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)
Febrile neutropenia01.02.03.002; 08.05.02.0040.009324%
Feeling abnormal08.01.09.014--Not Available
Fibrosis08.03.01.0010.000533%Not Available
Fluid overload14.05.06.001; 02.05.04.0040.000799%Not Available
Fungal infection11.03.05.0010.003197%Not Available
Gait disturbance17.02.05.016; 08.01.02.002--
Gastric haemorrhage24.07.02.007; 07.12.01.0010.000799%
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Glomerular filtration rate decreased13.13.01.0090.000799%Not Available
Gout15.01.06.001; 14.09.01.0010.000533%Not Available
Granulocytes abnormal13.01.06.0340.000533%Not Available
Haematochezia07.12.02.003; 24.07.02.012--Not Available
Haematocrit decreased13.01.05.0010.000347%Not Available
Haematuria24.07.01.047; 20.02.01.006--
Haemoglobin abnormal13.01.05.0110.000533%Not Available
Haemoglobin decreased13.01.05.0030.005861%Not Available
Haemolysis01.06.04.0020.002131%
Haemolytic anaemia01.06.03.0020.002131%Not Available
Haemoptysis24.07.01.006; 22.02.03.004; 02.01.02.006--Not Available
Haemorrhage intracranial24.07.04.003; 17.08.01.008--
Headache17.14.01.001--
Heart rate irregular13.14.04.0030.000533%Not Available
Hepatic failure09.01.03.0020.000347%
Hepatic function abnormal09.01.02.001--Not Available
Hepatic neoplasm16.07.03.001; 09.04.03.0010.000799%Not Available
Hepatitis09.01.07.0040.001066%Not Available
Hepatitis B11.05.06.002; 09.01.09.0030.000799%
Hepatomegaly09.01.05.0010.001066%Not Available
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