Duavee is a brand-name prescription drug. It’s FDA-approved for the following uses in women who have a uterus:

Duavee has certain limitations of use. For more information about its limitations, see the “Duavee uses” section below.

Note: If you’ve had a procedure called a hysterectomy (removal of the uterus), you no longer have a uterus. And Duavee is only approved for use in women with a uterus.

Drug details

Duavee contains two active drugs:

Duavee’s active drugs work together to regulate the amount of estrogen in your body.

Duavee comes as tablets that are taken by mouth. It’s typically taken once a day. Duavee is available in one strength: 0.45 milligrams (mg) of conjugated estrogens/20 mg of bazedoxifene.

Effectiveness

For information about the effectiveness of Duavee, see the “Duavee uses” section below.

Duavee contains the active drugs conjugated estrogens and bazedoxifene. It’s available only as a brand-name medication. Duavee is not currently available in generic form. (A generic drug is an exact copy of the active drugs in a brand-name medication.)

Duavee can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Duavee. These lists do not include all possible side effects.

For more information about the possible side effects of Duavee, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they’ve approved. If you would like to notify the FDA about a side effect you’ve had with Duavee, you can do so through MedWatch.

Mild side effects

Mild side effects of Duavee can include*:

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Duavee. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Duavee’s Patient Information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Duavee aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

* Tell your doctor right away about any vaginal bleeding that you have after you’ve gone through menopause. This type of bleeding could indicate cancer of your endometrium (the lining of the uterus).
† For more information about these side effects, see “Side effect details” below.
‡ Duavee has boxed warnings for these side effects. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Side effect details

You may wonder how often certain side effects occur with this drug or whether certain side effects pertain to it. Here’s some detail about certain side effects this drug may or may not cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Duavee. But the number of people who may have had an allergic reaction to this drug in clinical studies isn’t known.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth, swelling, or redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Duavee. But call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Cancer

Duavee may increase your risk for certain types of cancer, including endometrial,* ovarian, and breast cancer. However, the number of people who may have developed cancer after taking Duavee in clinical studies isn’t known.

If you’re concerned about your risk for cancer while taking Duavee, talk with your doctor. They may recommend pelvic exams, breast exams, or mammograms. Below are some details about how your risk for certain types of cancer may increase while you’re taking Duavee.

* Duavee has boxed warnings for these side effects. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Endometrial cancer

Taking Duavee can increase your risk for endometrial cancer.* This is a type of cancer that starts in the endometrium (the lining of the uterus).

Symptoms of endometrial cancer can include:

Taking drugs that contain estrogen, such as Duavee, can thicken the lining inside the uterus in women who’ve gone through menopause and who have a uterus.† This increased growth can cause endometrial cancer.

However, Duavee also contains the active drug bazedoxifene. This drug can help prevent increased growth of the uterine lining that occurs with estrogen therapy alone. So people who take Duavee might have a lower risk for endometrial cancer compared with people who use estrogen therapy alone.

Note: Taking other drugs that contain estrogen while you’re taking Duavee can increase your risk for endometrial cancer even more. For more information, see the “Duavee precautions” section below.

* Duavee has a boxed warning for endometrial cancer. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.
† Women who’ve had a procedure called a hysterectomy no longer have a uterus.

Ovarian cancer

Taking Duavee may increase your risk for ovarian cancer. This is a type of cancer that starts in the ovaries.

Symptoms of ovarian cancer can include:

  • abdominal (belly) pain
  • bloating
  • constipation
  • fatigue (lack of energy)
  • loss of appetite
  • unexpected vaginal bleeding
  • urinating more often than usual
  • weight loss

Some cells in the ovaries may be sensitive to estrogen. So if you take drugs that contain estrogen, such as Duavee, cancer cells may grow in your ovaries.

Duavee also contains the active drug bazedoxifene. However, it isn’t known how bazedoxifene might affect your risk for ovarian cancer.

Breast cancer

It’s possible that taking Duavee could increase your risk for invasive breast cancer. “Invasive” means the cancer has spread into nearby tissue.

Symptoms of breast cancer can include:

  • a lump in your armpit or breast
  • breast pain or nipple pain
  • change in the shape or size of your breast
  • dimpling of breast tissue
  • nipple discharge other than breast milk, such as blood
  • redness or flakiness on your breast or nipple
  • swelling of your breasts

Taking drugs that contain estrogen, such as Duavee, can cause breast cancer cells to grow. This is because certain breast cancer cells are sensitive to estrogen.

Duavee also contains the active drug bazedoxifene. But it isn’t known how your risk for breast cancer might be different after taking Duavee, compared with after taking estrogen by itself.

Neck pain

Neck pain is a possible side effect of Duavee.

In clinical studies, women who’d gone through menopause took therapy to either treat hot flashes or prevent osteoporosis. In these studies, neck pain occurred in:

  • 5% of women who took Duavee
  • 4% of women who took a placebo (a treatment with no active drug)

However, how long people’s neck pain lasted during these studies isn’t known.

If you have bothersome neck pain while taking Duavee, talk with your doctor. They may suggest ways to relieve this side effect.

Gallbladder disease

Some people who take Duavee may develop gallbladder disease.

Your risk for gallbladder disease is two to four times higher than usual if you take a drug that contains estrogen (such as Duavee) after you’ve gone through menopause. But it isn’t known how many people developed gallbladder disease after taking Duavee in clinical studies.

