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Osphena

ospemifene
Used for Menopause, Atrophic Vaginitis
Used for Menopause, Atrophic Vaginitis

Osphena (ospemifene) is a medication that helps with vaginal dryness and painful sex for people who have gone through menopause. This medication belongs to a drug class called selective estrogen receptor modulators, or SERMs. Osphena (ospemifene) is a tablet that's taken by mouth once every day. Some side effects include hot flashes and vaginal discharge.

Reviewed by:
reviewer
Cydnee Ng, PharmD
reviewer
Michelle Nguyen, PharmD
Last reviewed on July 7, 2024
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageInteractionsCostContraindicationsAlternativesLatest newsImagesReferencesPricesMedicare
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What is Osphena (ospemifene)?

What is Osphena (ospemifene) used for?

How Osphena (ospemifene) works

Estrogen helps moisten the lining of your vagina. During menopause, your estrogen levels drop, which cause your vagina to become dry and irritated. This can make sex painful and uncomfortable.

Osphena (ospemifene) is a selective estrogen receptor modulator, or SERM for short. This medication acts like estrogen in your vaginal tissue. This helps relieve vaginal dryness and make sex less painful.

Drug Facts

Common BrandsOsphena
Drug ClassSelective estrogen receptor modulator (SERM)
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only

More on Osphena (ospemifene) essentials

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Written by Tegan Smedley, PharmD, BCPS, APh
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What are the side effects of Osphena (ospemifene)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Hot flashes (12%)
  • Vaginal discharge (6%)
  • Muscle spasms (5%)

Other Side Effects

  • Headaches
  • Excessive sweating
  • Vaginal bleeding
  • Night sweats

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Blood clot in arm or leg: swelling, pain, or tenderness in the arm or leg; skin that's warm to the touch
  • Blood clot in the lung: trouble breathing, chest pain
  • Heart attack: chest pain, arm pain, shortness of breath, cold sweat, lightheadedness
  • Stroke: sudden weakness on one side of the body, drooping face, changes in your speech or vision, confusion, bad headache
  • Abnormal vaginal bleeding that doesn't go away or keeps happening

Source: DailyMed

The following side effects have also been reported

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Vaginal bleeding

Incidence not known

Anxiety

change in vaginal discharge

chest pain

cough

dizziness or lightheadedness

fainting

fast heartbeat

fever

hives, itching, skin rash

hoarseness

irritation

joint pain, stiffness, or swelling

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

pain or feeling of pressure in the pelvis

pain, redness, or swelling in the arm or leg

redness of the skin

swelling of the eyelids, face, lips, hands, or feet

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

tightness in the chest

troubled breathing or swallowing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Feeling of warmth

redness of the face, neck, arms, and occasionally, upper chest

sudden sweating

white or brownish vaginal discharge

Less common

Headache

increased sweating

muscle spasms

night sweats

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

pros-and-cons

Pros and cons of Osphena (ospemifene)

thumbs-up

Pros

Taken just once daily

Generally well tolerated

thumbs-down

Cons

Might have bothersome hot flashes

Might not be the best option for people with risk factors for blood clots or for people with severe liver problems

No lower-cost generic available; brand name only

pharmacist-tips

Pharmacist tips for Osphena (ospemifene)

pharmacist

  • Take Osphena (ospemifene) once a day with food. Taking the medication with food helps it get absorbed into the body better.

    • It's normal to experience hot flashes, vaginal discharge, and sweating while you're taking Osphena (ospemifene). Talk to a healthcare professional if these symptoms become too bothersome for you.

      • If you have a hot flash, it's recommended to limit how much spicy foods you eat or how much alcohol and caffeine you drink. These foods and beverages can make hot flashes feel worse. Keep a fan nearby and keep your room cool to help you feel more comfortable when you get hot flashes.

        • Tell your prescriber about any planned surgeries or bedrest. Some types of surgeries and periods of time when you won't be moving much can put you at risk for blood clots while you're taking Osphena (ospemifene). Your prescriber can tell you when to stop taking Osphena (ospemifene) — typically at least 4 to 6 weeks before — and when you can restart the medication. This helps lower the risk for blood clots.

