What is menopause?

Menopause is a normal, natural change in a woman’s life when her period stops. That’s why some people call menopause “the change of life” or “the change.” Your period may start to change as your body moves into menopause. You may have irregular or heavier periods. Speak with your health care provider about any changes in your periods or bleeding.

During menopause, a woman’s body slowly produces less of the hormones, estrogen and progesterone. This often happens between ages 45 and 55. A woman has reached menopause when she has not had a period for 12 months in a row.

What are the symptoms of menopause?

Every woman’s period will stop at menopause. Some women may not have any other symptoms at all. As you near menopause, you may have:

• Changes in your period—time between periods or flow may be different.

• Hot flashes (“hot flushes”)—getting warm in the face, neck, or chest, with and without sweating.

• Night sweats that may lead to problems sleeping and feeling tired, stressed, or tense.

• Vaginal changes—the vagina may become dry and thin, and sex may be painful.

• Thinning of your bones, which may lead to loss of height and bone breaks (osteoporosis).

Speak with your health care provider to discuss whether treatment is right for you if your menopause symptoms are interfering with your usual activities or get worse.

Treatments for menopausal symptoms include hormone therapy and non-hormonal therapy. In addition, hormone therapy can be used to prevent bone loss in some situations.

Hormone therapy

What is hormone therapy for menopause?

Lower hormone levels in menopause may lead to hot flashes, vaginal dryness. To help with these problems, some women choose to treat their symptoms with hormone medicines, sometimes called menopausal hormone therapy (MHT). Women may be prescribed estrogen or estrogen with progestin (another hormone).

Menopause hormone therapy is not for everyone. Like all medicines, hormone therapy has benefits and risks. Talk with your health care provider about hormone therapy. If you decide to use hormone therapy, use it at the lowest dose that helps. Also use hormones for the shortest time that you need them.

Who should not take hormone therapy for menopause?

Women who:

• Think they are pregnant.
• Have problems with vaginal bleeding.
• Have certain kinds of cancers.
• Have had a stroke or heart attack.
• Have had blood clots.
• Have liver disease.

What are the benefits of using hormone therapy for menopause?

• Hormone therapy may help relieve hot flashes, night sweats, vaginal dryness, or dyspareunia (pain with sexual activity).
• Hormones may reduce your chances of getting osteoporosis—thin, weak bones that break easily.

What are the risks of using hormone therapy?

For some women, hormone therapy may increase their chances of getting blood clots, heart attacks, strokes, breast cancer, and gall bladder disease. For a woman with a uterus, estrogen increases the chance of getting endometrial cancer (cancer of the uterine lining). Adding progestin lowers this risk.

How long should I use hormone therapy for menopause symptoms?

Treatment of menopausal symptoms should be decided with your health care provider, as there are many different FDA-approved hormones for treatment of the symptoms of menopause.

Does it make a difference what form of hormones I use for menopause?

Yes. FDA recommends that women use hormone therapies that are FDA-approved. FDA-approved hormone therapies are evaluated for safety and effectiveness.

Are compounded “bioidentical hormones” safer or more effective than FDA-approved hormone therapy for menopause?

Many marketed products that are called “bioidentical hormones” are compounded drugs, which are not FDA-approved. FDA does not have evidence that compounded “bioidentical hormones” are safe and effective, or safer or more effective than FDA-approved hormone therapy.

FDA has approved drugs containing hormones that are identical to the hormones made naturally by women in their reproductive years.

Is the hormone estriol a “safer form of estrogen”?

FDA does not have evidence that drugs containing estriol are safe and effective, or are “safer forms of estrogen.” There are no FDA-approved drugs containing estriol. Marketed drugs that contain estriol are compounded drugs, which are not FDA-approved.

Non-hormone treatments

Some women use non-hormonal medicines for their menopause symptoms. FDA has approved:

• A medicine used to reduce moderate to severe hot flashes associated with menopause.
• A medicine used to reduce moderate to severe vasomotor symptoms due to menopause. Vasomotor symptoms are the feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating (“hot flashes” or “hot flushes”).
• A medicine used to treat and prevent postmenopausal osteoporosis, and reduce the risk of invasive breast cancer in post-menopausal women, including postmenopausal women at high risk for invasive breast cancer.
• A medicine used after menopause for women with or without a uterus to treat moderate to severe pain during sexual intercourse due to changes in and around the vagina.

