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 leukaemia01.10.03.004; 16.01.03.004; 17.02.10.0190.000224%-
Acute graft versus host disease in skin10.02.01.053; 12.02.09.022; 23.07.04.0200.000168%-
Acute graft versus host disease in liver09.01.07.030; 10.02.01.052; 12.02.09.0210.000112%-
Acute graft versus host disease in intestine07.11.01.019; 10.02.01.051; 12.02.09.0200.000224%-
Graft versus host disease in lung10.02.01.061; 12.02.09.030; 22.01.01.0210.000168%-
Acute lung injury22.01.03.0100.000112%-
Epstein-Barr virus associated lymphoma01.15.01.003; 11.05.10.007; 16.28.01.0030.000112%-
Chronic graft versus host disease in skin10.02.01.057; 12.02.09.025; 23.07.04.0220.000112%-
Graft versus host disease in gastrointestinal tract07.11.01.027; 10.02.01.059; 12.02.09.0280.000504%-
Internal haemorrhage24.07.01.0720.000224%-
Blastic plasmacytoid dendritic cell neoplasia01.12.01.004; 16.20.01.004; 23.07.04.0210.000168%-
Acute erythroid leukaemia01.10.05.006; 16.01.05.0060.000112%-
Acute megakaryocytic leukaemia01.10.05.007; 16.01.05.0070.000112%-
Administration site pain08.02.04.029; 12.07.04.0290.000112%-
Anaemic hypoxia01.03.02.017; 22.02.02.0140.000112%-
Autoimmune encephalopathy10.04.10.018; 17.13.02.0130.000112%-
Cardiac dysfunction02.11.01.0040.000336%-
Differentiation syndrome08.01.07.016; 12.03.01.063; 16.32.03.037; 22.02.01.0360.000783%-
Dilated cardiomyopathy02.04.01.017---
Haemophagocytic lymphohistiocytosis01.05.01.026; 10.02.01.077; 16.32.03.0380.000392%-
Hepatic cytolysis09.01.07.0360.000224%-
Hypersensitivity pneumonitis10.01.03.056; 22.01.01.0270.000112%-
Juvenile chronic myelomonocytic leukaemia01.10.07.005; 16.01.07.0050.000112%-
Lung opacity22.12.01.0060.000112%-
Malignant neoplasm of unknown primary site16.16.01.0190.000168%-
Myelodysplastic syndrome with excess blasts01.10.04.010; 16.01.04.0100.000112%-
Myelodysplastic syndrome with single lineage dysplasia01.10.04.013; 16.01.04.0130.000112%-
Myelosuppression01.03.03.0150.002071%-
Therapeutic product effective for unapproved indication08.06.01.056; 12.09.02.0040.000112%-
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ADReCS-Target
Drug Name ADR Term Target
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