Adverse Drug Reaction Classification System

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 inflammation04.05.01.0060.000112%
Central nervous system leukaemia17.02.10.019; 16.01.03.004; 01.10.03.0040.000224%Not Available
Acute graft versus host disease in skin23.07.04.020; 12.02.09.022; 10.02.01.0530.000168%Not Available
Acute graft versus host disease in liver10.02.01.052; 09.01.07.030; 12.02.09.0210.000112%Not Available
Acute graft versus host disease in intestine12.02.09.020; 10.02.01.051; 07.11.01.0190.000224%Not Available
Graft versus host disease in lung12.02.09.030; 10.02.01.061; 22.01.01.0210.000168%Not Available
Acute lung injury22.01.03.0100.000112%Not Available
Epstein-Barr virus associated lymphoma16.28.01.003; 11.05.10.007; 01.15.01.0030.000112%Not Available
Chronic graft versus host disease in skin23.07.04.022; 12.02.09.025; 10.02.01.0570.000112%Not Available
Graft versus host disease in gastrointestinal tract12.02.09.028; 10.02.01.059; 07.11.01.0270.000504%Not Available
Internal haemorrhage24.07.01.0720.000224%Not Available
Blastic plasmacytoid dendritic cell neoplasia01.12.01.004; 23.07.04.021; 16.20.01.0040.000168%Not Available
Acute erythroid leukaemia16.01.05.006; 01.10.05.0060.000112%Not Available
Acute megakaryocytic leukaemia16.01.05.007; 01.10.05.0070.000112%Not Available
Administration site pain08.02.04.029; 12.07.04.0290.000112%Not Available
Anaemic hypoxia22.02.02.014; 01.03.02.0170.000112%Not Available
Autoimmune encephalopathy17.13.02.013; 10.04.10.0180.000112%Not Available
Cardiac dysfunction02.11.01.0040.000336%Not Available
Differentiation syndrome22.02.01.036; 16.32.03.037; 12.03.01.063; 08.01.07.0160.000783%Not Available
Dilated cardiomyopathy02.04.01.017--Not Available
Haemophagocytic lymphohistiocytosis16.32.03.038; 10.02.01.077; 01.05.01.0260.000392%Not Available
Hepatic cytolysis09.01.07.0360.000224%Not Available
Hypersensitivity pneumonitis22.01.01.027; 10.01.03.0560.000112%Not Available
Juvenile chronic myelomonocytic leukaemia16.01.07.005; 01.10.07.0050.000112%Not Available
Lung opacity22.12.01.0060.000112%Not Available
Malignant neoplasm of unknown primary site16.16.01.0190.000168%Not Available
Myelodysplastic syndrome with excess blasts16.01.04.010; 01.10.04.0100.000112%Not Available
Myelodysplastic syndrome with single lineage dysplasia16.01.04.013; 01.10.04.0130.000112%Not Available
Myelosuppression01.03.03.0150.002071%Not Available
Therapeutic product effective for unapproved indication12.09.02.004; 08.06.01.0560.000112%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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