Patricia Weiser, PharmD, is a licensed pharmacist and freelance medical writer.
Mary Choy, PharmD, is board-certified in geriatric pharmacotherapy and is an active leader in professional pharmacy associations.
The Food and Drug Administration (FDA) has issued a boxed warning for Segluromet. Boxed warnings are the agency’s strongest warnings for serious and potentially life-threatening risks.
The boxed warning states:
Cases of metformin-associated lactic acidosis have resulted in death, hypothermia (body core temperature below 95 degrees F), hypotension (low blood pressure), and resistant bradyarrhythmias (an unusually slow resting heart rate). Symptoms included fatigue, muscle ache, respiratory distress (fluid buildup in the lungs), and abdominal pain.
Risk factors include preexisting kidney issues, simultaneous use of certain drugs, hypoxic states (low oxygen in the tissues), excessive alcohol intake, and preexisting liver issues.
If lactic acidosis (lactic acid buildup in the bloodstream) is suspected, discontinue it and institute general supportive measures in a hospital setting. Prompt hemodialysis (the process of purifying the blood of a person whose kidneys are not functioning correctly) is recommended.
Segluromet (ertugliflozin and metformin) is an orally administered prescription medication that contains two active ingredients: Ertugliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a biguanide.
Segluromet is used along with diet and exercise to improve blood sugar control in adults 18 and older with type 2 diabetes mellitus.
Segluromet’s ingredients work together to lower blood sugar levels. Ertugliflozin works in the kidney to remove excess sugar.
In comparison, metformin works by decreasing sugar production in the liver and also reduces sugar absorption in your digestive system.
While no generic combination of ertugliflozin and metformin exists, brand-name Segluromet is available via prescription. It comes as a tablet to be taken by mouth.
Generic Name: Ertugliflozin and metformin
Brand Name(s): Segluromet, Synjardy, Synjardy XR
Drug Availability: Prescription
Administration Route: Oral
Therapeutic Classification: Hypoglycemic
Available Generically: No
Controlled Substance: N/A
Active Ingredient: Ertugliflozin and metformin hydrochloride
Dosage Form(s): Tablet
The FDA approved Segluromet to be used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes.
Insulin is a hormone made by your pancreas that helps cells take up blood sugar to be used as energy. If you have type 2 diabetes, cells fail to respond normally to insulin, creating insulin resistance. As a result, your pancreas produces more insulin to make cells function properly.
Eventually, your pancreas cannot keep up, and levels of blood sugar rise, resulting in prediabetes and type 2 diabetes. Hypertension (high blood sugar) can cause serious health problems, including heart disease and kidney disease.
This medication is not used to treat type 1 diabetes (when the pancreas creates little to no insulin). It is also not used to treat diabetic ketoacidosis, a rare complication of diabetes.
This combination drug is safe for people with kidney impairment in addition to type 2 diabetes.
Take Segluromet twice a day or as directed by your healthcare provider. Take each dose with food. If your provider determines your dose needs to be increased, it should be done gradually to minimize side effects.
Store Segluromet at room temperature in a dry place, away from heat and moisture (do not store in a bathroom). Keep this medication out of the reach of children and pets.
Segluromet starts working about an hour after you take your first dose. However, it may take at least a week to see the full effects on your blood sugar levels.
Moreover, it may also take a few months to see a change in your hemoglobin A1C (HbA1c test; a test used to measure the body’s average blood sugar level).
This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.
Common side effects of Segluromet include:
The FDA has issued a boxed warning for Segluromet. Boxed warnings are the agency’s strongest warnings for serious and potentially life-threatening risks.
The boxed warning states:
Cases of metformin-associated lactic acidosis have resulted in death, hypothermia (body core temperature below 95 degrees F), hypotension (low blood pressure), and resistant bradyarrhythmias (an unusually slow resting heart rate). Symptoms included fatigue, muscle ache, respiratory distress (fluid buildup in the lungs), and abdominal pain.
Risk factors include preexisting kidney issues, simultaneous use of certain drugs, hypoxic states (low oxygen in the tissues), excessive alcohol intake, and preexisting liver issues.
