Important safety information

For Menova compounded estradiol + progesterone cream · [MEDICAL DIRECTOR TO REVIEW BEFORE PUBLISHING]

Menova cream is compounded for you by an FDA‑registered 503A/503B pharmacy. Compounded medications are not FDA approved and have not been evaluated by FDA for safety, effectiveness, or quality. The information below summarizes the FDA‑required labeling for estrogen and progesterone products and applies to the active ingredients in your prescription. Read it, and talk with your physician about anything you do not understand.

Boxed warning for estrogen and estrogen plus progestogen therapy

Endometrial cancer. Using estrogen alone increases the risk of cancer of the uterine lining in women who have a uterus. Adding a progestogen, such as progesterone, lowers that risk. Report any unusual vaginal bleeding to your physician right away.
Cardiovascular disorders and probable dementia. Estrogen with or without a progestogen should not be used to prevent heart disease or dementia. The Women’s Health Initiative studies reported increased risks of stroke and blood clots in the legs and lungs, and, with estrogen plus a progestin, of heart attack and invasive breast cancer, in postmenopausal women taking oral conjugated estrogens. The WHI Memory Study reported an increased risk of probable dementia in women 65 and older.
Breast cancer. Estrogen plus progestin therapy was associated with an increased risk of invasive breast cancer.
Use estrogen, with or without a progestogen, at the lowest effective dose and for the shortest time consistent with your treatment goals and risks. Your physician will review whether continued treatment is right for you at least once a year.

Who should not use Menova cream

Undiagnosed abnormal vaginal bleeding
Known, suspected, or history of breast cancer, or other estrogen‑ or progesterone‑dependent cancer
Active or history of blood clots in the legs or lungs (DVT or pulmonary embolism)
Active or recent stroke or heart attack
Known inherited or acquired clotting disorders (for example protein C, protein S, or antithrombin deficiency)
Liver disease or impairment
Known or suspected pregnancy, or breastfeeding
Known allergy to estradiol, progesterone, or any ingredient in the cream

Tell your physician before starting if you have

High blood pressure, high triglycerides, diabetes, gallbladder disease, migraine, asthma, epilepsy, lupus, or endometriosis
A family history of breast cancer, ovarian cancer, or blood clots
A history of depression
Upcoming surgery or a period of prolonged immobility
Any prescription or over‑the‑counter medications, supplements, or herbal products, including St. John’s wort, anticonvulsants, rifampin, certain antifungals and antivirals, thyroid medication, and grapefruit juice, which can change hormone levels

Common side effects

Breast tenderness or enlargement, headache, nausea or bloating, breakthrough bleeding or spotting, fluid retention, mood changes, and skin irritation at the application site. Progesterone can cause drowsiness or dizziness. Many effects lessen after the first weeks; tell your physician if they persist.

Serious side effects: seek medical care immediately

Chest pain, sudden shortness of breath, or coughing up blood
Pain, swelling, warmth, or redness in a leg
Sudden severe headache, vision changes, weakness or numbness, trouble speaking
New breast lump or change
Unusual vaginal bleeding
Yellowing of the skin or eyes, severe abdominal pain
Swelling of the face, lips, or throat, or difficulty breathing

Using the cream safely

Apply one metered pump to clean, dry skin on the inner forearm (or as your physician directs) at the same time each day. Let it dry fully before dressing.
Wash your hands after applying. Avoid skin‑to‑skin contact with the application site by children, partners, or pets for at least one hour; transfer of estradiol can cause harm.
Do not apply to the breasts or to broken or irritated skin. Avoid sunscreen or lotion on the site for at least an hour after applying.
Keep out of reach of children and pets. Store at room temperature away from heat.
Do not stop or change your dose without talking to your physician.

Reporting side effects

Report side effects to your physician through the patient portal. You may also report to FDA MedWatch at fda.gov/medwatch or 1‑800‑FDA‑1088, and to the pharmacy that dispensed your medication (listed on your label and on our Contact page).

Sources

FDA class labeling for estrogen and estrogen plus progestin products (boxed warning)
The Menopause Society, 2022 Hormone Therapy Position Statement
Women’s Health Initiative (WHI) and WHI Memory Study (WHIMS) publications

This page is a summary and does not replace the pharmacy’s dispensing information or your physician’s advice.