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For visual reference only; actual product may vary

  • US Name:

    Estalis

  • Alternative Names:

    Estalis

  • Active Ingredients:

    Estalis

  • Brand Manufacturer:

    Novartis

  • Manufacturer Location:

    Canada

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Estalis *

For visual reference only; actual product may vary

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Estalis is a hormone replacement therapy patch that combines an estrogen and a progestin to treat menopausal hormone deficiency.

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Estalis Brand 50mcg/250mcg
8 Patches
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Estalis Brand 50mcg/140mcg
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Estalis (generic name: estalis) is a hormone replacement therapy patch that combines an estrogen and a progestin to treat menopausal hormone deficiency. It contains estradiol (a form of estrogen) and norethindrone acetate (a synthetic progesterone-like hormone). As a transdermal patch, Estalis delivers these hormones through the skin and into the bloodstream continuously. By replacing declining estrogen levels, it helps alleviate menopausal symptoms such as hot flashes, night sweats, and vaginal dryness.  Estradiol in the patch binds to estrogen receptors in the body, reducing vasomotor symptoms. For example, it helps stabilize the temperature control center in the brain to decrease the frequency of hot flashes. Norethindrone’s role is to protect the uterus. Women with an intact uterus require additional progesterone to prevent overgrowth of the uterine lining caused by estrogen alone. This combination therapy is intended for postmenopausal women who have not had a hysterectomy. Menopause typically occurs in women during their late 40s to mid-50s, when the ovaries stop producing estrogen. The resulting hormone drop leads to the symptoms that Estalis is designed to treat. By replenishing estrogen and including a progestin for uterine protection, Estalis helps the body adjust to this menopausal change.  Unlike many other HRTs, it is used continuously over the full monthly cycle, with no hormone-free interval, so it generally does not cause a monthly period. For many women, this patch allows them to carry on daily activities with far fewer disruptions from hot flashes or other menopause-related discomforts. In addition, Estalis may be used to help prevent postmenopausal osteoporosis in certain high-risk women, as estrogen has a beneficial effect on bone density.  Estalis should be used under regular medical supervision. Patients are often advised to have periodic check-ups (at least once a year) including blood pressure monitoring, breast exams, and possibly mammograms to watch for any complications.  The patch provides a steady, regulated dose of hormones, avoiding first-pass metabolism in the liver that oral tablets undergo. This allows effective symptom control with a lower dose of hormones. Estalis does not restore fertility and is not a contraceptive. It is a prescription medication and should be used under medical supervision as part of a comprehensive plan to address menopausal health needs. For more information on menopause and hormone therapy, see the FDA’s guidance on menopause treatments.

Dosage and Administration

It is essential to follow the instructions for application and replacement of the patches as specified in the manufacturer’s information leaflet. Estalis is usually administered as a skin patch applied and worn continuously, with replacements on a twice-weekly schedule. Each patch is usually worn for 3 to 4 days before being replaced with a new one. Typically, a new patch is applied on the same two days each week (for example, one patch on Monday and one on Thursday), so that each patch provides continuous hormone delivery for 3–4 days.  The patch should be applied to a clean, dry, hairless area on the lower abdomen or buttocks. Avoid applying it to the breasts or to irritated skin. Remove the protective backing and press the patch firmly in place to ensure it adheres well. If you forget to change the patch on your scheduled day, apply a new one as soon as you remember. Don’t skip it even if the next scheduled change is soon. Apply a patch and then continue with your normal schedule. Never apply two patches at once to make up for a missed dose. If a patch falls off or loses its stickiness, try to reattach it. If it doesn’t stay on, apply a fresh patch on a new spot and continue with the routine. Apply each new patch to a slightly different area of skin (rotating sites) to help prevent skin irritation over time.

