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)
Erythema23.03.06.001--Not Available
Erythema multiforme23.03.01.003; 10.01.03.0150.000219%
Fasciitis15.03.03.0010.000219%Not Available
Feeling jittery08.01.09.0160.001865%Not Available
Flank pain20.02.03.006; 15.03.04.003; 08.01.08.0070.001601%
Food allergy10.01.01.0120.000746%Not Available
Fracture15.08.02.001; 12.04.02.001--
Fungal infection11.03.05.001--Not Available
Gallbladder disorder09.03.02.0010.000483%Not Available
Gastric ulcer07.04.03.0020.000483%
Gastrointestinal disorder07.11.01.001--Not Available
Genital candidiasis11.03.03.002; 21.10.03.001--Not Available
Genital rash23.03.13.016; 21.10.01.0090.003466%Not Available
Glycosuria20.02.01.0050.003905%
Gout15.01.06.001; 14.09.01.0010.000856%Not Available
Granuloma annulare23.03.15.0050.000746%Not Available
Groin pain15.03.02.0040.000483%Not Available
Haematocrit increased13.01.05.002--Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.0060.008775%
Headache17.14.01.001--
Hemiplegia17.01.04.0020.000219%Not Available
Hepatic cirrhosis09.01.04.0010.000329%Not Available
Hepatic function abnormal09.01.02.0010.001470%Not Available
Hepatitis09.01.07.0040.000548%Not Available
Hepatitis acute09.01.07.0050.000219%Not Available
Hunger14.03.02.012; 08.01.09.0030.000856%Not Available
Hyperglycaemia14.06.02.002; 05.06.02.0020.001733%
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperkalaemia14.05.03.0010.004409%
Hypernatraemia14.05.04.0010.001185%
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