Steglatro Side effects and how to manage them
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Watson, PharmD on April 10, 2022 OverviewSteglatro (ertugliflozin) is a brand-name prescription medication. It’s approved by the Food and Drug Administration (FDA) to treat type 2 diabetes in adults. Steglatro is typically a long-term treatment to help improve blood sugar levels in combination with diet and exercise. Here are some fast facts about Steglatro:Active ingredient: ertugliflozinDrug class: sodium glucose co-transporter 2 inhibitorDrug form: oral tabletFDA approval year: 2017 Like other drugs, Steglatro can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Steglatro, including details about its uses, see this article. More common side effects of Steglatro Steglatro can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist. These are just a few of the more common side effects reported by people who took Steglatro in clinical trials:headachevaginal itchingcommon coldgenital or urinary tract infection*increased urination* * For more information about this side effect, see “Side effect specifics” below. Mild side effects of Steglatro Mild side effects can occur with Steglatro use. This list doesn’t include all possible mild side effects of the drug. For more details, you can refer to Steglatro’s prescribing information. Mild side effects that have been reported with Steglatro include:headachevaginal itchingcommon coldweight lossdry throat, dry mouth, or excessive thirstmild genital or urinary tract infection*increased urination*back pain* These side effects may be temporary, lasting a few days to weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist. Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Steglatro and want to tell the FDA about it, visit MedWatch. * For more information about this side effect, see “Side effect specifics” below. Serious side effects of Steglatro Steglatro may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more details, you can refer to Steglatro’s prescribing information. If you develop serious side effects while taking Steglatro, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number. Serious side effects that have been reported and their symptoms include:Low blood sugar when Steglatro is used in combination with certain diabetes drugs. Symptoms can include:sweatingconfusionjitterinessdizzinessirritabilityheadacheKetoacidosis (a life-threatening condition that causes a high level of acid in the blood). Symptoms can include:trouble breathingbreath that smells sweet or fruitydry mouth or excessive thirstfatigueswelling of the ankles or feetDehydration, which can lead to kidney damage or low blood pressure. Symptoms can include:dry mouthlightheadednessheadachedark urine or trouble urinatingHigh cholesterol. This condition doesn’t typically cause symptoms but can be detected with a cholesterol test.Increased risk of amputation (surgical removal) of a leg, foot, or toe.Serious genital or urinary tract infection.*Allergic reaction.*† * For more information about this side effect, see “Side effect specifics” below. † An allergic reaction is possible after using Steglatro. But this side effect wasn’t reported in clinical trials. FAQs about the side effects of Steglatro Steglatro may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers. How do side effects of the 5-mg and 15-mg strengths of Steglatro compare The side effects of the 5-milligram (mg) strength of Steglatro are expected to be the same as for the 15-mg strength. However, certain side effects may be more common at the drug’s higher strength. Examples of side effects that were more common in clinical trials of the 15-mg strength than of the 5-mg strength include:weight lossgenital infections*back pain* To learn more about what to expect with the 5-mg and 15-mg strengths of Steglatro, talk with your doctor or pharmacist. * For more information about this side effect, see “Side effect specifics” below. What long-term side effects can Steglatro cause In rare cases, Steglatro may cause side effects that have long-term complications. Examples of these side effects include:ketoacidosis (a life-threatening condition that causes a high level of acid in the blood)kidney damage that results from dehydrationhigh cholesterolamputation (surgical removal) of a leg, foot, or toeserious genital or urinary tract infection* If you’re concerned about long-term side effects with Steglatro, talk with your doctor or pharmacist. They can advise on your risk of these side effects and potential ways to lower them. They can also recommend ways to ease your symptoms if they happen. * For more information about this side effect, see “Side effect specifics” below. Does Steglatro cause diarrhea It isn’t likely. Diarrhea wasn’t reported as a side effect in clinical trials of Steglatro. Keep in mind that other diabetes medications may cause diarrhea. An example is metformin (Fortamet, Glumetza, Riomet). Steglatro may be taken in combination with other diabetes drugs. So, you may have diarrhea if you’re taking Steglatro with these medications. But this side effect probably isn’t caused by Steglatro itself. If you have questions about diarrhea and Steglatro, talk with your doctor or pharmacist. They can discuss your risk of this side effect while you’re taking Steglatro with other diabetes medications. Side effect specifics Learn more about some of the side effects that Steglatro may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Steglatro. Genital or urinary tract infection Steglatro may cause certain genital or urinary tract infections (UTIs). Read on for details about each type of infection. Genital infection Mild female* yeast infections were a common side effect in clinical trials of Steglatro. Mild male* yeast infections were less common. In females, symptoms of yeast infection can include:itching, redness or discoloration, or swelling of the vagina or vulva (tissue around the vagina)thick, white vaginal discharge with a texture that resembles cottage cheesepain or burning sensation while urinating Male yeast infections typically cause symptoms around the penis and groin, such as redness or discoloration, itching, and white or pale-looking skin patches. In rare cases, Steglatro may cause a condition called Fournier’s gangrene. This is a severe, life-threatening type of flesh-eating disease that affects the genitals. Symptoms include swelling and pain in the genital area along with an unpleasant odor coming from the affected skin. You may have an increased risk of genital infections if you take higher doses of Steglatro. * Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth. Urinary tract infection Mild UTIs were a somewhat common side effect in clinical trials of Steglatro. But rarely, a more serious UTI can occur. Mild UTI can cause symptoms such as:cloudy urinepainful urinationurinating a lesser amount than usual, but doing so more frequently than usualpain in your side or back A more serious UTI may cause symptoms such as chills, fever, nausea, back pain, or vomiting. This condition is typically severe enough to require treatment in a hospital. What you can do Below are a few suggestions for what you can do about a genital infection or UTI. Genital infection Before taking Steglatro, tell your doctor if you’ve had yeast infections in the past. Also, tell them if you have yeast infections that continue to come back. These factors can increase your risk of getting a yeast infection with Steglatro. If you have symptoms of a yeast infection while taking Steglatro, talk with your doctor. They can suggest over-the-counter treatments, such as Monistat (miconazole) cream or suppositories. Or they can prescribe a medication that will treat the infection. If you have symptoms of Fournier’s gangrene, contact your doctor right away. You’ll likely need antibiotics and surgery to treat the affected area. Urinary tract infection Before taking Steglatro, tell your doctor if you’ve had UTIs in the past. You may have a higher risk of UTIs with Steglatro. If you have UTI symptoms, talk with your doctor. They can tell you if your infection is mild or serious. For mild infections, your doctor may prescribe you a medication to treat the infection. But for a serious infection, they’ll likely tell you to go to the hospital right away for treatment. Increased urination Steglatro may cause increased urination. This was a less common side effect in clinical trials of the drug. With increased urination, you may urinate in larger amounts, frequently at night, or more often than usual. You may also have urinary urgency (an intense need to urinate without having a full bladder). What you can do If you have increased urination with Steglatro, talk with your doctor. They can suggest ways to ease your symptoms, such as avoiding caffeine and drinking less liquid. Back pain Back pain may occur with Steglatro. This was a less common side effect in clinical trials of the drug. However, you may have an increased risk of back pain if you take higher doses of Steglatro. Keep in mind that back pain can be a symptom of urinary tract infection (UTI). For details, see “Genital or urinary tract infection” above. What you can do If you have back pain with Steglatro, talk with your doctor. They may check with you about other symptoms of UTI. If you have back pain that isn’t caused by UTI, your doctor can suggest ways to ease your symptoms. For example, they may recommend over-the-counter pain relievers. Examples include Tylenol (acetaminophen) and Advil (ibuprofen). Allergic reaction As with most drugs, Steglatro can cause an allergic reaction in some people. Although this side effect wasn’t reported in clinical trials, it has been reported since the drug became available for use. Symptoms can be mild or serious and can include:skin rashitchingflushingswelling under your skin, typically in your lips, eyelids, feet, or handsswelling of your mouth, tongue, or throat, which can make it hard to breathe What you can do For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Steglatro. But if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number. Precautions for Steglatro Be sure to talk with your doctor about your health history before you take Steglatro. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include: Kidney problems. Before taking Steglatro, tell your doctor about any kidney problems you have. Steglatro may cause dehydration as a side effect, which could worsen your condition. And doctors typically will not prescribe Steglatro for people on dialysis. If you have kidney problems but aren’t on dialysis, talk with your doctor before starting treatment with Steglatro. They can advise if it’s safe to take Steglatro. Liver problems. It isn’t known if Steglatro is safe for people with severe liver problems. For this reason, doctors typically will not prescribe Steglatro for people with this condition. If you have any liver problems, talk with your doctor before starting treatment with Steglatro. They can advise if it’s safe to take Steglatro. Pancreatitis. Before taking Steglatro, tell your doctor if you have pancreatitis (inflammation of your pancreas). Also, tell them if you’ve had surgery on your pancreas in the past. You may have a higher risk of ketoacidosis with Steglatro. (This is a life-threatening condition that causes a high level of acid in the blood.) Your doctor can recommend if it’s safe for you to take Steglatro. Planned surgery. If you have any surgeries planned, tell your doctor. This is because having surgery could increase your risk of ketoacidosis with Steglatro. To reduce this risk, your doctor may have you stop taking Steglatro a few days before surgery. History of yeast infections or urinary tract infections (UTIs). Yeast infections and UTI are possible side effects of Steglatro. People who’ve had these conditions in the past may have a higher risk of these side effects. If you have had either of these conditions in the past, talk with your doctor. They can recommend if Steglatro is the right treatment option for you. Factors increasing your risk of amputation. Before taking Steglatro, tell your doctor if you have certain factors that could increase your risk of amputation. (This is surgery to remove a body part.) Examples of these factors include nerve damage in your legs or feet, poor blood circulation, diabetic foot ulcers, or having an amputation in the past. You doctor can advise if Steglatro is the right treatment for you. Allergic reaction. If you’ve had an allergic reaction to Steglatro or any of its ingredients, your doctor will likely not prescribe Steglatro. Ask your doctor what other medications may be better options for you. Alcohol use with Steglatro It may be best to avoid drinking large amounts of alcohol while taking Steglatro. Consuming large amounts of alcohol could increase your risk of certain side effects with Steglatro. Examples include:low blood sugarketoacidosisdehydration If you drink alcohol, talk with your doctor about how much is safe for you to drink while taking Steglatro. Pregnancy and breastfeeding while taking Steglatro Below are details about taking Steglatro while pregnant or breastfeeding. Pregnancy and Steglatro It isn’t known if Steglatro is safe to take during pregnancy. There haven’t been enough human trials of the drug to know for sure. However, animal trials have shown harm to offspring exposed to Steglatro during pregnancy. Animal studies don’t always predict what happens with humans. But to be safe, your doctor may recommend that you avoid taking Steglatro during the second and third trimesters of pregnancy. If you’re pregnant or planning to become pregnant, talk with your doctor. They can recommend other medications that may be safer for you. Breastfeeding and Steglatro It isn’t known if Steglatro passes into breast milk. So, it isn’t known for sure if the drug could affect a breastfed child. Because of the possible risk to a breastfed child, it’s recommended that you avoid breastfeeding while taking Steglatro. If you’re breastfeeding or planning to do so, talk with your doctor before starting Steglatro treatment. They can suggest other healthy ways to feed your child. When to talk with your doctor Most side effects of Steglatro are expected to be mild. But in rare cases, serious side effects may occur. If you’d like to learn more about Steglatro, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug. Besides talking with your doctor, you can do some research on your own. These articles might help:More information about Steglatro. For details about other aspects of Steglatro, refer to this article.Dosage details. For more information on Steglatro’s dosage, see this article.A look at diabetes. For details about type 2 diabetes, see our diabetes hub and list of related articles. Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. 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