The term “gallbladder disease” can indicate different types of gallbladder problems, such as:

  • Cholecystitis (gallbladder inflammation). This condition can cause:
    • pain or tenderness in the upper right part of your abdomen (belly)
  • Gallstones (hardened lumps of digestive fluid that form in the gallbladder). Most people with gallstones don’t have any symptoms.

Talk with your doctor about your risk of gallbladder disease after taking Duavee. And if you have any symptoms of gallbladder problems, tell your doctor.

Cardiovascular disease

Your risk for cardiovascular disease* may increase after taking Duavee. Cardiovascular disease refers to problems with your heart and blood vessels. It includes conditions such as stroke and certain blood clots called venous thromboembolism (VTE). These conditions are each discussed in more detail below.

One study looked at women who had a hysterectomy (no longer had a uterus). This study showed that taking drugs that contain estrogen (such as Duavee) after menopause can increase the risk of cardiovascular disease. However, Duavee isn’t approved for use in women who’ve had a hysterectomy.

In addition, it isn’t known how many people developed cardiovascular disease after taking Duavee in clinical studies.

If you’re concerned about your risk for cardiovascular disease after taking Duavee, talk with your doctor. They can discuss your risk for this side effect.

* Duavee has a boxed warning for cardiovascular disease. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Stroke

Using Duavee may increase your risk for stroke. With stroke, the blood flow to your brain is reduced. This keeps your brain from getting the oxygen it needs to function properly.

Symptoms of a stroke can include:

  • confusion
  • headache
  • trouble walking, speaking, or seeing
  • weakness in your face, leg, or arm (usually on one side of your body)

If you have symptoms of a stroke, call your doctor right away. But if your symptoms feel life threatening, call 911 or your local emergency number.

Blood clots

Taking Duavee can increase your risk for blood clots. Certain blood clots are called venous thromboembolism (VTE). VTE may refer to either deep vein thrombosis (DVT) or pulmonary embolism (PE).

DVT is a blood clot that forms in a deep vein (often in your lower leg). PE is a blood clot that forms in your lungs.

Symptoms of DVT or PE may include:

  • swelling in your arm or leg
  • pain in your arm, leg, or chest
  • warmth in the affected area
  • trouble breathing

In clinical studies, no one who took Duavee for either treating hot flashes or preventing osteoporosis after menopause developed VTE. In comparison, 0.1% of people who took a placebo developed VTE. (A placebo is a treatment with no active drug.) However, the type of VTE that people had in these studies isn’t known.

If you have symptoms of a blood clot, call your doctor right away. But if your symptoms feel life threatening, call 911 or your local emergency number.

Dementia

Your risk for dementia* may be increased while you’re taking Duavee. Dementia is a condition that causes trouble with memory, thinking, and communication. Symptoms of dementia can include:

  • changes in mood or personality
  • feeling lost or confused
  • forgetting where you’ve put everyday items
  • memory loss
  • showing less interest in being part of activities
  • trouble communicating
  • trouble finishing familiar tasks

A 1998 clinical study looked at the risk of dementia in women who took drugs containing estrogen (which is one of the active drugs in Duavee). Women in this study were ages 65 to 79 years, and they had already gone through menopause.

In this study, women who took drugs containing estrogen had a higher risk for dementia, compared with women who took a placebo. (A placebo is a treatment with no active drug.)

However, this study didn’t involve people taking Duavee, which contains estrogen and another active drug (bazedoxifene). And, it isn’t known how many people in clinical studies of Duavee may have developed dementia.

Talk with your doctor if you have concerns about developing dementia after taking Duavee.

* Duavee has a boxed warning for dementia. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Weight gain and weight loss (not side effects)

Weight gain and loss aren’t side effects of Duavee. And, these weight changes weren’t seen in clinical studies of the drug.

However, unexplained weight loss may be a sign of cancer. And taking Duavee may increase your risk for certain types of cancer, including endometrial*, ovarian, and breast cancer.

If you have unexplained weight loss while taking Duavee, tell your doctor right away. They may ask you about other symptoms of these types of cancer. (For more information, see the “Cancer” side effect detail above.)

It’s also common for women to gain weight during menopause. Generally, during their 50s and 60s, women gain an average of 1.5 pounds (0.7 kilograms) each year. Women who’ve gone through menopause may also gain more fat around their bellies, compared with other areas of the body.

The reasons for weight gain and changes in body fat during menopause aren’t known. But your genes, lifestyle, and age may be possible reasons for these changes.

Changes in hormone levels, such as estrogen levels, during menopause can also increase your chance for gaining weight. Because Duavee contains estrogen, you may gain weight after you start taking Duavee.

Talk with your doctor if you’re concerned about weight changes while taking Duavee. Your doctor can recommend ways to manage a healthy weight during menopause.

* Duavee has a boxed warning for endometrial cancer. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

The Duavee dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition for which you’re using Duavee
  • your age
  • your body size
  • other medical conditions you may have

Typically, your doctor will start you on the Duavee dosage that’s recommended for treating your condition. Then they’ll monitor you over time to decide if you need to continue taking the drug.

Ultimately, your doctor will prescribe Duavee for the shortest amount of time needed to treat your condition while keeping your risk for side effects low. (For information about possible side effects, see the “Duavee side effects” section above.)

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Duavee comes as tablets that are taken by mouth. Each tablet contains two active drugs:

Duavee is available in one strength: 0.45 milligrams (mg) of conjugated estrogens/20 mg of bazedoxifene.

