Important Safety Information
WARNING: RISK OF HEART FAILUREOSENI can cause heart failure and cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Before you start taking OSENI, tell your doctor if you have ever had heart failure or have problems with your kidneys. Call your doctor right away if you experience shortness of breath or trouble breathing (especially when you lie down), an unusually fast increase in weight or swelling or fluid retention (especially in the feet, ankles or legs). These may be symptoms of heart failure.
OSENI may not be right for everyone. OSENI can cause serious side effects.
Do not take OSENI if you are allergic to any of its ingredients.
Stop taking OSENI and contact your doctor or go to the nearest hospital emergency room right away if you experience swelling of your face, lips, throat, or other areas on your skin, difficulty swallowing or breathing, raised red areas on your skin (hives), skin rash, itching, flaking, or peeling, as these may be symptoms of a serious allergic reaction.
Inflammation of the pancreas (pancreatitis), which may be severe, can happen to people taking OSENI. Tell your doctor if you have ever had pancreatitis, kidney problems, or liver problems. Stop taking OSENI and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
OSENI may cause liver problems. Call your doctor right away if you experience nausea, vomiting, stomach pain, unusual or unexplained tiredness, loss of appetite, dark urine, or yellowing of your skin or eyes.
Women are at a higher risk of having broken bones (fractures) while taking OSENI.
There may be an increased chance of having bladder cancer when you take OSENI. You should not take OSENI if you are receiving treatment for bladder cancer. Tell your doctor right away if you have blood or a red color in your urine, an increased need to urinate, or pain while you urinate as these may be symptoms of bladder cancer.
If you take OSENI with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take OSENI. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, and then call your doctor. Signs and symptoms of low blood sugar include shaking or feeling jittery, sweating, fast heartbeat, change in vision, hunger, headache, change in mood, confusion, or dizziness.
Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly.
If you are a woman of childbearing age, but do not have monthly periods, talk to your doctor before taking OSENI, as it could increase your chance of becoming pregnant.
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Before taking OSENI, you should tell your doctor if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if OSENI can harm an unborn baby, or if it passes into breast milk.
The most common side effects of OSENI were stuffy or runny nose and sore throat (4.9%), back pain (4.2%), and cold-like symptoms (upper respiratory tract infection; 4.1%).
Tell your doctor about all the medicines, vitamins, and supplements you take. Medicines can affect each other. You should contact your doctor before you start or stop other medicines. You may need to have your dose of OSENI, or certain other medicines, changed.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
Indication for OSENI
OSENI is a prescription medicine used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. OSENI is not for patients with type 1 diabetes or diabetic ketoacidosis (increased ketones in blood or urine).