Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Decitabine
Drug ID BADD_D00593
Description Myelodysplastic syndromes (MDS) are a heterogeneous group of hematopoietic neoplasms with variable underlying etiology and presentation, including neutropenia and thrombocytopenia. Further mutations leading to increased proliferation of cancerous cells can eventually lead to secondary acute myeloid leukemia, which has a poor prognosis.[A215082, A215092] Among treatment options, nucleoside analogues such as decitabine and [azacitidine] integrate into cellular DNA and inhibit the action of DNA methyltransferases, leading to global hypomethylation and related downstream therapeutic benefits.[A2263, A2264, A2265, A215317, L14962] Decitabine was developed by MGI Pharma/SuperGen Inc. and was approved by the FDA for the treatment of MDS on February 5, 2006. It was first marketed under the name Dacogen®.[L14962] It is also available as an oral combination product together with the cytidine deaminase inhibitor [cedazuridine].
Indications and Usage Decitabine is indicated for the treatment of patients with myelodysplastic syndromes (MDS) including all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia), as well as for MDS scored as belonging to the intermediate-1, intermediate-2, or high-risk group in the International Prognostic Scoring System.[L14962]
Marketing Status approved; investigational
ATC Code L01BC08
DrugBank ID DB01262
KEGG ID D03665
MeSH ID D000077209
PubChem ID 451668
TTD Drug ID D0X5XU
NDC Product Code 64679-067; 68001-573; 70860-219; 67430-275; 43598-348; 43598-427; 47335-361; 50742-430; 55150-376; 67457-316; 72205-031; 72205-036; 50137-4147; 54245-7035; 65129-1223; 16729-224; 68001-422; 68180-738; 70710-1656; 75834-190; 17404-1029; 55111-556; 69097-905; 71288-119; 55111-915; 76055-0018; 68083-528; 69539-115; 72603-107; 54893-0056; 59148-046; 63323-825; 70121-1644; 51916-360; 66529-0007; 82920-016; 0143-9385; 67184-0535; 70771-1713
UNII 776B62CQ27
Synonyms Decitabine | 5-Aza-2'-deoxycytidine | 5 Aza 2' deoxycytidine | 5-AzadC | AzadC Compound | Compound, AzadC | 5AzadC | 2'-Deoxy-5-azacytidine | 2' Deoxy 5 azacytidine | 5-Azadeoxycytidine | 5 Azadeoxycytidine | Dacogen | 5-Deoxyazacytidine | 5 Deoxyazacytidine | NSC 127716 | NSC-127716 | NSC127716 | Decitabine Mesylate | Mesylate, Decitabine
Chemical Information
Molecular Formula C8H12N4O4
CAS Registry Number 2353-33-5
SMILES C1C(C(OC1N2C=NC(=NC2=O)N)CO)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)
Upper gastrointestinal haemorrhage07.12.02.006; 24.07.02.0240.000112%
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection11.01.14.004; 20.08.02.001--
Urticaria23.04.02.001; 10.01.06.001--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Mental status changes19.07.01.0010.000112%Not Available
General physical health deterioration08.01.03.0180.000672%Not Available
Left ventricular dysfunction02.04.02.0110.000280%
Urethral haemorrhage24.07.03.006; 20.07.01.003--Not Available
Blood bilirubin decreased13.03.04.017--Not Available
Contusion15.03.05.007; 24.07.06.001; 23.03.11.002; 12.01.06.001--
Musculoskeletal chest pain22.09.01.001; 15.03.04.012--
Staphylococcal bacteraemia11.02.05.001--Not Available
Deep vein thrombosis24.01.02.0030.000280%Not Available
Post procedural haemorrhage24.07.01.014; 12.02.05.004--
Catheter site haemorrhage24.07.01.003; 12.07.02.002; 08.02.02.002--Not Available
Systemic inflammatory response syndrome08.01.05.005; 24.06.03.008; 10.02.01.0080.000280%Not Available
Malignant neoplasm progression16.16.01.0050.000392%Not Available
Acute coronary syndrome02.02.02.015; 24.04.04.011--Not Available
Catheter site erythema23.03.06.014; 12.07.02.003; 08.02.02.003--Not Available
Catheter site pain12.07.02.004; 08.02.02.004--Not Available
Lymphatic disorder01.09.01.003--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Injection site swelling08.02.03.017; 12.07.03.018--Not Available
Haemorrhage24.07.01.0020.000224%Not Available
Pulmonary mass22.02.07.004--Not Available
The 8th Page    First    Pre   8 9 10    Next   Last    Total 10 Pages
ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene