Raloxifene

(Brand name: Evista^®)

Raloxifene is a drug treatment for osteoporosis. It can help to strengthen bones, making them less likely to break. It is taken as a daily tablet that you swallow. 

Because of the way it works, raloxifene will only be an option if you're a woman and have been through the menopause. It's only given to women who have already broken a bone due to osteoporosis and are at risk of breaking another. It'll probably be an option only if you've already tried one of the more common drug treatments, or if other treatments aren't suitable for you. 

Raloxifene is a type of medicine called a selective estrogen receptor modulator (SERM).

What does raloxifene do and how does it work? 

Raloxifene can help to make your bones stronger and reduce your risk of broken bones, particularly in your spine. 

Bones are made up of living tissue. The inside of our bones is constantly being broken down and rebuilt by specialist bone cells. As long as this process is in balance, your bones should stay healthy and strong.

But if the process becomes out of balance, our bodies can start to break down more bone than we build. This can cause the bones to become weaker and more likely to break easily. 

Around the time of a woman's menopause, her level of the female sex hormone oestrogen decreases. Oestrogen helps to keep bones strong, so this decrease in the level of oestrogen causes the bones to get weaker. 

Raloxifene is not oestrogen, but it acts like or 'mimics' oestrogen inside your bones. This can slow the breakdown of bone and help to keep your bones strong. 

You may still break a bone while taking raloxifene. If this happens, it doesn't necessarily mean the drug isn't working. No medication can stop all fractures, but taking raloxifene will make them much less likely. 

Raloxifene is not a pain-relieving medicine, so it won't reduce the pain caused by broken bones. But there are other treatments and ways to manage pain. 

Who can have raloxifene? 

Raloxifene may be suitable if you have been through the menopause and have already broken a bone because of osteoporosis. It will usually only be an option if you've already tried a standard drug treatment for your bones, or if other drugs aren't suitable for you. 

When is raloxifene not suitable? 

Raloxifene will not be suitable if you:

• are a man
• are a woman who has not yet been through the menopause
• have severe liver or kidney problems 
• have ever had a blood clot 
• are pregnant or breast-feeding 
• have unexplained bleeding from your vagina. 

There are some other situations where raloxifene may not be suitable. Your doctor should discuss your own personal risks and benefits with you, to help decide if raloxifene is the right treatment for you. 

For example, raloxifene may not be the best treatment option if: 

• you are at risk of developing blood clots - because taking raloxifene could add to this risk 
• you have had, or are at risk of having, a stroke - because while raloxifene does not increase the risk of having a stroke, people who have a stroke while taking the drug may be more severely affected
• you have breast cancer - you won't be able to start raloxifene until you've finished having cancer treatment, so a different osteoporosis drug treatment will probably be more suitable 
• you have a high risk of breaking a hip - because it isn't clear if raloxifene reduces the risk of hip fractures as much as other drugs. 

No link between raloxifene and a higher risk of breast of womb cancer

Some types of hormone replacement therapy (HRT) that contain oestrogen are linked with a small increase in the risk of breast or endometrial (womb lining) cancer. 

Raloxifene is not HRT and does not contain oestrogen. It acts like oestrogen inside your bones, but it does not harm breast or womb tissue. 

This means that taking raloxifene will not increase your risk of developing breast or endometrial cancer. In fact, raloxifene can help to lower the risk of certain types of breast cancer that are fuelled by oestrogen. 

However, raloxifene won't be an option if you currently have - or might have - breast or endometrial cancer. This is because it isn't clear whether it is safe to take raloxifene while you're having treatment for these types of cancer. 

How do I take raloxifene? 

You'll take one tablet (60mg) each day. Swallow the tablet whole, with a glass of water. You can take it at any time of the day, with or without food. 

If you miss a tablet

If you occasionally miss a tablet, this probably won't affect your bone health in the long term. But try to avoid this if you can. If you often forget your medication, talk to your doctor. They may be able to suggest a more suitable medication. 

How will my treatment be monitored?

You won’t need regular appointments while you’re taking raloxifene. Your doctor probably won’t need to see you again, unless you ask for an appointment to discuss your medication or general bone health.

Do speak to a doctor or pharmacist if you have any problems with your treatment. They may be able to suggest ways to help manage any side effects. You should also contact them if you’re struggling to take your tablets regularly.

If you break a bone while having raloxifene, speak to your GP. Breaking a bone doesn’t necessarily mean your treatment isn’t working. But it may be a good idea to have a bone health assessment. 

Unlike some other osteoporosis drug treatments, there’s no maximum length of time that you can stay on raloxifene. It’s common to keep taking it for several years. But you should still have a formal treatment review after about five years.

At this review, your doctor will check if you still need a drug treatment, and that raloxifene is still the right treatment for you. You may have a bone density scan, which will give your doctor some information about your bone strength. But they will need to consider other things as well, such as whether you’ve broken any bones since starting on raloxifene.

While there’s no way to prove for certain that your treatment is working, research has shown that raloxifene does lower the risk of broken bones, particularly in your spine.

After your review, your doctor may advise you to:

• stay on raloxifene
• start a different drug treatment instead of raloxifene
• stop having any treatment.

Your doctor can advise you on what’s best for you, based on your own situation.

What are the possible side effects?

As with any drug, raloxifene can sometimes cause side effects. The most common side effects are listed on page 4. 

It is important to remember that in general, side effects are less common than many people think. Most people on raloxifene don’t have any problems. Even if you do get side effects at first, they usually improve quickly and there are ways to manage them. 

For a full list of possible side effects, look at the patient information leaflet that comes with your tablets. If you don’t have a copy, ask your doctor or pharmacist for one.

It’s important to understand that many of these problems aren’t actually caused by the drug. When a medicine is first tested, the people taking it have to report anything unusual to the researchers. The problems they report are often just as common in people who aren’t taking the drug.

The following table has information on the main side effects and how common they are. For example, at least 1 person in every 10 people who take raloxifene will get hot flushes. Up to 9 in every 10 people who use the drug will not have this problem.

Uncommon health risks: 

If you do get any side effects that don't go away, it may help to: 

• make sure the problem isn’t caused by any other medication you are taking
• tell your doctor or pharmacist, who may be able to help find out what is causing the problem
• ask your doctor or pharmacist if any other treatments might be suitable for you.

Making a decision about treatment

As with any treatment, there are advantages and disadvantages to taking raloxifene. You should think about these when deciding whether to have raloxifene, and about what’s important to you. Here are some of the main things to consider.

Advantages

• It can help to reduce your risk of broken bones, particularly in your spine.
• You can take the tablet at any time of day, with or without food. Many people find this easier than other osteoporosis drug treatments.

Disadvantages

• As with all medications, some people get side effects.
• Daily tablets aren’t suitable for everyone.

If you’ve thought carefully about the advantages and disadvantages but still feel unsure, we have more information to help guide you through deciding whether or not to have a drug treatment.

Content reviewed: April 2023