Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Canagliflozin
Drug ID BADD_D00344
Description Canagliflozin, also known as _Invokana_, is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used in the management of type 2 diabetes mellitus along with lifestyle changes including diet and exercise [FDA label]. It was initially approved by the FDA in 2013 for the management of diabetes and later approved in 2018 for a second indication of reducing the risk of cardiovascular events in patients diagnosed with type 2 diabetes mellitus [L5897], [FDA label]. Canagliflozin is the first oral antidiabetic drug approved for the prevention of cardiovascular events in patients with type 2 diabetes [L5897]. Cardiovascular disease is the most common cause of death in these patients [A177083].
Indications and Usage This drug is used in conjunction with diet and exercise to increase glycemic control in adults diagnosed with type 2 diabetes mellitus [FDA label]. Another indication for canagliflozin is the prevention of major cardiovascular events (myocardial infarction, stroke, or death due to a cardiovascular cause) in patients with type 2 diabetes, as well as hospitalization for heart failure in patients with type 2 diabetes[L5897,[L8917]. In addition to the above, canagliflozin can be used to lower the risk of end-stage kidney disease and major increases in serum creatinine and cardiovascular death for patients with a combination of type 2 diabetes mellitus, diabetic nephropathy, and albuminuria.[L8917] It is important to note that this drug is **not** indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis [FDA label].
Marketing Status approved
ATC Code A10BK02
DrugBank ID DB08907
KEGG ID D09592
MeSH ID D000068896
PubChem ID 24812758
TTD Drug ID D08DFX
NDC Product Code 55111-978; 50923-1216; 50090-4364; 12578-615; 59651-065; 17314-575; 50090-5029; 50090-5033; 12578-611; 14445-017; 42385-735; 70966-0001; 17314-577; 50090-5034; 55154-1425; 50458-140; 50458-141; 55154-1426
UNII 0SAC974Z85
Synonyms Canagliflozin | Invokana | Canagliflozin Hemihydrate | Canagliflozin, Anhydrous | 1-(Glucopyranosyl)-4-methyl-3-(5-(4-fluorophenyl)-2-thienylmethyl)benzene - T777973
Chemical Information
Molecular Formula C24H25FO5S
CAS Registry Number 842133-18-0
SMILES CC1=C(C=C(C=C1)C2C(C(C(C(O2)CO)O)O)O)CC3=CC=C(S3)C4=CC=C(C=C4)F
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)
Limb discomfort15.03.04.0140.001313%Not Available
Malnutrition14.03.02.004--Not Available
Vaginal disorder21.08.01.0050.001529%Not Available
Erectile dysfunction21.03.01.007; 19.08.04.0010.004336%
Renal injury20.01.03.015; 12.01.05.0010.000360%Not Available
Genital infection female21.14.04.003; 11.01.10.011--Not Available
Metabolic encephalopathy17.13.01.001; 14.11.01.0130.000180%Not Available
Urinary tract pain20.02.03.0130.000612%
Renal impairment20.01.03.0100.005415%Not Available
Unevaluable event08.01.03.0510.005469%Not Available
Genital infection male21.09.03.006; 11.01.19.006--Not Available
Peripheral arterial occlusive disease24.04.03.0100.000450%Not Available
Cystitis noninfective20.03.02.001--
Hypophagia07.01.06.010; 19.09.01.004; 14.03.01.0060.000630%Not Available
Non-high-density lipoprotein cholesterol increased13.12.01.017--Not Available
Skin haemorrhage24.07.01.103; 23.06.07.0010.000396%Not Available
Chronic kidney disease20.01.03.017--
Vulvovaginal mycotic infection21.14.02.004; 11.03.05.004--Not Available
Soft tissue necrosis24.04.02.007; 15.03.02.0020.000180%
Penile oedema21.12.01.0070.000612%Not Available
Type 1 diabetes mellitus05.06.01.010; 14.06.01.010; 10.04.08.0070.000180%Not Available
Vulvovaginal burning sensation21.08.02.0070.000612%Not Available
Vulvovaginal pain21.08.02.0090.000396%
Acute kidney injury20.01.03.0160.009175%
Abnormal loss of weight14.03.02.0190.002015%Not Available
Pancreatitis relapsing07.18.01.0110.000270%Not Available
Rash papulosquamous23.03.08.0140.000612%Not Available
Diabetic foot24.04.03.015; 23.07.03.008; 17.09.04.006; 14.07.06.001; 05.07.06.0010.005937%Not Available
Foot deformity15.10.03.0050.000666%Not Available
Penile erythema21.12.01.0170.001007%Not Available
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