If lactic acidosis (lactic acid buildup in the bloodstream) is suspected, discontinue it and institute general supportive measures in a hospital setting. Prompt hemodialysis (the process of purifying the blood of a person whose kidneys are not functioning correctly) is recommended.
Serious side effects may occur while taking Segluromet. Call your healthcare provider right away if you experience a serious side effect. If your symptoms feel life-threatening or you think you’re having a medical emergency, call 911.
Severe side effects and their symptoms may include:
It is possible for Segluromet and other drugs containing SGLT2 inhibitors, such as ertugliflozin, to increase the chance of needing a lower leg or foot amputation. However, an extensive review of clinical trials did not find this risk.
Over time, high blood sugar levels can lead to foot ulcers or sores that may become infected. Serious infection in the feet or toes can increase the risk of amputation.
While taking Segluromet, check your legs and feet daily, and seek medical care right away if you notice any irritation or sores.
Segluromet may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of Segluromet, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. You should not take two doses at once to make up for a missed dose.
The following changes (modifications) should be kept in mind when using Segluromet:
Severe allergic reaction: Avoid using Segluromet if you have a known allergy to it or its ingredients. Ask your healthcare provider for a complete list of the ingredients if you’re unsure.
Pregnancy: Segluromet is not recommended during the second and third trimesters of pregnancy. Published studies with metformin use during pregnancy have not reported a clear association between it and major birth defects/miscarriage.
There is not enough data to determine a drug-associated risk for major birth defects or miscarriage. However, there are risks to the parent and fetus associated with poorly controlled diabetes in pregnancy.
Breastfeeding: There is no information regarding the presence of Segluromet in human breast milk, the effects on the breastfed infant, or the effects on milk production. However, some studies report that metformin is present in human milk
Adults over 65: No overall differences in safety were observed between people over the age of 65 years and younger people. However, older adults are more likely to have decreased kidney function. Because kidney function issues can occur after starting ertugliflozin, and metformin is known to be flushed by the kidneys, care should be taken in dose selection for this age group.
Children: The safety and effectiveness of Segluromet have not been established in children.
An overdose of drugs containing metformin can increase your risk of lactic acidosis (lactic acid buildup in the bloodstream) and can cause hypoglycemia.
Prompt medical treatment including dialysis may be needed to treat an overdose.
If you think you or someone else may have overdosed on Segluromet, call a healthcare provider or the Poison Control Center (800-222-1222).
If someone collapses or isn’t breathing after taking Segluromet, call 911 immediately.
It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine during the second and later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.
Under certain conditions, too much metformin can cause a serious condition called lactic acidosis. It usually occurs when other serious health problems are present, including heart attack or kidney failure. Check with your doctor right away if you have decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, stomach discomfort, and unusual sleepiness, tiredness, or weakness. If you have more than one of these symptoms together, you should get immediate emergency medical help.
Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Drinking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.
Ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination.
Tell your doctor if you have bloody urine, decrease in how much or how often you urinate, painful or difficult urination, lower back or side pain, fever, chills, or swelling of the face, finger, or lower legs. These may be symptoms of a serious kidney problem.
This medicine may increase your risk of having urinary tract infections, including pyelonephritis or urosepsis. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.
This medicine may increase your risk of having lower leg or toe amputation (leg removal surgery). Check with your doctor right away if you have pain, tenderness, sores or ulcers, or infections on your leg or foot.
This medicine can cause hypoglycemia (low blood sugar). However, low blood sugar can occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, cannot eat because of nausea or vomiting, or take certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. Some symptoms of low blood sugar include: behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headaches that continue, nausea, shakiness, slurred speech, or unusual tiredness or weakness. Talk to your doctor about the best way to treat low blood sugar.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your diabetes medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away.Some symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed and dry skin, a fruit-like breath odor, increased frequency and amount of urination, ketones in the urine, loss of appetite, nausea or vomiting, rapid and deep breathing, tiredness, or unusual thirst. Talk to your doctor about the best way to treat high blood sugar.
This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients who have a history of genital yeast infections or in men who are not circumcised. Women may have a vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Check with your doctor right away if you have any of these symptoms.
