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The use of estrogen, whether alone or in combination with progestin, carries certain risks that require careful consideration and discussion with your healthcare provider. Below are important safety warnings and precautions you should be aware of:

• Cardiovascular Risks: Using estrogen or estrogen/progestin therapies can increase the chances of developing blood clots, heart attacks, and strokes. The risk is higher for individuals with a personal or family history of blood clots, those with high blood pressure, diabetes, high cholesterol, smokers, individuals with obesity, or those with systemic lupus erythematosus (SLE).

• Breast Cancer Risk: Estrogen/progestin combinations may heighten the risk of breast cancer, especially with prolonged use. It is crucial to avoid these therapies if you have a history of breast cancer. Regular breast examinations and mammograms are recommended to monitor any changes.

• Uterine or Endometrial Cancer: Estrogen can affect the uterine lining, potentially leading to cancer. The risk is particularly significant for those who use estrogen without a progestin. Regular monitoring is advised for those undergoing long-term therapy.

• Dementia: Hormonal therapies may increase the risk of dementia, particularly when initiated after age 65. These medications should not be used to prevent dementia.

• Ovarian Cancer: There is a potential risk of ovarian cancer with the use of hormone replacement therapies. Report any unusual vaginal symptoms to your healthcare provider.

• Liver and Gallbladder Issues: Estrogen use may lead to gallbladder disease or liver problems. Those with a history of liver disease or jaundice should be cautious and report any recurrence of symptoms.

• Calcium Level Alterations: Estrogen can affect calcium levels in the blood, particularly in individuals with cancer that has spread to the bones. Symptoms of high calcium should be promptly reported.

• Vision Problems: Though rare, some individuals may experience vision issues due to blood clots in the eyes. Any sudden changes in vision should be immediately evaluated.

• High Triglycerides: Estrogen may elevate triglyceride levels, potentially affecting the pancreas. Regular blood tests may be necessary to monitor this.

• Thyroid Hormone Levels: Estrogen can interfere with thyroid hormone levels, necessitating adjustments in medication and regular monitoring if you have thyroid issues.

• Fluid Retention: Hormonal therapies can cause fluid retention, which is concerning for those with heart or kidney conditions. Monitoring for swelling and other signs is important.

• Exacerbation of Other Conditions: Estrogen-containing medications can worsen conditions such as high blood pressure, hereditary angioedema, asthma, diabetes, migraines, and seizures. A thorough medical history should be discussed with your healthcare provider.

Contraindications: This medication should not be used under certain conditions, including:

• Undiagnosed abnormal vaginal bleeding
• A history of breast cancer or other estrogen-sensitive cancers
• Previous incidents of blood clots, heart attack, or stroke
• Liver disease or blood clotting disorders

If you have any of these conditions, consult your healthcare provider before starting treatment. Regular consultations and physical exams are essential to evaluate the necessity and safety of continued use of these therapies.

When taking this medication, some common side effects may include breast tenderness, headaches, accidental injuries, and upper respiratory tract infections such as coughs or sore throats. Some users may also experience sinus infections, postmenopausal bleeding, nausea, weight gain, ovarian cysts, stomach flu, viral infections, vaginal yeast infections, mood swings, and back pain. For most people, these effects are mild and should subside over time. However, if they persist or worsen, consult your healthcare provider.

Other side effects that have been reported include changes in vaginal bleeding patterns, stomach pain, gas, bloating, diarrhea, common cold symptoms, trouble sleeping, fatigue, dizziness, nervousness, hair loss or excessive hair growth, swelling in the arms, legs, or feet, changes in weight, appetite, or sex drive. While these are not as common, they should still be monitored, and any concerns should be discussed with your healthcare provider.

It is crucial to be aware of rare but serious side effects such as blood clots, heart attacks, or strokes, which require urgent medical attention. Symptoms can include difficulty breathing, leg pain or swelling, chest pain, arm pain, sudden weakness, or changes in speech or vision. Additionally, high or low calcium levels can manifest as tiredness, muscle weakness, nausea, muscle spasms, or tingling sensations and should be addressed immediately. Unusual vaginal bleeding, discharge, or pelvic pain are also serious and warrant prompt medical consultation. If you experience signs of a severe allergic reaction, such as rash, swelling, or difficulty breathing, seek emergency help right away. Always communicate with your healthcare provider about any side effects you encounter.

Activella (estradiol/norethindrone) may interact with various medications, so it is crucial to inform your doctor and pharmacist about all the medicines, supplements, vitamins, or herbal products you are using. Some medications, such as aromatase inhibitors (like Anastrozole, Exemestane, Letrozole), fezolinetant, Fulvestrant, ospemifene, Raloxifene, Tamoxifen, Toremifene, and Tranexamic Acid, can interact with Activella, potentially affecting its effectiveness or safety.

Additionally, Activella can interfere with certain lab tests, such as the metyrapone test, which may lead to inaccurate results. Therefore, it is important to ensure that all healthcare providers and laboratory personnel are aware that you are taking this medication.

Certain drugs should not be combined with Activella, including boceprevir, Cyclosporine, dasabuvir, eltrombopag, Gemfibrozil, ombitasvir, paritaprevir, Ritonavir, and tranexamic acid, due to the risk of significant interactions. In some cases, it may be necessary to adjust the dose or frequency of one or both medications if they are used together. Always consult your healthcare provider to understand the potential risks and necessary precautions.