Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Venetoclax
Drug ID BADD_D02345
Description Venetoclax is a BCL-2 inhibitor that was initially approved by the FDA in April 2016 [FDA label]. Proteins in the B cell CLL/lymphoma 2 (BCL-2) family are important regulators of the apoptotic (programmed cell death) process [A18565], [A18566]. Venetoclax is used to treat chronic lymphocytic leukemia (CLL) and certain types of small lymphocytic lymphoma [FDA label]. CLL is the most prevalent leukemia diagnosed in Western countries [A40022]. Venetoclax was developed through reverse engineering of the BCL-2 protein family inhibitor, navitoclax [A40022]. Venetoclax is approximately 10 times more potent than navitoclax with regard to induction of apoptosis in CLL cells [A40022]. A new indication was approved in 2018 for the treatment patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy [FDA label]. Previously, this drug was indicated only for patients with 17p gene deletion [F2130].
Indications and Usage A BCL-2 inhibitor indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy [FDA label].
Marketing Status approved; investigational
ATC Code L01XX52
DrugBank ID DB11581
KEGG ID D10679
MeSH ID C579720
PubChem ID 49846579
TTD Drug ID Not Available
NDC Product Code 76462-0576; 0074-0576; 0074-0579; 71796-008; 0074-0566; 68543-0576; 54893-0090; 68513-0566; 0074-0561; 68513-0576; 68513-0561
UNII N54AIC43PW
Synonyms venetoclax | 4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide | benzamide, 4-(4-((2-(4-chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl)methyl)-1-piperazinyl)-n-((3-nitro-4-(((tetrahydro-2h-pyran-4-yl)methyl)amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)- | GDC-0199 | RG-7601 | RG7601 | ABT-199 | Venclexta
Chemical Information
Molecular Formula C45H50ClN7O7S
CAS Registry Number 1257044-40-8
SMILES CC1(CCC(=C(C1)C2=CC=C(C=C2)Cl)CN3CCN(CC3)C4=CC(=C(C=C4)C(=O)NS(=O)(=O)C5=CC(=C(C =C5)NCC6CCOCC6)[N+](=O)[O-])OC7=CN=C8C(=C7)C=CN8)C
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)
Deafness04.02.01.0010.000280%Not Available
Death08.04.01.0010.093964%
Diarrhoea07.02.01.001--
Diffuse large B-cell lymphoma16.28.02.001; 01.15.02.0010.000392%Not Available
Diverticulum07.10.01.0010.000112%Not Available
Drug interaction08.06.03.001--Not Available
Dysphagia07.01.06.0030.006234%
Dyspnoea02.11.05.003; 22.02.01.004--
Ear pain04.03.01.0030.000112%
Ecchymosis24.07.06.002; 23.06.01.001; 01.01.03.0010.000112%Not Available
Electrolyte imbalance14.05.01.0020.000112%Not Available
Failure to thrive19.07.05.001; 18.04.01.003; 14.03.02.0080.000168%Not Available
Fatigue08.01.01.002--
Febrile neutropenia08.05.02.004; 01.02.03.0020.003973%
Feeling cold08.01.09.0080.000168%Not Available
Fibrosis08.03.01.0010.000112%Not Available
Gastric haemorrhage24.07.02.007; 07.12.01.0010.000224%
Gastric perforation07.04.03.001; 12.02.03.0070.000112%
Gastrointestinal carcinoma16.13.04.001; 07.21.03.0010.000168%Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal necrosis24.04.08.006; 07.15.01.0030.000112%
Gastrointestinal pain07.01.05.0050.000112%
Gout15.01.06.001; 14.09.01.0010.000358%Not Available
Haemolysis01.06.04.0020.000728%
Haemolytic anaemia01.06.03.0020.000951%Not Available
Headache17.14.01.001--
Hepatic failure09.01.03.0020.000672%
Hepatic neoplasm16.07.03.001; 09.04.03.0010.000168%Not Available
Hepatitis09.01.07.0040.000336%Not Available
Hepatitis acute09.01.07.0050.000112%Not Available
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