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)
Genital infection21.10.03.002; 11.01.08.011--Not Available
Peripheral swelling08.01.03.053; 02.05.04.015--Not Available
Localised oedema08.01.07.011; 02.05.04.006; 14.05.06.0090.000091%
Carotid artery occlusion24.04.06.008; 17.08.01.0120.000091%Not Available
Tachyarrhythmia02.03.02.0080.000091%Not Available
Muscle fatigue15.05.03.0060.000309%Not Available
Scrotal abscess21.09.03.008; 11.01.19.008--Not Available
Left ventricular dysfunction02.04.02.0110.000091%
Dry gangrene24.04.03.018; 23.06.06.0030.000091%Not Available
Penile discharge21.12.01.0050.000200%Not Available
Fluid imbalance14.05.01.0030.000200%Not Available
Systemic inflammatory response syndrome24.06.03.008; 10.02.01.008; 08.01.05.0050.000091%Not Available
Prostatomegaly21.04.01.0020.000400%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.0150.000137%Not Available
Metabolic syndrome14.06.02.007; 05.06.02.007; 24.08.02.0140.000200%Not Available
Epigastric discomfort07.01.02.0040.000200%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Secretion discharge08.01.03.0190.000309%Not Available
Nodule08.03.05.0020.000464%Not Available
Genital burning sensation21.10.01.0050.000555%Not Available
Scrotal erythema23.03.06.013; 21.12.02.0080.000091%Not Available
Postmenopausal haemorrhage24.07.03.002; 21.02.01.0020.000200%Not Available
Fluid intake reduced14.05.10.0010.000246%Not Available
Pulmonary mass22.02.07.0040.000246%Not Available
Asymptomatic bacteriuria20.02.01.028; 11.02.01.025--Not Available
Vulvovaginal pruritus23.03.12.009; 21.08.02.0040.002530%Not Available
Urine odour abnormal20.02.01.0200.001593%Not Available
Breast cancer female21.05.01.011; 16.10.01.0040.000091%Not Available
Dyslipidaemia14.08.04.015--Not Available
Genital tract inflammation21.10.03.0120.000182%Not Available
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