Important Risk Information

Changes to hormone therapy labels

In November 2025 the FDA asked makers of menopause hormone therapy to take heart disease, breast cancer and probable dementia out of the boxed warning, and in February 2026 it approved the first updated labels. The risks of stroke, blood clots, heart attack and breast cancer are still listed in every systemic hormone therapy label. Estrogen used without a progestogen still carries a boxed warning about cancer of the lining of the uterus.

Many labels have not been updated yet, and compounded products have no FDA label. The label on the medicine you receive may still show these risks in a boxed warning. The information on this page applies under both the older and the updated labels. A licensed clinician weighs these risks against your health history before prescribing.

Who fills your prescription

Prescriptions are filled and shipped by a licensed partner pharmacy. Jevra LLC does not make, compound or dispense any medication. Our partner pharmacies are listed in our Terms of Use; which one fills your prescription depends on the medication and where you live.

Estradiol (cream, patch or tablet)

Estradiol is a prescription estrogen used to treat moderate to severe hot flashes and night sweats from menopause. If you have a uterus, using estrogen without a progestogen raises the risk of cancer of the lining of the uterus (endometrial cancer). That is why it is prescribed with progesterone.

Estrogen, with or without progesterone, may raise the risk of stroke, blood clots in the legs or lungs, heart attack, breast cancer, ovarian cancer, gallbladder disease and high blood pressure. In a large study of women 65 and older, estrogen with or without a progestin was linked to a higher risk of probable dementia. Do not use estrogen to prevent heart disease, heart attack, stroke or dementia.

Who should not use estradiol

• Anyone with unusual vaginal bleeding that hasn’t been checked by a clinician.
• Anyone who has or has had breast cancer or another estrogen-dependent cancer.
• Anyone who has or has had blood clots, a stroke or a heart attack.
• Anyone with liver disease or a blood-clotting disorder.
• Anyone allergic to estradiol or any ingredient in the medicine.
• Anyone who is pregnant. Estradiol is not for use in pregnancy and is not birth control.

Call your clinician right away if you have

• Unusual vaginal bleeding.
• A new breast lump.
• Chest pain or shortness of breath.
• Pain or swelling in a leg.
• A sudden severe headache.
• Changes in vision or speech.

Common side effects of estradiol

Common side effects include breast tenderness, headache, nausea, bloating and vaginal bleeding or spotting. Tell your clinician about any side effect that bothers you or does not go away. Talk with your clinician regularly about whether you still need treatment.

If you’ve had a hysterectomy

If you don’t have a uterus, your clinician decides whether you need progesterone. Estrogen taken on its own still carries the other risks on this page.

Estradiol cream

Estradiol on the skin can pass to other people through skin contact. Wash your hands after applying it, let the area dry, and keep children from touching the skin where you applied it. Keep pets away from it too.

Estradiol cream is compounded by a state-licensed partner pharmacy. Compounded medications are not reviewed by the FDA for safety, effectiveness or quality, and the strength can vary more than in manufactured products.

Estradiol patch

The patch can irritate the skin where it’s applied. Change where you place it each time, and don’t put it on your breasts.

Estradiol tablet

Tell your clinician about the other medicines you take. Some medicines and grapefruit products can raise or lower estrogen levels.

Progesterone

Progesterone is prescribed with estrogen to lower the risk of cancer of the lining of the uterus in women who have a uterus. It is not prescribed on its own for hot flashes. Estrogen plus a progestogen may raise the risk of breast cancer, stroke, blood clots and heart attack.

Progesterone can cause dizziness and drowsiness, so it is usually taken at bedtime. Be careful driving or using machinery until you know how it affects you. Many progesterone capsules contain peanut oil, so tell your clinician if you are allergic to peanuts.

Do not take progesterone if you have unusual vaginal bleeding that hasn’t been checked, have or have had breast cancer, have or have had blood clots, a stroke or a heart attack, or have liver disease.

Common side effects include breast tenderness, headache, dizziness, tiredness, bloating, nausea and mood changes.

Hormone therapy during perimenopause

Estradiol is labeled for hot flashes and night sweats due to menopause. If you are in perimenopause and still having periods, prescribing it is a clinical judgment and may be off-label. Your clinician explains what that means for you.

Paroxetine (non-hormone option)

Paroxetine is an SSRI antidepressant. It is approved by the FDA to treat depression and some other mental health conditions, and clinicians sometimes prescribe it off-label for hot flashes.

Antidepressants raised the risk of suicidal thoughts and behaviors in children and young adults. Watch for new or worse depression, anxiety, agitation, or unusual changes in mood or behavior, and call your clinician right away if they happen. If you have thoughts of suicide, call or text 988, or call 911.

Paroxetine can cause serotonin syndrome, especially with other medicines that affect serotonin such as other antidepressants, triptans, tramadol or St. John’s wort. Do not take it with, or within 14 days of, an MAOI, or with thioridazine or pimozide. It can make tamoxifen work less well, so tell your clinician if you take tamoxifen. It can raise the risk of bleeding, especially with aspirin, NSAIDs or blood thinners. It can also cause low sodium, a type of glaucoma (angle-closure), bone fractures, seizures and mania.

Do not take paroxetine if you are pregnant. Common side effects include headache, tiredness and nausea or vomiting.

Desvenlafaxine (non-hormone option)

Desvenlafaxine is an SNRI antidepressant. Its FDA approval is for major depressive disorder in adults. Clinicians sometimes prescribe it off-label for hot flashes.

Antidepressants raised the risk of suicidal thoughts and behaviors in children, teens and young adults. Watch for new or worse depression or unusual changes in mood or behavior, especially when starting or changing the dose, and call your clinician right away if they happen. If you have thoughts of suicide, call or text 988, or call 911.

Desvenlafaxine can cause serotonin syndrome, especially with other medicines that affect serotonin. Do not take it with, or within 14 days of, an MAOI. It can raise blood pressure, so your blood pressure should be checked. It can raise the risk of bleeding, and can cause a type of glaucoma (angle-closure), mania, seizures, low sodium, rare lung problems and sexual side effects.

Do not stop it suddenly. Stopping can cause dizziness, nausea, headache, irritability and other symptoms, so your clinician will lower the dose gradually.

Common side effects include nausea, dizziness, trouble sleeping, sweating, constipation, sleepiness, decreased appetite and anxiety.

Pregnancy and birth control

Hormone therapy is not birth control, and you can still get pregnant during perimenopause. None of the medicines offered through this program is for use in pregnancy. Tell your clinician if you are pregnant, could be pregnant, plan to become pregnant or are breastfeeding.

Compounded medications

Any medication compounded by a licensed partner pharmacy is labeled as compounded in its details on the homepage. Compounded medications are not reviewed by the FDA for safety, effectiveness or quality. They don’t come with labeling approved by the FDA, and their strength and absorption can vary.

Other medicines

Tell your clinician about every medicine, vitamin and supplement you take, especially tamoxifen, blood thinners, aspirin or NSAIDs, other antidepressants, migraine medicines called triptans, tramadol, St. John’s wort and grapefruit products.

Before you start

Tell your clinician about your full health history, including any history of breast or uterine cancer, blood clots, stroke, heart disease, high blood pressure, liver or gallbladder disease, lupus, unexplained vaginal bleeding, glaucoma, seizures, bipolar disorder, depression or thoughts of suicide. Use your medicine exactly as prescribed.

Reporting side effects

Contact your clinician about any side effect.

You can report side effects to the FDA’s MedWatch program at 1-800-FDA-1088 or www.fda.gov/medwatch.