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)
Vasodilation procedure25.03.01.001--Not Available
Cytomegalovirus viraemia11.05.01.003--Not Available
Angiopathy24.03.02.007--Not Available
Metastases to central nervous system17.02.10.013; 16.22.02.004--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Drug resistance08.06.01.005--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
Neurological symptom17.02.05.010--Not Available
Prostate cancer16.25.01.001; 21.04.02.002--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Inflammation10.02.01.089; 08.01.05.007--Not Available
Limb discomfort15.03.04.014--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Partial seizures17.12.03.0100.000112%Not Available
Abnormal behaviour19.01.01.001--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.001--
Ill-defined disorder08.01.03.049--Not Available
Urinary tract obstruction20.08.01.0040.000168%
Blood disorder01.05.01.004--Not Available
Cardiac fibrillation02.03.02.021--Not Available
Autoimmune disorder10.04.04.003--
Disease progression08.01.03.0380.000168%
Disease recurrence08.01.03.0500.000414%Not Available
Obstructive airways disorder22.03.01.0110.000112%Not Available
Pulmonary toxicity12.03.01.013; 22.01.02.007--Not Available
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