Ospemifene

Generic Name: ospemifene (os-PEM-i-feen)
Brand Name: Osphena

Ospemifene may increase the chance of cancer of the uterus. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus. Tell your doctor right away if you have any unusual vaginal bleeding while you use ospemifene.

Ospemifene may also increase the chance of serious blood clots (eg, in the lungs or legs) or stroke. Tell your doctor right away if you have calf or leg pain, redness, tenderness, or swelling; chest pain; confusion; coughing up blood; one-sided weakness; shortness of breath; slurred speech; or vision problems.

Ospemifene should be used for the shortest possible length of time at the lowest effective dose. Talk with your doctor regularly about your need to use ospemifene.


Ospemifene is used for:

Treating painful intercourse due to vaginal changes (eg, dryness) caused by menopause. It may also be used for other conditions as determined by your doctor.

Ospemifene is an estrogen agonist/antagonist. It works like an estrogen to improve vaginal symptoms and decrease pain with intercourse.

Do NOT use ospemifene if:

  • you are allergic to any ingredient in ospemifene
  • you have unusual vaginal bleeding
  • you are pregnant or think you may be pregnant
  • you have known or suspected breast cancer or another estrogen-dependent cancer, or you have a history of breast cancer
  • you have active blood clots (eg, of the legs or lungs) or a history of blood clots
  • you have a history of heart attack or stroke
  • you have severe liver problems
  • you are taking estrogen, fluconazole, or rifampin

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using ospemifene:

Some medical conditions may interact with ospemifene. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a vaginal infection or a history of uterus problems (eg, fibroids, endometriosis, unusual vaginal bleeding, cancer), or you have had your uterus removed (hysterectomy)
  • if you have a history of breast lumps, breast disease, or an abnormal mammogram, or if a member of your family has had breast cancer
  • if you have high blood pressure, high blood cholesterol or triglyceride levels, diabetes, lupus, or a history of liver problems
  • if you smoke, use tobacco, are very overweight, will be having surgery, or will be confined to a bed or chair for a period of time
  • if a member of your family has a history of blood clots (eg, in the leg or lung), lupus, or is very overweight

Some MEDICINES MAY INTERACT with ospemifene. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Estrogen, fluconazole, or ketoconazole because they may increase the risk of ospemifene's side effects
  • Rifampin because it may decrease ospemifene's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if ospemifene may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use ospemifene:

Use ospemifene as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with ospemifene. Talk to your pharmacist if you have questions about this information.
  • Take ospemifene by mouth with food.
  • If you miss a dose of ospemifene, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use ospemifene.

Important safety information:

  • Tell your doctor or dentist that you take ospemifene before you receive any medical or dental care, emergency care, or surgery. If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor at least 4 to 6 weeks beforehand. You may need to stop taking ospemifene or take other special precautions for a period of time.
  • Lab tests may be performed while you use ospemifene. You should have breast and pelvic exams and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Talk with your doctor regularly (eg, every 3 to 6 months) about whether you need to continue taking ospemifene.
  • Ospemifene is not approved for use in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use ospemifene if you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if ospemifene if found in breast milk. If you are or will be breast-feeding while you use ospemifene, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of ospemifene:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Hot flashes; increased sweating; muscle spasms; vaginal discharge.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf or leg pain, redness, tenderness, or swelling; chest pain; confusion; coughing up blood; one-sided weakness; shortness of breath; slurred speech; severe or persistent tiredness or weakness; sudden, severe headache; unusual vaginal bleeding; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of ospemifene:

Store ospemifene at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep ospemifene out of the reach of children and away from pets.

General information:

  • If you have any questions about ospemifene, please talk with your doctor, pharmacist, or other health care provider.
  • Ospemifene is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take ospemifene or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ospemifene. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ospemifene. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using ospemifene.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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