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)
Skin discolouration23.03.03.005--Not Available
Skin disorder23.03.03.007--Not Available
Skin exfoliation23.03.07.003--Not Available
Skin hyperpigmentation23.05.01.003--
Skin lesion23.03.03.0100.000246%Not Available
Skin reaction23.03.03.013; 10.01.03.019--Not Available
Somnolence19.02.05.003; 17.02.04.0060.000168%
Stomatitis07.05.06.0050.000392%
Stress19.06.02.004--Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.018--Not Available
Tachycardia02.03.02.0070.000224%Not Available
Tachypnoea22.02.01.0140.000112%Not Available
Tension19.06.02.005--Not Available
Throat irritation22.12.03.029; 07.05.05.037--Not Available
Throat tightness22.12.03.031; 19.01.02.005--Not Available
Thrombocytopenia01.08.01.0020.000728%Not Available
Thrombosis24.01.01.006--Not Available
Thrombotic microangiopathy24.01.01.013; 20.01.07.004; 01.01.02.006--Not Available
Thrombotic thrombocytopenic purpura24.07.06.014; 23.06.01.011; 01.08.01.005--
Toxic epidermal necrolysis23.03.01.008; 11.07.01.006; 12.03.01.015; 10.01.01.006--
Tumour lysis syndrome16.32.03.002; 14.05.01.004--
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Vasculitis24.12.04.027; 10.02.02.006--
Venoocclusive liver disease12.02.09.039; 24.04.07.002; 09.01.06.0020.001959%
Ventricular extrasystoles02.03.04.007--Not Available
Visual impairment06.02.10.0130.000112%Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
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