Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Steglatro (Ertugliflozin). If you are concerned about side effects, discuss the risks and benefits of Steglatro (Ertugliflozin) with your doctor.

The following side effects have been reported by at least 1% of people taking Steglatro (Ertugliflozin). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• headache
• thirst

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Low Blood Pressure (e.g., dizziness when standing, fainting, lightheadedness)
• redness or rash of the penis or foreskin (yeast infection)
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine, painful or difficult urination)
• skin ulcers or sores
• symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness, blurred vision)
• symptoms of a kidney infection (e.g., painful, frequent or urgent need to urinate, Fever or chills, cloudy or foul smelling urine, blood in the urine)
• symptoms of vaginal yeast infection (women; e.g., vaginal odour, curd-like discharge, itching)
• symptoms of yeast infection of the penis (men; e.g., lumpy, odorous discharge under foreskin; red, swollen, itchy head of the penis; pain when urinating or during sexual activity)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of diabetic ketoacidosis (e.g., difficulty breathing, nausea, vomiting, stomach pain, loss of appetite, confusion, extreme thirst, and unusual tiredness)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a severe infection that has spread throughout the body (sepsis; fever, rapid breathing, fast heartbeat, pain or difficult urination)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Steglatro (Ertugliflozin).

5 mg
Each pink, triangular-shaped, film-coated tablet, debossed with "701" on one side and plain on the other side, contains 5 mg of Steglatro (Ertugliflozin). Nonmedicinal ingredients: hypromellose, iron oxide red, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide and triacetin.

15 mg
Each red, triangular-shaped, film-coated tablet, debossed with "702" on one side and plain on the other side, contains 15 mg of Steglatro (Ertugliflozin). Nonmedicinal ingredients: hypromellose, iron oxide red, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide and triacetin.

Do not take this medication if you:

• are allergic to Steglatro (Ertugliflozin) or any ingredients of Steglatro (Ertugliflozin)
• have severely reduced kidney function, end stage Kidney Disease, or are receiving dialysis

There may be an interaction between Steglatro (Ertugliflozin) and any of the following:

• acetylsalicylic acid (Asa)
• atypical antipsychotics (e.g., Clozapine, Olanzapine, Quetiapine, Risperidone)
• blood pressure medications
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• diabetes medications (e.g., chlorpropamide, Glyburide, Metformin, Rosiglitazone)
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Disopyramide
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Glucagon
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• insulin
• Lanreotide
• mifepristone
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Niacin
• Nilotinib
• Octreotide
• Pasireotide
• pentamidine
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Sirolimus
• somatostatin acetate
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• Sunitinib
• Tacrolimus
• testosterone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Steglatro (Ertugliflozin). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Steglatro (Ertugliflozin).

Amputation: There may be an increased risk for lower leg or toe amputations in people taking Steglatro (Ertugliflozin). Good foot care is very important for people with diabetes. Contact your doctor as soon as possible if you notice symptoms of leg pain, poor circulation, bluish, cold skin, and poor hair or toenail growth.

Dehydration: Steglatro (Ertugliflozin) may cause an increased amount of fluid to be removed from the body, resulting in dehydration. Dehydration can cause decreased blood pressure and also contribute to heart problems. Certain other medications, such as diuretics (water pills) can cause dehydration. If you experience symptoms of dehydration, such as thirst, decreased urine or tear production, dizziness or Headaches, contact your doctor.

Diabetic ketoacidosis (DKA): Steglatro (Ertugliflozin) has been associated with DKA. This is a potentially life-threatening condition that occurs when the body does not have enough insulin to use the glucose in the bloodstream. When this happens, the body starts to burn ketones for fuel instead, which can make the blood acidic. This condition is more likely to develop if you are following a very low carbohydrate diet, are dehydrated, or have consumed a large amount of alcohol. Symptoms of DKA include difficulty breathing, nausea, vomiting, abdominal pain, confusion, loss of appetite, excessive thirst, and unusual fatigue or sleepiness. If you experience these symptoms, get immediate medical help.

Dizziness: Some people taking Steglatro (Ertugliflozin) may experience decreases in blood pressure. This occurs because the medication causes an increased amount of fluid to be removed from the body through the kidneys. These blood pressure drops could lead to dizziness, lightheadedness, and falls. This may occur when you shift your body position, such as rising from a sitting or lying position. If you experience this problem, try getting up more slowly. If it persists or if you faint, contact your doctor.

Glucose control: When Steglatro (Ertugliflozin) is taken along with other medications for diabetes, glucose levels may drop too far, causing confusion, cold sweats, cool and pale skin, headache, fast heartbeat, or weakness. Your doctor may suggest decreasing the dose of your other medications when you first start taking Steglatro (Ertugliflozin). If you take other medications for diabetes, discuss with your doctor how Steglatro (Ertugliflozin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: Steglatro (Ertugliflozin) may cause a decrease in kidney function. If you have reduced kidney function or kidney disease, discuss with your doctor how Steglatro (Ertugliflozin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Steglatro (Ertugliflozin), and whether any special monitoring is needed.

Urinary Tract Infections: Steglatro (Ertugliflozin) has been associated with urinary tract infections, including kidney infections and blood infections caused by bacteria spreading from the urinary tract. If you experience symptoms of a urinary tract infection, such as a burning feeling when you urinate, pain or pressure in your back or lower abdomen, cloudy, dark, bloody or strange-smelling urine, or fever or chills, contact your doctor as soon as possible.

Yeast infections: There is an increased risk of developing genital or vaginal yeast infections when taking Steglatro (Ertugliflozin) as a result of increased glucose in the urine. This is more likely to occur for uncircumcised males and for people who have a history of yeast infections.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Steglatro (Ertugliflozin), contact your doctor immediately.

Breast-feeding: It is not known if Steglatro (Ertugliflozin) passes into breast milk. If you are a breast-feeding mother and are taking Steglatro (Ertugliflozin), it may affect your baby. It is recommended that women do not breast-feed if they are taking this medication.

Children: The safety and effectiveness of using Steglatro (Ertugliflozin) have not been established for children.

Seniors: People over the age of 65 are more likely to experience side effects of taking Steglatro (Ertugliflozin). Doses for seniors should generally be lower and increase more slowly than for other adults.