What the label lists and what reports show
Empagliflozin and metformin side effects
Empagliflozin and metformin's FDA label: “Most common adverse reactions associated with empagliflozin (5% or greater incidence) were urinary tract infections and female genital mycotic infections.” FAERS holds 3,459 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 nausea (241 reports).
- No generic listed
- Boxed warning
Check it at the source: the empagliflozin and metformin FDA label on DailyMed (effective August 11, 2026, Boehringer Ingelheim 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 SYNJARDY or SYNJARDY XR?SYNJARDY or SYNJARDY XR may cause serious side effects, including: See " What is the most important information I should know about SYNJARDY or SYNJARDY XR? " Low blood sugar (hypoglycemia). In adults, if you take SYNJARDY or SYNJARDY XR with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. In children 10 years of age and older, the risk for low blood sugar is higher with SYNJARDY even if you do not use another medicine that can also lower blood sugar. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take SYNJARDY or SYNJARDY XR. Signs and symptoms of low blood sugar may include: headache drowsiness weakness irritability hunger fast heartbeat confusion shaking or feeling jittery dizziness sweating Amputations. […]
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective August 11, 2026 (SPL set 8006ba29-ee3a-f852-a9bb-c8ec9b41cf66), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions associated with empagliflozin (5% or greater incidence) were urinary tract infections and female genital mycotic infections.
Table 2 Adverse Reactions Reported in ≥2% of Adults with Type 2 Diabetes Mellitus Treated with Empagliflozin and Greater than Placebo in Pooled Placebo-Controlled Clinical Trials of Empagliflozin Monotherapy or…
| Adverse Reactions | Placebo (%) N=995 | Empagliflozin 10 mg (%) N=999 | Empagliflozin 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 |
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: Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1) ] Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [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 [see Warnings and Precautions (5.5) ] Lower Limb Amputation [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Vitamin B 12 Deficiency [see Warnings and Precautions (5.8) ] Most common adverse reactions associated with empagliflozin (5% or greater incidence) were urinary tract infections and female genital mycotic infections. ( 6.1 ) Most common adverse reactions associated with metformin HCl (>5%) are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective August 11, 2026 (SPL set 8006ba29-ee3a-f852-a9bb-c8ec9b41cf66), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,459 reports list empagliflozin and metformin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 115 are coded as a death and 1,070 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. Of the 20 reactions below, 11 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?
- Empagliflozin and metformin: 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