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What the label lists and what reports show

Empagliflozin and linagliptin and metformin side effects

Empagliflozin and linagliptin and metformin's FDA label: “Most common adverse reactions (5% or greater incidence) were upper respiratory tract infection, urinary tract infection, nasopharyngitis, diarrhea, constipation, headache, and gastroenteritis.” FAERS holds 118 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 blood glucose increased (19 reports).

  • No generic listed
  • Boxed warning

Check it at the source: the empagliflozin and linagliptin and metformin FDA label on DailyMed (effective August 24, 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 TRIJARDY XR?

TRIJARDY XR may cause serious side effects, including: See " What is the most important information I should know about TRIJARDY XR? " Low blood sugar (hypoglycemia). If you take TRIJARDY 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. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take TRIJARDY 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. SGLT2 inhibitors may increase your risk of lower limb amputations. […]

Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective August 24, 2026 (SPL set 71873567-9594-452a-bb92-34a129adecac), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reactions (5% or greater incidence) were upper respiratory tract infection, urinary tract infection, nasopharyngitis, diarrhea, constipation, headache, and gastroenteritis.

Table 1 Adverse Reactions Reported in ≥5% of Patients Treated with Empagliflozin, Linagliptin, and Metformin HCl in an Active-Controlled Clinical Trial of 52 Weeks

Adverse ReactionsEmpagliflozin 10 mg + Linagliptin 5 mg + Metformin HCl (%) n=136Empagliflozin 25 mg + Linagliptin 5 mg + Metformin HCl (%) n=137
Upper respiratory tract infection10.38.0
Urinary tract infection a9.610.2
Nasopharyngitis8.15.8
Diarrhea6.62.2
Constipation5.15.8
Headache5.15.1
Gastroenteritis2.95.8

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, continued

The 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) ] Pancreatitis [see Warnings and Precautions (5.3) ] Volume Depletion [see Warnings and Precautions (5.4) ] Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections [see Warnings and Precautions (5.5) ] Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.6) ] Lower Limb Amputation [see Warnings and Precautions (5.7) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] Vitamin B 12 Deficiency [see Warnings and Precautions (5.9) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.10) ] Bullous Pemphigoid [see Warnings and Precautions (5.11) ] Heart Failure [see Warnings and Precautions (5.12) ] Most common adverse reactions (5% or greater incidence) were upper respiratory tract infection, urinary tract infection, nasopharyngitis, diarrhea, constipation, headache, and gastroenteritis.

Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective August 24, 2026 (SPL set 71873567-9594-452a-bb92-34a129adecac), via openFDA; the full label on DailyMed

What do FAERS reports show?

118 reports list empagliflozin and linagliptin and metformin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 23 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, 7 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.

The 25 most reported reactions

  • Blood Glucose Increased19
  • Fatigue9
  • Off Label Use (a use or a product term, not a reaction)9
  • Diarrhoea (named in the label)6
  • Nausea (named in the label)6
  • Vomiting (named in the label)6
  • Weight Decreased6
  • Drug Ineffective (a use or a product term, not a reaction)5
  • Glycosylated Haemoglobin Increased5
  • Headache (named in the label)5
  • Dyspnoea4
  • Product Physical Issue4
  • Abdominal Pain Upper3
  • Arterial Occlusive Disease3
  • Asthenia (named in the label)3
  • Catheterisation Cardiac3
  • Death (an outcome recorded in the report)3
  • Decreased Appetite3
  • Dizziness (named in the label)3
  • Extra Dose Administered3
  • Haemorrhage3
  • Prescribed Underdose (a use or a product term, not a reaction)3
  • Product Odour Abnormal3
  • Product Use Complaint (a use or a product term, not a reaction)3
  • Rash (named in the label)3

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Empagliflozin and linagliptin and metformin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions