What the label lists and what reports show
Ertugliflozin side effects
Ertugliflozin's FDA label: “Most common adverse reactions (incidence ≥ 5%) were female genital mycotic infections.” FAERS holds 1,091 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 (88 reports).
- No generic listed
Check it at the source: the ertugliflozin 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 STEGLATRO?STEGLATRO may cause serious side effects, including: See " What is the most important information I should know about STEGLATRO? " Low blood sugar (hypoglycemia). If you take STEGLATRO 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 STEGLATRO. Signs and symptoms of low blood sugar may include: headache confusion hunger shaking or feeling jittery drowsiness dizziness fast heartbeat weakness sweating irritability Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking STEGLATRO and call your healthcare provider right away or go to the nearest hospital emergency room. See “ Who should not take STEGLATRO? ”. […]
Source: FDA drug label, Merck Sharp & Dohme LLC, effective June 3, 2026 (SPL set e6f3e718-bb99-48f1-ab94-b9f0af05fed6), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 5%) were female genital mycotic infections.
Table 1: Adverse Reactions Reported in ≥2% of Patients with Type 2 Diabetes Mellitus Treated with STEGLATRO The three placebo-controlled studies included one monotherapy trial and two add-on combination trials with…
| Reaction | Placebo N = 515 | STEGLATRO 5 mg N = 519 | STEGLATRO 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 and Other Ketoacidosis [see Warnings and Precautions (5.1) ] Lower Limb Amputation [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 or Insulin Secretagogues [see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence ≥ 5%) were female genital mycotic infections. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Pool of Placebo-Controlled Trials Evaluating STEGLATRO 5 and 15 mg The data in Table 1 are derived from a pool of three 26-week, placebo-controlled trials. …
Source: FDA drug label, Merck Sharp & Dohme LLC, effective June 3, 2026 (SPL set e6f3e718-bb99-48f1-ab94-b9f0af05fed6), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,091 reports list ertugliflozin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 12 are coded as a death and 319 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, 10 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?
- Ertugliflozin: 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