Dosage for treating moderate to severe hot flashes due to menopause

Duavee is approved to treat moderate to severe vasomotor symptoms* related to menopause in women who have a uterus.

For this use, the typical dosage of Duavee is one tablet once every day. Your doctor may prescribe a different dosage for you depending on several factors, including your age and body size. If you have questions about the dosage that’s right for you, talk with your doctor.

* Vasomotor symptoms are hot flashes, night sweats, and other symptoms caused by changes in your blood vessels.

Dosage for preventing osteoporosis after menopause

Duavee is approved to prevent osteoporosis* after menopause, in women who have a uterus.

The typical dosage of Duavee for this use is one tablet once every day. Your doctor may prescribe a different dosage for you depending on several factors, including your age and body size. If you have questions about the dosage that’s right for you, talk with your doctor.

* Osteoporosis is a condition that causes weakened bones.

What if I miss a dose?

If you miss a dose of Duavee, take your missed dose as soon as you remember. If it’s almost time for your next dose, skip your missed dose and take your next dose at its regular time. If you aren’t sure whether to take your missed dose or skip it, talk with your doctor or pharmacist.

Don’t take two doses at the same time to make up for a missed dose. “Doubling up” on doses could increase your risk for side effects. (For more information about possible side effects, see the “Duavee side effects” section above.)

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

Duavee isn’t meant to be used as a long-term treatment. You should only take Duavee for as long as needed to manage your conditions. Your doctor will check in with you regularly to decide how long you should take Duavee.

There aren’t any known interactions between Duavee and alcohol. However, drinking alcohol during menopause can worsen hot flashes, which Duavee is used to treat.

In addition, the National Institutes of Health warn that excessive alcohol use over long periods of time can increase your risk for osteoporosis, which Duavee is also used to treat. (With osteoporosis, you have weakened bones.)

Menopause also increases your risk for osteoporosis. So you may have a higher risk for osteoporosis if you’re going through menopause and have a history of excessive alcohol use.

You may also be more likely to have certain side effects of Duavee if you drink alcohol while taking the drug. These side effects include:

  • Blood clots. According to the American Heart Association, binge drinking alcohol might increase your risk for a blood clot. Blood clots are also a possible side effect of Duavee. So drinking excessive amounts of alcohol while taking Duavee can increase your risk for a blood clot.
  • Breast cancer. According to the American Cancer Society, drinking alcohol may increase your risk for breast cancer. Taking Duavee can also increase your risk for breast cancer. So you may have an increased risk of breast cancer if you drink alcohol while taking Duavee.

For more information about possible side effects of Duavee, see the “Duavee side effects” section above.

If you plan to drink alcohol while using Duavee, talk with your doctor. They can recommend whether there’s an amount of alcohol that’s safe for you to drink.

As with all medications, the cost of Duavee can vary. The actual price you’ll pay will depend on your insurance plan, your location, and the pharmacy you use.

Your insurance plan may require you to get prior authorization before they approve coverage for Duavee. This means that your doctor will need to send a request to your insurance company asking them to cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Duavee, contact your insurance company.

Financial assistance

If you need financial support to pay for Duavee, help is available. Pfizer Inc., the manufacturer of Duavee, offers the Duavee Savings Card. For more information and to find out if you’re eligible for support, call 866-881-2545 or visit the program website.

Generic version

Duavee is not available in a generic form. (A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.)

Other drugs are available that can be used to either:

Some drugs may be a better fit for you than others. If you’re interested in finding an alternative to Duavee, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when an FDA-approved drug is used for a purpose other than what it’s approved for.

Alternatives for treating moderate to severe hot flashes due to menopause

Other drugs besides Duavee can be used to treat moderate to severe vasomotor symptoms (such as hot flashes). And these other drugs may or may not contain hormones.

Drugs that contain hormones, such as estrogen, are considered hormone replacement therapy (HRT). They’re used as treatment to balance hormone levels. Below, we describe drugs that do and do not contain hormones.

Hormone therapy for treating moderate to severe hot flashes due to menopause

Examples of hormone therapy drugs that may be used to treat moderate to severe vasomotor symptoms related to menopause include:

  • estradiol (a type of estrogen hormone), such as:
    • estradiol that’s taken by mouth (Estrace)
    • estradiol patch that’s applied to your skin (Alora, Climara, Minivelle, Vivelle-Dot)
    • estradiol that’s injected into your muscle (Depo-Estradiol, Delestrogen)
    • estradiol gel that’s applied to your skin (Divigel, Elestrin, EstroGel)
    • estradiol spray that’s applied to your skin (Evamist)
    • estradiol ring that’s placed in your vagina (Femring)
  • estradiol/progestin therapy, such as:
    • estradiol/norethindrone that’s taken by mouth (Activella, Amabelz, Lopreeza)
    • estradiol/drospirenone that’s taken by mouth (Angeliq)
    • estradiol/levonorgestrel that’s applied to your skin (Climara Pro)
    • ethinyl estradiol/norethindrone that’s taken by mouth (Femhrt, Jevantique Lo, Jinteli)
    • estradiol/norgestimate that’s taken by mouth (Prefest)
  • other types of estrogen hormones, such as:
    • conjugated estrogens that are placed in your vagina (Premarin)
    • esterified estrogens that are taken by mouth (Menest)
    • estrogen/methyltestosterone that’s taken by mouth (Covaryx)
    • estrogen/medroxyprogesterone that’s taken by mouth (Prempro, Premphase)
    • estropipate that’s taken by mouth

Non-hormone therapy for treating moderate to severe hot flashes due to menopause

Examples of non-hormone therapy (drugs that don’t contain hormones) that may be used to treat moderate to severe vasomotor symptoms related to menopause include:

Alternatives for preventing osteoporosis after menopause

Examples of other drugs that may be used to prevent osteoporosis after menopause include:

The Food and Drug Administration (FDA) approves prescription drugs such as Duavee to treat certain conditions.

