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)
Vertigo17.02.12.002; 04.04.01.003--
Visual acuity reduced17.17.01.011; 06.02.03.001--
Visual impairment06.02.06.008--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
White blood cell count decreased13.01.06.0120.006927%
White blood cell count increased13.01.06.0130.004795%Not Available
Mental status changes19.07.01.001--Not Available
Mobility decreased17.02.05.018; 15.03.01.003; 08.01.03.0300.001066%Not Available
Urosepsis20.08.02.002; 11.01.11.0050.000533%Not Available
Anal abscess11.01.07.015; 07.19.04.0040.000533%Not Available
Peripheral swelling08.01.03.053; 02.05.04.015--Not Available
Osteopenia15.02.03.003; 14.04.04.0040.000533%Not Available
Emotional distress19.04.02.008--Not Available
Neutropenic sepsis01.02.03.007; 11.01.11.0060.000625%Not Available
Blood phosphorus decreased13.11.01.0150.000533%Not Available
Blood phosphorus increased13.11.01.0160.000486%Not Available
Contusion24.07.06.001; 23.03.11.002; 15.03.01.008; 12.01.06.001--
Lower gastrointestinal haemorrhage07.12.02.007; 24.07.02.0300.000533%
Streptococcal bacteraemia11.02.06.0040.000533%Not Available
Deep vein thrombosis24.01.02.003--Not Available
Cardiopulmonary failure02.05.01.004; 22.02.06.0040.000208%Not Available
Central nervous system lesion17.02.10.011--Not Available
Malignant neoplasm progression16.16.01.0050.001737%Not Available
Escherichia urinary tract infection20.08.02.009; 11.02.10.0030.000533%Not Available
Bacterial sepsis11.02.01.0290.000278%Not Available
Red cell distribution width increased13.01.05.0250.000208%Not Available
Escherichia bacteraemia11.02.10.0010.000139%Not Available
Helicobacter infection11.02.18.0010.000533%Not Available
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