Are herbs and other "natural" products useful in treatment symptoms of menopause?

Some women may decide to use products marketed as dietary supplements or over-the-counter “natural” hormone creams to help them deal with their menopausal symptoms. At this time, FDA does not know if herbs or other “natural” products are helpful or safe. These products may also have health risks. Don’t get scammed by products making false claims about miracle cures for weight gain, hair loss, wrinkles, or other changes that can happen during or after menopause. Get the facts.

• Check with your health care provider for information about using these products.
• Learn more about dietary supplements.

Living with menopause

Women often spend many years of their lives in the postmenopausal period.

• Work with your health care provider to develop a plan to build and maintain a healthy life during and after menopause.
• Be sure to learn about how to protect your heart and prevent bone loss as you get older.
• Always tell your health care provider if you have any vaginal bleeding after menopause. This may be a sign of an urgent medical problem.

If your menopause symptoms bother you, talk to your doctor or nurse. Your doctor or nurse can suggest medicines to help with your symptoms. All medicines have risks, and your doctor can help you figure out which medicines are best for you.

• Low-dose hormonal birth control may help if you are in the years leading up to your final period. These may help stop or reduce hot flashes, vaginal dryness, and mood swings. They can also help with heavy or irregular periods. You should not use hormonal birth control if you smoke. Hormonal birth control, especially combination birth control pills and possibly other forms of combination hormonal birth control like the vaginal ring or skin patch, can raise your risk for blood clots and high blood pressure, and the risk is higher for women who smoke.
• Menopausal hormone therapy helps treat menopause symptoms after menopause, but it can raise your risk for blood clots, stroke, and some cancers. If you decide to take menopausal hormone therapy, use the lowest dose possible for the shortest amount of time that helps your symptoms.
• Two non-hormonal medicines approved by the Food and Drug Administration (FDA) may help treat certain menopause symptoms. One low-dose selective serotonin reuptake inhibitor (SSRI), a type of medicine usually used to treat depression, is approved to treat hot flashes in women who do not already have mood or anxiety problems. A medicine that acts like estrogen in the body is approved for the treatment of painful sex caused by menopause. You can also talk to your doctor about other medicines approved by the FDA for depression and anxiety that may also help with menopause symptoms.
• A hormonal medicine, with the generic name prasterone, is approved by the FDA to treat women who experience pain during sex caused by vaginal dryness after menopause. The medicine is applied in the vagina once a day.
• Over-the-counter (OTC) products can treat vaginal discomfort, dryness, or pain. A water-based vaginal lubricant can help make sex more comfortable. A vaginal moisturizer can help keep needed moisture in vaginal tissues and make sex more comfortable.
• Certain prescription medicines may help with vaginal discomfort, dryness, or pain if OTC products don’t work. These include estrogen creams, tablets, or rings that you put in your vagina (see information on topical hormone therapy).
• Menopausal hormone therapypill or patch may help if you have severe vaginal dryness.

The U.S. Food and Drug Administration approved Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause. It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.

“Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, in the FDA’s Center for Drug Evaluation and Research. “The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women.”

Menopause is a normal, natural change in a woman’s life when her period stops, usually occurring between ages 45 and 55. Menopause is often referred to as “the change of life” or “the change.” During menopause a woman’s body slowly produces less of the hormones estrogen and progesterone. A woman has reached menopause when she has not had a menstrual period for 12 consecutive months. Hot flashes occur in around 80% of menopausal women and can include periods of sweating, flushing and chills lasting for several minutes.

Some women who experience hot flashes and have a history of vaginal bleeding, stroke, heart attack, blood clots or liver disease, cannot take hormone therapies. Veozah is not a hormone. It targets the neural activity which causes hot flashes during menopause.

