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)
Hepatitis fulminant11.07.01.003; 09.01.07.0070.000112%Not Available
Hepatomegaly09.01.05.0010.000280%Not Available
Hepatosplenomegaly09.01.05.002; 01.09.03.0010.000168%Not Available
Hepatotoxicity09.01.07.009; 12.03.01.0080.000504%Not Available
Hodgkin's disease01.16.01.001; 16.31.01.0010.000224%Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.0030.000604%Not Available
Hypercalcaemia14.04.01.003; 05.04.01.0020.000783%
Hyperphosphataemia14.04.03.0070.000448%
Hyperuricaemia14.09.01.0030.000358%
Hypervolaemia02.05.04.019; 14.05.06.0030.000224%Not Available
Hypocalcaemia14.04.01.0040.000224%
Hypokalaemia14.05.03.002--
Hypomagnesaemia14.04.02.0010.000168%
Hypophosphataemia14.04.03.0010.000392%
Hypoxia22.02.02.0030.000504%
Intestinal perforation07.04.06.0020.000168%Not Available
Iron deficiency14.13.02.0020.000112%Not Available
Jaundice cholestatic09.01.01.0050.000168%Not Available
Leukaemia16.01.03.001; 01.10.03.0010.001175%
Leukocytosis01.02.01.0020.000638%
Leukopenia01.02.02.0010.001276%Not Available
Lung infiltration22.01.02.0040.000336%Not Available
Lymph node pain01.09.01.0070.000112%
Lymphadenitis01.09.01.0010.000112%Not Available
Lymphadenopathy01.09.01.0020.003358%Not Available
Lymphocytic leukaemia01.10.09.001; 16.01.09.0010.000168%Not Available
Lymphocytosis01.02.01.0030.000336%Not Available
Lymphoma16.20.01.001; 01.12.01.0010.000839%Not Available
Malaise08.01.01.003--
Mallory-Weiss syndrome24.07.02.038; 07.12.01.0040.000112%Not Available
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