Ospemifene

Ospemifene is a prescription medication used to treat painful sexual intercourse caused by changes in the tissues in the vagina due to menopause. 

Ospemifene belongs to a group of drugs called estrogen agonist/antagonists. Although it is not an estrogen, it works by binding to estrogen receptors in some tissues and blocking estrogenic pathways in others. 

This medication comes in tablet form. It is taken once daily, with food. 

Common side effects include hot flashes, vaginal discharge, muscle spasms, and increased sweating.

Ospemifene is a prescription medication used to treat painful sexual intercourse caused by changes in the tissues in the vagina due to menopause.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ospemifene may be found in some form under the following brand names:

• Osphena

Serious side effects have been reported with ospemifene. See the "Ospemifene Precautions" section. 

Common side effects of ospemifene include the following:

• hot flashes
• vaginal discharge
• muscle spasms
• increased sweating

This is not a complete list of ospemifene side effects. Ask your doctor or pharmacist for more information. 

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. 

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you are taking:

• estrogens or estrogen agonist/antagonist such as estradiol (Estrace)
• fluconazole and ketoconazole
• rifampin 

This is not a complete list of ospemifene drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with ospemifene including the following:

• stroke
• blood clots
• cancer of the lining of the uterus (womb)
• unusual vaginal bleeding. 
• changes in vision or speech
• sudden new severe headaches
• severe pains in your chest or legs with or without shortness of breath, weakness and fatigue

Tell your doctor right away if you notice any of the side effects listed above. 

Do not take ospemifene if you:

• are allergic to ospemifene or any of its ingredients
• have unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
• currently have or have had certain cancers. Estrogen may increase the chances of getting certain types of cancers, such as cancer of the lining of the uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take ospemifene.
• currently have or have had blood clots
• had a stroke or heart attack
• liver failure. Ospemifene should not be used in women whose liver does not work well
• think you may be pregnant. Ospemifene is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not take ospemifene if the test is positive and talk to your healthcare provider.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ospemifene, there are no specific foods that you must exclude from your diet when receiving this medication. 

Before taking ospemifene, tell your doctor about all of your medical conditions. Especially tell your doctor if:

• are allergic to ospemifene or any of its ingredients
• have any unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
• have any other medical conditions such as severe liver problems.
• are going to have surgery or will be on bed rest. Your healthcare provider will let you know if you need to stop taking ospemifene
• are pregnant or plan to become pregnant. 
• are breast feeding. It is not known if ospemifene can pass into your breast milk.

Tell you doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ospemifene falls into category X. It has been shown that women taking ospemifene during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweighs the risks of harm to the baby. This medication should never by used by pregnant women. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if ospemifene crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or to stop use of this medication. Your doctor and you will decide if the benefits outweight the risk of using ospemifene. 

Take ospemifene exactly how your healthcare provider tells you to take it.

• Take ospemifene by mouth 1 time each day with food.
• You and your healthcare provider should talk regularly (every 3 to 6 months) about the dose you are taking and whether or not you still need treatment with ospemifene.

It is recommended you have a pelvic exam, breast exam and mammogram (breast x-ray) every year unless your healthcare provider tells you something else.

If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram (breast x-ray), you may need to have breast exams more often.

If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or use tobacco, you may have a higher chance of getting heart disease. 

If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• your treatment goals
• your risks with this medication

The recommended dose of Osphena (ospemifene) for the treatment of painful sexual intercourse caused by changes in the tissues in the vagina due to menopause is one 60 mg tablet once daily with food. 

If you take too much ospemifene, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

• Store ospemifene at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep this and all medications out of the reach of children. 

OSPHENA is a medicine that works like estrogen in the lining of the uterus (womb), but can work differently in other parts of the body.

Taking estrogen-alone or OSPHENA may increase your chance of getting cancer of the lining of the uterus (womb). Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Tell your healthcare provider right away if you have any unusual vaginal bleeding while you are taking OSPHENA.

OSPHENA may increase your chance of getting strokes and blood clots.

You and your healthcare provider should talk regularly about whether you still need treatment with OSPHENA.