Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Trabectedin
Drug ID BADD_D02253
Description Trabectedin, also referred as ET-743 during its development, is a marine-derived antitumor agent discovered in the Carribean tunicate _Ecteinascidia turbinata_ and now produced synthetically. Trabectedin has a unique mechanism of action. It binds to the minor groove of DNA interfering with cell division and genetic transcription processes and DNA repair machinery. It is approved for use in Europe, Russia and South Korea for the treatment of advanced soft tissue sarcoma. It is currently under evaluation for the treatment of breast cancer, prostate cancer, in addition to pediatric sarcomas. Both the European Commission and the U.S. Food and Drug Administration (FDA) have approved trabectedin as an orphan drug in soft tissue sarcomas and ovarian cancer. On October 23, 2015, the FDA approved trabectedin, (as Yondelis), for the treatment of specific soft tissue sarcomas.
Indications and Usage Indicated for treatment of advanced soft tissue sarcoma in patients refractory to or unsuitable to receive anthracycline or ifosfamide chemotherapy in Europe, Russia and South Korea. Approved for orphan drug status by the U.S. FDA for treatment of soft tissue sarcomas and ovarian cancer. Investigated for use/treatment in cancer/tumors (unspecified), gastric cancer, ovarian cancer, pediatric indications, sarcoma, and solid tumors.
Marketing Status approved; investigational
ATC Code L01CX01
DrugBank ID DB05109
KEGG ID D06199
MeSH ID D000077606
PubChem ID 108150
TTD Drug ID D03RTK
NDC Product Code 59676-610; 42973-310; 54893-0092; 70225-1110; 57884-0033
UNII ID0YZQ2TCP
Synonyms Trabectedin | Yondelis | Ecteinascidin 743 | ET-743 | ET743 | ET 743 | NSC 684766
Chemical Information
Molecular Formula C39H43N3O11S
CAS Registry Number 114899-77-3
SMILES CC1=CC2=C(C3C4C5C6=C(C(=C7C(=C6C(N4C(C(C2)N3C)O)COC(=O)C8(CS5)C9=CC(=C(C=C9CCN8) O)OC)OCO7)C)OC(=O)C)C(=C1OC)O
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)
Catheter site related reaction08.02.02.001; 12.07.02.0010.000660%-
Cholestasis09.01.01.0010.000336%-
Constipation07.02.02.0010.000716%
Cough22.02.03.001--
Death08.04.01.001--
Dehydration14.05.05.001--
Dermatitis23.03.04.002---
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspepsia07.01.02.0010.000112%
Dyspnoea02.11.05.003; 22.02.01.0040.000918%
Encephalopathy17.13.02.0010.000112%
Enteritis07.08.03.0020.000112%
Erythema23.03.06.0010.000683%-
Extravasation08.01.03.0080.001802%-
Fatigue08.01.01.0020.001366%
Febrile neutropenia01.02.03.002; 08.05.02.0040.002015%
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Gamma-glutamyltransferase increased13.03.04.024--
Gastrooesophageal reflux disease07.02.02.0030.000112%
Gastrointestinal disorder07.11.01.001---
Gastrointestinal pain07.01.05.005--
Generalised oedema08.01.07.004; 14.05.06.0070.000112%
Haemoglobin13.01.05.018---
Headache17.14.01.001--
Hepatic failure09.01.03.0020.000448%
Hepatic function abnormal09.01.02.0010.000392%-
Hepatic pain09.01.05.005--
Hepatitis09.01.07.0040.000224%-
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