Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Belinostat
Drug ID BADD_D00225
Description Belinostat is a novel agent that inhibits the enzyme histone deacetylase (HDAC) with a sulfonamide-hydroxamide structure. It was developed as an orphan drug to target hematological malignancies and solid tumors by TopoTarget. The safety and efficacy of belinostat is currently being evaluated for use in combination with traditional front-line therapies for the treatment of PTCL. Intravenous administration of the agent is available as Beleodaq as monotherapy and the dosing regimen involves a 21-day cycle. It was US-approved in July 2014 as a therapeutic agent for relapsed or refractory peripheral T-cell lymphoma.
Indications and Usage Belinostat is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) with manageable safety profile. It is a potential alternative therapy for patients who did not experience adequate response to first-line drugs for PTCL. It can be used in patients with baseline thrombocytopenia [A19161].
Marketing Status Prescription
ATC Code L01XH04
DrugBank ID DB05015
KEGG ID D08870
MeSH ID C487081
PubChem ID 6918638
TTD Drug ID D0XT6W
NDC Product Code 65392-2509; 68152-108; 54893-0074; 72893-002
Synonyms belinostat | Belecodaq | PXD101
Chemical Information
Molecular Formula C15H14N2O4S
CAS Registry Number 866323-14-0
SMILES C1=CC=C(C=C1)NS(=O)(=O)C2=CC=CC(=C2)C=CC(=O)NO
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)
Abdominal pain07.01.05.002--
Anaemia01.03.02.001--
Asthenia08.01.01.001--Not Available
Blood creatinine increased13.13.01.004--
Blood lactate dehydrogenase increased13.04.02.002--
Body temperature increased13.15.01.001--Not Available
Chills15.05.03.016; 08.01.09.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Death08.04.01.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dyspnoea22.02.01.004; 02.01.03.002--
Electrocardiogram QT prolonged13.14.05.004--
Fatigue08.01.01.002--
Febrile neutropenia08.05.02.004; 01.02.03.002--
Gastrointestinal pain07.01.05.005--
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Hyperlactacidaemia14.01.01.006--Not Available
Hypokalaemia14.05.03.002--
Hypotension24.06.03.002--
Infection11.01.08.002--Not Available
Nausea07.01.07.001--
Neoplasm malignant16.16.01.001--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Phlebitis24.05.03.001; 12.02.01.002--
Pneumonia11.01.09.003; 22.07.01.003--Not Available
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