Activella Risks, Warnings, and Complications

CARDIOVASCULAR DISORDERS: Taking combination estrogen and progestin therapy can increase the risk of venous thromboembolism (blood clots) which can lead to pulmonary embolism, deep vein thrombosis, stroke, and myocardial infarction. You will need to immediately stop taking Activella if you develop these serious health complications or your doctor suspects them. 

Tell your doctor if you have a personal or family medical history of venous thromboembolism or cardiovascular disease. Work with your healthcare professional to lower your risk factors for arterial vascular disease, such as high blood pressure, diabetes, high cholesterol, smoking, and obesity. 

CANCER RISKS

Breast Cancer: Taking estrogen plus progestin hormone replacement therapy such as Activella is associated with an increased risk of invasive breast cancer. The risk increases with the duration of use and appears to return to baseline about 5 years after stopping treatment. 

Endometrial Cancer: Unopposed estrogen in women who still have their uterus is associated with a 2-12 times increased risk of endometrial cancer compared to women who do not take hormone replacement therapy (HRT). The risk appears to correlate to the duration of treatment and estrogen dose and can be 15-24 times higher with use of estrogen therapy for 5-10 years. The increased risk persists for 8-15 years after stopping treatment.

Your doctor will perform a physical examination and order diagnostic studies to rule out malignancy if you have undiagnosed abnormal vaginal bleeding that is persistent or keeps recurring for an unknown cause.

Progestins exert a protective effect on the uterine lining. The addition of progesterone to estrogen therapy in postmenopausal women lowers the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.

Ovarian Cancer: Taking estrogen plus progestin hormonal therapy for menopausal symptoms can increase the risk of ovarian cancer. 

PROBABLE DEMENTIA: Estrogen plus progestin use by postmenopausal women between the ages of 65 and 79 years has been found to increase the risk of probable dementia. 

GALLBLADDER DISEASE: Taking hormone therapy is associated with a 2-4 times higher risk of gallbladder disease requiring surgery.

HYPERCALCEMIA: Estrogen can cause severe hypercalcemia (high calcium levels) in women with breast cancer that has spread to the bones. You will need to stop Activella if this happens. 

VISION CHANGES: Retinal vascular lesions have been reported in women who took estrogens. Tell your doctor without delay if you develop vision changes such as double vision, protrusion of the eyeball, sudden partial or complete loss of vision, or migraine headache. 

INCREASED BLOOD PRESSURE: A small number of women develop significantly increased blood pressure after taking estrogens. Tell your doctor if you notice higher than usual blood pressure readings at home.

WORSENING HYPERTRIGLYCERIDEMIA: In women with hypertriglyceridemia (high triglyceride levels), estrogens can cause worsening, which can increase the risk of pancreatitis. 

IMPAIRED LIVER FUNCTION: Estrogens are poorly metabolized in women with reduced liver function. Tell your doctor if you have a history of cholestatic jaundice (yellowing of the skin or eyes) with past estrogen use or during pregnancy.

WORSENING HYPOTHYROIDISM: Estrogen can lead to increased thyroid-binding globulin (TBG) levels. In women with normal thyroid function, this is compensated by making more thyroid hormone to maintain normal thyroid hormone levels. However, women who are dependent on thyroid hormone replacement therapy may require an increase in dose when they are on estrogen. If you have hypothyroidism (underactive thyroid), talk to your doctor about how often you need to monitor thyroid function tests to ensure your thyroid hormone levels are in the goal range.

FLUID RETENTION: Taking estrogen plus progesterone therapy can lead to fluid retention. Tell your healthcare provider if you have any conditions that can increase your risk of fluid retention, such as a heart failure or kidney disease. 

HYPOCALCEMIA: Estrogen can increase risk of hypocalcemia (low calcium) in women with hypoparathyroidism. Your doctor will carefully weigh the benefits versus risks of estrogen therapy if you have hypoparathyroidism. 

WORSENING ENDOMETRIOSIS: There are a few reports of malignant transformation of residual endometriosis implants in women treated with estrogen therapy alone after undergoing a hysterectomy. 

WORSENING OF OTHER CONDITIONS: Taking estrogen therapy can exacerbate symptoms of hereditary angioedema, hepatic hemangiomas, asthma, diabetes, migraine, epilepsy, systemic lupus erythematosus, and porphyria. Talk to your doctor about the benefits versus risks of Activella if you have any of these diagnoses.

LABORATORY TESTS: Hormone therapy can interfere with the results of certain lab tests. Tell all laboratory personnel and healthcare providers you are on hormone therapy.