Short answer: In the label's pool of 12 adult type 2 diabetes trials, the most common Farxiga side effects were genital yeast infections in women (8.4% on 5 mg and 6.9% on 10 mg vs 1.5% on placebo), nasopharyngitis (6.6% and 6.3% vs 6.2%) and urinary tract infections (5.7% and 4.3% vs 3.7%). Farxiga has no boxed warning; ketoacidosis is its first listed serious risk.
What Farxiga is approved for: Farxiga is an SGLT2 inhibitor approved to lower the risk of kidney decline, end-stage kidney disease, cardiovascular death and heart failure hospitalization in adults with chronic kidney disease at risk of progression; to lower the risk of cardiovascular death, heart failure hospitalization and urgent heart failure visits in adults with heart failure; to lower the risk of heart failure hospitalization in adults with type 2 diabetes and heart disease or several heart risk factors; 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
FARXIGA (dapagliflozin) tablets, for oral use, prescribing information and Medication Guide. AstraZeneca. DailyMed, version published September 11, 2026. DailyMed setid 72ad22ae-efe6-4cd6-a302-98aaee423d69
No. The current Farxiga 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 Farxiga.
| Adverse reaction | Placebo N=1393 (%) | FARXIGA 5 mg N=1145 (%) | FARXIGA 10 mg N=1193 (%) |
|---|---|---|---|
| Female genital mycotic infections | 1.5 | 8.4 | 6.9 |
| Nasopharyngitis | 6.2 | 6.6 | 6.3 |
| Urinary tract infections | 3.7 | 5.7 | 4.3 |
| Back pain | 3.2 | 3.1 | 4.2 |
| Increased urination | 1.7 | 2.9 | 3.8 |
| Male genital mycotic infections | 0.3 | 2.8 | 2.7 |
| Nausea | 2.4 | 2.8 | 2.5 |
| Influenza | 2.3 | 2.7 | 2.3 |
| Dyslipidemia | 1.5 | 2.1 | 2.5 |
| Constipation | 1.5 | 2.2 | 1.9 |
| Discomfort with urination | 0.7 | 1.6 | 2.1 |
| Pain in extremity | 1.4 | 2.0 | 1.7 |
Pool of 12 placebo-controlled trials (12 to 24 weeks) in adults with type 2 diabetes; mean exposure 21 weeks. Female genital yeast infections are a percent of women (placebo 677, 5 mg 581, 10 mg 598); male genital yeast infections a percent of men (placebo 716, 5 mg 564, 10 mg 595). Urinary tract infections and increased urination are grouped terms.
| Trial (24 weeks) and measure | Placebo/Active Control | FARXIGA 5 mg | FARXIGA 10 mg |
|---|---|---|---|
| Monotherapy, severe | 0 | 0 | 0 |
| Monotherapy, glucose <54 mg/dL | 0 | 0 | 0 |
| Add-on to metformin, severe | 0 | 0 | 0 |
| Add-on to metformin, glucose <54 mg/dL | 0 | 0 | 0 |
| Add-on to glimepiride, severe | 0 | 0 | 0 |
| Add-on to glimepiride, glucose <54 mg/dL | 1 (0.7) | 3 (2.1) | 5 (3.3) |
| Add-on to metformin and a sulfonylurea, severe | 0 | - | 0 |
| Add-on to metformin and a sulfonylurea, glucose <54 mg/dL | 3 (2.8) | - | 7 (6.4) |
| Add-on to pioglitazone, severe | 0 | 0 | 0 |
| Add-on to pioglitazone, glucose <54 mg/dL | 0 | 1 (0.7) | 0 |
| Add-on to DPP4 inhibitor, severe | 0 | – | 1 (0.4) |
| Add-on to DPP4 inhibitor, glucose <54 mg/dL | 1 (0.4) | – | 1 (0.4) |
| Add-on to insulin with or without other oral diabetes drugs, severe | 1 (0.5) | 2 (0.9) | 2 (1.0) |
| Add-on to insulin with or without other oral diabetes drugs, glucose <54 mg/dL | 43 (21.8) | 55 (25.9) | 45 (23.0) |
Severe: severe impairment in consciousness or behavior needing someone else's help. Values are n (%). Group sizes: monotherapy 75/64/70; metformin 137/137/135; glimepiride 146/145/151; metformin and a sulfonylurea 109/-/109; pioglitazone 139/141/140; DPP4 inhibitor 226/-/225; insulin 197/212/196. A dash means that dose was not studied.
Genital yeast infections overall: 0.9% on placebo, 5.7% on 5 mg and 4.8% on 10 mg. With a past history of them: 10.0%, 23.1% and 25.0%. In the DECLARE trial, 0.9% on Farxiga stopped because of a genital yeast infection vs under 0.1% on placebo.
In the DECLARE trial of 17,143 adults, diabetic ketoacidosis was reported in 27 of 8,574 on Farxiga vs 12 of 8,569 on placebo, and severe low blood sugar in 0.7% vs 1.0%.
Fluid-loss side effects (dehydration, low blood pressure) in the 12-trial pool: 0.4% on placebo, 0.6% on 5 mg and 0.8% on 10 mg; in DECLARE, 2.4% vs 2.5% (Table 2).
Serious allergic reactions, severe skin reactions and angioedema: 0.3% on Farxiga vs 0.2% on comparators. At week 24, hematocrit above 55% was 1.3% on 10 mg vs 0.4% on placebo; LDL cholesterol changed +2.9% vs -1.0%.
Creatinine rises slightly and eGFR falls within about two weeks of starting, then stabilizes; in two trials the change reversed after stopping. No new side effects were found in the heart failure and kidney disease trials.
In a trial of adults with type 2 diabetes and eGFR 30 to under 60, 13 people on Farxiga had bone fractures vs none on placebo.
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, Farxiga greatly raises the risk of life-threatening diabetic ketoacidosis. Fatal ketoacidosis has been reported in type 2 diabetes with SGLT2 inhibitors, including Farxiga. Blood sugar may be 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, Farxiga is stopped.
Fluid loss and low blood pressure. Farxiga 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. Farxiga 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 several surgeries or causing death. Pain, redness or swelling of the genital area with fever or feeling unwell needs prompt evaluation.
Low blood sugar with insulin or sulfonylureas. Farxiga may raise the risk of low blood sugar when used with insulin or an insulin secretagogue such as a sulfonylurea, so a lower dose of those may be needed.
Who should not use it. People with a history of a serious allergic reaction to dapagliflozin or any ingredient in Farxiga. Anaphylaxis and angioedema have been reported.
Pregnancy and breastfeeding. Based on kidney effects in animals, Farxiga 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 Farxiga:
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.