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)
Rash23.03.13.001---
Rash papular23.03.13.0170.000168%-
Rectal haemorrhage07.12.03.001; 24.07.02.0180.000112%
Renal failure20.01.03.0050.000280%-
Renal tubular necrosis20.01.07.0030.000112%-
Respiratory arrest22.02.01.009---
Respiratory failure14.01.04.003; 22.02.06.0020.001287%
Sepsis11.01.11.003--
Septic shock11.01.11.004; 24.06.02.011---
Sinus congestion22.04.06.001---
Sinusitis11.01.13.005; 22.07.03.007--
Skin disorder23.03.03.007---
Skin lesion23.03.03.0100.000112%-
Splenomegaly01.09.02.0010.000112%-
Stomatitis07.05.06.005--
Sudden death02.03.04.013; 08.04.01.0030.000168%
Supraventricular tachycardia02.03.03.012--
Swelling face08.01.03.100; 10.01.05.018; 23.04.01.018---
Tachycardia02.03.02.007---
Tenderness08.01.08.005---
Therapeutic response decreased08.06.01.0160.000224%-
Thrombocytopenia01.08.01.0020.001343%-
Thrombocytosis01.08.02.0010.000112%-
Thrombophlebitis24.01.02.0010.000112%-
Thrombotic microangiopathy01.01.02.006; 20.01.07.004; 24.01.01.0130.000224%-
Tongue ulceration07.14.01.003---
Tooth abscess07.09.01.003; 11.01.04.003---
Toothache07.09.06.001--
Transfusion reaction01.05.01.005; 10.02.04.001; 12.02.08.001---
Tumour lysis syndrome14.05.01.004; 16.32.03.0020.000168%
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ADReCS-Target
Drug Name ADR Term Target
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