Duavee for moderate to severe hot flashes due to menopause

Duavee is FDA-approved to treat moderate to severe vasomotor symptoms related to menopause. For this purpose, Duavee should only be used by women who have a uterus.*

Vasomotor symptoms are hot flashes, night sweats, and other symptoms caused by changes in your blood vessels.

* If you’ve had a procedure called a hysterectomy (removal of the uterus), you no longer have a uterus.

What happens with menopause

You’ve gone through menopause when you haven’t had a period for at least 1 year. For most women, this happens between ages 45 and 55 years.

With menopause, the amount of estrogen and progesterone in your body decreases. (Estrogen and progesterone are reproductive hormones that help regulate the menstrual cycle.) These hormonal changes can cause symptoms of menopause, including:

Limitations of use for hot flashes due to menopause

You should use Duavee for the shortest amount of time needed to treat your condition. This is because of the risk of serious side effects from Duavee with long-term use. (For details, see the “Duavee side effects” section above.)

Your doctor will monitor you during treatment to recommend whether you need to keep taking the drug.

Effectiveness for moderate to severe hot flashes due to menopause

Duavee has been shown to be effective in treating moderate to severe hot flashes in women who have gone through menopause.

In a 12-week clinical study, women who’d gone through menopause and had a uterus took either Duavee or a placebo. (A placebo is a treatment without an active drug). The study compared the women’s average number of hot flashes per day after they started treatment with their average before they started treatment. The following results were seen:

Women taking Duavee had, on averageWomen taking a placebo had, on average
After 4 weeks of treatment5.9 fewer hot flashes each day2.8 fewer hot flashes each day
After 12 weeks of treatment7.6 fewer hot flashes each day4.9 fewer hot flashes each day

The study also compared the severity of the hot flashes that women had each day, before and after starting treatment. After 4 weeks, women taking Duavee and women taking a placebo had less severe hot flashes each day compared with before treatment.

And after 12 weeks, hot flashes were even less severe than they were after just 4 weeks of treatment. However, women taking Duavee had a greater improvement in the severity of their hot flashes than women taking a placebo, at both 4 weeks and 12 weeks after treatment.

Duavee for preventing osteoporosis after menopause

Duavee is FDA-approved to prevent osteoporosis after menopause. For this purpose, Duavee should only be used by adult women who have a uterus.*

* If you’ve had a procedure called a hysterectomy (removal of the uterus), you no longer have a uterus.

What happens with osteoporosis

Osteoporosis is a condition that causes weakened bones. It occurs when your body doesn’t make new bone as quickly as it loses old bone. The risk of osteoporosis is increased with:

  • taller height
  • more body weight
  • older age

Osteoporosis usually doesn’t cause any symptoms, unless you’ve had the condition for a while. Over time, osteoporosis can cause you to have a bent-over posture or cause you to get a little bit shorter. Additionally, if your bones become weak due to osteoporosis, they may start to fracture easily.

Hormonal changes during menopause also increase your risk for osteoporosis. Specifically, the amount of estrogen and progesterone in your body decreases with menopause. Decreases in these hormones can cause symptoms of menopause, including:

Limitations of use for osteoporosis after menopause

Duavee should only be used to prevent osteoporosis in women who have a very high risk for developing osteoporosis, such as those with a family history of the disease.

And Duavee shouldn’t be used to prevent osteoporosis until after you and your doctor have considered other, non-hormonal medications for your treatment. This is because of the risk of serious side effects from using Duavee. (For details, see the “Duavee side effects” section above.)

Effectiveness for preventing osteoporosis after menopause

Duavee has been shown to be effective at preventing osteoporosis from developing after menopause.

Clinical studies have compared Duavee with a placebo (a treatment with no active drug) for preventing osteoporosis. These studies compared women’s spinal bone density after starting treatment with their bone density before treatment. (Bone density describes how strong your bones are. Higher bone density indicates stronger bones.)

Women in this study were grouped based on the length of time that had passed since they’d gone through menopause.

In women taking Duavee, spinal bone density wasIn women taking a placebo, spinal bone density was
In women who’d gone through menopause 1 to 5 years agoincreased by an average of 1.72%decreased by an average of 1.90%
In women who’d gone through menopause more than 5 years agoincreased by an average of 1.64%decreased by an average of 1.47%

Bone density in the hip was also reported. Compared with women taking a placebo, hip bone density in women taking Duavee was:

  • an average of 1.96% higher in women who’d gone through menopause 1 to 5 years ago
  • an average of 1.73% higher in women who’d gone through menopause more than 5 years ago

Duavee and children

Duavee is not approved for use in children. It isn’t known if the drug is safe and effective for use in children. Instead, it’s only approved for use in adults ages 18 years and older.

