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 For the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.
Marketing Status Prescription
ATC Code L01XX52
DrugBank ID DB11581
KEGG ID D10679
MeSH ID C579720
PubChem ID 49846579
TTD Drug ID Not Available
NDC Product Code 68513-0566; 0074-0576; 68513-0561; 54893-0090; 68543-0576; 71796-008; 0074-0579; 68513-0576; 0074-0566; 0074-0561; 46708-920
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Transaminases increased13.03.01.0150.001066%Not Available
Haemorrhage24.07.01.002--Not Available
Fluid intake reduced14.05.10.0010.000533%Not Available
Pulmonary mass22.02.07.0040.001066%Not Available
Fungal sepsis11.03.05.0150.000208%Not Available
Gastrointestinal toxicity07.08.03.006; 12.03.01.0190.000799%Not Available
Drug resistance08.06.01.005--Not Available
Hepatic enzyme increased13.03.01.019--Not Available
Neurological symptom17.02.05.0100.000533%Not Available
Prostate cancer21.04.02.002; 16.25.01.001--Not Available
General symptom08.01.03.0210.000208%Not Available
Bacterial infection11.02.01.0050.001066%Not Available
Pneumonia bacterial22.07.06.004; 11.02.01.0090.000139%Not Available
Cardiac disorder02.01.01.003--Not Available
Haematotoxicity12.03.01.025; 01.05.01.0070.001865%Not Available
Inflammation08.01.05.0070.001066%Not Available
Lung infection22.07.01.008; 11.01.09.0080.000556%
Intervertebral disc degeneration15.10.01.0020.000533%Not Available
Intra-abdominal haemorrhage24.07.02.035; 07.12.02.0080.000533%
Ischaemic stroke17.08.01.018; 24.04.06.010--Not Available
Malnutrition14.03.02.0040.000533%Not Available
Mantle cell lymphoma16.28.05.001; 01.15.05.0010.000764%Not Available
Neoplasm progression16.16.02.005--Not Available
Pneumonia fungal22.07.08.002; 11.03.05.0080.000278%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Renal injury20.01.03.015; 12.01.05.0010.000533%Not Available
Ill-defined disorder08.01.03.0490.000799%Not Available
Parkinson's disease17.01.05.0100.000139%Not Available
Blood disorder01.05.01.0040.000799%Not Available
Immunodeficiency10.03.02.0020.001066%Not Available
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