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)
Skin discolouration23.03.03.0050.002249%Not Available
Skin disorder23.03.03.007--Not Available
Skin fissures23.03.03.0080.000702%Not Available
Skin necrosis23.03.03.0110.000270%Not Available
Skin odour abnormal23.03.03.0120.001007%
Skin ulcer24.04.03.007; 23.07.03.0030.007610%
Sunburn23.03.09.007; 12.05.02.001--Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Testicular pain21.13.01.0050.000396%
Therapeutic response decreased08.06.01.016--Not Available
Therapeutic response increased08.06.01.0210.001223%Not Available
Therapeutic response unexpected08.06.01.0010.006386%Not Available
Thirst14.03.02.007; 08.01.09.0210.006009%Not Available
Toothache07.09.06.0010.000396%
Ulcer08.03.06.0010.000792%Not Available
Urethral disorder20.07.01.002--Not Available
Urinary incontinence20.02.02.010; 17.05.01.0080.002321%
Urinary retention20.02.02.0110.001385%
Urinary tract disorder20.08.01.0010.001403%Not Available
Urinary tract infection11.01.14.004; 20.08.02.001--
Urine abnormality20.02.01.0130.001403%Not Available
Urticaria10.01.06.001; 23.04.02.0010.011298%
Vaginal discharge21.08.02.0020.000486%
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Vaginal infection21.14.02.002; 11.01.10.002--
Varicose vein24.10.04.0010.000612%Not Available
Vasculitis24.12.04.027; 10.02.02.0060.000486%
Vomiting07.01.07.003--
Vulvitis21.14.02.006; 11.01.10.007--
Vulvovaginal candidiasis21.14.02.003; 11.03.03.005--Not Available
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