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 approved; investigational
ATC Code L01XH04
DrugBank ID DB05015
KEGG ID D08870
MeSH ID C487081
PubChem ID 6918638
TTD Drug ID D0XT6W
NDC Product Code 65392-2509; 54893-0074; 72893-002
UNII F4H96P17NZ
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Neutropenia01.02.03.0040.000168%-
Obesity14.03.02.0090.000112%
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.0110.000112%
Pain08.01.08.0040.000694%
Pain in extremity15.03.04.0100.000224%
Palpitations02.11.04.0120.000112%
Paraesthesia17.02.06.005; 23.03.03.0940.000168%
Peripheral sensory neuropathy17.09.03.0050.000112%
Phlebitis12.02.01.002; 24.12.03.004--
Pneumonia11.01.09.003; 22.07.01.003---
Pollakiuria20.02.02.0070.000112%
Proteinuria20.02.01.0110.000112%
Pruritus23.03.12.0010.000336%
Pyrexia08.05.02.0030.000224%
Rash23.03.13.001---
Rash maculo-papular23.03.13.0040.000112%
Rhinitis allergic10.01.04.003; 22.04.04.0030.000112%
Sinus tachycardia02.03.03.0100.000336%
Skin lesion23.03.03.0100.000112%-
Stomatitis07.05.06.0050.000112%
Supraventricular tachycardia02.03.03.0120.000112%
Thrombocytopenia01.08.01.002---
Transient ischaemic attack17.08.04.001; 24.04.06.0050.000112%
Tremor17.01.06.0020.000112%
Tumour lysis syndrome14.05.01.004; 16.32.03.002--
Ventricular fibrillation02.03.04.008--
Vomiting07.01.07.0030.000728%
Malignant neoplasm progression16.16.01.0050.000112%-
Infusion site pain08.02.05.014; 12.07.05.0020.000381%-
Gastrointestinal toxicity07.08.03.006; 12.03.01.019---
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