Ospemifene Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Ospemifene Tablet (ospemifene) is a prescription selective estrogen receptor modulator (SERM) used by postmenopausal women to treat moderate to severe vaginal dryness and painful sexual intercourse caused by menopause. It acts like estrogen in certain tissues, especially the vaginal lining, without being a hormone itself. It is taken once daily by mouth with food, and carries warnings related to uterine lining changes, stroke, and blood clots.

What is Ospemifene Tablet

Ospemifene is a prescription tablet used by postmenopausal women to treat vaginal dryness and painful sexual intercourse caused by menopause. It acts like the hormone estrogen in some parts of the body, but it is not itself a hormone.

Ospemifene Tablet uses

• Treats moderate to severe painful sexual intercourse (dyspareunia) caused by menopause
• Treats moderate to severe vaginal dryness caused by menopause
• Treats vaginal irritation related to menopause

Benefits of Ospemifene Tablet

• Helps relieve moderate to severe pain during sexual intercourse (dyspareunia) caused by menopause
• Helps improve moderate to severe vaginal dryness associated with menopause
• Helps improve the thickness and condition of vaginal tissues
• Reduces symptoms of vulvar and vaginal atrophy after menopause
• Provides an oral non-estrogen treatment option with estrogen-like effects on vaginal tissue

How Ospemifene Tablet works

Ospemifene works by acting like estrogen in some tissues of the body, especially binding to estrogen receptors in the vaginal lining. This helps restore vaginal tissue and can improve dryness and pain during sex.

Ospemifene Tablet dosage

Take by mouth with a glass of water and with food. Take at around the same time every day. Follow the directions on your prescription label and do not take it more often than directed. Do not stop taking it unless your care team tells you to. This medicine is not approved for use in children.

If you miss a dose, take it as soon as you can; if it is almost time for your next dose, skip the missed dose and take your next dose at the regular time. Do not take double or extra doses.

Women who are pregnant or may become pregnant should not handle the tablets or breathe in dust from them, since the drug can be absorbed through skin and lungs.

Available forms and strengths

• Tablet

Side effects of Ospemifene Tablet

Common

• Excessive sweating
• Headache
• Hot flashes
• Muscle spasms
• Vaginal discharge
• Night sweats
• Flushing (feeling of warmth, redness of face, neck, arms, and sometimes upper chest)

Serious

• Allergic reactions such as skin rash, itching, hives, or swelling of the face, lips, tongue, or throat
• Signs of a blood clot, such as pain, swelling, or warmth in the leg, shortness of breath, or chest pain
• Signs of a stroke, such as sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance, dizziness, severe headache, or vision changes
• Vaginal bleeding after menopause or pelvic pain
• Angioedema (large, hive-like swelling of the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs)

Warnings and precautions

• This medicine may increase the risk of a cancer of the lining of the uterus (endometrial cancer). Report any unusual vaginal bleeding to your doctor immediately.
• This medicine may increase the risk of stroke and blood clots. Tell your doctor about any personal or family history of stroke, heart attack, or blood clots.
• Smoking increases the risk of blood clots or stroke while taking this medicine, and this risk is higher for women over 35.
• This medicine does not prevent hot flashes and may actually cause them in some people.
• If your uterus has not been removed, your doctor may prescribe a progestin along with this medicine to lower the risk of uterine lining changes that could lead to cancer, though the progestin itself carries additional risks to discuss with your doctor.
• You may need to stop taking this medicine before surgery or a long period of bed rest, so tell any doctor or dentist treating you that you take this medicine.
• Ospemifene should not be used during pregnancy, as it may harm an unborn baby. If you think you might be pregnant, stop taking it and contact your doctor right away.
• There isn't enough research to know how this medicine affects a breastfeeding infant, so you should weigh the possible benefits and risks with your doctor before using it while breastfeeding.
• Tell your doctor if you have or have ever had liver disease, since this medicine may not be recommended for people with severe liver disease.
• Alcohol may interact with this medicine, so talk with your healthcare professional about using alcohol while taking it.

Storage

• Store at 20–25°C (68–77°F) at controlled room temperature.
• Keep tablets in the original, tightly closed container until use.
• Protect from excessive heat, moisture, and direct sunlight.
• Avoid storing in bathrooms or other hot and humid areas.
• Keep out of reach and sight of children and pets.

When to see a doctor

• Get medical help right away if you have signs of an allergic reaction, such as rash, itching, hives, or swelling of the face, lips, tongue, or throat.
• Call your doctor immediately if you have signs of a blood clot or stroke, such as leg swelling or pain, warm or red skin, slurred speech, dizziness, weakness or numbness in an arm or leg, sudden severe headache, sudden vision changes, chest pain, or shortness of breath.
• Contact your doctor right away if you have any unusual vaginal bleeding while taking this medicine.
• If you think you may be pregnant while taking this medicine, stop taking it and call your doctor immediately.
• If you think you have taken too much of this medicine, contact a poison control center or go to an emergency room right away.

Alternatives

• Intrarosa
• Imvexxy
• Vagifem
• Yuvafem