Overview: Osphena is used to reduce vaginal dryness or pain during sex in people after menopause. It acts like estrogen in the vaginal area to thicken the walls of the vagina, increase moisture, and increase vaginal secretions. The most common side effects are hot flashes, vaginal discharge or bleeding, and headache. Talk with your healthcare provider right away about any unusual vaginal bleeding or headaches.
Uses
What is Osphena used for?
Osphena (ospemifene) is commonly used to reduce postmenopausal vaginal dryness or pain during sex.
Osphena may also be used for other conditions as determined by your healthcare provider.
How does Osphena work (mechanism of action)?
Osphena acts like estrogen (a natural hormone) in some tissues and blocks estrogen activity in other tissues. Vaginal dryness and pain during sex can be a symptom of vulvovaginal atrophy (thinning, drying, irritation of the vagina and surrounding tissues). Osphena binds to estrogen receptors acting like estrogen in the vaginal area to thicken the walls of the vagina, increase level moisture in that area, and increase vaginal secretions to reduce vaginal dryness and pain during sex.
How is Osphena supplied (dosage forms)?
Brands and other names
- Osphena
Dosage forms and strengths
- 60 mg oral tablets
How should I store Osphena?
Osphena should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.
Side Effects
What are the most common side effects of Osphena?
The most common side effects of Osphena are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Hot flashes
- Vaginal discharge or bleeding
- Muscle spasms
- Headache
- Excessive sweating, including night sweats
There may be other side effects of Osphena that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Osphena?
While less common, the most serious side effects of Osphena are described below, along with what to do if they happen.
Severe Allergic Reactions. Osphena may cause allergic reactions, which can be serious. Stop taking Osphena and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Blood Clots. Osphena may cause blood clots in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep venous thrombosis (DVT). Stop taking Osphena and get emergency help if you have any of the following signs of blood clots.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech or trouble understanding speech
- Pain, swelling, or tenderness in your arm or leg
- Vision loss
- Bulging eyes
- Double vision
Uterine Cancer. You may be at higher risk for cancer of the uterus (womb) or in the lining of your uterus (endometrial cancer) if you take Osphena. Call your healthcare provider right away if you have any of the following symptoms.
- Abnormal vaginal bleeding or discharge
- Pain when you have sex
- Difficulty or pain when you pee
Warnings & Precautions
Who should not use Osphena?
Allergies to Ingredients. People who are allergic to any of the following should not take Osphena.
- Osphena
- Ospemifene
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Osphena.
Pregnant. Do not take Osphena if you are pregnant. If you become pregnant, contact your healthcare professional right away. See the Pregnancy section for more details.
Unusual Vaginal Bleeding. Osphena should not be taken if you have abnormal bleeding from your vagina that has not been diagnosed by a healthcare provider.
Blood Clots. Osphena should not be taken if you have now or have a history of blood clots in your veins, such as a deep venous thrombosis (DVT), or your lungs, such as a pulmonary embolism (PE).
Estrogen Dependent Cancer. Osphena should not be taken if you have cancer that needs estrogen to grow. Examples of these cancers include some breast cancers, ovarian cancer, and endometrial or uterine cancer.
Stroke or Heart Attack. Osphena should not be taken if you have had a stroke or heart attack.
What should I know about Osphena before using it?
Do not take Osphena unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Osphena with other people, even if they have the same condition as you. It may harm them.
Keep Osphena out of the reach of children.
Take Osphena once a day with food.
You should perform monthly self-breast exams and have regular breast exams (done by a healthcare provider) and mammograms (x-ray to look closely at breast tissue) before taking Osphena and during treatment with it.
What should I tell my healthcare provider before using Osphena?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Osphena is right for you.
In particular, make sure that you discuss any of the following.
Other Medicines and Supplements. Osphena may interact with other medicines and supplements. Before using/taking Osphena, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Liver Problems. Osphena should not be used if your liver is not working as well as it should be. If there is a concern about the health of your liver, your healthcare provider may do tests to determine if it is working well enough to take this medicine.
Upcoming Surgery or Bed Rest. You may be at increased risk for some side effects of Osphena if you do not move around normally for an extended period of time. Tell your healthcare provider if you have any upcoming surgeries or need to be on bed rest. Your healthcare provider can tell you if or when you need to stop taking Osphena.
Pregnancy. Do not take Osphena and tell your healthcare provider if you are, think you are, or plan to become pregnant. Osphena may cause harm to an unborn baby.
Breastfeeding. It is not known if Osphena passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should stop breastfeeding or stop Osphena.
How can I get more information about Osphena?
For more information about Osphena, you can visit the manufacturer’s website at www.osphena.com or call them at 888-559-2188.
Interactions
Does Osphena interact with foods or drinks?
There are no known interactions between Osphena and foods or drinks.
It is unknown if drinking alcohol will affect Osphena. However, the risk of hot flashes may be increased if you drink alcohol while taking Osphena because alcohol can trigger hot flashes.
Does Osphena interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are taking.
In particular, make sure that you discuss if you are taking any of the following before taking Osphena.
- Ketoconazole or fluconazole (Diflucan), which is a medicine used for fungal infections
- Rifampin, which is a medicine commonly used to treat an infection called tuberculosis
- Estrogen, such as certain birth control pills or estrogen patches, creams, rings, or vaginal suppositories
- Conjugated estrogens/bazedoxifene (Duavee), raloxifene (Evista), tamoxifen (Nolvadex, Soltamox), or toremifene (Fareston), which is a medicine commonly used for bone loss or weak bones (osteoporosis), symptoms of menopause, or to treat or prevent certain types of breast cancer
Some other medicines may alter the blood levels of Osphena, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Osphena. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Osphena?
If you or someone else has used too much Osphena, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Osphena?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.
Are you currently using Osphena (ospemifene)?
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