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)
Autoimmune disorder10.04.04.0030.000533%
Disease progression08.01.03.0380.008409%
Disease recurrence08.01.03.050--Not Available
Drug intolerance08.06.01.013--Not Available
Hepatic lesion09.01.08.0050.000533%Not Available
Metastasis16.22.01.0010.000139%Not Available
Renal impairment20.01.03.010--Not Available
Respiratory tract infection22.07.07.001; 11.01.08.017--Not Available
Unevaluable event08.01.03.051--Not Available
Hepatic enzyme abnormal13.03.01.0200.000799%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.001066%Not Available
Gastrointestinal inflammation07.08.03.0070.000533%Not Available
Blood count abnormal13.01.07.0010.003730%Not Available
Bone marrow failure01.03.03.0050.004529%
Cytopenia01.03.03.0120.008259%Not Available
Treatment failure08.06.01.0170.000417%Not Available
Anorectal discomfort07.03.03.0030.000533%Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.004--
Acute kidney injury20.01.03.016--
Posterior reversible encephalopathy syndrome17.13.02.0070.000533%
Autoimmune haemolytic anaemia01.06.01.004; 10.04.01.0050.002398%Not Available
Candida infection11.03.03.0210.000139%
Aspergillus infection11.03.01.0040.000556%Not Available
Immune thrombocytopenic purpura10.04.01.008; 01.08.01.0070.002131%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000834%
Liver function test increased13.03.01.0440.001332%Not Available
Abdominal mass07.01.01.0030.000139%Not Available
B-cell small lymphocytic lymphoma16.28.06.001; 01.15.06.0010.000208%Not Available
Biopsy bone marrow13.01.08.0020.000533%Not Available
Chloroma16.01.08.003; 01.10.08.0030.000533%Not Available
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