What the label lists and what reports show
Ertugliflozin and sitagliptin side effects
Ertugliflozin and sitagliptin's FDA label: “Most common adverse reactions associated with ertugliflozin (incidence ≥5%): female genital mycotic infections.” 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 dyspnoea (16 reports).
- No generic listed
Check it at the source: the ertugliflozin and sitagliptin FDA label on DailyMed (effective June 3, 2026, Merck Sharp & Dohme LLC); 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 STEGLUJAN?STEGLUJAN may cause serious side effects, including: See " What is the most important information I should know about STEGLUJAN? " Kidney problems (sometimes requiring dialysis). Sudden kidney injury has happened to people treated with STEGLUJAN. Talk to your healthcare provider right away if you: reduce the amount of food or liquid you drink, for example, if you are sick or cannot eat or you start to lose liquids from your body, for example, from vomiting, diarrhea or being in the sun too long Low blood sugar (hypoglycemia). If you take STEGLUJAN 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 or insulin may need to be lowered while you take STEGLUJAN. […]
Source: FDA drug label, Merck Sharp & Dohme LLC, effective June 3, 2026 (SPL set c2c553d8-5a9d-4366-bf53-8bdb5a876d19), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions associated with ertugliflozin (incidence ≥5%): female genital mycotic infections.
Table 1: Adverse Reactions Reported in ≥2% of Patients with Type 2 Diabetes Mellitus Treated with Ertugliflozin The three placebo controlled studies included one monotherapy trial and two add-on combination trials with…
| Reaction | Placebo N = 515 | Ertugliflozin 5 mg N = 519 | Ertugliflozin 15 mg N = 510 |
|---|---|---|---|
| Female genital mycotic infections Includes: genital candidiasis, genital infection… | 3.0% | 9.1% | 12.2% |
| Male genital mycotic infections Includes: balanitis candida, balanoposthitis, genital… | 0.4% | 3.7% | 4.2% |
| Urinary tract infections Includes: cystitis, dysuria, streptococcal urinary tract… | 3.9% | 4.0% | 4.1% |
| Headache | 2.3% | 3.5% | 2.9% |
| Vaginal pruritus Includes: vulvovaginal pruritus and pruritus genital. Percentages… | 0.4% | 2.8% | 2.4% |
| Increased urination Includes: pollakiuria, micturition urgency, polyuria, urine output… | 1.0% | 2.7% | 2.4% |
| Nasopharyngitis | 2.3% | 2.5% | 2.0% |
| Back pain | 2.3% | 1.7% | 2.5% |
| Weight decreased | 1.0% | 1.2% | 2.4% |
| Thirst Includes: thirst, dry mouth, polydipsia, and dry throat. | 0.6% | 2.7% | 1.4% |
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 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) ] Lower Limb Amputation [see Warnings and Precautions (5.3) ] Acute Renal Failure [see Warnings and Precautions (5.4) ] Volume Depletion [see Warnings and Precautions (5.5) ] Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), and Genital Mycotic Infections [see Warnings and Precautions (5.6) ] Heart Failure [see Warnings and Precautions (5.7) ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.8) ] Hypersensitivity Reactions [see Warnings and Precautions (5.9) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.10) ] Bullous Pemphigoid [see Warnings and Precautions (5.11) ] Most common adverse reactions associated with ertugliflozin (incidence ≥5%): female genital mycotic infections. ( 6.1 ) Most common adverse reactions associated with sitagliptin (incidence ≥5%): upper respiratory tract infection, nasopharyngitis and headache. …
Source: FDA drug label, Merck Sharp & Dohme LLC, effective June 3, 2026 (SPL set c2c553d8-5a9d-4366-bf53-8bdb5a876d19), via openFDA; the full label on DailyMed
What do FAERS reports show?
118 reports list ertugliflozin and sitagliptin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 44 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 21 reactions below, 4 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ertugliflozin and sitagliptin: 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