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)
Lethargy08.01.01.008; 19.04.04.004; 17.02.04.003--
Leukopenia01.02.02.001--Not Available
Liver disorder09.01.08.0010.000112%Not Available
Loss of consciousness17.02.04.004--Not Available
Lung disorder22.02.07.001--Not Available
Lymphadenopathy01.09.01.002--Not Available
Lymphoma16.20.01.001; 01.12.01.001--Not Available
Melanoderma23.05.01.012--Not Available
Memory impairment19.20.01.003; 17.03.02.003--
Menopausal symptoms21.02.02.002--Not Available
Menopause26.03.01.001--Not Available
Metastatic malignant melanoma23.08.01.002; 16.03.01.002--Not Available
Miosis17.02.11.002; 06.05.03.0030.000112%Not Available
Mouth ulceration07.05.06.0040.000168%Not Available
Movement disorder17.01.02.010--Not Available
Mucosal inflammation08.01.06.0020.000616%Not Available
Muscle twitching15.05.03.005--Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.000112%
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Myasthenia gravis15.05.08.001; 10.04.05.001; 17.05.04.001--
Mydriasis06.05.03.004; 17.02.11.003--Not Available
Myelodysplastic syndrome16.01.04.001; 01.10.04.0010.000951%
Myocardial infarction24.04.04.009; 02.02.02.0070.000112%
Nasal congestion22.04.04.001--
Nausea07.01.07.001--
Necrosis24.04.02.006; 08.03.03.001--Not Available
Neoplasm16.16.02.001--Not Available
Neoplasm malignant16.16.01.001--Not Available
Nephrolithiasis20.04.01.002--
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