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 Prescription
ATC Code L01XH02
DrugBank ID DB06176
KEGG ID D06637
MeSH ID C087123
PubChem ID 5352062
TTD Drug ID D0L7LC
NDC Product Code 0703-4004; 54893-0083; 63323-926; 59572-984; 53183-4026; 68254-0009
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
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--
Acute respiratory distress syndrome22.01.03.001--
Alanine aminotransferase increased13.03.01.003--
Amenorrhoea21.01.02.001; 05.05.01.0020.001066%
Anaemia01.03.02.0010.001066%
Arrhythmia supraventricular02.03.03.001--Not Available
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.0010.000799%Not Available
Blood uric acid increased13.02.04.001--Not Available
Body temperature increased13.15.01.001--Not Available
Cardiogenic shock24.06.02.006; 02.05.01.003--Not Available
Cellulitis23.09.01.001; 11.02.01.001--Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Chills15.05.03.016; 08.01.09.001--
Constipation07.02.02.001--
Cough22.02.03.001--
Death08.04.01.0010.000208%
Dehydration14.05.05.001--
Dermatitis23.03.04.002--Not Available
Dermatitis exfoliative10.01.01.004; 23.03.07.001--
Diarrhoea07.02.01.0010.000533%
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspnoea22.02.01.004; 02.01.03.002--
Electrocardiogram QT prolonged13.14.05.004--
Extravasation08.01.03.0080.000533%Not Available
Fatigue08.01.01.0020.001066%
Febrile neutropenia08.05.02.004; 01.02.03.002--
Gastrointestinal disorder07.11.01.0010.000533%Not Available
Gastrointestinal pain07.01.05.005--
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