Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bendamustine hydrochloride
Drug ID BADD_D00231
Description Bendamustine is a nitrogen mustard drug indicated for use in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendamustine is a bifunctional mechlorethamine derivative capable of forming electrophilic alkyl groups that covalently bond to other molecules. Through this function as an alkylating agent, bendamustine causes intra- and inter-strand crosslinks between DNA bases resulting in cell death. It is active against both active and quiescent cells, although the exact mechanism of action is unknown.
Indications and Usage Bendamustine is indicated for use in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Marketing Status approved; investigational
ATC Code L01AA09
DrugBank ID DB06769
KEGG ID D07085
MeSH ID D000069461
PubChem ID 77082
TTD Drug ID D01CYA
NDC Product Code 63459-390; 63459-391; 70225-1101; 55150-391; 60505-6096; 81955-0011; 82920-005; 16729-250; 17337-0306; 55111-938; 60505-6228; 42367-521; 63459-348; 68001-572; 54893-0003; 60505-6095; 48943-0019; 10019-079; 16729-251; 68001-571; 71225-120; 55150-392
UNII 981Y8SX18M
Synonyms Bendamustine Hydrochloride | Hydrochloride, Bendamustine | Bendamustine | Bendamustin | Cytostasan | IMET 3393 | Ribomustin | Treanda | Zimet 3393
Chemical Information
Molecular Formula C16H22Cl3N3O2
CAS Registry Number 3543-75-7
SMILES CN1C2=C(C=C(C=C2)N(CCCl)CCCl)N=C1CCCC(=O)O.Cl
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)
Pulmonary fibrosis22.01.02.006--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Sepsis11.01.11.003--
Sinusitis22.07.03.007; 11.01.13.005--
Skin irritation23.03.04.009--Not Available
Skin necrosis23.03.03.011--Not Available
Skin reaction23.03.03.013; 10.01.03.019--Not Available
Somnolence17.02.04.006; 19.02.05.003--
Stomatitis07.05.06.005--
Swelling08.01.03.015--Not Available
Tachycardia02.03.02.007--Not Available
Tumour lysis syndrome16.32.03.002; 14.05.01.004--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract infection20.08.02.001; 11.01.14.004--
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Wheezing22.03.01.009--
White blood cell count decreased13.01.06.012--
Infusion related reaction12.02.05.009; 10.01.01.017; 08.01.03.002--
Catheter site pain12.07.02.004; 08.02.02.004--Not Available
Infusion site pain12.07.05.002; 08.02.05.014--Not Available
Infusion site reaction08.02.05.005; 12.07.05.006--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Bone marrow failure01.03.03.005--
Acute kidney injury20.01.03.016--
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