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)
Thrombocytopenia01.08.01.0020.002071%Not Available
Thrombophlebitis24.01.02.0010.000112%Not Available
Toxic epidermal necrolysis12.03.01.015; 23.03.01.008; 11.07.01.006; 10.01.01.0060.000112%
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.001063%
Unresponsive to stimuli17.02.05.0310.000168%Not Available
Upper gastrointestinal haemorrhage07.12.02.006; 24.07.02.0240.000168%
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.0010.001019%
Vasculitis10.02.02.006; 24.12.04.0270.000672%
Vein disorder24.03.02.0150.000571%Not Available
Venoocclusive liver disease12.02.09.039; 24.04.07.002; 09.01.06.0020.000112%
Visual impairment06.02.10.0130.000392%Not Available
Vomiting07.01.07.0030.001802%
Waldenstrom's macroglobulinaemia16.28.03.001; 01.15.03.0010.000112%Not Available
Weight decreased13.15.01.005--
Wheezing22.03.01.009--
White blood cell count decreased13.01.06.012--
Mental status changes19.07.01.0010.000224%Not Available
Infusion site erythema23.03.06.016; 12.07.05.009; 08.02.05.0080.000951%Not Available
General physical health deterioration08.01.03.0180.000560%Not Available
Left ventricular dysfunction02.04.02.0110.000112%
Ventricular hypokinesia02.04.02.0130.000112%Not Available
Systemic inflammatory response syndrome24.06.03.008; 10.02.01.008; 08.01.05.0050.000168%Not Available
Malignant neoplasm progression16.16.01.0050.001287%Not Available
Cytokine release syndrome10.02.01.0100.001007%
Catheter site pain12.07.02.004; 08.02.02.004--Not Available
Adenocarcinoma pancreas16.13.10.002; 07.21.09.0030.000112%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Injection site swelling12.07.03.018; 08.02.03.0170.000246%Not Available
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