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 Canagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Use in type 1 diabetes mellitus patients or in treatment of diabetic ketoacidosis is not recommended.
Marketing Status Prescription
ATC Code A10BK02
DrugBank ID DB08907
KEGG ID D09592
MeSH ID D000068896
PubChem ID 24812758
TTD Drug ID D08DFX
NDC Product Code 50090-5034; 55154-1425; 50090-5029; 70966-0001; 12578-615; 50923-1216; 50458-141; 55111-978; 50458-140; 42385-735; 17314-575; 59651-065; 50090-4364; 46708-886; 14445-017; 17314-577; 12578-611; 55154-1426; 50090-5033
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
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)
Penile oedema21.12.01.0070.000766%Not Available
Liver injury12.01.02.003; 09.01.07.022--Not Available
Oral herpes11.05.02.005; 07.05.07.002--Not Available
Type 1 diabetes mellitus10.04.08.007; 14.06.01.010; 05.06.01.0100.000766%Not Available
Vulvovaginal burning sensation21.08.02.0070.000766%Not Available
Creatinine renal clearance abnormal13.13.01.0160.002681%Not Available
Vulvovaginal pain21.08.02.0090.000766%
Acute kidney injury20.01.03.0160.035615%
Hepatic cancer16.07.02.004; 09.04.02.008--Not Available
Candida infection11.03.03.0210.007276%
Abnormal loss of weight14.03.02.0190.003064%Not Available
Anion gap13.02.01.0180.000200%Not Available
Colonoscopy13.05.05.0040.000766%Not Available
Glomerular filtration rate abnormal13.13.01.0220.000766%Not Available
Glomerular filtration rate increased13.13.01.0290.001915%Not Available
Osteomyelitis acute15.02.05.008; 11.01.01.0080.008042%Not Available
Osteomyelitis chronic15.02.05.010; 11.01.01.0090.003830%Not Available
Rash papulosquamous23.03.08.0140.000766%Not Available
Tibia fracture15.08.03.016; 12.04.01.0160.000766%Not Available
Diabetic ulcer24.04.03.020; 14.07.06.004; 23.07.03.014; 05.07.06.0040.003064%Not Available
Urine alcohol test positive13.17.02.0150.000766%Not Available
Blood ketone body13.02.04.0080.001149%Not Available
Blood ketone body increased13.02.04.0090.004213%Not Available
Urine ketone body13.02.04.0140.000766%Not Available
Diabetic foot14.07.06.001; 05.07.06.001; 24.04.03.015; 23.07.03.008; 17.09.04.0060.015318%Not Available
Escherichia infection11.02.10.0040.001532%Not Available
Foot deformity15.10.03.0050.001915%Not Available
Penis injury21.12.01.021; 12.01.15.0060.000766%Not Available
Penile erythema21.12.01.0170.001532%Not Available
Penile burning sensation21.12.01.0150.001149%Not Available
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