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)
Sudden death08.04.01.003; 02.03.04.0130.000112%
Supraventricular tachycardia02.03.03.0120.000448%
Swelling08.01.03.015--Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.002015%
Tachycardia02.03.02.007--Not Available
Tenderness08.01.08.0050.000168%Not Available
Therapeutic response decreased08.06.01.0160.000839%Not Available
Thrombocytopenia01.08.01.0020.010544%Not Available
Thrombocytopenic purpura23.06.01.007; 01.08.01.0030.000168%Not Available
Thrombocytosis01.08.02.0010.000560%Not Available
Thrombophlebitis24.01.02.0010.000112%Not Available
Tongue ulceration07.14.01.003--Not Available
Tonic convulsion17.12.03.0110.000112%Not Available
Toothache07.09.06.0010.000168%
Toxoplasmosis11.06.01.001--Not Available
Transfusion reaction01.05.01.005; 12.02.08.001; 10.02.04.001--Not Available
Transplant rejection12.02.05.022; 10.02.03.0020.000112%Not Available
Trismus17.01.03.004; 15.05.04.0040.000112%
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000616%
Ulcer08.03.06.0010.000112%Not Available
Upper gastrointestinal haemorrhage24.07.02.024; 07.12.02.0060.000280%
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary retention20.02.02.0110.000839%
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria10.01.06.001; 23.04.02.001--
Vascular purpura24.07.06.011; 23.06.01.008; 01.01.04.007--Not Available
Vasculitis24.12.04.027; 10.02.02.0060.000280%
Venous thrombosis24.01.01.0080.000168%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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