Short answer: In pooled active-controlled trials of up to 52 weeks, the most common Glyxambi side effects were urinary tract infection (12.5% on 10 mg/5 mg and 11.4% on 25 mg/5 mg), upper respiratory infection (7.0% on both) and stuffy or runny nose (5.9% and 6.6%). These trials had no placebo group. Glyxambi has no boxed warning; its serious risks include ketoacidosis and pancreatitis.
What Glyxambi is approved for: Glyxambi combines empagliflozin, an SGLT2 inhibitor, with linagliptin, a DPP-4 inhibitor. It is approved, along with diet and exercise, to improve blood sugar control in adults with type 2 diabetes, and its empagliflozin part lowers the risk of heart death in adults with type 2 diabetes and established heart disease (section 1). It is not recommended for type 1 diabetes.
Source
GLYXAMBI (empagliflozin and linagliptin) tablets, for oral use, prescribing information and Medication Guide. Boehringer Ingelheim Pharmaceuticals. DailyMed, version published February 2, 2026. DailyMed setid ddbab689-f76c-488c-9613-4168d41dd730
No. The current Glyxambi 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 Glyxambi.
| Adverse reaction | GLYXAMBI 10 mg/5 mg (n=272) | GLYXAMBI 25 mg/5 mg (n=273) |
|---|---|---|
| Urinary tract infection | 12.5% | 11.4% |
| Nasopharyngitis | 5.9% | 6.6% |
| Upper respiratory tract infection | 7.0% | 7.0% |
Pooled active-controlled trials of up to 52 weeks, 1,363 patients in total; there was no placebo group. Urinary tract infection is a grouping that includes asymptomatic bacteriuria and cystitis. Nasopharyngitis means a stuffy or runny nose with sore throat.
| Add-on to metformin (52 weeks) | GLYXAMBI 10 mg/5 mg (n=136) | GLYXAMBI 25 mg/5 mg (n=137) |
|---|---|---|
| Overall | 2.2% | 3.6% |
| Severe | 0 | 0 |
Added to metformin, 52 weeks. Overall means a glucose of 70 mg/dL or less or needing help; severe means needing help regardless of glucose.
Empagliflozin vs placebo (10 mg, 25 mg, placebo): urinary tract infection 9.3%, 7.6% and 7.6%; female genital yeast infections 5.4%, 6.4% and 1.5%; increased urination 3.4%, 3.2% and 1.0%; male genital yeast infections 3.1%, 1.6% and 0.4%.
Linagliptin 5 mg vs placebo: stuffy or runny nose 7.0% vs 6.1%, diarrhea 3.3% vs 3.0%, and cough 2.1% vs 1.4%.
Pancreatitis in the linagliptin program: 15.2 cases per 10,000 patient-years on linagliptin vs 3.7 on comparator, plus three more cases after the last linagliptin dose.
Fluid-loss events (low blood pressure and fainting) were reported in 3 patients (1.1%) on Glyxambi plus metformin.
Lower limb amputation across four empagliflozin outcome trials: 4.3 vs 5.0 events per 1,000 patient-years on placebo vs empagliflozin.
Reported after approval, with frequency unknown: acute pancreatitis including fatal cases; constipation; mouth ulcers; allergic reactions including anaphylaxis and angioedema; Fournier's gangrene, urosepsis and kidney infection; ketoacidosis; rhabdomyolysis; severe joint pain; acute kidney injury; bullous pemphigoid; and rash or hives.
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. Ketoacidosis, which can be fatal, can happen even with blood sugar below 250 mg/dL. It is checked for whatever the blood sugar, and Glyxambi is stopped if it is suspected. It is not recommended in type 1 diabetes.
Pancreatitis. Acute pancreatitis, including fatal pancreatitis, has been reported. Glyxambi is stopped promptly if it is suspected.
Volume depletion. Empagliflozin can cause fluid loss and low blood pressure, especially with kidney problems, in older people or with loop diuretics. Fluid status and kidney function are checked before starting.
Urinary and genital infections, including Fournier's gangrene. Serious urinary infections, kidney infections, genital yeast infections and a rare serious genital-area infection (Fournier's gangrene) have been reported. Pain, redness or swelling in the genital area with fever is checked right away.
Low blood sugar with insulin or a sulfonylurea. A lower dose of insulin or a medicine that makes the body release insulin may be considered when starting Glyxambi.
Lower limb amputation. People are watched for infections or ulcers of the legs and feet, which are treated.
Allergic reactions. Serious allergic reactions such as anaphylaxis, angioedema and skin peeling conditions have occurred with empagliflozin and linagliptin. Glyxambi is stopped if one occurs.
Severe and disabling joint pain. Severe joint pain has been reported with linagliptin. It is considered as a possible cause, and the drug stopped if appropriate.
Bullous pemphigoid. A blistering skin condition needing hospital care has been reported. Glyxambi is stopped if it is suspected.
Heart failure. Heart failure was seen with two other DPP-4 inhibitors. Risks and benefits are weighed in people with heart failure risk factors, and they are watched for symptoms.
From the Medication Guide that comes with Glyxambi:
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.