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 For treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of 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) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups (scores ≥0.5).
Marketing Status Prescription
ATC Code L01BC08
DrugBank ID DB01262
KEGG ID D03665
MeSH ID D000077209
PubChem ID 451668
TTD Drug ID D0X5XU
NDC Product Code 68001-422; 54245-7035; 55111-915; 51916-360; 69097-905; 43598-348; 0781-3296; 43598-427; 68180-738; 68083-528; 59148-046; 55111-556; 75834-190; 62756-503; 70860-219; 67184-0535; 69097-285; 50137-4147; 50742-430; 70121-1644; 63323-825; 72205-036; 70747-1005; 16729-224; 67457-316; 25021-231; 72205-031; 63759-0016; 71288-119; 66529-0007; 64679-067; 47335-361; 54893-0056; 76055-0018; 72603-107; 69539-115; 16714-928; 55150-376; 65129-1223
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Pre-eclampsiaSerpin B5P70564Not Available26389732
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Neoplasm progression16.16.02.0050.000139%Not Available
Pneumonia fungal22.07.08.002; 11.03.05.0080.000278%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.001598%
Serratia infection11.02.25.0010.000533%Not Available
Ill-defined disorder08.01.03.049--Not Available
Inner ear disorder04.04.02.002--Not Available
Blood disorder01.05.01.004--Not Available
Disease progression08.01.03.0380.000903%
Diverticular perforation07.04.04.0080.000139%Not Available
Hepatobiliary disease09.01.08.003--Not Available
Respiratory tract infection22.07.07.001; 11.01.08.0170.000533%Not Available
Device related infection11.01.08.018; 08.07.01.005--
Breath sounds abnormal13.15.01.008--Not Available
Procedural pain12.02.05.007; 08.01.08.009--Not Available
Skin abrasion23.03.11.018; 12.01.06.010--Not Available
Immune reconstitution inflammatory syndrome10.02.01.043; 08.06.02.0140.000533%Not Available
Bone marrow failure01.03.03.0050.003463%
Acute graft versus host disease10.02.01.028; 12.02.09.0020.000139%Not Available
Chronic graft versus host disease12.02.09.003; 10.02.01.0290.000278%Not Available
Cytopenia01.03.03.0120.000533%Not Available
Treatment failure08.06.01.0170.000278%Not Available
Liver injury12.01.02.003; 09.01.07.0220.000799%Not Available
Oral herpes11.05.02.005; 07.05.07.002--Not Available
Organising pneumonia22.01.02.0080.001598%Not Available
Oral disorder07.05.01.005--Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.0040.000533%
Acute kidney injury20.01.03.0160.002398%
Mycobacterium test13.08.05.003--Not Available
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