Prescription medicine
Ertugliflozin Brand names: Steglatro
Ertugliflozin (Steglatro) is a prescription medicine with an FDA approval on record since 2017. No generic is listed; pharmacies paid $11.44 per Steglatro 15 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the ertugliflozin FDA label on DailyMed (effective June 3, 2026, Merck Sharp & Dohme LLC); the NDA 209803 record on Drugs@FDA; every ertugliflozin label on DailyMed.
Highlights of the record
FDA label of June 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSTEGLATRO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Forms and strengths
- 5 mg
- 15 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 19, 2017 Steglatro, Msd Sub Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first July 13, 2023; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 19, 2031 Steglatro tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $11.44 per tablet Steglatro 15 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 1,091 through July 30, 2026
What is ertugliflozin used for?
From the label: indications and usageSTEGLATRO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. STEGLATRO is a sodium glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ].
Conditions named in the indications of ertugliflozin's FDA labels, with every medicine labeled for each:
Source: FDA drug label (STEGLATRO), 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 patient leaflet for ertugliflozin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about STEGLATRO?STEGLATRO may cause serious side effects, including: Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. STEGLATRO can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who: are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. […] Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness swelling redness of skin (erythema) Also tell your healthcare provider if you have any of these signs or symptoms of urinary tract infections or yeast infections: Urinary tract infection: burning feeling when you urinate need to urinate often or right away pain in the lower part of your stomach (pelvis) blood in your urine You may also have a fever, back pain, nausea, or vomiting. […]
From the patient leaflet: How should I store STEGLATRO?Store STEGLATRO at room temperature between 68°F to 77°F (20°C to 25°C). Keep STEGLATRO dry. Keep STEGLATRO and all medicines out of the reach of children.
Source: FDA drug label (STEGLATRO), Merck Sharp & Dohme LLC, effective June 3, 2026 (SPL set e6f3e718-bb99-48f1-ab94-b9f0af05fed6), via openFDA; the full label on DailyMed
Is there a generic for ertugliflozin (Steglatro)?
The FDA approved the first generic ertugliflozin on July 13, 2023. 3 generic applications are approved; 0 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 1 patent for Steglatro tablets: the compound patent runs to December 19, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2023 first generic approved
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ertugliflozin (Steglatro)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $11.44 per Steglatro 15 mg tablet, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Steglatro 5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Steglatro 15 mg tablet | Brand | $11.44 per tablet | $343.28 | +0.2% |
| Steglatro 5 mg tablet | Brand | $11.44 per tablet | $343.09 | +0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ertugliflozin been recalled?
The FDA's Enforcement Report lists 1 recall naming ertugliflozin since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ertugliflozin label say about other medicines?
The ertugliflozin label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Lithium | drug interactions | Clinical Impact: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention: Monitor serum lithium concentration more frequently during STEGLATRO initiation and dosage changes. |
Source: FDA drug label (STEGLATRO), 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 for ertugliflozin?
The FDA Adverse Event Reporting System holds 1,091 reports that list ertugliflozin among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ertugliflozin?
31 other medicines are given the same way (oral) and in the same FDA class as ertugliflozin or labeled mainly for the same use (type 2 diabetes), the same class first. Type 2 diabetes lists all 52 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Metformin | Type 2 diabetes | 83 labelers | $0.0145 per tablet 500 mg tablet | No current entry |
| Glipizide | Type 2 diabetes | 31 labelers | $0.0339 per tablet 5 mg tablet | No current entry |
| Glimepiride | Type 2 diabetes | 29 labelers | $0.0507 per tablet 4 mg tablet | No current entry |
| Pioglitazone | Type 2 diabetes | 22 labelers | $0.0675 per tablet 15 mg tablet | No current entry |
| Glyburide | Type 2 diabetes | 16 labelers | $0.0643 per tablet 5 mg tablet | A presentation being discontinued |
| Dapagliflozin and metformin | Type 2 diabetes | 8 labelers | $0.720 per tablet 10-1,000 mg tablet | No current entry |
| Metformin and sitagliptin | Type 2 diabetes | 4 labelers | $1.76 per tablet 50 mg-1,000 mg tablet | No current entry |
| Sitagliptin | Type 2 diabetes | 4 labelers | $3.77 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as ertugliflozin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ertugliflozin
- 31 medicines for the same use
- Ertugliflozin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other