Raloxifene oral tablet side effects: A detailed guide

Specifically, the Food and Drug Administration (FDA) has approved raloxifene oral tablet to:

• prevent and treat osteoporosis after menopause (the end of periods)
• lower the risk of invasive breast cancer after menopause if you have osteoporosis or are at high risk of invasive breast cancer

This article describes possible side effects of raloxifene oral tablet. You’ll also find information on cost savings and coupon options for raloxifene. You can explore this overview article to learn more about raloxifene, including the drug’s uses, side effects, ways to save on cost, and more.

Raloxifene oral tablet is a generic version of the brand-name drug Evista.

Boxed warning: Risk of blood clots and death from stroke

Raloxifene oral tablet has a boxed warning for the risk of blood clots and death from stroke. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

For details, see the “Side effects of raloxifene in detail” section below.

More common side effects of raloxifene

Raloxifene oral tablet may cause mild or serious side effects. Below are some of the more common side effects of this medication.

Commonly reported side effects of raloxifene oral tablet include:

• hot flashes*
• joint pain
• leg cramps
• sweating
• swelling in the feet, ankles, or legs due to fluid retention

* To learn more about this side effect, see the “Side effects of raloxifene in detail” section below.

Mild side effects of raloxifene

Raloxifene oral tablet may cause certain mild side effects. Usually, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.

Mild side effects of raloxifene oral tablet that occurred in studies include:

• diarrhea
• gas
• headache
• hot flashes*
• joint pain
• leg cramps
• muscle aches
• nausea or vomiting
• sleep problems
• sweating
• swelling in the feet, ankles, or legs due to fluid retention
• vaginal discharge or itching
• weight gain
• mild allergic reaction*†

Raloxifene oral tablet may cause more mild side effects than those listed above. For details, see the drug’s prescribing information.

* To learn more about this side effect, see the “Side effects of raloxifene in detail” section below.
† An allergic reaction is possible with raloxifene oral tablet. But it’s unclear whether it occurred in the drug’s studies.

Serious side effects of raloxifene

Raloxifene oral tablet may cause certain serious side effects. If you have any serious side effects from raloxifene oral tablet, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.

After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with raloxifene oral tablet.

Serious side effects of raloxifene oral tablet that occurred in studies include:

• risk of blood clots and death from stroke*†
• severe allergic reaction*‡

* To learn more about this side effect, see the “Side effects of raloxifene in detail” section below.
† Raloxifene oral tablet has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of raloxifene in detail” section below.
‡ An allergic reaction is possible with raloxifene oral tablet. But it’s unclear whether it occurred in the drug’s studies.

Common questions about side effects of raloxifene

Here are answers to some common questions about the side effects of raloxifene oral tablet. If you have other questions, talk with your doctor or pharmacist.

How do side effects of raloxifene compare with those seen with tamoxifen?

Raloxifene oral tablet and tamoxifen are both selective estrogen receptor modulators (SERMs). So they have similar side effects and warnings. This includes boxed warnings about the risk of blood clots and death from stroke. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Side effects of raloxifene in detail” section below.

Tamoxifen also has a boxed warning about an increased risk of uterine cancer. Raloxifene oral tablet doesn’t have this boxed warning. In studies comparing raloxifene to tamoxifen, the risk of uterine cancer was lower in the raloxifene group.

You can learn more about how the side effects and warnings for these two drugs compare by talking with your doctor.

If I stop taking raloxifene, will I experience certain side effects?

No, stopping raloxifene oral tablet isn’t likely to cause specific side effects. But stopping it can cause problems if you also take the drug warfarin. Stopping raloxifene also means you aren’t getting the benefits of its effect on your condition.

If you want to stop taking raloxifene, talk with your doctor first. They can help make sure it’s safe to stop it or suggest other treatment options.

Does raloxifene cause long-term side effects?

No, long-term side effects are unlikely with raloxifene oral tablet. In studies, specific side effects weren’t seen in people who had taken the drug for a long time. Also, long-term side effects weren’t reported after treatment had ended.

Talk with your doctor if you have any questions about possible long-term side effects with raloxifene.

Coupon for raloxifene

Visit this page to access Optum Perks coupons and get price estimates for raloxifene when you use the coupons. These coupons can provide significant savings on your prescription costs.

Note: Optum Perks coupons cannot be used with insurance copays or benefits.

Side effects of raloxifene in detail

Below you’ll find details on some of the side effects of raloxifene oral tablet.

