Osphena

Introduction

Written by Sarah Lewis, PharmD
Medically reviewed by Amber Watson, PharmD 
Updated on October 12, 2023

Osphena (os fee’ nah) is a brand-name medication prescribed for certain symptoms of menopause (the end of monthly periods). Osphena belongs to a group of drugs called selective estrogen receptor modulators (SERMs).

Boxed warnings

Osphena has boxed warnings about the risks of endometrial cancer and serious heart and blood vessel problems. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

For details, see the “Interactions and warnings for Osphena” section.

Common questions about Osphena

Below you’ll find answers to a few commonly asked questions about Osphena.

Can Osphena cause weight gain or hair loss?

No, weight gain or hair loss aren’t expected side effects of Osphena. These problems weren’t reported in studies of Osphena. But both weight gain or hair loss can be symptoms of menopause (the end of monthly periods). Hormonal changes during this time play a role in both of them.

Doctors prescribe Osphena to treat certain symptoms of menopause associated with changes in the vagina. But it isn’t approved to treat weight gain or hair loss related to menopause. 

If you’re experiencing weight gain or hair loss, talk with your doctor. They can suggest ways to manage them.

Is Osphena similar to estradiol?

Yes, Osphena is similar to estradiol in some ways. Estradiol is a kind of hormone called estrogen. Osphena has the same effects as estrogen in the vagina, vulva, and uterus. This is how it relieves certain menopause symptoms in the vagina and vulva. But unlike estradiol, it can block the effects of estrogen in other parts of the body.

Osphena isn’t a hormone, so this also makes it different from estradiol. It’s one of the alternatives to hormone replacement therapy for menopause.

You can learn more about how these two medications compare by talking with your doctor or pharmacist.

How does Osphena work? And how long does it take to start working?

Osphena works by acting like estrogen in the vagina, vulva, and uterus. In menopause, symptoms of vaginal dryness and pain can occur from having low estrogen levels. By acting like estrogen, Osphena can help relieve these symptoms. 

Osphena may start working to improve your symptoms within a few weeks of starting it. But it can take up to 12 weeks to see its full effect. 

If you’d like to know more about how Osphena works, talk with your doctor or pharmacist.

Side effects of Osphena

Osphena may cause mild or serious side effects. More common mild side effects of Osphena and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

To learn more about Osphena’s side effects, ask your doctor or pharmacist. You can also refer to the prescribing information for Osphena listed in the “Resources” section.

Mild side effects

More common mild side effects reported with Osphena are listed below. 

This article doesn’t include all possible mild side effects of the drug. To learn more about Osphena’s side effects, refer to the prescribing information for Osphena listed in the “Resources” section.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Osphena’s mild side effects include:

• hot flashes
• muscle spasms
• sweating
• vaginal discharge
• mild allergic reaction*

* For details about this side effect, see the “Interactions and warnings for Osphena” section.

Serious side effects

Serious side effects of Osphena are listed below. 

This article doesn’t include all possible serious side effects of the drug. To learn more about Osphena’s side effects, refer to the prescribing information for Osphena listed in the “Resources” section.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.

In general, Osphena’s serious side effects include: 

• boxed warning: risk of endometrial cancer and serious heart and blood vessel problems*
• severe allergic reaction*

* For details about this side effect, see the “Interactions and warnings for Osphena” section.

Uses of Osphena

The Food and Drug Administration (FDA) approves prescription drugs such as Osphena for certain conditions. Approved uses for Osphena are described below. 

Use for symptoms related to menopause

Doctors may prescribe Osphena oral tablet for treating certain symptoms of menopause (the end of monthly periods). It’s used for this purpose in adults. It’s usually prescribed as a long-term treatment. But doctors try to limit treatment with Osphena to the shortest period of time possible.

With menopause, low estrogen levels cause changes in the vaginal and vulval tissues. This leads to thinning of these tissues, which can cause dryness and pain during sex. Osphena can help relieve these symptoms.

Interactions and warnings for Osphena

Below you’ll find information about Osphena’s possible interactions and warnings.

Interactions of Osphena

Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.

Before you take Osphena, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:

• prescription or over-the-counter drugs 
• vitamins, herbs, or supplements

To learn about drug-condition interactions, see the “Warnings for Osphena” section below.

Warnings for Osphena

Some people should not take Osphena, and others should take it cautiously.

Boxed warnings

Osphena has boxed warnings about the risk of endometrial cancer and serious heart and blood vessel problems. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

To learn more about these warnings, read below. You can also talk with your doctor or pharmacist.

Risk of endometrial cancer. Taking Osphena may increase the risk of developing endometrial cancer (cancer of the lining of the uterus). This side effect wasn’t reported in studies of Osphena. But endometrial cancer is a known risk of using the hormone estrogen. Because Osphena acts like estrogen in the uterus, endometrial cancer is a risk.

Symptoms may include:

• fullness in the lower belly
• painful sex
• pelvic pain
• vaginal bleeding or spotting after menopause

If you experience any of these symptoms, tell your doctor. They’ll likely recommend testing to find the cause.

Risk of serious heart and blood vessel problems. Taking Osphena increases the risk of stroke, heart attack, and blood clots, including deep vein thrombosis (DVT). These side effects were rarely reported in studies of Osphena.

Symptoms may include:

• chest pain, pressure, or discomfort
• leg pain, coolness, or discoloration
• shortness of breath
• trouble speaking
• drooping on one side of the face
• weakness or numbness on one side of the body

If you experience any of these symptoms, seek emergency medical care or call 911.

Other warnings

Osphena could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether Osphena is a safe option for you. 

Ask your doctor about specific warnings for Osphena, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Allergic reaction

Osphena can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to Osphena or any of its ingredients, your doctor will likely not prescribe Osphena. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause breathing problems

If you have an allergic reaction to Osphena, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Overdose of Osphena

If you take Osphena by mouth, you should not take more Osphena than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.

If you think you’ve taken too much Osphena, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

Pregnancy or breastfeeding and Osphena

Information about Osphena and pregnancy and breastfeeding is described below.

Osphena and pregnancy

Osphena should not be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. Your doctor may suggest birth control options to use during treatment with Osphena.

Osphena and breastfeeding

Osphena should not be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other ways to feed your child during treatment with Osphena.

What to ask your doctor

Let your doctor know if you have questions about Osphena or would like more details about it.

Here’s a list of some possible questions you may want to ask your doctor:

• How should I take Osphena?
• Am I at higher risk of side effects than other people?
• What alternative medications are available to treat my condition?
• What are my options if I can’t afford my medication?

Resources

• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
• Osphena (ospemifene) tablets, for oral use. (2023). https://files.duchesnay.com/duchesnay-usa/osphena/osphena-prescribing-information.pdf

Disclaimer: Optum Perks 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 another 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.