Patients taking Veozah should take one 45 milligram pill orally, once a day, with or without food. The pill should be taken at the same time each day. If a dose is missed, or not taken at the regular time, patients should take it as soon as possible and return to their regular schedule the following day.

The effectiveness of Veozah to treat moderate to severe hot flashes was demonstrated in each of the first 12-week, randomized, placebo-controlled, double-blind portions of two phase 3 clinical trials. In both trials, after the first 12 weeks, the women on placebo were then re-randomized to Veozah for a 40-week extension study to evaluate safety. Each trial ran a total of 52 weeks. The average age of the trial participants was 54 years old.

The prescribing information for Veozah includes a warning for elevated hepatic transaminase, or liver injury. Before using Veozah, patients should have blood work done to test for liver damage. While on Veozah, routine bloodwork should be performed every three months for the first nine months of using the medication. Patients experiencing symptoms related to liver damage—such as nausea, vomiting, or yellowing of the skin and eyes—should contact a physician. Veozah cannot be used with CYP1A2 inhibitors. Patients with known cirrhosis, severe renal damage or end-stage renal disease should not take Veozah.

The most common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated hepatic transaminases.

Menopausal hormone therapy is prescription medicine to help relieve your menopause symptoms, such as hot flashes and vaginal dryness, if they are severe enough to disrupt your daily life. Menopausal hormone therapy is sometimes called hormone therapy or hormone replacement therapy.

During menopause, your ovaries make very low levels of the hormones estrogen and progesterone. Menopausal hormone therapy replaces some of the hormones no longer made by your ovaries with artificial estrogen and progesterone.

Menopausal hormone therapy can help with hot flashes and other menopause symptoms. It is usually taken as a pill each day. You can also get estrogen or estrogen plus progesterone menopausal hormone therapy as a skin patch. Like all medicines, menopausal hormone therapy has risks. If you decide to take it, use the lowest dose for the shortest time needed. Other types of menopausal hormone therapy, called topical hormone therapy, do not treat hot flashes but can help with vaginal dryness.

Topical (TOP-ih-kuhl) hormone therapy is usually a low-dose estrogen cream applied directly to the vagina. It relieves vaginal dryness but does not help with other symptoms, such as hot flashes. It also is available as a vaginal ring, insert, and gel. The risks of topical hormone therapy are different from the risks of menopausal or hormone replacement therapy.

Menopausal hormone therapy, sometimes called hormone replacement therapy, is safe for some women, but it also has risks. That is why the FDA advises women who want to try menopausal hormone therapy to use the lowest dose that works for the shortest time needed.

Research shows that:

• Menopausal hormone therapy may be an option for women up to age 59, but usually only within 10 years of menopause. Younger women and those closer to their final menstrual period are less likely to have the harmful side effects from menopausal hormone therapy.
• Menopausal hormone therapy reduces menopause symptoms, such as hot flashes, sleep problems, mood changes, and vaginal dryness.
• Hot flashes usually require higher doses of estrogen therapy that affect the whole body.
• Women with vaginal dryness or discomfort during sex may find relief with low doses of topical vaginal estrogen.
• Estrogen alone and estrogen plus progesterone raise the risk of stroke and blood clots in the legs and lungs. The risks are rare in women between 50 and 59.

Menopausal hormone therapy may not be safe for some women. You should discuss your risks with your doctor if you have:

• A history of heart disease or risk factors, such as high cholesterol
• A family or personal history of breast cancer
• High levels of triglycerides, a type of fat in your blood
• A family history of gallbladder disease
• Liver disease
• A history of stroke or blood clots

The FDA recommends that women take estrogen-only or estrogen plus progesterone menopausal hormone therapy at the lowest dose that works for the shortest time needed.

Talk to your doctor to weigh the risk and benefits of menopausal hormone therapy based on your symptoms, age, and risk factors.

Companies that make bioidentical hormone therapy use the term “bioidentical” to suggest that their products are exactly the same as natural hormones. Many of these companies also claim that their products are safer than menopausal hormone therapy. However, the FDA does not recognize this term or regulate these products. No studies have been done to evaluate how safe or effective these products are.

