WARNING: CONGESTIVE HEART FAILURE See full prescribing information for complete boxed warning Thiazolidinediones, including pioglitazone, cause orexacerbate congestive heart failure in some patients., After initiation of OSENI and after dose increases, monitorpatients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone in OSENI must be considered., OSENI is not recommended in patients with symptomatic heart failure., Initiation of OSENI in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated. Before you start taking Oseni, tell your doctor:, About any medications you take, including prescription, over-the-counter, vitamins, and supplements, About any health conditions you have, If you are pregnant or plan to become pregnant, If you are breastfeeding or plan to breastfeed, Oseni can worsen or cause congestive heart failure. Tell your doctor if you have trouble breathing with activity or when lying down, fatigue, weakness, swelling in the abdomen, legs, ankles, and feet, abnormal heart beat, a cough that won't go away, rapid weight gain, nausea, no appetite, problems concentrating, or chest pain., Oseni can cause acute pancreatitis. Seek medical care right away if you develop pain in your abdomen, pain that radiates from your abdomen to your back, tenderness of the abdomen, fever, quickened pulse, nausea, and vomiting., Oseni can cause liver problems that can sometimes be fatal., Oseni can cause swelling., Oseni can increase the risk for fractures in female patients., Oseni can increase the risk for bladder cancer. If you have a history of bladder cancer, caution should be used. Do not take Oseni if you have active bladder cancer., Low blood sugar can occur when taking Oseni with insulin or other medications that can also lower your blood sugar. Monitor for signs of low blood sugar and treat your low blood sugar as your doctor has instructed., Tell your doctor if you experience vision problems while taking Oseni. About any medications you take, including prescription, over-the-counter, vitamins, and supplements, About any health conditions you have, If you are pregnant or plan to become pregnant, If you are breastfeeding or plan to breastfeed