          • Don't take other estrogen medications to help with menopause symptoms with Osphena (ospemifene). We don't know how safe it is to take these medications at the same time.

            faqs

            Frequently asked questions about Osphena (ospemifene)

            Does Osphena (ospemifene) cause hair loss?
            People who took Osphena (ospemifene) during clinical studies didn't report any hair loss. Let your healthcare team know if you notice any hair thinning or hair loss while you're taking this medication. They might suggest that you visit your primary care provider to check out what could be causing hair loss.
            Does Osphena (ospemifene) cause weight gain?
            People who took Osphena (ospemifene) during clinical studies didn't report gaining weight. Keep in mind that it can be normal to gain weight during menopause. Speak with a healthcare professional if you notice unwanted weight gain while you're taking Osphena (ospemifene). Your healthcare team can recommend ways to manage weight during menopause, such as getting exercise like swimming and yoga and creating balanced and nutritious meals.
            How long can you take Osphena (ospemifene)?
            It isn't clear how long you can take Osphena (ospemifene) for. Clinical studies have looked into how safe the medication is for up to a year of use. This means that we don't know how safe Osphena (ospemifene) is beyond a year of use. Follow up with your prescriber about how well the medication is working to improve your symptoms. And discuss with them about how long you should take Osphena (ospemifene).
            Can I just stop taking Osphena (ospemifene)?
            It's always a good idea to check with your prescriber before you stop taking Osphena (ospemifene). There are no known reports of bothersome side effects happening after people stop taking the medication. But you should discuss with your prescriber whether your symptoms are manageable enough to stop treatment and whether you're having bothersome side effects from the medication itself. Your prescriber can best advise what you should do next.
            Can you take Osphena (ospemifene) and estrogen together?
            No. Don't take Osphena (ospemifene) and other estrogen medications together. We don't know whether it's safe to take these medications together because it hasn't been studied.
            How long does it take for Osphena (ospemifene) to work?
            Some people who took Osphena (ospemifene) during a clinical study started noticing improvement in vaginal dryness and symptoms of painful sex as soon as 1 month after they started treatment. Keep in mind that it took most people in the study up to 3 months of treatment to notice improvement. Regularly check in with your prescriber about how well Osphena (ospemifene) is helping your symptoms.
            Can Osphena (ospemifene) help improve bone mineral density (BMD)?
            Osphena (ospemifene) isn't FDA approved for osteoporosis to help improve bone mineral density (BMD), a measure of how dense and strong your bones are. There aren't many studies that look at the effect of Osphena (ospemifene) on BMD. Some research suggests that the medication might have overall positive effects on bone health, but more studies need to be done to confirm a beneficial effect. Speak with your prescriber or primary care provider about your bone health during menopause and what steps you can take to keep your bones healthy.
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            What are the risks and warnings for Osphena (ospemifene)?

            Osphena (ospemifene) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

            risk-warning

            Risk for blood clots, stroke, or heart attack

            • Risk factors: Personal or family history of blood clots | High blood pressure | High blood sugar (diabetes) | High cholesterol | Tobacco use | Systemic lupus erythematosus (SLE)

              Though rare, some people who took Osphena (ospemifene) developed a blood clot during clinical studies with the medication. Sometimes, these blood clots led to a heart attack or stroke. Let your prescriber know about your full medical history so they can check your risk for blood clots before you start taking Osphena (ospemifene).

              Be aware of the signs and symptoms of a blood clot, heart attack, and stroke.

              • Blood clot in arm or leg: swelling or pain in the arm or leg

                • Blood clot in the lung: chest pain, trouble breathing

                  • Heart attack (blood clot near the heart): chest pain, arm pain, shortness of breath, a cold sweat, lightheadedness

                    • Stroke (blood clot in the brain): sudden weakness on one side of the body, drooping face, trouble breathing, bad headache, changes in speech or vision

                      Stop taking Osphena (ospemifene) and get medical help right away if you have any signs or symptoms of a blood clot.

                      risk-warning

                      Uterine or endometrial cancer

                      • Risk factors: Estrogen therapy without additional progestin | People with a uterus | Using estrogen therapy for more than 1 year

                        Osphena (ospemifene) acts like estrogen in your uterus. It can thicken and change the lining of your uterus, called the endometrium. Uncontrolled growth of the uterus lining can cause uterine or endometrial cancer in people with a healthy uterus. In general, the risk for endometrial cancer is higher in people who take estrogen therapy without progestin (another hormone) to balance out estrogen's effect on the growth of the uterine lining.