Duavee is approved to:

With menopause, the amount of estrogen and progesterone in your body decreases. (Estrogen and progesterone are female reproductive hormones that help regulate the menstrual cycle). Decreases in these hormones can cause vasomotor symptoms such as hot flashes. It can also increase your risk for osteoporosis.

Duavee works by regulating the amount of estrogen in your body. To do this, Duavee contains two active drugs:

  • Conjugated estrogens. These drugs work to increase your estrogen levels. “Conjugated” means the drug contains a mixture of different types of estrogen. Conjugated estrogens are considered hormone replacement therapy (HRT), which is treatment used to balance hormone levels.
  • Bazedoxifene. This drug works to prevent thickening of the endometrium (the lining of the uterus) that can cause endometrial cancer*. Bazedoxifene does this by acting like estrogen in certain areas of the body and working against estrogen in other areas of the body. This drug belongs to a group of medications called selective estrogen receptor modulators (SERMs).

* Duavee has a boxed warning for endometrial cancer. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

How long does it take to work?

If you’re taking Duavee to reduce vasomotor symptoms related to menopause, it may take several weeks for the drug to start relieving your symptoms.

On the other hand, Duavee starts working right away to prevent osteoporosis after menopause. You won’t be able to feel Duavee working, but the drug can help to strengthen your bones over time. It can also make you less likely to have fractures.

You should take Duavee according to your doctor’s or healthcare provider’s instructions.

When to take

You’ll likely take Duavee once per day. When your doctor recommends that it’s time for you to stop taking Duavee, they may have you start taking the drug every other day. However, you shouldn’t change your dosage of Duavee (how much of the drug you take or how frequently you take it) without talking with your doctor first.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Taking Duavee with food

Duavee can be taken with or without food.

Can Duavee be crushed, split, or chewed?

It may not be safe to crush, split, or chew Duavee tablets. If you have trouble swallowing tablets, talk with your doctor. They may suggest a drug other than Duavee for you.

Here are answers to some frequently asked questions about Duavee.

How do I stop taking Duavee?

Your doctor will monitor you during Duavee treatment to determine whether you need to keep taking the drug. This monitoring helps your doctor recommend the amount of time that it’s safe for you to take Duavee.

Ultimately, your doctor will prescribe Duavee for the shortest amount of time needed to manage your condition while keeping your risk for side effects low. (For information about side effects, see the “Duavee side effects” section above.)

If you want to stop taking Duavee, talk with your doctor first. They can discuss the risks and benefits of stopping treatment with you. They can also suggest ways to safely stop taking the drug.

Does Duavee cause hair loss?

No. Hair loss wasn’t a side effect reported in clinical studies of Duavee. (For information, see the “Duavee side effects” section above.)

However, hair loss can happen naturally during menopause. Hair loss is also a possible side effect of other drugs that are used treat menopause symptoms, such as estrogen/medroxyprogesterone (Prempro).

If you’re concerned about hair loss while taking Duavee, talk with your doctor.

Do I need to take progesterone with Duavee?

No, in general, you don’t need to take progesterone while you’re taking Duavee.

Sometimes progesterone is taken with estrogen therapy. (Estrogen is one of the active drugs in Duavee.) Taking progesterone with estrogen helps to prevent thickening of the endometrium (the lining of the uterus) that can happen with estrogen therapy alone. In some cases, this thickening can lead to endometrial cancer.*

Instead of progesterone, Duavee contains a second active drug called bazedoxifene. Like progesterone, this drug works to prevent thickening of the endometrium that can cause endometrial cancer. Bazedoxifene does this by working against estrogen in the uterus.

If you have any questions about taking other drugs with Duavee, talk with your doctor.

* Duavee has a boxed warning for endometrial cancer. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Why do I have to keep Duavee in its original package instead of a pillbox?

Duavee tablets should be kept in their original packaging so that they’re protected from light and moisture. If Duavee tablets are exposed to light or moisture, the drug could become less effective. You should keep Duavee in its original package until it’s time to take your usual dose.

Talk with your doctor or pharmacist if you have questions about how to store Duavee safely.

Is it OK to take calcium and vitamin D with Duavee?

Yes, if your doctor recommends it, Duavee can be taken with calcium and vitamin D. These nutrients help your body build and maintain strong bones. For more information, see the “Duavee with other treatments” section below.)

Your doctor may check your levels of calcium and vitamin D to determine whether you need to take these nutrients with Duavee. If you have questions about whether you need to take calcium and vitamin D with Duavee, talk with your doctor.

Duavee can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Duavee and other medications

Below are some details about some medications that can interact with Duavee. These lists do not contain all the drugs that may interact with Duavee.

Before taking Duavee, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

Duavee and CYP3A4 inhibitors

An enzyme called CYP3A4 breaks down Duavee in your body so that it can be cleared from your system.

CYP3A4 inhibitors are a group of drugs that inhibit (block) this enzyme from working. Inhibiting CYP3A4 can increase the level of Duavee in your blood, increasing your risk for side effects from Duavee. (For more information, see the “Duavee side effects” section above.)

Examples of drugs that inhibit CYP3A4 include:

Tell your doctor about any drugs you’re taking before you start taking Duavee. They can help you determine if any of the drugs you’re taking are CYP3A4 inhibitors. And they can adjust your medications if needed.

Duavee and CYP3A4 inducers

CYP3A4 is an enzyme that your body uses to break down Duavee. CYP3A4 inducers work to induce (increase) the activity of this enzyme. If CYP3A4 becomes too active, the level of Duavee in your blood can decrease. And this can make the drug less effective.

