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)
Myocarditis02.04.03.0010.000533%
Myositis15.05.01.0010.000533%
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neoplasm malignant16.16.01.001--Not Available
Nervous system disorder17.02.10.001--Not Available
Neuropathy peripheral17.09.03.0030.000533%Not Available
Neutropenia01.02.03.0040.006927%Not Available
Neutrophil count decreased13.01.06.0100.002131%
Night sweats23.02.03.006; 08.01.03.031--Not Available
Oedema14.05.06.010; 08.01.07.0060.000799%Not Available
Oedema peripheral08.01.07.007; 02.05.04.007; 14.05.06.0110.000799%
Oral candidiasis11.03.03.004; 07.05.07.001--Not Available
Oral pain07.05.03.002--
Osteonecrosis15.02.04.007; 24.04.05.0040.000533%
Otitis media11.01.05.004; 04.05.01.0010.000533%
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pallor23.03.03.031; 08.01.03.032; 24.03.04.001--Not Available
Palmar-plantar erythrodysaesthesia syndrome23.07.04.001; 17.02.07.0090.000533%
Pancytopenia01.03.03.0030.003197%Not Available
Pericardial effusion02.06.01.0020.001332%
Petechiae24.07.06.004; 23.06.01.003; 01.01.03.002--Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Phlebitis24.05.03.001; 12.02.01.0020.000533%
Platelet count decreased13.01.04.0010.002931%
Pleural effusion22.05.02.0020.002131%
Pneumonia22.07.01.003; 11.01.09.0030.012788%Not Available
Pneumonia respiratory syncytial viral22.07.05.005; 11.05.13.0020.000533%Not Available
Pneumonitis22.01.01.0060.001066%
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