Storage Guidelines

Proper storage of Estalis patches will help maintain their effectiveness. Unopened boxes should be kept refrigerated at 2°C to 8°C (36°F to 46°F) until use. Do not freeze the patches. If the patches have been refrigerated, allow the package to reach room temperature before opening it to prevent condensation from affecting the adhesive.  After a box is opened and the first patch is applied, store any remaining patches at room temperature (below about 25°C or 77°F), away from direct heat or sunlight. Once removed from refrigeration, the patches should be used within about 6 months or before the expiration date on the package, whichever comes first. Always keep Estalis patches out of the reach of children and pets.

Questions about Estalis

Are the hormones in Estalis natural or bioidentical?
The estradiol in Estalis is chemically identical to the primary estrogen produced by a woman’s ovaries, so it is considered a bioidentical hormone. In other words, when using Estalis, the estrogen entering the body is the same as natural estrogen. Norethindrone acetate, on the other hand, is a synthetic hormone. It is a type of progestin (a laboratory-made analog of progesterone) rather than the exact same molecule as human progesterone. Norethindrone is designed to mimic the effects of natural progesterone on the uterine lining, and it has been a well-studied, reliable progestin in hormone therapies for many years. While it is not bioidentical to human progesterone, it effectively fulfills the protective role needed in combined HRT. 
Which menopausal symptoms does Estalis help relieve?
Estalis is formulated to effectively alleviate the common symptoms of menopause that result from low estrogen levels. The most prominent symptoms it targets are hot flashes and night sweats – sudden bouts of intense heat and sweating that many menopausal women experience. By providing estradiol, Estalis helps reduce the frequency and severity of these vasomotor episodes. It also helps with vaginal dryness and irritation that occur due to estrogen deficiency in the vaginal tissues. Improving the moisture and thickness of the vaginal lining can relieve pain during intercourse and reduce urinary discomfort, such as burning with urination. Many women find that by easing severe hot flashes and sleep-disrupting night sweats, Estalis indirectly leads to better sleep quality and more stable mood. Overall, Estalis specifically targets estrogen-related symptoms of menopause and can provide significant relief for those issues.
How long can hormone replacement therapy be used safely?
There is no single time limit that applies to everyone – the safe duration of HRT use varies for each individual. In general, experts advise using hormone therapy for the shortest period necessary to manage menopausal symptoms. Many women use HRT for around three to five years to get through the worst of their symptoms. Longer use is not automatically dangerous, but the risks of certain problems like breast cancer or blood clots can increase the longer HRT is continued. Therefore, women who need ongoing treatment should be evaluated regularly. Regular follow-ups, at least annually, are usually conducted to decide whether HRT should be continued. During these check-ups, the doctor will review the patient’s health status and risk factors to ensure that continuing HRT is still appropriate. Some women are able to taper off hormones after a few years as their symptoms naturally wane, while others with persistent symptoms may remain on HRT longer under close medical supervision. The key is that the treatment plan is personalized and periodically reassessed to maintain the safest and most beneficial balance for the patient’s health.

This text is for informational purposes only. Please consult a doctor or pharmacist before using any medication. 

Read the information leaflet that comes with the medication.

Most people who use Estalis do not experience any adverse side effects. Doctors prescribe this medication because they assess the benefits of such treatment outweigh any likely unwanted effects.

If a sudden allergic reaction (anaphylaxis) occurs after applying the Estalis patch, with symptoms like swelling of the face, tongue, or throat making it difficult to breathe or swallow, or there is wheezing, hives, rash, blistering, or peeling of the skin, remove the patch immediately, and call a doctor or 911 right away, or go to an emergency room immediately. 

Some of the side effects that have been reported include mild skin irritation at the patch application site. Other common side effects include breast tenderness, nausea, bloating, headache, mood swings, or slight weight changes. These side effects often improve as the body adjusts in the first few months. Some mild spotting or menstrual-like cramping can occur initially. If the side effects are bothersome or do not subside, a doctor may adjust the dose or suggest ways to manage them.

Although uncommon, serious adverse effects can occur with estrogen–progestin therapy and require prompt medical attention. These include signs of a blood clot in the legs or lungs – for example, sudden leg pain or swelling (especially in the calf), chest pain, or coughing up blood, accompanied by difficulty breathing

Not all side effects are listed here. If these or other unlisted symptoms persist or worsen, consult a healthcare provider or pharmacist.

