Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dapagliflozin
Drug ID BADD_D00578
Description Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor indicated for managing diabetes mellitus type 2.[A6757] When combined with diet and exercise in adults, dapagliflozin helps to improve glycemic control by inhibiting glucose resorption in the proximal tubule of the nephron and causing glycosuria.[A6757] Dapagliflozin was approved by the FDA on Jan 08, 2014.[L6034]
Indications and Usage Dapagliflozin is indicated to improve glycemic control in adult patients with type 2 diabetes mellitus along with diet and exercise[Label,A6757,A6758].
Marketing Status approved
ATC Code A10BK01
DrugBank ID DB06292
KEGG ID D08897
MeSH ID C529054
PubChem ID 9887712
TTD Drug ID D01TNW
NDC Product Code 0310-8210; 12783-1428; 59651-135; 66064-1029; 69037-0027; 50090-3482; 12783-1427; 17228-6205; 59285-012; 75945-600; 55154-6933; 54921-620; 55111-987; 66529-0003; 0310-6205; 50193-1427; 14501-0028; 0310-6210; 66039-933; 54921-621; 65727-073; 55154-6932; 0310-8205; 17228-6210; 50090-3481
UNII 1ULL0QJ8UC
Synonyms dapagliflozin | (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol | Farxiga | Forxiga | 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol | BMS 512148 | BMS512148 | BMS-512148
Chemical Information
Molecular Formula C21H25ClO6
CAS Registry Number 461432-26-8
SMILES CCOC1=CC=C(C=C1)CC2=C(C=CC(=C2)C3C(C(C(C(O3)CO)O)O)O)Cl
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)
Cardiovascular disorder02.11.01.010; 24.03.02.0090.000548%-
Cerebral infarction17.08.01.004; 24.04.06.0020.001426%-
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Chest discomfort02.02.02.009; 08.01.08.019; 22.12.02.0020.002259%-
Cholecystitis09.03.01.0010.000219%
Chromaturia20.02.01.0020.001448%
Cold sweat08.01.03.024; 23.02.03.0020.000219%-
Colon cancer07.21.01.001; 16.13.01.0010.000439%-
Confusional state17.02.03.005; 19.13.01.001--
Constipation07.02.02.001--
Coronary artery disease02.02.01.001; 24.04.04.0060.000592%-
Cystitis haemorrhagic20.03.02.0030.000592%-
Death08.04.01.0010.031370%
Dehydration14.05.05.0010.011319%
Dermatitis23.03.04.0020.000439%-
Dermatitis allergic10.01.03.014; 23.03.04.0030.000219%-
Diabetes mellitus05.06.01.001; 14.06.01.0010.002435%-
Diabetes mellitus inadequate control05.06.01.004; 14.06.01.0040.003729%-
Diabetic hyperosmolar coma05.07.04.001; 14.07.04.001; 17.02.09.0030.000329%-
Diabetic ketoacidosis05.07.03.001; 14.07.03.0010.039157%-
Diabetic neuropathy05.07.04.003; 14.07.04.003; 17.09.04.0020.000219%-
Discomfort08.01.08.003---
Diverticulum intestinal07.10.01.002---
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.0070.029768%
Dizziness postural02.11.04.008; 17.02.05.004; 24.06.02.0080.000483%-
Drug eruption08.01.06.015; 10.01.01.005; 23.03.05.0010.000812%-
Dry mouth07.06.01.0020.003532%
Dysgeusia07.14.03.001; 17.02.07.003--
Dysuria20.02.02.0020.004146%
Electrolyte imbalance14.05.01.0020.000219%-
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