Frequently asked questions
Many women have questions when they begin using Divigel®—that’s to be expected! Get informed by browsing through some of the most common concerns about starting and staying with Divigel®.

There’s no substitute for an open conversation with your healthcare professional, however—be sure to give him or her a call if you still have any questions or concerns.

General Information

What is Divigel®?

Divigel® is a once-a-day medication to treat moderate to severe hot flashes due to menopause. It contains a plant-based bioidentical estrogen hormone called estradiol. Bioidentical estrogen is chemically identical to estrogen produced by women naturally (primarily in the ovaries) before menopause2. Divigel® is formulated as a clear, colorless, smooth gel that is applied to the skin. Divigel® is invisible and odorless when dry, so no one knows you're using medication.1

What dose of Divigel® is right for me?

Because every woman is different, one dose will not fit all. Divigel® has 3 FDA-approved doses, so your healthcare professional can choose the one that's right for you. Generally, women should be started at 0.25 mg/day.1

Your healthcare professional will recommend the appropriate starting dose for you, and he or she may adjust the dose depending on your response.

Where can I learn more about Divigel®?

Patient Information is included in each box of Divigel®. Read this information before you start using Divigel® and each time you refill your Divigel® prescription. There may be new information. Read the current patient leaflet online, and please be sure to speak with your healthcare professional regarding other questions about Divigel®.

Application

Can I apply Divigel® to any part of my body?

No. Divigel® should only be applied to your upper thigh. You should alternate between your right and left thigh each day to minimize the chance of a sensitive skin reaction.1

  • Application of Divigel® to other areas of the body, such as the arms or abdomen, has not been tested in clinical studies and, therefore, is not recommended
  • Do not apply Divigel® to your face, breasts, or irritated skin. Never apply Divigel® in or around the vagina. Contact of the gel with the eyes should be avoided1

How many times a day should I apply Divigel®?

Divigel® should be applied to the skin once a day, around the same time each day. You can choose to apply it either in the morning or in the evening, whichever time is most convenient for you.1

Because Divigel® should be applied to clean and dry skin, many women choose to apply it after their daily bath or shower. The application site should be completely dry before dressing.1

Do I need to take progestogen with Divigel®?

That depends.

  • If you have not had a hysterectomy (and your uterus is intact), then the answer is probably yes. That’s because taking estrogen alone may increase the chance of cancer of the uterus (also known as uterine or endometrial cancer). Taking progestogen helps reduce this risk. Your healthcare professional can help you make the right decisions and recommend the appropriate dose of progestogen3
  • If you have had a hysterectomy (removal of the uterus), then the answer is probably no. After a hysterectomy, your healthcare professional may recommend that you take estrogen therapy without progestogen3
  • It is important to speak regularly with your healthcare professional. Always report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus. If you experience any unusual vaginal bleeding, tell your healthcare professional so that he or she can determine the cause3

Common Concerns

How long do I have to use Divigel® before I get relief from my hot flashes?

It’s important to apply Divigel® around the same time each day. This will help your body sustain a more consistent level of estrogen to help relieve your symptoms. As with all estrogen products, it will take some time before the full effect of Divigel® is seen.1,2

In a 12-week, randomized, double-blind, placebo-controlled clinical trial of 495 postmenopausal women, Divigel® was shown to significantly reduce the number of daily moderate to severe hot flashes, which include night sweats, at 12 weeks compared to placebo.1,2,4

In a 12-week, randomized, double-blind, placebo-controlled clinical trial of 495 postmenopausal women, Divigel® was shown to significantly reduce the number of daily moderate to severe hot flashes, which include night sweats.1

What are the most common side effects associated with Divigel®?

Common side effects that may occur with Divigel® include headache; breast pain; irregular vaginal bleeding or spotting; stomach or abdominal cramps, bloating; nausea and vomiting; hair loss; fluid retention and vaginal yeast infection.

These are not all the potential side effects. For more information, please read the patient leaflet and the Full Prescribing Information, or speak with your healthcare professional.

Are there any potentially serious side effects with estrogen therapy, including Divigel®?

Serious but less common side effects include1

  • Heart attack
  • Stroke
  • Blood clots
  • Dementia
  • Breast cancer
  • Cancer of the lining of the uterus (womb)
  • Cancer of the ovary
  • High blood pressure
  • High blood sugar
  • Gallbladder disease
  • Liver problems
  • Enlargement of benign tumors of the uterus (“fibroids”)

Call your healthcare professional right away if you get any of the following warning signs or any other unusual symptoms that concern you1:

  • New breast lumps
  • Unusual vaginal bleeding
  • Changes in vision or speech
  • Sudden new severe headaches
  • Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue

Will Divigel® irritate my skin?

Divigel® is skin friendly—in a clinical trial, less than 1% of patients treated experienced a form of skin irritation.1

Who should not take Divigel®?

Do not start using Divigel® if you1:  

  • Have unusual vaginal bleeding
  • Currently have or have had certain cancers
    • Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare professional about whether you should use Divigel®
  • Had a stroke or heart attack
  • Currently have or have had blood clots
  • Currently have or have had liver problems
  • Have been diagnosed with a bleeding disorder
  • Are allergic to Divigel® or any of its ingredients
  • Think you may be pregnant

What Divigel® Is Used For

What is Divigel® used for?

