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)
Haemolysis01.06.04.002--
Headache17.14.01.001--
Herpes simplex23.11.05.004; 11.05.02.001--Not Available
Herpes zoster11.05.02.003; 23.11.05.005; 17.09.03.026--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hyperuricaemia14.09.01.003--
Hypokalaemia14.05.03.002--
Hypotension24.06.03.002--
Infection11.01.08.002--Not Available
Insomnia17.15.03.002; 19.02.01.002--
Laryngeal pain22.12.03.010--
Lymphocyte count decreased13.01.06.006--
Malaise08.01.01.003--
Mucosal inflammation08.01.06.002--Not Available
Myelodysplastic syndrome16.01.04.001; 01.10.04.001--
Nasal congestion22.04.04.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neoplasm malignant16.16.01.001--Not Available
Neutrophil count decreased13.01.06.010--
Night sweats23.02.03.006; 08.01.03.031--Not Available
Oedema peripheral02.05.04.007; 14.05.06.011; 08.01.07.007--
Oral candidiasis11.03.03.004; 07.05.07.001--Not Available
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Phlebitis24.12.03.004; 12.02.01.002--
Platelet count decreased13.01.04.001--
Pneumonia11.01.09.003; 22.07.01.003--Not Available
Pruritus23.03.12.001--
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