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)
Thrombocytosis01.08.02.001--Not Available
Thrombophlebitis24.01.02.0010.000533%Not Available
Tongue ulceration07.14.01.003--Not Available
Tooth abscess07.09.01.003; 11.01.04.003--Not Available
Toothache07.09.06.001--
Transfusion reaction12.02.08.001; 10.02.04.001; 01.05.01.005--Not Available
Tremor17.01.06.002--
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000799%
Upper gastrointestinal haemorrhage24.07.02.024; 07.12.02.0060.000533%
Upper respiratory tract infection22.07.03.011; 11.01.13.0090.001332%
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.0040.000799%
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--
White blood cell count decreased13.01.06.0120.001332%
White blood cell count increased13.01.06.0130.002131%Not Available
Mental status changes19.07.01.0010.000533%Not Available
Anal abscess11.01.07.015; 07.19.04.0040.000799%Not Available
Neutropenic sepsis11.01.11.006; 01.02.03.0070.000347%Not Available
Left ventricular dysfunction02.04.02.0110.001332%
Urethral haemorrhage24.07.03.006; 20.07.01.003--Not Available
Excoriation12.01.06.007; 23.03.11.003--Not Available
Blood bilirubin decreased13.03.01.014--Not Available
Contusion24.07.06.001; 23.03.11.002; 15.03.01.008; 12.01.06.001--
Musculoskeletal chest pain15.03.04.012; 22.09.01.001--
Staphylococcal bacteraemia11.02.05.001--Not Available
Deep vein thrombosis24.01.02.0030.000799%Not Available
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