Examples of CYP3A4 inducers include:

  • carbamazepine (Carbatrol, Tegretol), which is a seizure medication
  • phenobarbital, which is a seizure medication
  • rifampin (Rifadin), which is an antibiotic

Before you start treatment with Duavee, tell your doctor about all of the drugs you’re taking. They can determine if any of the drugs are CYP3A4 inducers. And your doctor may adjust your medications if needed.

Duavee and UGT inducers

Your body uses an enzyme called uridine diphosphate glucuronosyltransferase (UGT) to break down bazedoxifene (one of Duavee’s active drugs). UGT inducer drugs work to induce (increase) the activity of the UGT enzyme.

If UGT becomes too active, the level of bazedoxifene in your blood can decrease. This can increase your risk for cancer of the endometrium* (the lining of the uterus,) which is a possible side effect of Duavee. (For more information about side effects, see the “Duavee side effects” section above.)

Examples of UGT inducers include:

  • carbamazepine (Carbatrol, Tegretol), which is a seizure medication
  • phenobarbital, which is a seizure medication
  • rifampin (Rifadin), which is an antibiotic
  • phenytoin (Dilantin), which is a seizure medication

Make sure to tell your doctor about any drugs you’re taking before starting Duavee. Your doctor can adjust your medications, if needed.

* Duavee has a boxed warning for endometrial cancer. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Certain products that should be used with caution while taking Duavee

Duavee can sometimes change the level of thyroid hormones in your body. If you take medications that work to regulate your thyroid hormone levels, taking Duavee may make those drugs less effective. Below is more information about taking these types of medications with Duavee.

Duavee and thyroid replacement therapy

Thyroid replacement drugs are used to increase thyroid hormone levels in people who have hypothyroidism (an underactive thyroid gland). Examples of these drugs include:

If you take Duavee with any thyroid replacement drugs, your doctor may increase your dosage of your thyroid drug. Your doctor may do this because Duavee can lower the thyroid hormone levels in your body.

Your doctor may also check thyroid function tests more often than usual while you’re taking Duavee with a thyroid replacement drug. This allows your doctor to be sure your thyroid hormone levels stay within a healthy range.

If you have questions about taking Duavee with thyroid replacement drugs, talk with your doctor.

Duavee and herbs and supplements

The manufacturer of Duavee hasn’t reported any specific interactions with herbs or supplements. However, you should still check with your doctor or pharmacist before using any of these products while taking Duavee.

Below, we describe products that may increase your risk for side effects from Duavee or that might make Duavee less effective.

Be sure to tell your doctor or pharmacist about any herbs or supplements you’re using while taking Duavee.

Duavee and black cohosh

Black cohosh is an herb that’s sometimes used for hot flashes due to menopause. Taking black cohosh while you’re taking Duavee can increase your risk for side effects from Duavee. This is because black cohosh can cause side effects similar to those caused by Duavee. (For more information, see the “Duavee side effects” section above.)

If you have questions about using black cohosh to treat hot flashes, talk with your doctor about whether this might be safe for you.

Duavee and St. John’s wort

The herb St. John’s wort may cause Duavee to be less effective if it’s taken with Duavee. Make sure to talk with your doctor or pharmacist before using any herbs or supplements while you’re taking Duavee.

Duavee and foods

Certain foods may interact with Duavee. This means that you may need to avoid eating certain foods while you’re taking Duavee. One of these foods is described below.

Duavee and grapefruit

Eating grapefruit or drinking grapefruit juice while taking Duavee may increase the amount of Duavee in your blood. And this could increase your risk for side effects from Duavee. (To learn about possible side effects, see the “Duavee side effects” section above.)

If you have questions about eating certain foods while you’re taking Duavee, talk with your doctor.

Duavee and lab tests

Duavee may affect the results of certain lab tests, including:

If you’ll be having any lab tests done while you’re taking Duavee, be sure to tell your doctor you’re taking this drug. And if you have questions about how Duavee may affect the results of your lab tests, talk with your doctor.

Duavee is approved to treat moderate to severe vasomotor symptoms related to menopause. It’s also approved to prevent osteoporosis after menopause.* Osteoporosis is a condition that causes weakened bones.

For more information about osteoporosis and menopause, see the “Duavee uses” section above.

Around the time of menopause, your doctor may give you a calcium test or a vitamin D test to determine whether you have low levels of these nutrients. Calcium and vitamin D help your body build and maintain strong bones. If you have low levels of these nutrients, your doctor may recommend that you take a calcium and vitamin D supplement while you’re taking Duavee.

Talk with your doctor if you have questions about taking using other treatments while you’re taking Duavee.

* Duavee is approved only for use in women who have a uterus. If you’ve had a procedure called a hysterectomy (removal of the uterus), you no longer have a uterus.

Duavee shouldn’t be taken during pregnancy. Duavee is only approved for use in women who’ve gone through menopause, meaning they can no longer become pregnant.

No clinical studies of Duavee have looked at the drug’s use during pregnancy. However, one of Duavee’s active drugs, bazedoxifene, has been studied in pregnant animals.

Animal studies have shown that bazedoxifene may cause harm to the fetus if used during pregnancy at normal doses. Animals given bazedoxifene during pregnancy had:

  • fewer live offspring
  • offspring with lower than normal birth weights
  • offspring with an increased risk of certain heart and skeletal defects

However, keep in mind that animal studies don’t always predict what will happen in humans.

