PS
BONE MARROW CONDITIONING REGIMEN
STAPHYLOCOCCAL INFECTION
1
PS
BONE MARROW CONDITIONING REGIMEN
THROMBOCYTOPENIA
1
PS
BONE MARROW CONDITIONING REGIMEN
UNEVALUABLE EVENT
1
PS
BONE MARROW TRANSPLANT
ACUTE GRAFT VERSUS HOST DISEASE
1
PS
BONE MARROW TRANSPLANT
ACUTE PULMONARY OEDEMA
2
PS
BONE MARROW TRANSPLANT
CARDIAC ARREST
2
PS
BONE MARROW TRANSPLANT
CARDIAC FAILURE
2
PS
BONE MARROW TRANSPLANT
CHRONIC GRAFT VERSUS HOST DISEASE
1
PS
BONE MARROW TRANSPLANT
KERATITIS
1
PS
BONE MARROW TRANSPLANT
MATERNAL EXPOSURE BEFORE PREGNANCY
1
PS
BONE MARROW TRANSPLANT
PREGNANCY
1
PS
BONE MARROW TRANSPLANT
PREMATURE MENOPAUSE
1
PS
BONE MARROW TRANSPLANT
RASH
1
PS
BONE MARROW TRANSPLANT
TRANSPLANT
1
PS
MYELOID LEUKAEMIA
ASPERGILLOSIS
2
PS
MYELOID LEUKAEMIA
BRONCHOPULMONARY ASPERGILLOSIS
2
PS
MYELOID LEUKAEMIA
CHRONIC GRAFT VERSUS HOST DISEASE
2
PS
MYELOID LEUKAEMIA
FUNGAL INFECTION
2
PS
MYELOID LEUKAEMIA
GRAFT VERSUS HOST DISEASE
2
PS
MYELOID LEUKAEMIA
RENAL FAILURE
4
PS
STEM CELL TRANSPLANT
ACUTE PULMONARY OEDEMA
1
PS
STEM CELL TRANSPLANT
ACUTE RESPIRATORY DISTRESS SYNDROME
2
PS
STEM CELL TRANSPLANT
BRAIN NATRIURETIC PEPTIDE INCREASED
1
PS
STEM CELL TRANSPLANT
CHOLESTASIS
1
PS
STEM CELL TRANSPLANT
CYTOLYTIC HEPATITIS
3
PS
STEM CELL TRANSPLANT
ENTEROCOCCUS TEST POSITIVE
2
PS
STEM CELL TRANSPLANT
PROTHROMBIN TIME PROLONGED
2
PS
STEM CELL TRANSPLANT
PROTHROMBIN TIME SHORTENED
1
PS
STEM CELL TRANSPLANT
PULMONARY ALVEOLAR HAEMORRHAGE
1
PS
STEM CELL TRANSPLANT
SEPSIS
1
PS
STEM CELL TRANSPLANT
STEM CELL TRANSPLANT
2
PS
STEM CELL TRANSPLANT
SURGICAL PROCEDURE REPEATED
1
SS
BONE MARROW TRANSPLANT
ASCITES
8
SS
BONE MARROW TRANSPLANT
BILIRUBIN CONJUGATED INCREASED
8
SS
BONE MARROW TRANSPLANT
CYTOMEGALOVIRUS TEST POSITIVE
8
SS
BONE MARROW TRANSPLANT
HEPATIC FAILURE
8
SS
BONE MARROW TRANSPLANT
HEPATIC FUNCTION ABNORMAL
8
SS
BONE MARROW TRANSPLANT
HISTIOCYTOSIS HAEMATOPHAGIC
8
SS
BONE MARROW TRANSPLANT
JAUNDICE
8
SS
BONE MARROW TRANSPLANT
NEUTROPHIL COUNT INCREASED
8
SS
BONE MARROW TRANSPLANT
PLEURAL EFFUSION
8
SS
BONE MARROW TRANSPLANT
SYSTEMIC CANDIDA
8
SS
BONE MARROW TRANSPLANT
THROMBOTIC MICROANGIOPATHY
8
SS
BONE MARROW TRANSPLANT
VENOOCCLUSIVE LIVER DISEASE
8
SS
BONE MARROW TRANSPLANT
WEIGHT INCREASED
8
SS
VENOOCCLUSIVE LIVER DISEASE
ASCITES
2
SS
VENOOCCLUSIVE LIVER DISEASE
BILIRUBIN CONJUGATED INCREASED
2
SS
VENOOCCLUSIVE LIVER DISEASE
CYTOMEGALOVIRUS TEST POSITIVE
2
SS
VENOOCCLUSIVE LIVER DISEASE
HEPATIC FAILURE
2
SS
VENOOCCLUSIVE LIVER DISEASE
HEPATIC FUNCTION ABNORMAL
2
SS
VENOOCCLUSIVE LIVER DISEASE
HISTIOCYTOSIS HAEMATOPHAGIC
2
SS
VENOOCCLUSIVE LIVER DISEASE
JAUNDICE
2
SS
VENOOCCLUSIVE LIVER DISEASE
NEUTROPHIL COUNT INCREASED
2
SS
VENOOCCLUSIVE LIVER DISEASE
PLEURAL EFFUSION
2
SS
VENOOCCLUSIVE LIVER DISEASE
SYSTEMIC CANDIDA
2
SS
VENOOCCLUSIVE LIVER DISEASE
THROMBOTIC MICROANGIOPATHY
2
SS
VENOOCCLUSIVE LIVER DISEASE
VENOOCCLUSIVE LIVER DISEASE
2
SS
VENOOCCLUSIVE LIVER DISEASE
WEIGHT INCREASED
2
C
PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE
CYTOMEGALOVIRUS ENTEROCOLITIS
2
C
PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE
VENOOCCLUSIVE DISEASE
2
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