Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Romidepsin
Drug ID BADD_D01964
Description Romidepsin is a selective inhibitor of histone deacetylase, approved in the US in 2009 for the treatment of cutaneous T-cell lymphoma (CTCL) or/and peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior systemic therapy. These indications are based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.
Indications and Usage For the treatment of cutaneous T-cell lymphoma (CTCL) or/and peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior systemic therapy. These indications are based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.
Marketing Status approved; investigational
ATC Code L01XH02
DrugBank ID DB06176
KEGG ID D06637
MeSH ID C087123
PubChem ID 5352062
TTD Drug ID D0L7LC
NDC Product Code 63323-926; 53183-4026; 54893-0083; 0703-4004; 68254-0009; 59572-984
UNII CX3T89XQBK
Synonyms romidepsin | L-Valine, N-(3-hydroxy-7-mercapto-1-oxo-4-heptenyl)-D-valyl-D-cysteinyl-(Z)-2,3-didehydro-2-aminobutanoyl-, xi-lactone, cyclic (1-2)-disulfide, (S-(E))- | FK228 | FR 901228 | FR-901228 | FR901228 | istodax
Chemical Information
Molecular Formula C24H36N4O6S2
CAS Registry Number 128517-07-7
SMILES CC=C1C(=O)NC(C(=O)OC2CC(=O)NC(C(=O)NC(CSSCCC=C2)C(=O)N1)C(C)C)C(C)C
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)
Pyrexia08.05.02.0030.000168%
Sepsis11.01.11.003--
Septic shock24.06.02.011; 11.01.11.004--Not Available
Shock24.06.02.002--Not Available
Stomatitis07.05.06.005--
Syncope17.02.04.008; 02.11.04.015; 24.06.02.012--
Tachycardia02.03.02.007--Not Available
Thrombocytopenia01.08.01.0020.000392%Not Available
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000112%
Ventricular arrhythmia02.03.04.006--
Vomiting07.01.07.0030.000168%
Weight decreased13.15.01.005--
Deep vein thrombosis24.01.02.003--Not Available
Cardiopulmonary failure22.02.06.004; 02.05.01.004--Not Available
Lymphatic disorder01.09.01.003--Not Available
Candida sepsis11.03.03.017--Not Available
Cardiac disorder02.11.01.003--Not Available
Electrocardiogram ST-T change13.14.05.015--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.000302%
Blood disorder01.05.01.004--Not Available
Disease progression08.01.03.0380.000168%
Device related infection11.01.08.018; 08.07.01.005--
Cytopenia01.03.03.0120.000168%Not Available
Acute kidney injury20.01.03.016--
Multiple organ dysfunction syndrome08.01.03.057--
Peripheral T-cell lymphoma unspecified16.17.06.001; 01.11.06.0010.000336%Not Available
Cutaneous T-cell lymphoma01.11.03.002; 23.07.04.029; 16.17.03.002--Not Available
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