Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Busulfan
Drug ID BADD_D00318
Description Busulfan is a bifunctional alkylating agent, having a selective immunosuppressive effect on bone marrow. It is not a structural analog of the nitrogen mustards. It has been used in the palliative treatment of chronic myeloid leukemia (myeloid leukemia, chronic), but although symptomatic relief is provided, no permanent remission is brought about. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), busulfan is listed as a known carcinogen.
Indications and Usage For use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia (FDA has designated busulfan as an orphan drug for this use). It is also used as a component of pretransplant conditioning regimens in patients undergoing bone marrow transplantation for acute myeloid leukemia and nonmalignant diseases.
Marketing Status approved; investigational
ATC Code L01AB01
DrugBank ID DB01008
KEGG ID D00248
MeSH ID D002066
PubChem ID 2478
TTD Drug ID D07SUG
NDC Product Code 46439-8734; 72969-122; 51817-170; 67457-893; 46014-1116; 71288-158; 80725-620; 48957-0010; 72485-210; 14096-147; 0409-1112; 70121-1244; 72606-559; 69443-500; 59148-070; 69784-620; 29902-0007; 16729-351; 25021-241; 50683-0363; 71288-116; 82920-008
UNII G1LN9045DK
Synonyms Busulfan | Busulphan | Busulfan Wellcome | Wellcome, Busulfan | Busulfex | Myleran | Myléran | Myelosan | Mylecytan | n-Butane-1,3-di(methylsulfonate) | Glyzophrol
Chemical Information
Molecular Formula C6H14O6S2
CAS Registry Number 55-98-1
SMILES CS(=O)(=O)OCCCCOS(=O)(=O)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hepatobiliary disease09.01.08.003--Not Available
Pigmentation disorder23.05.03.001--Not Available
Venoocclusive disease24.03.02.0160.001007%Not Available
Renal impairment20.01.03.010--Not Available
Neutropenic colitis01.02.03.010; 07.08.01.0140.000168%Not Available
Cystitis noninfective20.03.02.001--
Idiopathic pneumonia syndrome22.01.02.015; 12.02.07.0060.000224%Not Available
Autism spectrum disorder17.03.05.003; 19.22.02.0020.000112%Not Available
Breath sounds abnormal13.15.01.008--Not Available
Bone marrow failure01.03.03.0050.000448%
Acute graft versus host disease12.02.09.002; 10.02.01.0280.000616%Not Available
Chronic graft versus host disease12.02.09.003; 10.02.01.0290.000392%Not Available
Cytopenia01.03.03.0120.000694%Not Available
Haematological malignancy16.21.01.002; 01.13.01.003--Not Available
Anorectal discomfort07.03.03.003--Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.000168%
Acute kidney injury20.01.03.0160.000280%
Pulmonary ossification22.01.02.020--Not Available
Peripheral artery thrombosis24.01.02.010--Not Available
Granulomatosis with polyangiitis24.12.04.011; 22.01.01.015; 20.05.01.013; 10.02.02.018--Not Available
Autoimmune haemolytic anaemia10.04.01.005; 01.06.01.0040.000336%Not Available
Sinus node dysfunction02.03.03.017--
Multiple organ dysfunction syndrome08.01.03.0570.000504%
Myeloproliferative neoplasm16.21.03.006; 01.13.03.0060.000112%Not Available
Non-Hodgkin's lymphoma recurrent16.35.01.002; 01.17.01.002--Not Available
Recurrent cancer16.16.01.0150.000224%Not Available
Tooth development disorder07.09.08.0050.000112%
Acute lymphocytic leukaemia recurrent16.01.01.003; 01.10.01.0030.000168%Not Available
Lymphoma transformation16.20.01.006; 01.12.01.006--Not Available
Graft versus host disease in skin12.02.09.031; 10.02.01.062; 23.07.04.0250.000112%Not Available
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