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)
Pollakiuria20.02.02.007--
Protein total decreased13.09.01.004--Not Available
Pruritus23.03.12.001--
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pulmonary haemorrhage24.07.01.016; 22.02.04.0030.000208%
Pulmonary oedema22.01.03.003; 02.05.02.0030.000139%
Pyrexia08.05.02.0030.006660%
Rales22.02.04.004--Not Available
Rash23.03.13.001--Not Available
Rash papular23.03.13.0170.000799%Not Available
Rectal haemorrhage07.12.03.001; 24.07.02.0180.000533%
Renal failure20.01.03.0050.000347%Not Available
Respiratory arrest22.02.01.009--Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.001251%
Seizure17.12.03.001--
Sepsis11.01.11.0030.002363%
Septic shock24.06.02.011; 11.01.11.0040.000556%Not Available
Sinus congestion22.04.06.001--Not Available
Sinusitis11.01.13.005; 22.07.03.007--
Skin disorder23.03.03.007--Not Available
Skin lesion23.03.03.0100.000139%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Splenomegaly01.09.02.001--Not Available
Stomatitis07.05.06.005--
Sudden death08.04.01.003; 02.03.04.0130.000139%
Supraventricular tachycardia02.03.03.012--
Swelling face23.04.01.018; 10.01.05.018--Not Available
Tachycardia02.03.02.007--Not Available
Tenderness08.01.08.005--Not Available
Thrombocytopenia01.08.01.0020.003730%Not Available
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