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)
Diffuse large B-cell lymphoma16.28.02.001; 01.15.02.0010.000224%Not Available
Discomfort08.01.08.003--Not Available
Disseminated intravascular coagulation01.01.02.002; 24.01.01.0100.000112%
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Drug hypersensitivity10.01.01.001--Not Available
Drug ineffective08.06.01.0060.001903%Not Available
Dry skin23.03.03.001--
Dyspepsia07.01.02.001--
Dysphagia07.01.06.003--
Dyspnoea02.11.05.003; 22.02.01.004--
Dysuria20.02.02.002--
Ear disorder04.03.01.001--Not Available
Ear pain04.03.01.003--
Ecchymosis24.07.06.002; 23.06.01.001; 01.01.03.001--Not Available
Epistaxis24.07.01.005; 22.04.03.0010.000392%
Erythema23.03.06.001--Not Available
Extravasation08.01.03.0080.000560%Not Available
Eye disorder06.08.03.001--Not Available
Failure to thrive19.07.05.001; 18.04.01.003; 14.03.02.0080.000112%Not Available
Fall12.01.08.002--
Fatigue08.01.01.002--
Febrile neutropenia08.05.02.004; 01.02.03.0020.003100%
Feeling abnormal08.01.09.014--Not Available
Fungal infection11.03.05.001--Not Available
Gastric haemorrhage24.07.02.007; 07.12.01.0010.000112%
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.000336%Not Available
Gastrointestinal pain07.01.05.005--
Gingival bleeding07.09.07.001; 24.07.02.010--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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