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)
Renal failure20.01.03.0050.000895%-
Respiratory distress22.02.01.0120.000504%-
Respiratory failure14.01.04.003; 22.02.06.0020.000895%
Respiratory tract irritation22.02.07.0120.000246%-
Restlessness17.02.05.021; 19.11.02.0020.000112%
Sepsis11.01.11.003--
Serum sickness10.01.03.004; 12.02.08.0040.000168%
Shock24.06.02.0020.000168%-
Sinus tachycardia02.03.03.0100.000112%
Sinusitis11.01.13.005; 22.07.03.007--
Skin discolouration23.03.03.0050.000437%-
Skin disorder23.03.03.0070.000492%-
Skin exfoliation23.03.07.0030.000492%-
Skin lesion23.03.03.0100.000761%-
Skin necrosis23.03.03.011---
Skin reaction10.01.03.019; 23.03.03.0130.000168%-
Somnolence17.02.04.006; 19.02.05.003--
Speech disorder17.02.08.003; 19.19.02.002; 22.12.03.0270.000224%-
Squamous cell carcinoma16.16.01.0020.000817%-
Squamous cell carcinoma of lung16.19.01.006; 22.08.01.0140.000112%-
Squamous cell carcinoma of skin16.03.02.005; 23.08.02.0050.000302%-
Stevens-Johnson syndrome10.01.01.045; 11.07.01.005; 12.03.01.014; 23.03.01.0070.000336%
Stomatitis07.05.06.0050.000582%
Subarachnoid haemorrhage12.01.10.011; 17.08.01.010; 24.07.04.0040.000112%-
Swelling08.01.03.0150.001254%-
Swelling face08.01.03.100; 10.01.05.018; 23.04.01.0180.000224%-
Swollen tongue07.14.02.003; 10.01.05.015; 23.04.01.0140.000112%-
Tachycardia02.03.02.0070.001052%-
Tachypnoea22.02.01.0140.000224%-
Therapeutic response decreased08.06.01.0160.000112%-
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