If you’re pregnant or planning to become pregnant, ask your doctor about treatments other than Duavee that might be safe and effective for you.

Duavee and fertility

Taking Duavee may lead to fertility problems (trouble conceiving a child) for some women. However, keep in mind that Duavee is only approved for use in women who’ve gone through menopause, meaning they can no longer become pregnant.

Duavee’s effect on fertility hasn’t been studied in humans. But animal studies have been done with bazedoxifene (one of Duavee’s active drugs). These studies showed that Duavee may affect fertility for females. But animal studies don’t always predict what will happen in humans.

If you have questions about your ability to get pregnant while taking Duavee, talk with your doctor.

Duavee isn’t safe to take during pregnancy. But the drug is only approved for use in women who’ve gone through menopause, which means they can no longer get pregnant. Talk with your doctor if you have questions about your birth control needs while you’re taking Duavee.

For more information about taking Duavee during pregnancy, see the “Duavee and pregnancy” section above.

Duavee shouldn’t be taken while breastfeeding. But keep in mind that the drug is only approved for use in women who’ve gone through menopause. Therefore, it’s not likely that someone using this drug would be breastfeeding.

Duavee hasn’t been studied in breastfeeding women. However, estrogen (one of Duavee’s active drugs) can decrease the amount and quality of breast milk that your body produces.

Estrogen has also been found in small amounts in breast milk, but its potential effects on breastfed children are not fully known. It also isn’t known whether Duavee’s other active drug (bazedoxifene) can pass into breast milk.

If you’re currently breastfeeding or planning to breastfeed, talk with your doctor about your treatment options and the best way to feed your child.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

  • Increased risk of endometrial cancer. If you have a uterus, taking Duavee may increase your risk for cancer of the endometrium (the lining of the uterus). If you’ve had a procedure called a hysterectomy (removal of the uterus), you no longer have a uterus. Let your doctor know right away if you have any vaginal bleeding while you’re taking Duavee, as this can be a symptom of endometrial cancer.
  • Cardiovascular disease. Duavee shouldn’t be used to prevent cardiovascular disease. This refers to problems in the heart and blood vessels, including conditions such as coronary heart disease and stroke. This is because taking Duavee can increase your risk for stroke and certain types of blood clots, including venous thromboembolism (VTE).
  • Dementia. Taking Duavee may increase your risk for dementia (trouble with memory, thinking, and communication). Your risk for dementia may also be higher if you’re age 65 years or older and you’ve been through menopause. Due to these possible increases in risk, Duavee shouldn’t be used to prevent dementia.

