Important Safety Information Including Boxed Warning and Indication


Osphena® works like estrogen in the lining of the uterus (endometrium), but can work differently in other parts of the body. Taking estrogen alone or Osphena® may increase your chance for getting cancer of the lining of the uterus. Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus. Your healthcare provider should check any unusual vaginal bleeding to find out the cause, so tell him or her right away if this happens while you are using Osphena®.

Osphena® may increase your chances of having a stroke or blood clots.

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

Indication: What is Osphena®?

Osphena® is a prescription oral pill that treats:

  • moderate to severe painful intercourse,
  • moderate to severe vaginal dryness, symptoms of changes in and around your vagina, due to menopause.

Most Important Information you should know about Osphena®

Call your healthcare provider right away if you have unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches, and pains in your chest or legs with or without shortness of breath, weakness and fatigue.

Who should not take OSPHENA?

Osphena® should not be used if you have unusual vaginal bleeding, have or have had certain types of cancers (including cancer of the breast or uterus), have or have had blood clots, had a stroke or heart attack, have severe liver problems, are allergic to Osphena® or any of its ingredients, or think you may be pregnant. Tell your healthcare provider if you are going to have surgery or will be on bed rest.


Serious but less common side effects can include:

  • stroke
  • blood clots
  • cancer of the lining of the uterus

Less serious, but common side effects include:

  • hot flushes or flashes
  • vaginal discharge
  • muscle spasms
  • headache
  • excessive sweating (hyperhidrosis)
  • heavy vaginal bleeding (vaginal hemorrhage)
  • night sweats

Tell your healthcare provider about all of the medicines and supplements you take, as some medicines may affect how Osphena® works. Osphena® may also affect how other medicines work.

Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

Please read accompanying Patient Information for Osphena®(ospemifene) tablets, including Boxed Warning in the U.S. Full Prescribing Information.

Osphena® now also indicated for moderate to severe vaginal dryness, a symptom of changes in and around your vagina due to menopause
Why Sex Hurts

Talk to your healthcare provider about painful sex due to menopause

Why sex can and should continue after menopause

Menopause comes with many changes. A loss of sexual intimacy does not have to be one of them.

Women enter menopause at an average age of  52 years and have a life expectancy of approximately 82 years.1,2 That means that 30 years of a woman's life could be spent post-menopause! That is a long time to suffer from painful sex!

Just because you are getting older does not mean that sexual intimacy is any less important. Sex after menopause is healthy and normal

If you are experiencing moderate to severe pain during or after intercourse, talk to your healthcare provider about once-daily, oral, hormone-free Osphena®.

Take the first step toward relief.

Ask your healthcare provider if Osphena® is right for you. 

Learn How Osphena Helps treat moderate to severe painful sex due to menopause.

1 Shifren JL, Gass ML. NMS Recommendations for Clinical Care of Midlife Women Working Group. Menopause. 2014;21(10):1038-1062.

2 U.S. National Center for Health Statistics Reports. Census Bureau. Table 104. Expectation of Life at Birth, 1970 to 2008, and Projections, 2010 to 2020. Table 105. Life expectancy by sex, age, and race: 2008. Statistical Abstract of the United States: 2012

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