Skip to main content
PlainMeds

What the label lists and what reports show

Empagliflozin and linagliptin side effects

Empagliflozin and linagliptin's FDA label: “Most common adverse reactions (5% or greater incidence) were urinary tract infections, nasopharyngitis, and upper respiratory tract infections ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc.” FAERS holds 1,937 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 (152 reports).

  • No generic listed

Check it at the source: the empagliflozin and linagliptin FDA label on DailyMed (effective January 20, 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 GLYXAMBI?

GLYXAMBI may cause serious side effects, including: See " What is the most important information I should know about GLYXAMBI? " Genital and urinary tract infections. Empagliflozin, one of the medicines in GLYXAMBI, can cause serious infections in your genital area or urinary tract that could require hospitalization. A rare but serious bacterial infection called necrotizing fasciitis can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). This infection may require hospitalization, multiple surgeries, and could lead to death. […]

Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective January 20, 2026 (SPL set ddbab689-f76c-488c-9613-4168d41dd730), 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 urinary tract infections, nasopharyngitis, and upper respiratory tract infections ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc.

From the label: adverse reactions, continued

The following important adverse reactions are described below and elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.1) ] Pancreatitis [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 with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.5) ] Lower Limb Amputation [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.8) ] Bullous Pemphigoid [see Warnings and Precautions (5.9) ] Heart Failure [see Warnings and Precautions (5.10) ] Most common adverse reactions (5% or greater incidence) were urinary tract infections, nasopharyngitis, and upper respiratory tract infections ( 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 January 20, 2026 (SPL set ddbab689-f76c-488c-9613-4168d41dd730), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,937 reports list empagliflozin and linagliptin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 63 are coded as a death and 466 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, 8 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

  • Blood Glucose Increased152
  • Diabetic Ketoacidosis (a use or a product term, not a reaction)148
  • Nausea (named in the label)106
  • Fungal Infection92
  • Weight Decreased86
  • Dizziness (named in the label)75
  • Vomiting (named in the label)70
  • Urinary Tract Infection (named in the label)61
  • Fatigue57
  • Drug Ineffective (a use or a product term, not a reaction)55
  • Headache (named in the label)49
  • Dehydration (named in the label)47
  • Diarrhoea (named in the label)47
  • Off Label Use (a use or a product term, not a reaction)42
  • Rash (named in the label)40
  • Asthenia39
  • Ketoacidosis (a use or a product term, not a reaction)39
  • Abdominal Pain Upper38
  • Euglycaemic Diabetic Ketoacidosis36
  • Glycosylated Haemoglobin Increased36
  • Pancreatitis (a use or a product term, not a reaction)35
  • Pollakiuria35
  • Fall34
  • Blood Glucose Abnormal33
  • Pruritus33

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

What next?

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