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)
Swelling08.01.03.015---
Swollen tongue07.14.02.003; 10.01.05.015; 23.04.01.0140.002084%-
Syncope02.11.04.015; 17.02.04.008; 24.06.02.0120.005506%
Tachypnoea22.02.01.0140.000658%-
Testicular pain21.13.01.0050.000592%
Testicular swelling21.13.01.0030.000856%-
Thirst08.01.09.021; 14.03.02.0070.001821%-
Tremor17.01.06.002--
Ulcer08.03.06.0010.000812%-
Urethral disorder20.07.01.002---
Urinary incontinence17.05.01.008; 20.02.02.0100.001558%
Urinary retention20.02.02.0110.002698%
Urinary tract disorder20.08.01.001---
Urinary tract infection11.01.14.004; 20.08.02.001--
Urine abnormality20.02.01.0130.000483%-
Urine flow decreased20.02.02.0120.000483%-
Urticaria10.01.06.001; 23.04.02.001--
Vaginal infection11.01.10.002; 21.14.02.002--
Ventricular arrhythmia02.03.04.0060.000329%
Ventricular extrasystoles02.03.04.0070.000856%-
Vomiting07.01.07.003--
Vulval abscess11.01.10.013; 21.14.02.009---
Vulvitis11.01.10.007; 21.14.02.006--
Vulvovaginal candidiasis11.03.03.005; 21.14.02.003---
Vulvovaginal discomfort21.08.02.0050.000746%-
Vulvovaginitis11.01.10.003; 21.14.02.005---
Tubulointerstitial nephritis20.05.02.0020.000439%-
Bladder spasm20.02.02.0130.001492%
Chapped lips07.05.01.0040.000746%-
Osteopenia14.04.04.004; 15.02.03.003---
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