Trijardy XR

• Risk factors: Kidney or liver problems | Age 65 or older | Use of contrast dye | Fasting from food or fluids | Low oxygen | Drinking alcohol | Dehydration | Taking other medications that can cause lactic acidosis

Some people taking metformin, one of the medications in Trijardy XR have reported lactic acidosis. This is a condition when lactic acid builds up in your blood. It can lead to serious problems, such as dangerously low body temperature, low blood pressure, low heart rate, and death. Get emergency medical help if you have symptoms of lactic acidosis, which include feeling unwell, muscle pain, difficulty breathing, slow or irregular heartbeat, sleepiness, and feeling cold.

• Risk factors: History of pancreatitis | History of alcoholism | Kidney problems | Gallstones | High triglyceride (a type of fat) levels

Linagliptin, one of the medications in Trijardy XR, might raise the risk for inflammation (or swelling) of the pancreas (pancreatitis). Some common symptoms of an inflamed pancreas are upper stomach pain, nausea, and vomiting. If you start to feel any of these symptoms, contact your prescriber right away.

• Risk factors: Taking high doses | Lowering your insulin dose | Sudden fever | Lower calorie intake | Surgery | Pancreas problems | Drinking too much alcohol | Fasting for long periods of time

Though rare, empagliflozin in Trijardy XR can raise the risk for a serious condition called ketoacidosis, This is when your body produces high levels of ketones. Stop taking this medication and seek medical help right away if you start experiencing nausea, vomiting, stomach pain, tiredness, and shortness of breath.

• Risk factors: Kidney problems | Older adults | Taking loop diuretics

Empagliflozin, a medication in Trijardy XR, can cause fluid loss, which might lead to low blood pressure or kidney damage. Due to this risk, your prescriber might monitor your kidneys during your treatment. Let your prescriber know if you experience dizziness, lightheadedness, tiredness, blurred vision, low urine production, swelling in the legs, nausea, tiredness, or shortness of breath.

• Risk factors: History of urinary tract infections | History of genital yeast infections | Uncircumcised males

Trijardy XR can raise the risk of urinary tract infections, genital yeast infections, and flesh-eating bacterial infections in the genital area (called Fournier's gangrene). Fournier's gangrene is a serious, life-threatening infection that can require hospitalization, surgery, and can lead to death. Let your prescriber know right away if you experience symptoms of a urinary tract infection (e.g., pain or burning while urinating, urinating often, blood in your urine, or itching), or genital infections (e.g., fever or itching, pain, tenderness, redness, or swelling in the genital area). Get emergency medical help right away if you develop pain, tenderness, swelling, or redness around your anus or genitals, as well as a fever above 100.4ºF or if you feel very weak, tired, or uncomfortable.

• Risk factors: Insulin use | Taking sulfonylureas or glinides | Older adults | Alcohol use | Malnourished

Trijardy XR can cause low blood sugar when taken together with insulin or medications that raise insulin levels (e.g., sulfonylureas or glinides). Symptoms of low blood sugar include headache, sleepiness, hunger, irritation, dizziness, confusion, sweating, shakiness, weakness, or fast heartbeat. Your prescriber might lower the dose of your medications that affect your insulin levels to lower the risk of low blood sugar.

• Risk factors: History of heart problems or kidney problems

Linagliptin in Trijardy XR might raise your risk of heart failure, especially in people who have a history of heart or kidney problems. Let your prescriber know if you have shortness of breath, sudden weight gain, or swelling of the feet.

• Risk factors: Low vitamin B12 or calcium intake or absorption

Metformin in Trijardy XR can lower your vitamin B12 levels, but your levels can usually return to normal if you start a vitamin B12 supplement, or if you stop taking this medication. Your prescriber might monitor your vitamin B12 levels every 2 to 3 years while you're on this medication.

Trijardy XR might cause severe joint pain, which can go away when the medication is stopped. Joint pain can happen at the start of Trijardy XR or it might show up years after. Tell your care team if you notice any joint pain.

• Risk factors: History of amputations | Peripheral artery disease (narrowed blood vessels) | Diabetic foot ulcers

Although rare, some people who took empagliflozin during clinical studies needed foot or leg amputations. The risk for this complication appears higher for people who've previously had an amputation or have blood circulation problems. In studies, the most common reasons for amputations for people who took this medication were peripheral artery disease and diabetic foot ulcers.

Let a healthcare professional know right away if you have any new pain, tenderness, sores, ulcers, or infections on your legs or feet. Your care team can recommend ways to manage these foot problems or treat them before they get worse. If you have diabetes, regularly visit your diabetes care team for foot exams.

Although rare, Trijardy XR might cause serious allergic reactions. Watch out for symptoms of an allergic reaction, including hives, trouble breathing, or swelling in your face or throat.

In some rare cases, people taking linagliptin in Trijardy XR have experienced a condition called bullous pemphigoid, a skin condition that causes large, fluid-filled blisters. This condition might require hospitalization. Stop taking Trijardy XR and let your prescriber know if you develop blisters on your body or if it looks like your skin is breaking down.