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. It is also indicated to reduce the risk of cardiovascular death in adult patients with both type 2 diabetes mellitus and established cardiovascular disease.[L13688] Empagliflozin is also available as a combination product with either metformin[L13679] and linagliptin[L13673] as an adjunct to diet and exercise in the management of type 2 diabetes mellitus in adults. An extended-release combination product containing empagliflozin, metformin, and linagliptin was approved by the FDA in January 2020 for the improvement of glycemic control in adults with type 2 diabetes mellitus when used adjunctively with diet and exercise.[L11479] Empagliflozin is also approved to reduce the risk of cardiovascular mortality and hospitalization in adults with heart failure with reduced ejection fraction[L13688] regardless of whether or not the patient has concomitant diabetes. Empagliflozin is not approved for use in patients with type 1 diabetes.
Marketing Status approved
ATC Code A10BK03
DrugBank ID DB09038
KEGG ID D10459
MeSH ID C570240
PubChem ID 11949646
TTD Drug ID D06ALD
NDC Product Code 42765-016; 69037-0029; 69766-052; 76072-1015; 49629-033; 64220-203; 69766-036; 70518-2447; 82891-005; 50090-4384; 50090-4492; 51869-0015; 65727-085; 71796-048; 50090-6457; 0597-0153; 67835-0024; 50090-6452; 59651-179; 55154-0411; 0597-0152; 12714-201; 49629-034; 71796-001; 55154-0412; 71610-177; 71901-608; 73309-389
UNII HDC1R2M35U
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
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)
Abdominal pain07.01.05.0020.006034%
Abnormal faeces07.01.03.0010.000309%Not Available
Acetonaemia14.01.01.0120.000291%Not Available
Acidosis14.01.03.0020.002484%
Acute myocardial infarction24.04.04.001; 02.02.02.0010.001383%Not Available
Albuminuria20.02.01.0010.000309%Not Available
Alcohol abuse19.07.06.0010.000137%Not Available
Altered state of consciousness19.07.01.003; 17.02.04.0010.000501%Not Available
Amnesia19.20.01.001; 17.03.02.001--
Angina pectoris24.04.04.002; 02.02.02.0020.000673%
Angina unstable24.04.04.004; 02.02.02.0040.000091%Not Available
Aortic valve stenosis02.07.03.0040.000137%Not Available
Aphonia17.02.08.009; 22.12.03.001; 19.19.01.0020.000200%
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.0050.005988%
Balanitis candida21.09.03.005; 11.03.03.018--Not Available
Balanoposthitis21.09.03.0010.002257%Not Available
Benign prostatic hyperplasia21.04.02.0010.000646%Not Available
Bladder cancer20.03.04.001; 16.08.01.0010.001138%Not Available
Bladder discomfort20.02.02.0190.000200%Not Available
Bladder irritation20.02.02.020--Not Available
Bladder neoplasm20.03.04.002; 16.08.03.0020.000228%Not Available
Bladder pain20.02.02.0010.000309%Not Available
Blood creatinine increased13.13.01.004--
Blood pressure ambulatory decreased13.14.03.017--Not Available
Blood pressure systolic decreased13.14.03.007--Not Available
Bradycardia02.03.02.002--Not Available
Calculus urinary20.04.03.0020.000246%Not Available
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