Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Defibrotide sodium
Drug ID BADD_D00598
Description Defibrotide is the sodium salt of a mixture of single-stranded oligodeoxyribonucleotides derived from porcine mucosal DNA. It has been shown to have antithrombotic, anti-inflammatory and anti-ischemic properties (but without associated significant systemic anticoagulant effects). It is marketed under the brand names Dasovas (FM), Noravid, and Prociclide in a variety of countries. In the USA it is was approved in March, 2016 as Defitelio.
Indications and Usage Indicated for the treatment of severe hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).[label]
Marketing Status approved; investigational
ATC Code B01AX01
DrugBank ID DB04932
KEGG ID D07423
MeSH ID C036901
PubChem ID 135565962
TTD Drug ID D0FM2W
NDC Product Code 68727-800; 68225-107
UNII L7CHH2B2J0
Synonyms defibrotide | defibrotide (bovine) | defibrinotide | defibrotide sodium | defibrotide sodium (porcine mucosa) | JZP-381 | JZP381 | Defitelio
Chemical Information
Molecular Formula C20H21N4O6P
CAS Registry Number 83712-60-1
SMILES CC(C)C1=C(C=C(C(=C1)C2=NNC(=O)N2C3=CC4=C(C=C3)N(C=C4)C)O)OP(=O)(O)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)
Cerebral haemorrhage17.08.01.003; 24.07.04.001---
Diarrhoea07.02.01.001--
Epistaxis22.04.03.001; 24.07.01.005--
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009---
Graft versus host disease10.02.01.027; 12.02.09.001---
Haemorrhage intracranial17.08.01.008; 24.07.04.003--
Hypersensitivity10.01.03.003--
Hyperuricaemia14.09.01.003--
Hypotension24.06.03.002--
Infection11.01.08.002---
Lung infiltration22.01.02.004---
Nausea07.01.07.001--
Pneumonia11.01.09.003; 22.07.01.003---
Pulmonary alveolar haemorrhage22.01.02.005; 24.07.01.015---
Pulmonary haemorrhage22.12.01.009; 24.07.01.016--
Sepsis11.01.11.003--
Vomiting07.01.07.003--
Haemorrhage24.07.01.002---
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