ADReCS

Pharmaceutical Information

Drug Name	Azacitidine
Drug ID	BADD_D00194
Description	A pyrimidine nucleoside analogue that inhibits DNA methyltransferase, impairing DNA methylation. It is also an antimetabolite of cytidine, incorporated primarily into RNA. Azacytidine has been used as an antineoplastic agent.
Indications and Usage	For treatment of patients with the following French-American-British myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation (now classified as acute myelogenous leukemia with multilineage dysplasia), and chronic myelomonocytic leukemia.
Marketing Status	approved; investigational
ATC Code	L01BC07
DrugBank ID	DB00928
KEGG ID	D03021
MeSH ID	D001374
PubChem ID	9444
TTD Drug ID	D09FAZ
NDC Product Code	0781-9253; 14096-121; 81955-0012; 16729-306; 55150-393; 63323-771; 68001-527; 69097-368; 69097-805; 71288-153; 72485-201; 65129-1222; 68554-0104; 72606-558; 53183-4011; 43598-678; 59572-102; 51916-350; 83137-0006; 16714-927; 43817-906; 59572-730; 68001-504; 71288-115; 63660-0010; 0781-3253; 42385-312; 66529-0013; 54893-0029; 82920-015; 68001-313; 42385-719; 43598-305; 16714-578; 51991-797; 64679-096; 70121-1237; 63592-1800; 0143-9606; 43598-143; 43598-465; 59572-740
UNII	M801H13NRU
Synonyms	Azacitidine \| 5-Azacytidine \| 5 Azacytidine \| Azacytidine \| Vidaza \| NSC-102816 \| NSC 102816 \| NSC102816

Chemical Information

Molecular Formula	C8H12N4O5
CAS Registry Number	320-67-2
SMILES	C1=NC(=NC(=O)N1C2C(C(C(O2)CO)O)O)N
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)
Middle ear inflammation	04.05.01.006	0.000112%
Central nervous system leukaemia	17.02.10.019; 16.01.03.004; 01.10.03.004	0.000224%		Not Available
Acute graft versus host disease in skin	23.07.04.020; 12.02.09.022; 10.02.01.053	0.000168%		Not Available
Acute graft versus host disease in liver	10.02.01.052; 09.01.07.030; 12.02.09.021	0.000112%		Not Available
Acute graft versus host disease in intestine	12.02.09.020; 10.02.01.051; 07.11.01.019	0.000224%		Not Available
Graft versus host disease in lung	22.01.01.021; 12.02.09.030; 10.02.01.061	0.000168%		Not Available
Acute lung injury	22.01.03.010	0.000112%		Not Available
Epstein-Barr virus associated lymphoma	16.28.01.003; 11.05.10.007; 01.15.01.003	0.000112%		Not Available
Chronic graft versus host disease in skin	23.07.04.022; 12.02.09.025; 10.02.01.057	0.000112%		Not Available
Graft versus host disease in gastrointestinal tract	12.02.09.028; 10.02.01.059; 07.11.01.027	0.000504%		Not Available
Internal haemorrhage	24.07.01.072	0.000224%		Not Available
Blastic plasmacytoid dendritic cell neoplasia	23.07.04.021; 16.20.01.004; 01.12.01.004	0.000168%		Not Available
Acute erythroid leukaemia	16.01.05.006; 01.10.05.006	0.000112%		Not Available
Acute megakaryocytic leukaemia	16.01.05.007; 01.10.05.007	0.000112%		Not Available
Administration site pain	12.07.04.029; 08.02.04.029	0.000112%		Not Available
Anaemic hypoxia	22.02.02.014; 01.03.02.017	0.000112%		Not Available
Autoimmune encephalopathy	10.04.10.018; 17.13.02.013	0.000112%		Not Available
Cardiac dysfunction	02.11.01.004	0.000336%		Not Available
Differentiation syndrome	22.02.01.036; 16.32.03.037; 12.03.01.063; 08.01.07.016	0.000783%		Not Available
Dilated cardiomyopathy	02.04.01.017	-	-	Not Available
Haemophagocytic lymphohistiocytosis	10.02.01.077; 01.05.01.026; 16.32.03.038	0.000392%		Not Available
Hepatic cytolysis	09.01.07.036	0.000224%		Not Available
Hypersensitivity pneumonitis	22.01.01.027; 10.01.03.056	0.000112%		Not Available
Juvenile chronic myelomonocytic leukaemia	01.10.07.005; 16.01.07.005	0.000112%		Not Available
Lung opacity	22.12.01.006	0.000112%		Not Available
Malignant neoplasm of unknown primary site	16.16.01.019	0.000168%		Not Available
Myelodysplastic syndrome with excess blasts	16.01.04.010; 01.10.04.010	0.000112%		Not Available
Myelodysplastic syndrome with single lineage dysplasia	16.01.04.013; 01.10.04.013	0.000112%		Not Available
Myelosuppression	01.03.03.015	0.002071%		Not Available
Therapeutic product effective for unapproved indication	12.09.02.004; 08.06.01.056	0.000112%		Not Available

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