Talk to your doctor or nurse before trying any bioidentical hormone therapy.

Some women report relief for hot flashes and other menopause symptoms with complementary or alternative therapies. Talk to your doctor or nurse before taking any herbal or vitamin supplement. The Food and Drug Administration (FDA) does not regulate supplements in the same way they regulate medicines. Many supplements can interfere with medicines and make them work incorrectly or not at all.

Some research studies show relief from premenstrual syndrome (PMS) symptoms with these herbal supplements, but other studies do not. Many herbal supplements should not be used with other medicines. Some herbal supplements women use for menopause symptoms are:

• Black cohosh. The underground stems and root of black cohosh are used fresh or dried to make tea, capsules, pills, or liquid extracts. Black cohosh is used to help treat menopausal symptoms, such as hot flashes.
• Red clover. Red clover has phytoestrogens (fayh-toh-ES-truh-juhnz), which are similar to estrogen. Phytoestrogens are also found in some cereals, vegetables, legumes (peas, beans, soy). You can take red clover in tea or as a pill. Red clover may not be safe for women who should not take menopausal hormone therapy with estrogen.
• Soy. Soy is a plant in the pea family. The seeds of soy are soybeans. Soybeans make isoflavones, a type of phytoestrogen. Soy can be found in dietary supplements or added to foods such as cheese and pasta. Soybeans can be cooked and eaten or used to make foods such as tofu and soy milk. Soy may not be safe for women who should not take menopausal hormone therapy with estrogen.
• Mind and body practices. Yoga, tai chi, and acupuncture may help reduce menopause symptoms, including sleep and mood problems, stress, and muscle and joint pain. One study also found that hypnosis (a trance-like state during which your mind is relaxed) helped decrease hot flashes by 74%.

Research continues on these and other alternative ways of relieving menopause. Talk to your doctor or nurse before trying natural remedies.

Medicines can treat health problems and help you live a healthier life. When used incorrectly, medicines can cause serious injuries or even death. Many of these problems can be prevented. Read this guide to learn four (4) ways to avoid common medicine mistakes.

1. Ask questions.
2. Keep a medicine list.
3. Follow directions.
4. Safely store and throw out medicines.

1. Ask Questions

Ask your doctor, nurse, or pharmacist to tell you the facts about each medicine you take.

• What is the name of the medicine?
• What is the active ingredient(s)?
• What is the medicine for?
• How much do I take and when should I take it?
• What does it look like?
• When does it expire?
• Are there any side effects or special warnings?
• What should I do if I start having side effects?
• Can I take it if I am pregnant or breastfeeding?
• What other medicines or foods should I avoid?

2. Keep a Medicine List

Write down the important facts about each medicine you take.

• List each prescription medicine.
• Include vitamins and over-the-counter medicines like aspirin and cold medicine.
• Keep the list with you all the time.
• Show it to your doctor, nurse, and pharmacist.

3. Follow Directions

Your medicine may not work if you don’t follow the directions. Taking too much or too little can make you very sick.

Use Medicines as Directed.

• Read the directions on the label and ask your healthcare provider how much you should take and when.
• Never skip taking your prescription medicine. Talk to your healthcare provider before you stop taking your medicines.
• Only take the suggested dose.

Avoid Common Problems.

• Don’t share medicines.
• Don’t use medicine in the dark where you can’t see what you are taking.
• Check the expiration date on your medicine. It may not be safe or work after it has expired.

4. Safely Throw Out Medicines

Ask your doctor, nurse or pharmacist how you should get rid of unused medicines. Find out if you should:

• flush it down the toilet or sink.
• put it in a sealed plastic bag with coffee grounds or kitty litter and throw it in the trash.
• drop it off at a drug take-back program in your community.

Be sure to scratch off your name and personal information before you put empty pill bottles in the trash.

Make sure that children can’t get to medicines including patches that you put in the trash.

Avoid common medicine mistakes.

• Get a record keeper to list your medicines.
• Download a booklet to help you talk to your doctor about your prescription medicines.
• Watch videos to learn other helpful tips.