This medicine may cause a rare but serious bacterial infection, called necrotizing fasciitis of the perineum or Fournier's gangrene, which can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). Fournier's gangrene may lead to hospitalization, multiple surgeries, or death. Check with your doctor right away if you have fever, unusual tiredness or weakness, or pain, tenderness, redness, or swelling of the area between and around your anus and genitals.
This medicine may cause some women who do not have regular monthly periods to ovulate. This can increase the chance of pregnancy. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.
Let your doctor or dentist know you are using this medicine. Your doctor may advise you to stop using this medicine at least 4 days before you have major surgery or diagnostic tests, especially tests that use a contrast dye.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (eg, urine glucose tests may not be accurate).
Do not drink a lot of alcohol while you are using this medicine. Heavy alcohol use can increase your risk for lactic acidosis.
There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes with a list of all your medicines.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Segluromet may not be safe for everyone.
This medication is not recommended if:
Segluromet can interact with some medications.
Before taking Segluromet, be sure to tell your healthcare provider all medications you are currently taking. Be sure to include prescription and over-the-counter (OTC) medications, including vitamins and supplements.
Some medications taken with Segluromet can increase the risk of a rare but serious condition called lactic acidosis.
Taking the following drugs with Segluromet may require more monitoring from your healthcare provider:
Certain other diabetes medications taken with Segluromet may increase the risk of hypoglycemia. Your healthcare provider may adjust the dose of your medication to help prevent this from happening. They may also have you monitor your blood sugar more often.
Some examples include:
You may also get a positive result on a urine glucose (sugar) test while taking Segluromet. Be sure to tell the lab or your provider you are taking this medication before giving a urine sample.
Below is a list of drugs also prescribed for the targeted condition. It is not a list of drugs recommended to take with Segluromet.
In fact, you should not take these drugs together. Ask your pharmacist or a healthcare practitioner if you have questions.
Alternatives to Segluromet include:
These medications are also FDA-approved to decrease cardiovascular events (such as a heart attack) in people with type 2 diabetes and underlying heart disease.
Synjardy and Invokamet are FDA-approved to help prevent end-stage kidney disease from worsening in people with type 2 diabetes.
Segluromet has not received FDA approval for these other uses.
Drinking alcohol while taking Segluromet can increase your risk of lactic acidosis. Do not consume excessive amounts of alcohol or consume alcohol frequently while taking Segluromet. Talk to your healthcare provider about how much alcohol (if any) is safe for you.
If you need a computed tomography (CT) scan or any other radiological procedure using contrast dye, be sure to tell your healthcare provider that you are taking Segluromet. They may advise you to stop taking Segluromet temporarily to reduce the risk of a rare but serious side effect called lactic acidosis.
It’s possible with long-term use. Metformin (one of the active ingredients in Segluromet) may cause a decrease in your blood level of vitamin B12.
Your healthcare provider will likely check your B12 levels from time to time during your treatment. Some people need to take a B12 supplement while taking metformin.
Steglatro and Segluromet are both oral medications used to treat type 2 diabetes. Steglatro is a tablet that contains ertugliflozin, while Segluromet is a tablet that combines ertugliflozin with metformin, a common diabetes drug.
Maintaining healthy blood sugar levels helps to prevent complications of diabetes.
Along with taking Segluromet as prescribed, here are a few key tips to keep your diabetes in check:
Also, it is important to check your feet daily and have your healthcare provider examine any cuts, sores, or ulcers that aren’t healing.
Verywell Health’s drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.
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Heyward J, Mansour O, Olson L, Singh S, Alexander GC. Association between sodium-glucose cotransporter 2 (SGLT2) inhibitors and lower extremity amputation: A systematic review and meta-analysis. PLoS One. 2020;15(6):e0234065. Published 2020 Jun 5. doi:10.1371/journal.pone.0234065
American Diabetes Association. Hyperglycemia (high blood glucose).
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Food and Drug Administration. Office of Women's Health. Diabetes medicines.
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Food and Drug Administration. Invokamet (canagliflozin and metformin hydrochloride tablets) prescribing information.
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Patricia Weiser, PharmD, is a licensed pharmacist and freelance medical writer. She has more than 14 years of professional experience.
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