Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Empagliflozin
Drug ID BADD_D00765
Description Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for the reabsorption of glucose in the kidney.[A203453] It is used clinically as an adjunct to diet and exercise, often in combination with other drug therapies,[L13673,L13679,L11479] for the management of type 2 diabetes mellitus.[L13688] The first known inhibitor of SGLTs, phlorizin, was isolated from the bark of apple trees in 1835 and researched extensively into the 20th century, but was ultimately deemed inappropriate for clinical use given its lack of specificity and significant gastrointestinal side effects.[A203501] Attempts at overcoming these limitations first saw the development of O-glucoside analogs of phlorizin (e.g. [remogliflozin etabonate]), but these molecules proved relatively pharmacokinetically unstable. The development of C-glucoside phlorizin analogs remedied the issues observed in the previous generation, and led to the FDA approval of [canagliflozin] in 2013 and both [dapagliflozin] and empagliflozin in 2014.[A203501] As the most recently approved of the "flozin" drugs, empagliflozin carries the highest selectivity for SGLT2 over SGLT1 (approximately 2700-fold).
Indications and Usage Empagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes.
Marketing Status Prescription
ATC Code A10BK03
DrugBank ID DB09038
KEGG ID D10459
MeSH ID C570240
PubChem ID 11949646
TTD Drug ID D06ALD
NDC Product Code 12714-201; 71796-001; 65727-085; 49629-033; 76072-1015; 0597-0152; 49629-034; 62756-159; 0597-0153; 55154-0412; 71610-177; 50090-4384; 59651-179; 50090-4492; 70518-2447; 46708-903; 42765-016; 67835-0024; 55154-0411; 69766-036; 69037-0029; 69766-052; 70518-1986
Synonyms empagliflozin | 1-chloro-4-(glucopyranos-1-yl)-2-(4-(tetrahydrofuran-3-yloxy)benzyl)benzene | BI 10773 | BI10773 | BI-10773 | Jardiance
Chemical Information
Molecular Formula C23H27ClO7
CAS Registry Number 864070-44-0
SMILES C1COCC1OC2=CC=C(C=C2)CC3=C(C=CC(=C3)C4C(C(C(C(O4)CO)O)O)O)Cl
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Penile infection21.09.03.003; 11.01.19.002--
Genital infection female11.01.10.011; 21.14.04.0030.000749%Not Available
Genital lesion21.10.05.0040.000749%Not Available
Pigmentation disorder23.05.03.0010.000749%Not Available
Vaginitis bacterial11.02.01.020; 21.14.02.010--Not Available
Renal impairment20.01.03.0100.009358%Not Available
Sinus disorder22.04.06.002--
Respiratory tract infection22.07.07.001; 11.01.08.017--Not Available
Unevaluable event08.01.03.051--Not Available
Genital infection male21.09.03.006; 11.01.19.006--Not Available
Peripheral arterial occlusive disease24.04.03.0100.000749%Not Available
Cystitis noninfective20.03.02.001--
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.003743%Not Available
Chronic kidney disease20.01.03.0170.002994%
Vulvovaginal mycotic infection21.14.02.004; 11.03.05.0040.003369%Not Available
Urogenital infection fungal11.03.05.019; 21.10.03.014; 20.08.02.011--Not Available
Soft tissue necrosis24.04.02.007; 15.03.02.0020.000749%
Genital discomfort21.10.01.0070.002246%Not Available
Type 1 diabetes mellitus14.06.01.010; 10.04.08.007; 05.06.01.0100.000749%Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.004--
Acute kidney injury20.01.03.0160.023956%
Drug-induced liver injury12.03.01.044; 09.01.07.023--Not Available
Candida infection11.03.03.0210.005240%
Abnormal loss of weight14.03.02.0190.002620%Not Available
Bacterial vaginosis21.14.02.012; 11.02.01.0260.000749%Not Available
Colonoscopy13.05.05.0040.000749%Not Available
Glomerular filtration rate abnormal13.13.01.0220.001872%Not Available
Glycosylated haemoglobin13.02.02.0130.002246%Not Available
Lichen sclerosus23.03.08.006; 21.10.03.0100.001872%Not Available
Pancreatitis relapsing07.18.01.0110.001497%Not Available
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