Estalis is FDA-approved to treat the symptoms of menopause which are caused by a state of estrogen deficiency. Its primary use is to alleviate moderate to severe vasomotor symptoms such as hot flashes and night sweats. These intense heat episodes can disrupt daily life and sleep, and Estalis reduces their frequency and intensity by restoring estrogen levels. Estalis also addresses menopausal genitourinary issues. It relieves vaginal dryness, itching, and burning caused by low estrogen. This improves comfort during sexual activity and eases urinary symptoms like burning during urination. 

In some cases, doctors may prescribe Estalis to women who experience premature or early menopause, for example, if the ovaries stop functioning at a younger age. In such situations, replacing estrogen can manage symptoms and support long-term health, including bone health. 

Estalis is recognized as a therapy to help prevent osteoporosis in postmenopausal women at high risk of fractures, particularly if they cannot take other bone-specific medications. The estrogen in Estalis helps maintain bone density, which can lower the risk of osteoporosis-related fractures while the treatment is being used. 

The general guidance is to use the lowest effective dose for the shortest duration necessary to manage symptoms in order to minimize long-term risks. The patient should promptly inform her healthcare provider if any concerning symptoms or side effects arise.

Note: Estalis is intended for postmenopausal women who still have a uterus. Women who have had a hysterectomy typically use estrogen-only therapy instead. Estalis should not be used during pregnancy. If a woman becomes pregnant while on Estalis, she should stop using it and consult a doctor. Similarly, Estalis is not recommended for mothers who are breastfeeding. The hormones can pass into breast milk and might affect the nursing infant or interfere with milk production. Women of childbearing age typically do not use Estalis, since it is intended for menopause, but it’s still crucial to rule out pregnancy before starting this therapy.

  • Can using Estalis help prevent osteoporosis?
    Yes. After menopause, women lose bone density because of lower estrogen levels. By reintroducing estrogen, Estalis slows down bone thinning and helps maintain bone strength. For instance, women may lose up to 10% of their bone mass in the first 5 years after menopause. Studies have shown that hormone therapy like Estalis reduces the risk of fractures during the years it is being used. In fact, Estalis is sometimes prescribed specifically to high-risk women who cannot tolerate other osteoporosis medications. However, HRT is usually not the first choice solely for bone health unless a woman also needs it for symptom relief, due to potential risks. The bone-protective effects last only while the therapy is ongoing – once Estalis is stopped, bone loss will resume, so a long-term plan for bone health should be discussed with a doctor. In summary, Estalis helps protect bone density during the years it is used, an added benefit for those using it to treat menopausal symptoms.
  • Who should avoid using hormone therapy like Estalis?
    Estalis and similar HRT should be avoided by certain groups of women because of safety concerns. It must not be used by women who are pregnant or breastfeeding (although pregnancy is very unlikely at menopause). It is also contraindicated for those with unexplained vaginal bleeding or a history of estrogen-dependent cancers such as breast or uterine cancer. Women who have had blood clots such as a deep vein thrombosis or pulmonary embolism, or who have had a stroke or heart attack, should generally not use Estalis, since estrogen can increase the tendency for blood to clot.
  • What is hormone replacement therapy and how does it work?
    Hormone replacement therapy (HRT) is the use of supplemental hormones to replace those that the body no longer produces after menopause. The goal is to ease symptoms caused by the sudden drop in natural hormone levels. In women, HRT typically involves giving estrogen to reduce hot flashes, night sweats, vaginal dryness, and other symptoms. If a woman still has her uterus, a progestin (like the norethindrone in Estalis) is included to protect the uterine lining from estrogen’s stimulating effects. During menopause, the ovaries sharply decrease estrogen production, and HRT works by restoring some estrogen to the body, which in turn relieves those symptoms. HRT can be delivered in various forms (pills, patches, gels, sprays, etc.), but all serve the same purpose of helping the body adjust to the new, lower hormone levels. It doesn’t reverse menopause or make reverse aging, but it makes this life transition much more comfortable for most women.

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