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)
Abdominal pain07.01.05.0020.009235%
Abdominal pain upper07.01.05.003--
Acidosis14.01.03.0020.001470%
Adrenal insufficiency14.11.01.004; 05.01.02.0010.000219%
Alopecia23.02.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angina unstable24.04.04.004; 02.02.02.0040.000219%Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Arrhythmia02.03.02.001--Not Available
Arteriosclerosis24.04.02.0010.000219%Not Available
Aspiration22.02.07.0070.000483%
Asthenia08.01.01.0010.009893%Not Available
Autoimmune hepatitis10.04.09.001; 09.01.07.019--Not Available
Back pain15.03.04.005--
Balanitis candida11.03.03.018; 21.09.03.005--Not Available
Balanoposthitis21.09.03.0010.001558%Not Available
Benign prostatic hyperplasia21.04.02.0010.000592%Not Available
Bladder cancer20.03.04.001; 16.08.01.0010.003510%Not Available
Bladder dilatation20.03.01.0070.000483%Not Available
Bladder neoplasm20.03.04.002; 16.08.03.0020.000592%Not Available
Bladder pain20.02.02.0010.001119%Not Available
Blister23.03.01.001; 12.01.06.002--Not Available
Blood creatinine increased13.13.01.004--
Blood pressure fluctuation24.06.01.002--Not Available
Blood urea increased13.13.01.006--Not Available
Carcinogenicity12.03.01.038--Not Available
Cardiac failure02.05.01.0010.005945%
Cardiac failure acute02.05.01.0050.000219%Not Available
Cardiomyopathy02.04.01.0010.000329%Not Available
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