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)
Weight increased13.15.01.006--
Wheezing22.03.01.009--
Mental status changes19.07.01.0010.000112%Not Available
Mobility decreased17.02.05.018; 15.03.05.023; 08.01.03.030--Not Available
Cardiotoxicity02.11.01.009; 12.03.01.0070.000168%Not Available
Peripheral swelling08.01.03.053; 02.05.04.015--Not Available
Left ventricular dysfunction02.04.02.0110.000168%
Shock haemorrhagic24.06.02.014; 14.05.05.0030.000168%Not Available
Cerebral haemorrhage foetal24.07.04.013; 18.03.02.007; 17.08.01.023--Not Available
Ejection fraction decreased13.14.02.003--
Post transplant lymphoproliferative disorder11.05.10.006; 16.21.02.004; 01.13.02.004--Not Available
Hyperuricosuria20.02.01.019--Not Available
Bone erosion15.02.04.019--Not Available
Ear pruritus04.03.01.011--Not Available
Dystrophic calcification08.03.04.009--Not Available
Lymphatic disorder01.09.01.003--Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Organ failure08.01.03.0410.000224%Not Available
Nodule08.03.05.002--Not Available
Corneal thinning06.06.03.009--Not Available
Skin burning sensation23.03.03.021; 17.02.06.009--Not Available
Transaminases increased13.03.04.036--Not Available
Haemorrhage24.07.01.002--Not Available
Varices oesophageal24.10.02.004; 09.01.06.009; 07.15.05.001--Not Available
Cognitive disorder17.03.03.003; 19.21.02.001--
Precocious puberty21.03.02.009; 05.05.03.0010.000112%
Dysplasia08.03.04.007--Not Available
Hypogonadism21.03.02.010; 05.05.04.002--Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.001--Not Available
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