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)
Muscle fatigue15.05.03.0060.000746%Not Available
Leukocyturia20.02.01.0140.000219%Not Available
Suprapubic pain08.01.08.0170.000746%Not Available
Photodermatosis23.03.09.0040.000746%Not Available
Fluid imbalance14.05.01.0030.000483%Not Available
Prostatomegaly21.04.01.0020.001119%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Cardiac flutter02.03.02.0120.000483%Not Available
Injection site swelling12.07.03.018; 08.02.03.0170.000746%Not Available
Genital burning sensation21.10.01.0050.000483%Not Available
Food craving19.09.01.010; 14.03.01.0090.000746%Not Available
Vulvovaginal pruritus23.03.12.009; 21.08.02.0040.001623%Not Available
Urine odour abnormal20.02.01.0200.000856%Not Available
Injection site nodule23.07.04.009; 12.07.03.034; 08.02.03.0340.000746%Not Available
Metabolic disorder14.11.01.0010.000219%Not Available
Dyslipidaemia14.08.04.015--Not Available
Angiopathy24.03.02.0070.000746%Not Available
Extremity necrosis24.04.03.0120.000439%Not Available
Urine output increased13.13.03.002--Not Available
Connective tissue disorder15.06.01.006; 10.04.04.026--Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000219%Not Available
Genital infection fungal21.10.03.003; 11.03.05.003--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Limb discomfort15.03.04.0140.000856%Not Available
Malnutrition14.03.02.004--Not Available
Perineal pain21.10.01.0030.000965%
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.0010.001338%
Renal injury20.01.03.015; 12.01.05.0010.000658%Not Available
Renal neoplasm20.01.04.004; 16.08.03.0010.000329%Not Available
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