Hormone Replacement Therapy — Important Safety Information (ISI)

Read this information carefully before starting hormone replacement therapy. Discuss any questions or concerns with your provider.

What Is Hormone Replacement Therapy?

Hormone Replacement Therapy (HRT), also called menopausal hormone therapy, treats the symptoms of perimenopause and menopause caused by declining hormone levels. Treatment may include estrogen (most often estradiol), progesterone or a progestin, and in some cases low-dose testosterone for women. Formulations prescribed at Tactus Health may include oral, transdermal (patch, gel, or cream), and other delivery methods. All formulations are prescription-only and require a clinical evaluation before treatment begins. The right combination and dose depend on your symptoms, your lab results, and whether you still have a uterus.

Boxed Warning — Endometrial Cancer (Estrogen-Alone Therapy)

WARNING: ENDOMETRIAL CANCER. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogen, meaning systemic estrogen taken without a progestogen. Adding adequate progesterone or a progestin to estrogen therapy substantially reduces this risk. Women with a uterus should not use estrogen-alone therapy. Any unusual or persistent vaginal bleeding should be reported to your provider promptly so it can be evaluated.

Note on labeling: In November 2025, the FDA initiated removal of the broader boxed warning previously applied to menopausal hormone therapy, retaining the boxed warning for endometrial cancer with systemic estrogen-alone use in women with a uterus. Cardiovascular and breast-cancer information remains in product labeling and is summarized below.

Contraindications

Hormone replacement therapy should not be used in patients with any of the following:

• Known or suspected pregnancy
• Undiagnosed abnormal genital or vaginal bleeding
• Known, suspected, or history of breast cancer, or other known or suspected estrogen- or progesterone-dependent cancer
• Active or recent (within the past year) arterial thromboembolic disease, such as stroke or heart attack
• Active deep vein thrombosis, pulmonary embolism, or a history of these conditions
• Known liver impairment or disease
• Known hypersensitivity to any ingredient in the formulation
• Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

Warnings and Precautions

• Cardiovascular Disorders: Estrogen with or without a progestin should not be used to prevent cardiovascular disease. Women’s Health Initiative (WHI) data reported increased risks of stroke, deep vein thrombosis, pulmonary embolism, and, with estrogen plus progestin, heart attack in treated postmenopausal women. Risk is influenced by age, time since menopause, and individual risk factors, which our medical team reviews before prescribing.
• Venous Thromboembolism (VTE): An increased risk of blood clots has been reported, with the risk highest in the first year of use. If a clot occurs or is suspected, hormone therapy should be stopped immediately. If feasible, estrogen should be discontinued 4 to 6 weeks before surgery associated with a high clot risk, or during prolonged immobilization.
• Breast Cancer: Some studies have reported an increased risk of breast cancer with estrogen plus progestin therapy. Regular breast screening and prompt evaluation of any breast changes are recommended during treatment.
• Endometrial Cancer: See the Boxed Warning above. Women with a uterus require adequate progesterone or progestin alongside estrogen to protect the uterine lining.
• Gallbladder Disease and Other Risks: Estrogen therapy may increase the risk of gallbladder disease, and has been associated with elevated blood pressure, elevated triglycerides in susceptible patients, and changes in thyroid and other lab values.
• Timing Considerations: Current evidence supports the most favorable benefit-risk balance when systemic hormone therapy is started for moderate to severe menopausal symptoms before age 60 or within 10 years of the onset of menopause. Your individual timing is discussed at your consultation.

Testosterone for Women

When low-dose testosterone is included in a woman’s HRT protocol, typically for low libido, it is prescribed off-label, as there is no FDA-approved testosterone product specifically for women. Potential side effects of excess testosterone include acne, unwanted hair growth, voice changes, and, rarely, scalp hair loss. Levels are monitored to keep dosing within an appropriate range. This option is discussed individually based on your symptoms and labs.

Most Common Adverse Reactions

The most commonly reported adverse reactions with hormone replacement therapy include:

• Headache and breast pain or tenderness
• Irregular vaginal bleeding or spotting, particularly in the first months
• Nausea and abdominal bloating or cramps
• Fluid retention and mood changes
• Vaginal discharge and changes in libido

Bioidentical and Compounded Hormones

Some HRT formulations are prepared by licensed compounding pharmacies rather than as FDA-approved finished products. Compounded preparations are not approved or evaluated by the FDA for safety, efficacy, or quality. Our medical team will tell you whether a given formulation is FDA-approved or compounded before you start, so you can make an informed decision.

Pregnancy and Lactation

Hormone replacement therapy is not for use during pregnancy and is contraindicated in women who are or may be pregnant. If you are still cycling and could become pregnant, discuss contraception and family-planning goals with our medical team. The effects of HRT during breastfeeding should be reviewed individually before treatment.

Full Prescribing Information

This ISI is a summary and does not include all of the information needed to use hormone therapy safely. Full prescribing information for the specific product you are prescribed is available in that product’s package insert and from the U.S. Food and Drug Administration at fda.gov. Discuss any questions with our medical team before your treatment.