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
How Osphena® Helps

Osphena is the only oral, hormone-free treatment for moderate to severe painful sex due to menopause

How safe is Osphena®?

 Osphena® is the only oral, hormone-free treatment for moderate to severe painful sex due to menopause.

Osphena® was approved by the FDA in 2013 and has safety and efficacy data from one of the largest clinical programs of post-menopausal women with dyspareunia.

Osphena® is used after menopause for women with or without a uterus to treat moderate to severe pain during sexual intercourse due to changes in and around your vagina.

The effectiveness and safety of Osphena® on moderate to severe symptoms of vulvar and vaginal atrophy in post-menopausal women were established through three placebo controlled clinical trials of up to 52 weeks (long-term safety study) with over 1,900 post-menopausal women studied.

Osphena’s post approval experience is identified through voluntary reports and information monitoring. In February 2015, the product information was expanded to include allergic conditions including hypersensitivity. No further adverse event information has required label changes/additions.

  • Based on its safety and efficacy profile, Osphena® is designated as Level A treatment recommendation from two pivotal medical organizations in women’s health (American College of Obstetricians and Gynecologists and North American Menopause Society).
  • Discontinuation rates with Osphena® due to hot flash were less than 1%.
  • No clinically significant breast changes in patients treated with Osphena® have been reported.
  • In clinical trials, less than 1% of patients experienced treatment related cardiovascular events.
  • There were no cases of endometrial cancer reported in our clinical trials.
  • No dose adjustments are necessary for patients with mild, moderate or severe kidney impairment.
  • No dose adjustments are necessary for patients with mild or moderate liver impairment.
  • Osphena® has not been studied in patients with severe liver impairment, therefore it cannot be recommended for use in those patients

The most important information you should know:

  • Osphena® carries a Boxed Warning for Endometrial Cancer and Cardiovascular Disorders.
  • The most common side effects are (≥1 percent) include hot flash, vaginal/genital discharge, muscle spasms & excessive sweating.

Before taking Osphena®, consult your doctor if you:

  • Have unusual vaginal bleeding
  • Currently have or have had certain cancers
  • Currently have or have had blood clots
  • Had a stroke or heart attack
  • Are allergic to Osphena® or any of its ingredients
  • Think you may be pregnant

Talk to your healthcare provider every 3 to 6 months about whether you need to continue treatment with Osphena® 

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

Want to speak to an Osphena® representative?

Call 1-855-OSPHENA

Monday to Friday
8:30 am to 5:30 pm EST



If you’re looking for additional information about Osphena®, click below to view our Frequently Asked Questions.

Get Answers to Questions About Osphena®



Duchesnay USA offers great savings programs that may make this treatment option affordable.

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