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)
Autoimmune disorder10.04.04.0030.000746%
Diabetic nephropathy20.05.03.011; 14.07.02.003; 05.07.02.0030.000219%Not Available
Penile infection21.09.03.003; 11.01.19.002--
Genital pain21.10.01.0080.000483%Not Available
Renal impairment20.01.03.0100.009389%Not Available
Genital infection male21.09.03.006; 11.01.19.006--Not Available
Peripheral arterial occlusive disease24.04.03.0100.000658%Not Available
Urethritis noninfective20.07.02.0020.000746%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.001448%Not Available
Chronic kidney disease20.01.03.0170.001470%
Vulvovaginal mycotic infection21.14.02.004; 11.03.05.004--Not Available
Orthostatic hypertension24.08.02.010; 17.05.01.0180.000746%Not Available
Soft tissue necrosis24.04.02.007; 15.03.02.0020.000219%
Penile oedema21.12.01.0070.000483%Not Available
Genital discomfort21.10.01.0070.000483%Not Available
Liver injury12.01.17.012; 09.01.07.0220.000329%Not Available
Type 1 diabetes mellitus14.06.01.010; 10.04.08.007; 05.06.01.0100.000439%Not Available
Cholestatic liver injury09.01.07.0160.000219%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.003159%
Vulvovaginal pain21.08.02.0090.000219%
Acute kidney injury20.01.03.0160.007129%
Drug-induced liver injury12.03.01.044; 09.01.07.023--Not Available
Mouth swelling07.05.04.007; 23.04.01.020; 10.01.05.0200.000856%Not Available
Abnormal loss of weight14.03.02.0190.000219%Not Available
Bladder cancer recurrent20.03.04.005; 16.08.01.0030.000219%Not Available
Cardiac failure chronic02.05.01.0090.000219%Not Available
Dermatitis exfoliative generalised23.03.07.002; 10.01.01.0290.000219%Not Available
Overweight14.03.02.0210.000219%Not Available
Urinary bladder haemorrhage24.07.01.086; 20.03.01.0230.000219%Not Available
Genital erythema23.03.06.019; 21.10.01.0150.000702%Not Available
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