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)
Mass08.03.05.0030.000112%Not Available
Myelodysplastic syndrome16.01.04.001; 01.10.04.0010.001455%
Myeloid leukaemia01.10.08.001; 16.01.08.0010.000112%Not Available
Nausea07.01.07.001--
Neoplasm16.16.02.0010.000392%Not Available
Neoplasm malignant16.16.01.0010.000750%Not Available
Nervous system disorder17.02.10.0010.000336%Not Available
Neutropenia01.02.03.0040.017718%Not Available
Night sweats23.02.03.006; 08.01.03.0310.000224%Not Available
Non-Hodgkin's lymphoma16.35.01.001; 01.17.01.0010.000224%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Pancytopenia01.03.03.0030.006044%Not Available
Pericardial effusion02.06.01.0020.000336%
Pericarditis02.06.02.0010.000112%
Phlebitis24.12.03.004; 12.02.01.0020.000246%
Plasma cell leukaemia16.23.02.003; 01.14.02.0030.000112%Not Available
Plasma cell myeloma16.23.02.004; 01.14.02.0040.002127%Not Available
Platelet disorder01.08.03.0010.000683%Not Available
Pleural effusion22.05.02.0020.001063%
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pneumonitis22.01.01.0060.000526%
Polymyalgia rheumatica15.06.01.001; 10.04.05.0030.000112%Not Available
Proctitis07.08.04.0010.000168%
Pulmonary alveolar haemorrhage22.01.02.005; 24.07.01.0150.000168%Not Available
Pulmonary haemorrhage22.12.01.009; 24.07.01.0160.000112%
Pyrexia08.05.02.0030.005731%
Rales22.12.01.0110.000112%Not Available
Renal failure20.01.03.0050.002183%Not Available
Respiratory disorder22.02.07.0020.000582%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.001455%
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