Short answer: In four pooled 26-week placebo-controlled trials, the most common Invokana side effects were genital yeast infections in women (10.6% on 100 mg and 11.6% on 300 mg vs 2.8% on placebo), urinary tract infections (5.9% and 4.4% vs 3.8%) and increased urination (5.1% and 4.6% vs 0.7%). Invokana has no boxed warning; its serious risks include ketoacidosis and lower limb amputation.
What Invokana is approved for: Invokana is an SGLT2 inhibitor approved, with diet and exercise, to improve blood sugar in adults and children 10 and older with type 2 diabetes; to lower the risk of major heart events in adults with type 2 diabetes and heart disease; and to lower the risk of end-stage kidney disease, doubling of creatinine, cardiovascular death and heart failure hospitalization in adults with type 2 diabetes and diabetic kidney disease with albuminuria over 300 mg/day (section 1).
Source
INVOKANA (canagliflozin) tablets, for oral use, prescribing information and Medication Guide. Janssen Pharmaceuticals. DailyMed, version published June 15, 2026. DailyMed setid b9057d3b-b104-4f09-8a61-c61ef9d4a3f3
No. The current Invokana label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Invokana.
| Adverse reaction | Placebo N=646 | INVOKANA 100 mg N=833 | INVOKANA 300 mg N=834 |
|---|---|---|---|
| Urinary tract infections | 3.8% | 5.9% | 4.4% |
| Increased urination | 0.7% | 5.1% | 4.6% |
| Thirst | 0.1% | 2.8% | 2.4% |
| Constipation | 0.9% | 1.8% | 2.4% |
| Nausea | 1.6% | 2.1% | 2.3% |
| Female genital mycotic infections | 2.8% | 10.6% | 11.6% |
| Vulvovaginal pruritus | 0.0% | 1.6% | 3.2% |
| Male genital mycotic infections | 0.7% | 4.2% | 3.8% |
One trial of Invokana alone and three add-on trials (with metformin, metformin and a sulfonylurea, or metformin and pioglitazone). Percentages were weighted by study. Urinary tract infections include cystitis, kidney infection and urosepsis. Increased urination includes needing to go more often, urgency and at night. Female rows: women only (N=312, 425, 430). Male row: men only (N=334, 408, 404).
| Measure | Placebo N=1,441 | INVOKANA 100 mg N=1,445 | INVOKANA 300 mg N=1,441 | INVOKANA (Pooled) N=2,886 |
|---|---|---|---|---|
| Patients with an amputation, n (%) | 22 (1.5) | 50 (3.5) | 45 (3.1) | 95 (3.3) |
| Total amputations | 33 | 83 | 79 | 162 |
| Amputation incidence rate (per 1,000 patient-years) | 2.8 | 6.2 | 5.5 | 5.9 |
| Hazard Ratio (95% CI) | -- | 2.24 (1.36, 3.69) | 2.01 (1.20, 3.34) | 2.12 (1.34, 3.38) |
Mean follow-up 5.7 years. Incidence counts people with at least one amputation; some had more than one. In CANVAS-R (Table 4), the rate was 7.5 vs 4.2 per 1,000 patient-years (HR 1.80).
| Baseline characteristic | Comparator group % | INVOKANA 100 mg % | INVOKANA 300 mg % |
|---|---|---|---|
| Overall population | 1.5% | 2.3% | 3.4% |
| 75 years of age and older | 2.6% | 4.9% | 8.7% |
| eGFR less than 60 mL/min/1.73 m2 | 2.5% | 4.7% | 8.1% |
| Use of loop diuretic | 4.7% | 3.2% | 8.8% |
Volume depletion means fluid loss: low blood pressure, dizziness on standing, fainting or dehydration. The comparator group includes placebo and active comparators. People could have more than one risk factor.
Low blood sugar with insulin (18 weeks): 49.3% on 100 mg and 48.6% on 300 mg vs 36.8% on placebo. With metformin and a sulfonylurea: 27.4% and 30.1% vs 15.4%. Alone: 3.6% and 3.0% vs 2.6% (Table 6).
Bone fractures in CANVAS: 1.09, 1.59 and 1.79 per 100 patient-years on placebo, 100 mg and 300 mg, starting within the first 26 weeks and mostly low-trauma fractures of the hands, arms, feet and legs.
Falls over a mean 85 weeks: 1.3% on comparator, 1.5% on 100 mg and 2.1% on 300 mg, with the higher risk in the first few weeks.
In the CREDENCE kidney trial, amputations were 12.3 vs 11.2 per 1,000 patient-years and low blood pressure 2.8% vs 1.5% (Invokana 100 mg vs placebo).
LDL cholesterol rose 4.5% on 100 mg and 8.0% on 300 mg vs placebo. Abdominal pain was 1.8% and 1.7% vs 0.8%. Men with yeast infections had recurrences in 22% vs none on placebo.
With moderate kidney impairment, potassium rose above 5.4 mEq/L and 15% over baseline in 5.3% on placebo, 5.0% on 100 mg and 8.8% on 300 mg.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Ketoacidosis. In type 1 diabetes, Invokana greatly raises the risk of life-threatening diabetic ketoacidosis. Fatal cases have also been reported in type 2 diabetes. Blood sugar may be lower than usual for ketoacidosis (under 250 mg/dL), and it can last longer than expected, up to 2 weeks after stopping. Invokana is stopped if ketoacidosis is suspected.
Lower limb amputation. Amputations were more common on Invokana than placebo in CANVAS and CANVAS-R, mostly toe and mid-foot, but also above and below the knee. Risk was highest with past amputation, peripheral vascular disease or nerve damage. The label stresses routine foot care.
Fluid loss. Invokana can lower blood volume, causing low blood pressure or short-term creatinine changes, and acute kidney injury has been reported. Risk is higher with eGFR under 60, in older people and with loop diuretics, and fluid status is corrected before starting.
Genital and urinary infections, including Fournier's gangrene. Invokana raises the risk of urinary and genital yeast infections. Serious infections, including urosepsis, kidney infection and necrotizing fasciitis of the perineum (Fournier's gangrene), have occurred, some leading to several surgeries or death.
Low blood sugar with insulin or a sulfonylurea. The risk of low blood sugar rises with insulin or a sulfonylurea, and a lower dose of those medicines may reduce it.
Allergic reactions. Angioedema and anaphylaxis have been reported, usually within hours to days of starting. Invokana is stopped if one occurs.
Bone fracture. A higher risk of fracture, starting as early as 12 weeks, was seen in CANVAS. Fracture risk factors are considered before starting.
From the Medication Guide that comes with Invokana:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.