Prescription medicine
Empagliflozin and metformin Brand names: Synjardy
Empagliflozin and metformin (Synjardy) is a prescription medicine with an FDA approval on record since 2015. No generic is listed; pharmacies paid $5.60 per Synjardy 12.5-1,000 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the empagliflozin and metformin FDA label on DailyMed (effective August 11, 2026, Boehringer Ingelheim Pharmaceuticals, Inc.); the NDA 206111 record on Drugs@FDA; every empagliflozin and metformin label on DailyMed.
Highlights of the record
FDA label of August 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
LACTIC ACIDOSIS.
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1) ]. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, hepatic impairment, and mitochondrial diseases [see Warnings and Precautions (5.1) ]. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information [see Dosage and Administration (2.1), Contraindications (4), Warnings and Precautions (5.1), Drug Interactions (7), and Use in Specific Populations (8.6 , 8.7) ]. […]
Used for
From the label: indications and usageSYNJARDY SYNJARDY is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride (HCl) immediate-release, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
Forms and strengths
- 5 mg / 1000 mg
- 5 mg / 500 mg
- 10 mg / 1000 mg
- 12.5 mg / 1000 mg
- 12.5 mg / 500 mg
- 25 mg / 1000 mg
Extended-release tablet; tablet.
On the market
- Earliest approval on file
- August 26, 2015 Synjardy, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first July 7, 2022; 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
- November 17, 2034 Synjardy tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $5.60 per tablet Synjardy 12.5-1,000 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2018 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 3,459 through July 30, 2026
What is empagliflozin and metformin used for?
From the label: indications and usageSYNJARDY SYNJARDY is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride (HCl) immediate-release, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. SYNJARDY XR SYNJARDY XR is a combination of empagliflozin, a SGLT2 inhibitor and metformin HCl extended-release, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. […]
Conditions named in the indications of empagliflozin and metformin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Biguanide and Sodium-Glucose Cotransporter 2 Inhibitor.
Source: FDA drug label (Synjardy XR), Boehringer Ingelheim Pharmaceuticals, Inc., effective August 11, 2026 (SPL set 8006ba29-ee3a-f852-a9bb-c8ec9b41cf66), via openFDA; the full label on DailyMed
What does the patient leaflet for empagliflozin and metformin 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 SYNJARDY or SYNJARDY XR?SYNJARDY or SYNJARDY XR can cause serious side effects, including: Lactic Acidosis. Metformin hydrochloride (HCl), one of the medicines in SYNJARDY and SYNJARDY XR, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. […] 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: What should I avoid while taking SYNJARDY or SYNJARDY XR?Avoid drinking alcohol very often, or drinking a lot of alcohol in a short period of time ("binge" drinking). It can increase your chances of getting serious side effects.
From the patient leaflet: How should I store SYNJARDY or SYNJARDY XR?Store SYNJARDY or SYNJARDY XR at room temperature between 68°F to 77°F (20°C to 25°C). Keep SYNJARDY or SYNJARDY XR and all medicines out of the reach of children.
Source: FDA drug label (Synjardy XR), Boehringer Ingelheim Pharmaceuticals, Inc., effective August 11, 2026 (SPL set 8006ba29-ee3a-f852-a9bb-c8ec9b41cf66), via openFDA; the full label on DailyMed
Is there a generic for empagliflozin and metformin (Synjardy)?
The FDA approved the first generic empagliflozin and metformin on July 7, 2022. 1 generic application is approved; 0 of it carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 5 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 14 patents for Synjardy tablets: the compound patent runs to August 1, 2028 (pediatric exclusivity to February 1, 2029), and the last listed entry to November 17, 2034; a patent listed only for Synjardy XR tablets runs to December 11, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2022 first generic approved
- 2034 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 empagliflozin and metformin (Synjardy)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $5.60 per Synjardy 12.5-1,000 mg tablet, down 44% from $10.08 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Synjardy XR 12.5-1,000 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Synjardy 12.5-1,000 mg tablet | Brand | $5.60 per tablet | $168.04 | -44% |
| Synjardy 12.5-500 mg tablet | Brand | $5.61 per tablet | $168.39 | -44% |
| Synjardy 5-1,000 mg tablet | Brand | $5.60 per tablet | $167.98 | -44% |
| Synjardy 5-500 mg tablet | Brand | $5.62 per tablet | $168.68 | -44% |
| Synjardy XR 10-1,000 mg tablet | Brand | $11.22 per tablet | $336.56 | -44% |
| Synjardy XR 12.5-1,000 mg tablet | Brand | $5.60 per tablet | $167.94 | -44% |
| Synjardy XR 25-1,000 mg tablet | Brand | $11.19 per tablet | $335.79 | -44% |
| Synjardy XR 5-1,000 mg tablet | Brand | $5.61 per tablet | $168.33 | -44% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has empagliflozin and metformin been recalled?
The FDA's Enforcement Report lists 4 recalls naming empagliflozin and metformin since 2018: 0 Class I (the most serious), 4 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. |
| September 4, 2018 | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. | Cross Contamination With Other Products: |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the empagliflozin and metformin label say about other medicines?
The empagliflozin and metformin label names 11 other medicines 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 |
|---|---|---|
| Acetazolamide | drug interactions | Clinical Impact; Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. … |
| Cimetidine | drug interactions | … [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see ]. |
| Dichlorphenamide | drug interactions | Clinical Impact; Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. … |
| Dolutegravir | drug interactions | … cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see ]. |
| Isoniazid | drug interactions | … estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. |
| Lithium | drug interactions | Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequently during SYNJARDY or SYNJARDY XR initiation and dosage changes. |
| Phenytoin | drug interactions | … thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. |
| Ranolazine | drug interactions | Clinical Impact; Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase … |
| Topiramate | boxed warning | Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart … |
| Vandetanib | drug interactions | Clinical Impact; Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase … |
| Zonisamide | drug interactions | Clinical Impact; Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. … |
Source: FDA drug label (Synjardy XR), Boehringer Ingelheim Pharmaceuticals, Inc., effective August 11, 2026 (SPL set 8006ba29-ee3a-f852-a9bb-c8ec9b41cf66), via openFDA; the full label on DailyMed
What do FAERS reports show for empagliflozin and metformin?
The FDA Adverse Event Reporting System holds 3,459 reports that list empagliflozin and metformin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 115 are coded as a death and 1,070 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 empagliflozin and metformin?
22 other medicines are given the same way (oral) and in the same FDA class as empagliflozin and metformin 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 |
|---|---|---|---|---|
| Dapagliflozin | Type 2 diabetes | 22 labelers | $0.184 per tablet 10 mg tablet | No current entry |
| Canagliflozin | Type 2 diabetes | none listed | $19.13 per tablet 100 mg tablet | No current entry |
| Bexagliflozin | Type 2 diabetes | none listed | n/a | No current entry |
| Dapagliflozin and saxagliptin | Type 2 diabetes | 1 labeler | n/a | 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 |
Every medicine labeled for the same conditions as empagliflozin and metformin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to empagliflozin and metformin
- 22 medicines for the same use
- Other biguanides
- the pharmacologic class, with prices and generics
- Empagliflozin and metformin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other