Other precautions

Before taking Duavee, talk with your doctor about your health history. Duavee may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Diabetes. Duavee can affect your levels of blood glucose (blood sugar). If you have diabetes, make sure to tell your doctor before you start taking Duavee. Your doctor may monitor your blood glucose more closely than usual during Duavee treatment. Your dosage of diabetes medication may also be adjusted.
  • Asthma. If you have asthma, takingDuavee can make your asthma worse. After you start taking Duavee, changes in your estrogen levels can cause your airway to swell if you have asthma. This swelling can trigger an asthma attack. Be sure to tell your doctor if you have asthma before you start Duavee treatment. They may suggest a treatment other than Duavee if you have asthma.
  • Epilepsy. Epilepsy is a condition that causes seizures. And if you have epilepsy, seizures may be triggered by changes in estrogen hormones. Because Duavee contains conjugated estrogens (a mixture of different estrogen types), taking Duavee could worsen epilepsy. Make sure to tell your doctor if you have epilepsy before you start taking Duavee. They may monitor your epilepsy more closely than usual. Your doctor may also recommend a treatment other than Duavee for you.
  • Heart failure. With heart failure, your body has trouble getting rid of fluids. This can cause swelling in your lower legs or hands. Water retention (swelling) in these areas is also common side effects of Duavee. So if you have heart failure, taking Duavee can make your swelling even worse. Before you start taking Duavee, make sure your doctor knows about any heart problems you have. If you have heart failure, your doctor may monitor your fluid levels more closely than usual during Duavee treatment. (For more information about swelling and other side effects, see the “Duavee side effects” section above.)
  • High triglyceride levels. You should be cautious about taking Duavee if your blood tests show have high levels of triglycerides. This is because Duavee can increase triglyceride levels even higher, which can lead to pancreatitis (inflammation of the pancreas). Your doctor will likely check your triglyceride levels before you start taking Duavee. If your levels are high, your doctor may monitor your triglycerides closely while you take Duavee. Or they may recommend a different treatment for you.
  • Liver tumors. Treatment with Duavee can worsen certain types of liver tumors. Be sure to tell your doctor if you have liver cancer or liver tumors before you start treatment with Duavee.
  • Migraine. Changes in levels of estrogen can trigger a migraine attack. If you get migraine attacks, tell your doctor before you start taking Duavee. They may suggest a different treatment.
  • Lupus. If you have lupus, taking Duavee treatment may trigger a lupus flare. (A lupus “flare” is an increase in your number or severity of lupus symptoms, or both.) Changes in estrogen levels can cause a flare, and Duavee contains estrogen. If you have lupus, be sure your doctor knows about your condition before you start taking Duavee. They may suggest a different treatment for your condition.
  • Hereditary angioedema (HAE). HAE causes episodes of severe swelling in certain areas of your body. Duavee can worsen swelling of your face or tongue. So if you have HAE, taking Duavee may increase your risk for facial swelling. Talk with your doctor about the risks and benefits of using Duavee if you have this condition.
  • Other hormone therapy. If you’re taking other types of hormone therapy, such as other estrogens, progestins, or selective estrogen receptor modulators (SERMs), you may have an increased risk for side effects from Duavee. Be sure to tell your doctor about all other medications you’re taking before you start taking Duavee. (For more information, see the “Duavee side effects” section above.)
  • History of jaundice. If you’ve had jaundice, you may have an increased risk for developing jaundice again after you start taking Duavee. Tell your doctor about any liver problems you’ve had before you start taking Duavee. Your doctor may monitor your liver more closely than usual while you’re taking Duavee. Or they may recommend a different medication.
  • Surgery or bed rest. Having surgery or being on bed rest can increase your risk for getting a blood clot. Blood clots are also a possible side effect of Duavee. So taking Duavee before having surgery or going on bed rest can raise your risk for blood clots even more. Be sure to tell your doctor if you’re using Duavee and you’re planning surgery or bed rest. Your doctor will decide if it’s safe for you to keep taking Duavee. (For information, see the “Duavee side effects” section above.)
  • Hypothyroidism. Duavee can decrease the levels of thyroid hormone in your body. So if you have hypothyroidism (low thyroid levels), taking Duavee can cause your thyroid levels to become even lower. If you’re taking thyroid replacement drugs, your doctor may change your dosage while you’re taking Duavee. Your doctor may also test your thyroid function more often. Talk with your doctor if you have questions about taking Duavee while you have hypothyroidism.
  • Hypoparathyroidism. If you have hypoparathyroidism (low parathyroid hormone levels), you may develop hypocalcemia (low calcium levels in your body). Taking Duavee can cause your calcium levels to drop even lower. And very low levels of calcium may lead to osteoporosis. Be sure to tell your doctor if you have hypoparathyroidism before you start taking Duavee. They may closely monitor your calcium levels during treatment.
  • Porphyria. Prophyria is a genetic condition that affects your skin and nervous system. Estrogen can worsen the symptoms of porphyria. Because Duavee contains estrogens, make sure to tell your doctor if you have porphyria. They may recommend a treatment other than Duavee for you.
  • Kidney problems. Problems with your kidneys, such as kidney disease, can cause water retention (swelling) in your lower legs or hands. Duavee may also cause water retention in these areas. So if you have kidney problems, taking Duavee can make your swelling even worse. Duavee is not recommended for people who have kidney problems. Be sure to tell your doctor if you have kidney problems. They may recommend a different treatment option for you.
  • Allergic reaction. If you’ve had an allergic reaction to Duavee or any of its ingredients, you shouldn’t take Duavee. Ask your doctor what other medications might be better options for you.
  • Pregnancy. Duavee shouldn’t be taken during pregnancy. For more information, see the “Duavee and pregnancy” section above.
  • Breastfeeding. Duavee shouldn’t be taken while breastfeeding. For more information, see the “Duavee and breastfeeding” section above.

Note: For more information about the potential negative effects of Duavee, see the “Duavee side effects” section above.

Using more than the recommended dosage of Duavee can lead to serious side effects.

Do not take more Duavee than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include:

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Duavee from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Duavee tablets should be stored at a room temperature of 68°F to 77°F (20°C to 25°C). The medication should be kept in its original packaging, away from light. Avoid storing Duavee in areas where it could get damp or wet, such as in bathrooms.

Disposal

If you no longer need to take Duavee and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

In adult women who have a uterus, Duavee is indicated for:

  • treatment of moderate to severe menopausal vasomotor symptoms
  • prevention of osteoporosis after menopause

Administration

Each tablet of Duavee contains 0.45 milligrams (mg) of conjugated estrogens and 20 mg of bazedoxifene. The recommended dosage is one tablet by mouth daily, with or without food.

Mechanism of action

Estrogen controls the secretion of follicle stimulating hormone, luteinizing hormone, and gonadotropins using a negative feedback loop. Estrogen lowers the levels of these hormones in postmenopausal women.

Bazedoxifene acts as an estrogen agonist in some tissues, while functioning as an antagonist in other tissues. Specifically, bazedoxifene acts as an estrogen antagonist in the uterus, thereby lowering the risk of endometrial cancer that occurs when estrogens stimulate growth of the uterine lining.

Pharmacokinetics and metabolism

After administration, peak concentrations of Duavee occurred between 2.5 and 6.5 hours. Its elimination half-life is about 17 hours. Duavee is metabolized primarily in the liver and is excreted in the bile and feces.

Contraindications

Duavee is contraindicated in women who have:

  • abnormal uterine bleeding without a formal diagnosis
  • allergy or hypersensitivity, such as anaphylactic reaction or angioedema, to Duavee or any of its ingredients
  • blood clotting disorders such as antithrombin, protein C, or protein S deficiency
  • history of breast cancer, suspected breast cancer, or a current diagnosis of breast cancer
  • current or suspected diagnosis of estrogen-dependent neoplasia
  • history or current diagnosis of venous thromboembolism (VTE) or arterial thromboembolism
  • liver disease
  • pregnancy

Storage

Duavee tablets should be stored at a room temperature of 68°F to 77°F (20°C to 25°C). Duavee should be kept in its original blister packaging, away from light. The drug shouldn’t be kept in areas where it could get damp or wet, such as in bathrooms.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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