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Here are important safety warnings and precautions associated with the use of Emflaza (deflazacort). Please read them carefully and consult your healthcare provider with any questions or concerns:

• Hormonal Changes: Emflaza can alter hormone levels, particularly with long-term use, leading to serious health issues. Stopping the medication abruptly may result in steroid withdrawal symptoms like nausea, headache, and weight loss. Consult your healthcare provider for guidance on tapering off the medication safely.

• Blood Sugar Levels: This medication may increase blood sugar, potentially worsening diabetes and affecting diabetes medication efficacy. Regular blood sugar monitoring is advised, and adjustments to your diabetes treatment may be necessary.

• Infection Risk: Emflaza can weaken the immune system, increasing susceptibility to infections. Vaccinations should be current, and any signs of infection should be reported immediately. Infection with chickenpox or measles while on Emflaza can be life-threatening. Past hepatitis B infection may reactivate.

• Cardiovascular and Renal Concerns: Emflaza can impact heart and kidney functions by increasing blood pressure and altering electrolyte levels. Inform your provider of any pre-existing heart or kidney issues to ensure safe use.

• Gastrointestinal Issues: There is a heightened risk of stomach problems such as ulcers or tears in the stomach lining. Disclose any history of stomach conditions or surgeries to your healthcare provider.

• Mood and Behavioral Changes: Emflaza may cause mood swings, hallucinations, or sleep disturbances. Report any mental health changes to your provider promptly.

• Bone Health: This medication can lead to bone loss and increase fracture risk, particularly in children and adolescents. Bone health should be monitored throughout treatment.

• Vision Problems: There is a potential risk for eye issues like cataracts or glaucoma. Notify your provider of any vision changes.

• Severe Skin Reactions: Rare but serious skin conditions, including toxic epidermal necrolysis, may occur. Seek immediate medical advice if a rash develops.

• Cancer Risk: Prolonged use of corticosteroids like Emflaza has been linked to a rare cancer called Kaposi's sarcoma. Discuss this risk with your provider if long-term treatment is required.

• Neuromuscular Concerns: Emflaza may exacerbate muscle weakness, especially in individuals with pre-existing nerve conditions or those on neuromuscular blockers. Report any new muscle weakness or breathing difficulties.

• Pregnancy and Breastfeeding: Use during pregnancy may cause birth defects, and the drug can pass into breast milk. Discuss the potential risks with your healthcare provider if you are pregnant or breastfeeding.

• Blood Clots: There is a rare risk of blood clots. If you have a history of clotting disorders, consult your provider to evaluate the safety of Emflaza for you.

Please engage in regular follow-ups with your healthcare provider while on this medication to address any side effects or concerns that may arise.

When taking this medication, you may experience some common side effects that are generally mild. These include facial puffiness, weight gain, increased appetite, and excessive hair growth. Some individuals might also experience upper respiratory infections, such as a common cold, cough, frequent urination, and infections in the nose or throat. Other mild effects can include redness, irritability, runny nose, stomach discomfort, watery eyes, nausea, thirst, and acne. If these persist or worsen, consult your healthcare provider for guidance.

There are other side effects that, while not as common, have been reported. These can include mood and behavior changes, dizziness, abnormal heart rates, pain, and hot flushes. Although these are not considered serious, it is important to monitor them and seek medical advice if they cause concern.

Rare but serious side effects demand immediate medical attention. These include symptoms of low cortisol levels, such as unusual tiredness, weakness, stomach pain, and severe headaches. A pheochromocytoma crisis can present with fluctuating blood pressure, high fever, and a racing heartbeat. Serious skin reactions may involve rashes, fever, and blistering or peeling skin, while severe allergic reactions can cause hives, difficulty breathing or swallowing, and swelling of the face or throat. Additionally, the medication may lower your ability to fight infections, leading to serious infections with symptoms like fever, chills, or vision changes. In rare cases, Kaposi's sarcoma may develop, characterized by purple or red spots on the skin and swelling in the legs or feet. Seek urgent care if you experience any of these severe symptoms.