Short answer: In the label's pooled adult type 2 diabetes trials, the most common Jardiance side effects were urinary tract infections (9.3% on 10 mg and 7.6% on 25 mg vs 7.6% on placebo) and genital yeast infections in women (5.4% and 6.4% vs 1.5%). More urination, upper respiratory infections and male yeast infections followed. Jardiance has no boxed warning; ketoacidosis is its first listed serious risk.
What Jardiance is approved for: Jardiance is an SGLT2 inhibitor approved to lower the risk of cardiovascular death and heart failure hospitalization in adults with heart failure; to lower the risk of kidney decline, end-stage kidney disease, cardiovascular death and hospitalization in adults with chronic kidney disease at risk of progression; to lower the risk of cardiovascular death in adults with type 2 diabetes and heart disease; and, with diet and exercise, to improve blood sugar in adults and children 10 and older with type 2 diabetes (section 1). It is not for blood sugar control in type 1 diabetes.
Source
JARDIANCE (empagliflozin tablets), for oral use, prescribing information and Medication Guide. Boehringer Ingelheim. DailyMed, version published February 2, 2026. DailyMed setid faf3dd6a-9cd0-39c2-0d2e-232cb3f67565
No. The current Jardiance 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 Jardiance.
| Adverse reaction | Placebo (%) N=995 | JARDIANCE 10 mg (%) N=999 | JARDIANCE 25 mg (%) N=977 |
|---|---|---|---|
| Urinary tract infection (a) | 7.6 | 9.3 | 7.6 |
| Female genital mycotic infections (b) | 1.5 | 5.4 | 6.4 |
| Upper respiratory tract infection | 3.8 | 3.1 | 4.0 |
| Increased urination (c) | 1.0 | 3.4 | 3.2 |
| Dyslipidemia | 3.4 | 3.9 | 2.9 |
| Arthralgia | 2.2 | 2.4 | 2.3 |
| Male genital mycotic infections (d) | 0.4 | 3.1 | 1.6 |
| Nausea | 1.4 | 2.3 | 1.1 |
Four 24-week placebo-controlled trials plus 18-week data from a trial with insulin; mean exposure about 23 weeks; hypoglycemia excluded. (a) Includes urinary tract infection, asymptomatic bacteriuria and cystitis. (b) Percent of women: placebo N=481, 10 mg N=443, 25 mg N=420. (c) Includes polyuria, pollakiuria and nocturia. (d) Percent of men: placebo N=514, 10 mg N=556, 25 mg N=557.
| Trial (length) and measure | Placebo | JARDIANCE 10 mg | JARDIANCE 25 mg |
|---|---|---|---|
| Monotherapy (24 weeks), overall (%) | 0.4 | 0.4 | 0.4 |
| Monotherapy (24 weeks), severe (%) | 0 | 0 | 0 |
| With metformin (24 weeks), overall (%) | 0.5 | 1.8 | 1.4 |
| With metformin (24 weeks), severe (%) | 0 | 0 | 0 |
| With metformin + sulfonylurea (24 weeks), overall (%) | 8.4 | 16.1 | 11.5 |
| With metformin + sulfonylurea (24 weeks), severe (%) | 0 | 0 | 0 |
| With pioglitazone +/- metformin (24 weeks), overall (%) | 1.8 | 1.2 | 2.4 |
| With pioglitazone +/- metformin (24 weeks), severe (%) | 0 | 0 | 0 |
| With basal insulin +/- metformin (18 weeks), overall (%) | 20.6 | 19.5 | 28.4 |
| With basal insulin +/- metformin (18 weeks), severe (%) | 0 | 0 | 1.3 |
| With MDI insulin +/- metformin (18 weeks), overall (%) | 37.2 | 39.8 | 41.3 |
| With MDI insulin +/- metformin (18 weeks), severe (%) | 0.5 | 0.5 | 0.5 |
Overall: glucose at or below 70 mg/dL. Severe: needing assistance regardless of glucose. Each trial had about 155 to 229 people per group (exact n per group is in the label). In the 18-week insulin trials, the insulin dose could not be adjusted.
Thirst was reported by 0% on placebo, 1.7% on 10 mg and 1.5% on 25 mg. Side effects linked to fluid loss (low blood pressure, dehydration, fainting) were 0.3%, 0.5% and 0.3%.
Genital yeast infections overall: 0.9% on placebo vs 4.1% on 10 mg and 3.7% on 25 mg. Urinary tract infections in women: 16.6%, 18.4% and 17.0%; in men: 3.2%, 3.6% and 4.1%.
In children 10 to 17, low blood sugar (under 54 mg/dL) occurred in 19.2% on Jardiance vs 7.5% on placebo, with no severe events.
LDL cholesterol rose 2.3% on placebo, 4.6% on 10 mg and 6.5% on 25 mg. Creatinine rises and eGFR falls within weeks of starting, then stabilizes, and the change reversed after stopping in an outcomes trial.
Across four outcome trials, lower limb amputations were 4.3 vs 5.0 per 1,000 patient-years on placebo vs Jardiance (HR 1.05). In the kidney disease trial, 2.9 vs 4.3 per 1,000 patient-years, mostly toe and mid-foot.
In people 75 and older, fluid-loss side effects were 2.1%, 2.3% and 4.4%, and urinary tract infections 10.5%, 15.7% and 15.1% (placebo, 10 mg, 25 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, Jardiance greatly raises the risk of life-threatening diabetic ketoacidosis, and fatal cases have occurred. Fatal ketoacidosis has also been reported in type 2 diabetes. Blood sugar may be lower than usual for ketoacidosis (under 250 mg/dL). Triggers include insulin cuts or missed insulin, fever, eating less, a ketogenic diet, surgery, fluid loss and heavy alcohol use. If suspected, Jardiance is stopped.
Fluid loss and low blood pressure. Jardiance 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. Fluid status and kidney function are checked before starting.
Genital and urinary infections, including Fournier's gangrene. Jardiance raises the risk of urinary tract and genital yeast infections. Serious infections, including kidney infection, urosepsis and necrotizing fasciitis of the perineum (Fournier's gangrene), have occurred, some needing surgery or causing death. Pain, redness or swelling of the genital area with fever or feeling unwell needs prompt evaluation.
Low blood sugar. Risk is higher in adults also taking insulin or a sulfonylurea, whose dose may be lowered, and in children 10 and older regardless of insulin.
Lower limb amputation. An imbalance in lower limb amputations has been seen with SGLT2 inhibitors. Risk was highest with a history of diabetic foot, peripheral artery disease or past amputation. The label stresses routine foot care and watching for new pain, sores or infection of the legs or feet.
Allergic reactions. Serious allergic reactions such as angioedema have been reported. Jardiance is stopped if one occurs, and it is contraindicated after a past allergy to empagliflozin (section 4).
Pregnancy and breastfeeding. Based on kidney effects in animals, Jardiance is not recommended in the second and third trimesters, and it is not recommended while breastfeeding (section 8.2).
From the Medication Guide that comes with Jardiance:
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.