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This document provides crucial safety and warning information regarding the use of Pioglitazone (Actos). Please read the following carefully and consult your healthcare provider with any concerns.

• Heart Failure and Fluid Retention: Pioglitazone may cause or exacerbate heart failure due to increased fluid retention, which burdens the heart. Alert your healthcare team immediately if you experience symptoms such as difficulty breathing, fatigue, swelling, or sudden weight gain. Dose adjustment or discontinuation may be necessary, especially if taken with insulin.

• Hypoglycemia Risk: While Pioglitazone rarely causes low blood sugar on its own, using it alongside other diabetes medications like insulin or sulfonylureas (e.g., glipizide, glimepiride) can increase this risk. Be aware of hypoglycemia symptoms such as shakiness, hunger, sweating, confusion, or rapid heartbeat, and inform your healthcare provider to possibly adjust medication dosages.

• Liver Concerns: There are rare reports of serious liver issues in patients using Pioglitazone. Though it is unclear if the medication is the direct cause, discuss any concerns with your healthcare team. Routine blood tests may be conducted to monitor liver function. Notify your provider if you experience severe fatigue, unexplained weight loss, abdominal discomfort, dark urine, or yellowing of the skin or eyes.

• Bladder Cancer Risk: There may be an association between Pioglitazone and bladder cancer, though evidence is inconclusive. It is not advisable for individuals with active bladder cancer. Inform your healthcare provider of any bladder cancer history. Report symptoms like blood in the urine, painful urination, or changes in urination patterns promptly.

• Bone Fracture Risk: Studies suggest an increased risk of fractures in the arms and feet among females taking Pioglitazone. Your prescriber may want to assess your bone health before starting treatment.

• Eye Issues: Pioglitazone can lead to macular edema, a condition that affects vision. Given that diabetes can also affect eyesight, regular eye exams are essential. Report any vision changes, such as cloudy, blurry, or dim vision, to your healthcare provider immediately.

Contraindications: This medication should not be used by individuals with moderate to severe heart failure due to potential health risks. If this applies to you, consult your healthcare provider before use.

When taking this medication, you might encounter some common side effects, which are generally mild but should be discussed with your healthcare provider if they persist or become bothersome. These include swelling, which occurs in about 27% of users, upper respiratory tract infections in 13%, headaches in 9%, heart failure in 8%, and sinus infections and pain in the arms and legs in approximately 6% of users each.

Other side effects have also been noted. While they can vary in severity, it's important to monitor your symptoms and consult a healthcare professional if necessary. These include sore throat, muscle pain, back pain, chest pain, and weight gain.

There are also serious side effects, though rare, that require immediate medical attention. These include worsening heart failure, characterized by difficulty breathing, unusual swelling, fatigue, and sudden weight gain. Additionally, serious liver problems may manifest as unexplained fatigue, poor appetite, dark urine, yellowing of the skin or eyes, and pain in the upper right stomach area. Low blood sugar is another serious side effect, with symptoms such as shakiness, rapid heartbeat, sweating, dizziness, anxiety, confusion, and intense hunger. If you experience any of these severe reactions, seek urgent medical care.