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%Not Available
Respiratory distress22.02.01.0120.000504%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000895%
Respiratory tract irritation22.02.07.0120.000246%Not Available
Restlessness19.11.02.002; 17.02.05.0210.000112%
Sepsis11.01.11.003--
Serum sickness12.02.08.004; 10.01.03.0040.000168%
Shock24.06.02.0020.000168%Not Available
Sinus tachycardia02.03.03.0100.000112%
Sinusitis22.07.03.007; 11.01.13.005--
Skin discolouration23.03.03.0050.000437%Not Available
Skin disorder23.03.03.0070.000492%Not Available
Skin exfoliation23.03.07.0030.000492%Not Available
Skin lesion23.03.03.0100.000761%Not Available
Skin necrosis23.03.03.011--Not Available
Skin reaction23.03.03.013; 10.01.03.0190.000168%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.000224%Not Available
Squamous cell carcinoma16.16.01.0020.000817%Not Available
Squamous cell carcinoma of lung22.08.01.014; 16.19.01.0060.000112%Not Available
Squamous cell carcinoma of skin16.03.02.005; 23.08.02.0050.000302%Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.0050.000336%
Stomatitis07.05.06.0050.000582%
Subarachnoid haemorrhage24.07.04.004; 17.08.01.010; 12.01.10.0110.000112%Not Available
Swelling08.01.03.0150.001254%Not Available
Swelling face23.04.01.018; 10.01.05.018; 08.01.03.1000.000224%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.000112%Not Available
Tachycardia02.03.02.0070.001052%Not Available
Tachypnoea22.02.01.0140.000224%Not Available
Therapeutic response decreased08.06.01.0160.000112%Not Available
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