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The following safety information outlines critical warnings and risks associated with the use of Odefsey. It is vital to understand these warnings and consult your healthcare provider if you have any concerns or questions.

• Worsening of Hepatitis B: Discontinuing Odefsey can lead to a severe flare-up of hepatitis B. Do not stop taking Odefsey unless advised by your healthcare provider. If instructed to stop or switch medications, ensure regular lab tests are conducted to monitor liver function and hepatitis B virus (HBV) levels.

• Liver Problems and Toxicity: Odefsey, which includes emtricitabine and tenofovir, may cause a serious liver condition known as lactic acidosis with hepatic steatosis, particularly in individuals with liver disease or infection. It is not recommended for those with moderate to severe liver conditions. Symptoms such as loss of appetite, abdominal pain, muscle pain, rapid breathing, fatigue, and sudden weakness require immediate medical attention. Regular liver function tests are necessary during treatment.

• Depression and Mood Changes: There is a risk of mood alterations, including depression and suicidal thoughts, with Odefsey. Contact your healthcare provider if you experience mood changes, and seek immediate help if you have thoughts of self-harm.

• Kidney Problems: Odefsey can lead to kidney issues, either shortly after starting or over time. Avoid combining it with other nephrotoxic medications, such as high-dose NSAIDs. Regular kidney function tests are recommended.

• Bone Problems: The medication may reduce bone mineral density, increasing the risk of osteoporosis and fractures. Calcium and vitamin D supplements may be advised. Your provider might conduct bone density tests if fractures occur or if you are at risk for bone issues.

• Immune Reconstitution Syndrome: As your immune system strengthens while on Odefsey, it may cause inflammation by fighting underlying infections. Consult your provider if you experience fever, breathing difficulties, or sudden health changes after beginning treatment.

Please ensure you follow these guidelines and maintain open communication with your healthcare provider to manage your health effectively while on Odefsey.

When taking this medication, some individuals may experience common side effects, which are generally mild and manageable. These include headaches and sleep problems, each occurring in about 2% of users. If these issues persist or become bothersome, it is advisable to consult a healthcare provider for guidance.

In addition to common side effects, other reactions like gas, strange or abnormal dreams, diarrhea, and nausea have been reported. While these are typically not severe, any persistence or increase in severity should prompt a discussion with a healthcare professional to ensure appropriate care.

Serious side effects, though rare, demand immediate medical attention due to their potential severity. These include allergic reactions characterized by skin rash, itching, hives, or swelling of the face, lips, tongue, or throat. Additionally, symptoms indicative of high lactic acid levels, such as muscle pain, cramps, stomach pain, trouble breathing, or general fatigue, should be addressed urgently. Kidney and liver injuries are also serious concerns, identifiable by symptoms like decreased urine output, swelling, right upper belly pain, loss of appetite, and changes in urine color or skin appearance. Lastly, any rash accompanied by fever and swollen lymph nodes, or thoughts of suicide, self-harm, worsening mood, and depression, should be considered critical and require immediate medical evaluation.