Risk of blood clots and death from stroke

Raloxifene has a boxed warning for the risk of blood clots and death from stroke. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

Taking raloxifene oral tablet increases the risk of deep vein thrombosis (DVT), which is a blood clot in the legs. It also increases the risk of pulmonary embolism (PE), which is a blood clot in the lung. It may also increase the risk of death from stroke. In studies, these serious conditions were rare in people taking raloxifene oral tablet. The risk of blood clots is highest in the first few months after starting treatment.

Symptoms of a DVT blood clot include:

• pain
• swelling
• warmth in the leg with the clot

Symptoms of a PE blood clot include:

• breathing problems
• chest pain
• coughing up blood

Symptoms of a stroke include:

• drooping on one side of the face
• slurred speech
• sudden weakness or numbness on one side of the body or face
• trouble speaking or understanding what people are saying to you
• vision changes

Certain factors can increase your risk of blood clots and stroke with raloxifene oral tablet. These include:

• sitting still for a long time
• having had a blood clot in your legs, lungs, or eye in the past
• having had a heart attack in the past
• having risk factors for a heart attack

Due to the risk of blood clots and death from stroke, doctors usually don’t prescribe raloxifene oral tablet to people who have blood clots or have had them in the past.

Ways to manage

If you have concerns about the risk of blood clots or stroke, tell your doctor. If you experience any of the symptoms of a blood clot or stroke, seek emergency medical care or call 911.

Hot flashes

In studies, hot flashes were very common in people taking raloxifene oral tablet. Hot flashes mostly happened in the first 6 months after starting treatment. This side effect is usually mild.

With hot flashes, you have a sudden feeling of warmth that spreads through your body. It can be most intense in your face, neck, and chest. Symptoms may also include flushing and sweating.

Ways to manage

If you have hot flashes, you can try managing them with lifestyle measures. Some options include dressing in layers, sipping on a cool drink, or carrying a portable fan. Keep in mind, hot flashes are most common in the first 6 months after starting treatment. Tell your doctor if hot flashes last longer than that or become bothersome.

Allergic reaction

For some people, raloxifene oral tablet can cause an allergic reaction. But it’s not clear whether this side effect occurred in the drug’s studies.

Symptoms can be mild or serious, and they may include:

• itchiness
• skin rash
• swelling under the skin, usually affecting eyelids, lips, hands, or feet
• swelling of the mouth, tongue, or throat, which can make it hard to breathe
• flushing (temporary warmth, redness, or deepening of skin color)

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to raloxifene oral tablet, your doctor may recommend taking a different medication instead.

Warnings for raloxifene

Below are some factors you may want to discuss with your doctor before taking raloxifene oral tablet.

Boxed warning: Risk of blood clots and death from stroke

Raloxifene has a boxed warning for the risk of blood clots and death from stroke. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

For details, see the “Side effects of raloxifene in detail” section above.

Warnings

It may not be safe for you to take raloxifene oral tablet if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether raloxifene oral tablet is a safe treatment option for you.

Before taking raloxifene oral tablet, tell your doctor about your health and medications you take. Things to consider include:

• kidney problems
• liver disease
• past blood clots in the legs, lungs, or eyes
• past breast cancer
• past heart attack
• past allergic reaction to raloxifene

Raloxifene and pregnancy

Raloxifene oral tablet should not be taken during pregnancy. Raloxifene oral tablet is for use after menopause (the end of your periods). This means it wasn’t studied in people who were pregnant.

Raloxifene and breastfeeding

Raloxifene oral tablet should not be taken while breastfeeding. Raloxifene oral tablet is for use after menopause (the end of your periods). This means it wasn’t studied in people who were breastfeeding.

Raloxifene and alcohol

Raloxifene oral tablet is not known to interact with alcohol.

But drinking a lot of alcohol increases the risk of osteoporosis and breast cancer. Keep in mind, doctors prescribe raloxifene oral tablet for both of these conditions.

If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with raloxifene oral tablet.

What to ask your doctor

This article describes common and serious side effects of raloxifene oral tablet. If your doctor prescribes this medication, they can discuss possible side effects with you. Let your doctor know if you have concerns or questions about treatment with this medication.

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

• How do the side effects of raloxifene oral tablet compare to other medications for my condition?
• Am I at higher risk of side effects from raloxifene oral tablet than other people?
• What can I do to lower my risk of side effects from raloxifene oral tablet?

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.