                        Although studies found that Osphena (ospemifene) thickens the lining of the uterus a little, there haven't been any reported cases of endometrial cancer in people who've taken the medication yet. And taking a progestin with Osphena (ospemifene) hasn't been studied, so it's not clear whether taking a progestin with this medication is beneficial.

                        To be safe, be aware of warning symptoms of uterine (endometrial) cancer, including vaginal bleeding that doesn't go away or keeps coming back or pelvic pain. Let your healthcare team know if you notice any unusual vaginal bleeding. Speak with your prescriber if you're worried about Osphena (ospemifene) and uterine cancer.

                        risk-warning

                        Breast cancer

                        • Risk factors: History of breast cancer

                          Osphena (ospemifene) hasn't been studied in people with breast cancer. It's unclear whether this medication can affect your risk for breast cancer. To be safe, you shouldn't take Osphena (ospemifene) if you currently have or have had breast cancer in the past. Remember to regularly do a breast cancer self-exam to check for any changes and get your scheduled breast scans (mammograms) done. Let your prescriber or primary care provider know if you notice any unusual changes to your breasts.

                          dosage

                          Osphena (ospemifene) dosage forms

                          The average cost for 30 tablets of 60mg of Osphena (ospemifene) is $198.00 with a free GoodRx coupon. This is 33.01% off the average retail price of $295.55.
                          tablet
                          Tablet
                          DosageQuantityPrice as low asPrice per unit
                          60mg30 tablets$198.00$6.60

                          Typical dosing for Osphena (ospemifene)

                          The typical dose is 60 mg by mouth once daily with food.

                          interactions

                          Interactions between Osphena (ospemifene) and other drugs

                          Osphena (ospemifene) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Osphena (ospemifene). Please note that only the generic name of each medication is listed below.

                          Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

                          Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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                          How much does Osphena (ospemifene) cost?

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                          contraindications-icon

                          Osphena (ospemifene) contraindications

                          Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Osphena (ospemifene) will not be safe for you to take.
                          alternatives

                          What are alternatives to Osphena (ospemifene)?

                          There are a number of medications that your doctor can prescribe in place of Osphena (ospemifene). Compare a few possible alternatives below.
                          Osphena (ospemifene)
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                          Intrarosa (prasterone)
                          Used for:

                          • Painful sexual intercourse as a result of menopause

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                          Estradiol vaginal insert
                          Used for:

                          • Vaginal dryness, thinning, and irritation caused by menopause - generic estradiol, Vagifem, and Yuvafem

                          • Moderate-to-severe painful sex due to vaginal dryness and thinning caused by menopause - Imvexxy only

                          $105.00 Lowest GoodRx priceView Prices
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                          Osphena (ospemifene) images

                          White Oval 60 - Osphena 60mg Tablet
                          This medicine is White, Oval Tablet Imprinted With "60".White Oval 60 - Osphena 60mg Tablet

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                          References

                          Best studies we found

                          Abraham, C. (2024). Experiencing vaginal dryness? Here’s what you need to know. The American College of Obstetricians and Gynecologists.

                          American Cancer Society. (2019). Signs and symptoms of endometrial cancer.

                          American Cancer Society. (2019). What is endometrial cancer?

                          View All References (9)

                          Archer, D. F., et al. (2019). Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe vaginal dryness: A phase 3, randomized, double-blind, placebo-controlled, multicenter trial. Menopause.

                          Duchesnay USA, Inc. (2024). Osphena- ospemifene tablet, film coated [package insert]. DailyMed.

                          Kim, J. J., et al. (2010). Role of progesterone in endometrial cancer. Seminars in Reproductive Medicine.

                          MedlinePlus. (2024). Bone density.

                          Menopause Society. (n.d.). Menopause topics: Sexual health.

                          Rosen, C., et al. (n.d.). Bone health and postmenopausal women. Endocrine Society.

                          Shin, J. J., et al. (2017). Ospemifene: A novel option for the treatment of vulvovaginal atrophy. Journal of Menopausal Medicine.

                          Simon, J. A., et al. (2018). Overall safety of ospemifene in postmenopausal women from placebo-controlled phase 2 and 3 trials. Journal of Women’s Health.

                          Wurz, G. T., et al. (2014). Safety and efficacy of ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy due to menopause. Clinical Interventions in Aging.

                          GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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