What the label lists and what reports show
Canagliflozin side effects
Canagliflozin's FDA label: “Most common adverse reactions (5% or greater incidence): female genital mycotic infections, urinary tract infection, and increased urination ( 6.1 ).” FAERS holds 29,747 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diabetic ketoacidosis (3,435 reports).
- No generic listed
Check it at the source: the canagliflozin FDA label on DailyMed (effective June 11, 2026, Janssen Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of INVOKANA?INVOKANA may cause serious side effects including: See " What is the most important information I should know about INVOKANA? " low blood sugar (hypoglycemia). If you take INVOKANA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take INVOKANA. Signs and symptoms of low blood sugar may include: headache confusion hunger shaking or feeling jittery drowsiness dizziness fast heartbeat weakness irritability sweating serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking INVOKANA and call your healthcare provider right away or go to the nearest hospital emergency room. See " Do not take INVOKANA if you: " . […]
Source: FDA drug label, Janssen Pharmaceuticals, Inc., effective June 11, 2026 (SPL set b9057d3b-b104-4f09-8a61-c61ef9d4a3f3), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (5% or greater incidence): female genital mycotic infections, urinary tract infection, and increased urination ( 6.1 ).
Table 2: Adverse Reactions from Pool of Four 26–Week Placebo-Controlled Trials Reported in ≥ 2% of INVOKANA-Treated Adult Patients The four placebo-controlled trials included one monotherapy trial and three add-on…
| Adverse Reaction | Placebo N=646 | INVOKANA 100 mg N=833 | INVOKANA 300 mg N=834 |
|---|---|---|---|
| Urinary tract infections Urinary tract infections include the following adverse… | 3.8% | 5.9% | 4.4% |
| Increased urination Increased urination includes the following adverse reactions:… | 0.7% | 5.1% | 4.6% |
| Thirst Thirst includes the following adverse reactions: Thirst, Dry mouth, and Polydipsia. | 0.1% | 2.8% | 2.4% |
| Constipation | 0.9% | 1.8% | 2.4% |
| Nausea | 1.6% | 2.1% | 2.3% |
| Female genital mycotic infections Female genital mycotic infections include the following… | 2.8% | 10.6% | 11.6% |
| Vulvovaginal pruritus | 0.0% | 1.6% | 3.2% |
| Male genital mycotic infections Male genital mycotic infections include the following… | 0.7% | 4.2% | 3.8% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following important adverse reactions are described below and elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes and Other Ketoacidosis [see Warnings and Precautions (5.1) ] Lower Limb Amputation [see Warnings and Precautions (5.2) ] Volume Depletion [see Warnings and Precautions (5.3) ] Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), and Genital Mycotic Infections [see Warnings and Precautions (5.4) ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.5) ] Hypersensitivity Reactions [see Warnings and Precautions (5.6) ] Bone Fracture [see Warnings and Precautions (5.7) ] Most common adverse reactions (5% or greater incidence): female genital mycotic infections, urinary tract infection, and increased urination ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. …
Source: FDA drug label, Janssen Pharmaceuticals, Inc., effective June 11, 2026 (SPL set b9057d3b-b104-4f09-8a61-c61ef9d4a3f3), via openFDA; the full label on DailyMed
What do FAERS reports show?
29,747 reports list canagliflozin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 685 are coded as a death and 10,711 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2018 (4,643, against a median of 824 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 23 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Canagliflozin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions