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)
Abdominal pain07.01.05.002--
Acute respiratory distress syndrome10.02.01.067; 22.01.03.001; 24.03.02.034--
Alanine aminotransferase increased13.03.04.005--
Amenorrhoea05.05.01.002; 21.01.02.0010.000224%
Anaemia01.03.02.0010.000168%
Arrhythmia supraventricular02.03.03.001---
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.0010.000168%-
Blood uric acid increased13.02.04.001---
Body temperature increased13.15.01.001---
Cardiogenic shock02.05.01.003; 24.06.02.006---
Cellulitis11.02.01.001; 23.11.02.004---
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Chills08.01.09.001; 15.05.03.016--
Constipation07.02.02.001--
Cough22.02.03.001--
Death08.04.01.0010.000504%
Dehydration14.05.05.001--
Dermatitis23.03.04.002---
Dermatitis exfoliative10.01.01.004; 23.03.07.001--
Diarrhoea07.02.01.0010.000112%
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspnoea02.11.05.003; 22.02.01.0040.000112%
Electrocardiogram QT prolonged13.14.05.004--
Extravasation08.01.03.0080.000246%-
Fatigue08.01.01.0020.000604%
Febrile neutropenia01.02.03.002; 08.05.02.0040.000112%
Gastrointestinal disorder07.11.01.0010.000112%-
Gastrointestinal pain07.01.05.005--
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