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)
Haemodynamic instability24.03.02.0060.000168%-
Gastrointestinal hypomotility07.02.02.0050.000112%-
Catheter site erythema08.02.02.003; 12.07.02.003; 23.03.06.0140.000246%-
Lymphatic disorder01.09.01.003---
Large intestinal haemorrhage07.12.03.003; 24.07.02.0260.000168%
Drug tolerance decreased08.06.01.0240.000112%-
Perirectal abscess07.19.04.001; 11.01.07.005---
Musculoskeletal discomfort15.03.04.001---
Leukaemia cutis01.10.03.002; 16.01.03.002---
Inappropriate antidiuretic hormone secretion05.03.03.001; 14.05.07.0010.000336%-
Febrile bone marrow aplasia01.03.03.007; 08.05.02.0050.000504%-
Injection site swelling08.02.03.017; 12.07.03.018---
Cerebral haematoma17.08.01.014; 24.07.04.0060.000112%-
Nodule08.03.05.002---
Klebsiella sepsis11.02.03.002---
Haemorrhoidal haemorrhage07.15.03.002; 24.10.02.001--
Infusion site reaction08.02.05.005; 12.07.05.006---
Haemorrhage24.07.01.0020.002742%-
Haemorrhage urinary tract20.02.03.005; 24.07.01.0070.000168%-
Faecaloma07.01.03.0040.000504%-
Pulmonary mass22.02.07.0040.000112%-
Intra-abdominal haematoma07.12.02.005; 24.07.02.0340.000112%-
Pneumatosis intestinalis07.11.01.0430.000280%-
Toxic skin eruption10.01.01.008; 12.03.01.073; 23.03.05.0030.000168%-
Staphylococcal infection11.02.05.002---
Metabolic disorder14.11.01.0010.000168%-
Lung neoplasm malignant16.19.02.001; 22.08.01.0010.000504%-
Application site discolouration08.02.01.030; 12.07.01.030; 23.03.03.0230.000112%-
Gastrointestinal toxicity07.08.03.006; 12.03.01.0190.000694%-
Angiopathy24.03.02.007---
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ADReCS-Target
Drug Name ADR Term Target
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