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)
Headache17.14.01.0010.000302%
Hyperbilirubinaemia01.06.04.003; 14.11.01.010; 09.01.01.003--Not Available
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hypermagnesaemia14.04.02.002--
Hypersensitivity10.01.03.003--
Hyperuricaemia14.09.01.003--
Hypoalbuminaemia09.01.02.003; 14.10.01.002--
Hypocalcaemia14.04.01.004--
Hypokalaemia14.05.03.002--
Hypomagnesaemia14.04.02.001--
Hyponatraemia14.05.04.002--
Hypophosphataemia14.04.03.001--
Hypotension24.06.03.002--
Infection11.01.08.002--Not Available
Leukocytosis01.02.01.0020.000112%
Leukopenia01.02.02.001--Not Available
Loss of consciousness17.02.04.004--Not Available
Lymphopenia01.02.02.002--Not Available
Malaise08.01.01.0030.000112%
Myocardial ischaemia24.04.04.010; 02.02.02.008--Not Available
Nausea07.01.07.0010.000716%
Neoplasm malignant16.16.01.001--Not Available
Nervous system disorder17.02.10.001--Not Available
Neutropenia01.02.03.0040.001007%Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Pleural effusion22.05.02.0020.000112%
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pruritus23.03.12.001--
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
The 2th Page    First    Pre   2 3    Next   Last    Total 3 Pages