Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bendamustine
Drug ID BADD_D00230
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 D07501
MeSH ID D000069461
PubChem ID 65628
TTD Drug ID D01CYA
NDC Product Code 68554-0050
UNII 9266D9P3PQ
Synonyms Bendamustine Hydrochloride | Hydrochloride, Bendamustine | Bendamustine | Bendamustin | Cytostasan | IMET 3393 | Ribomustin | Treanda | Zimet 3393
Chemical Information
Molecular Formula C16H21Cl2N3O2
CAS Registry Number 16506-27-7
SMILES CN1C2=C(C=C(C=C2)N(CCCl)CCCl)N=C1CCCC(=O)O
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)
Metabolic encephalopathy14.11.01.013; 17.13.01.0010.000112%-
Metastasis16.22.01.001---
Infusion site extravasation08.02.05.007; 12.07.05.0080.001959%
Chronic kidney disease20.01.03.0170.000112%
Infusion site irritation08.02.05.010; 12.07.05.0110.002093%-
Bone marrow failure01.03.03.0050.001063%
Cytopenia01.03.03.0120.000616%-
Oral disorder07.05.01.0050.000358%-
Oropharyngeal pain07.05.05.004; 22.12.03.0160.000470%
Acute kidney injury20.01.03.0160.001119%
Drug reaction with eosinophilia and systemic symptoms10.01.01.021; 12.03.01.064; 23.03.05.0050.000280%-
Pneumocystis jirovecii pneumonia11.03.07.005; 22.07.08.009---
Autoimmune haemolytic anaemia01.06.01.004; 10.04.01.0050.000336%-
Candida infection11.03.03.021--
Multiple organ dysfunction syndrome08.01.03.0570.000336%
Adenocarcinoma of colon07.21.01.008; 16.13.01.0100.000112%-
Chronic lymphocytic leukaemia recurrent01.10.06.003; 16.01.06.0030.000280%-
Diffuse large B-cell lymphoma recurrent01.15.02.002; 16.28.02.0020.000336%-
Diffuse large B-cell lymphoma refractory01.15.02.003; 16.28.02.0030.000168%-
Non-Hodgkin's lymphoma recurrent01.17.01.002; 16.35.01.0020.000112%-
Venous stenosis24.04.02.0290.000381%-
Secondary immunodeficiency10.03.03.0090.000112%-
Peripheral artery occlusion24.04.03.0220.000112%-
Richter's syndrome01.15.02.005; 16.28.02.0050.000168%-
Lymphoma transformation01.12.01.006; 16.20.01.0060.000112%-
Stress urinary incontinence20.02.02.0220.000761%-
Respiratory tract inflammation22.02.07.0150.000246%-
Bone marrow infiltration01.05.01.0180.000168%-
Blastic plasmacytoid dendritic cell neoplasia01.12.01.004; 16.20.01.004; 23.07.04.0210.000112%-
Autoimmune colitis07.08.01.017; 10.04.04.0100.000112%-
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