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)
Gastroenteritis viral11.05.04.005; 07.19.03.005--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal infection11.01.07.012; 07.19.02.0050.001872%Not Available
Genital candidiasis21.10.03.001; 11.03.03.0020.000749%Not Available
Genital herpes21.10.03.008; 11.05.02.0120.000749%Not Available
Genital rash23.03.13.016; 21.10.01.0090.003369%Not Available
Genital ulceration23.07.03.004; 21.10.05.0010.000749%Not Available
Gingival bleeding24.07.02.010; 07.09.07.001--Not Available
Gingival pain07.09.04.0010.000749%
Glomerular filtration rate decreased13.13.01.0090.008235%Not Available
Glossodynia07.14.02.0010.000749%Not Available
Glycosuria20.02.01.0050.001872%
Glucose urine present13.13.02.0010.000749%Not Available
Glycosylated haemoglobin decreased13.02.02.0120.001497%Not Available
Glycosylated haemoglobin increased13.02.02.0050.011229%Not Available
Gout15.01.06.001; 14.09.01.0010.001872%Not Available
Groin pain15.03.02.0040.000749%Not Available
Haematocrit decreased13.01.05.001--Not Available
Haematocrit increased13.01.05.0020.002620%Not Available
Haematuria24.07.01.047; 20.02.01.0060.011604%
Blood urine present13.13.02.0020.002246%Not Available
Haemoglobin abnormal13.01.05.0110.000749%Not Available
Haemoglobin increased13.01.05.0040.002620%
Haemolytic anaemia01.06.03.002--Not Available
Hallucination19.10.02.002--
Hand fracture15.08.03.014; 12.04.01.0140.000749%Not Available
Headache17.14.01.001--
Heart rate increased13.14.04.002--Not Available
Heart rate irregular13.14.04.003--Not Available
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