Divigel® is approved by the FDA for the treatment of moderate to severe hot flashes, which include night sweats, due to menopause.1,2

Can using Divigel® protect my bones against osteoporosis?

Divigel® has not been studied as a drug to prevent osteoporosis and is not intended for or approved by the FDA for the prevention of osteoporosis or for protection against bone loss.

Can Divigel® be used for the prevention of other conditions, such as heart disease or dementia?

No. Do not use Divigel®, with or without progestins, to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function). Divigel® is approved for the treatment of moderate to severe hot flashes due to menopause.1

Practical Matters

Can I take other medications while also using Divigel®?

Some medications may affect how Divigel® works. These include prescription and nonprescription medications, vitamins, and herbal supplements. Divigel® may also affect how other medications work. Tell your healthcare professional about all the medications you take. For a complete list, please call Medical Information at 1-877-95-VERTI (1-877-958-3784), or see the Full Prescribing Information for Divigel®.1

Can I apply other lotions or creams, such as sunscreen, to the area of skin where Divigel® has been applied?

Studies conducted using other approved topical estrogen gel products have shown that sunscreens could change the amount of estrogen that is absorbed through the skin into the body.1

The effect of applying sunscreen and Divigel® to the same application site has not been clinically evaluated.1

However, remember that Divigel®, unlike other topical estrogen therapies, is applied to a discreet area of the upper thigh. Using creams or lotions on other parts of the body should not change the absorption of Divigel® at the application site.

How should Divigel® be stored?

Divigel® should be stored at room temperature, between 68°F and 77°F.1

How long do I have to wait before washing the skin where Divigel® was applied?

To ensure that Divigel® is absorbed through the skin properly, do not wash your thigh for at least 1 hour after application.1 

If you apply Divigel® after a shower or bath as part of a daily routine, just make sure that your upper thigh is thoroughly dry before applying the gel.1

Do I need to stop using Divigel® before having surgery or other procedures where I will be immobilized for long periods of time?

Speak with your healthcare professional about all medications you are taking if you are considering surgery. 

That’s because blood clots may be more likely to occur following some types of surgery. And estrogen may increase your chances of blood clots.1,11

If possible, you should stop taking all estrogen-based medications, such as Divigel®, at least 4 to 6 weeks before you undergo a surgical procedure associated with an increased risk of blood clots or during periods of prolonged immobilization.1

How does the estrogen in Divigel® compare to the estrogen produced naturally in a woman's body?

  • The estrogen hormone in Divigel® is called estradiol1
  • The estradiol in Divigel® is made from plants, unlike some other estrogen therapies that are derived from animal sources (horse urine)4,12,13,18
  • Divigel® contains bioidentical estradiol that is chemically identical to the estrogen hormone women make in their bodies before menopause3

How long will treatment with Divigel® last?

Estrogen therapies such as Divigel® should be used for the shortest amount of time necessary.8 Each woman’s symptoms and response to treatment will be different.

Talk with your healthcare professional periodically about whether you still need treatment with Divigel®.

Concerned about how menopause will affect your lifestyle? Read on for more information to ease your worries.


Important Safety Information & Indication

Divigel® (estradiol gel) 0.1% is indicated for the treatment of moderate to severe hot flashes due to menopause.

What is the most important information I should know about Divigel® (an estrogen hormone)?
  • Using estrogen-alone increases your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Divigel®. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual bleeding to find out the cause.
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of brain function)
  • Using estrogen-alone may increase your chances of getting strokes or blood clots
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
  • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®

Divigel® should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, including cancer of the breast or uterus, had a stroke or heart attack; currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to Divigel® or any of its ingredients, or think you may be pregnant.

Tell your healthcare provider about all of your medical problems and the medicines you take, if you are going to have surgery or will be on bed rest, and if you are breastfeeding.

Call your healthcare provider right away if you get any of the following symptoms: new breast lumps, unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches, or severe pains in your chest or legs with or without shortness of breath, weakness and fatigue.

Common side effects that may occur with Divigel® include headache; breast pain; irregular vaginal bleeding or spotting; stomach or abdominal cramps, bloating; nausea and vomiting; hair loss; fluid retention and vaginal yeast infection.

Serious but less common side effects include heart attack, stroke, blood clots, dementia, breast cancer, cancer of the uterus, ovarian cancer, high blood pressure, high blood sugar, gallbladder disease, liver problems, and enlargement of benign uterus tumors (“fibroids”).

Alcohol-based gels are flammable. Avoid fire, flame or smoking until the gel has dried.

Please see Patient Information for Divigel® and talk to your healthcare provider. For more information, call 732-721-0070 or visit www.divigel.com.

You are encouraged to report negative side effects to Vertical Pharmaceuticals, LLC at 1-877-95-VERTI (1-877-958-3784), or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Important Safety Information & Indication
Important Safety Information & Indication

Divigel® (estradiol gel) 0.1% is indicated for the treatment of moderate to severe hot flashes due to menopause.

What is the most important information I should know about Divigel® (an estrogen hormone)?
  • Using estrogen-alone increases your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Divigel®. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual bleeding to find out the cause.
  • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of brain function)
  • Using estrogen-alone may increase your chances of getting strokes or blood clots
  • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
  • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
  • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older
  • You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®

Divigel® should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, including cancer of the breast or uterus, had a stroke or heart attack; currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to Divigel® or any of its ingredients, or think you may be pregnant.

Tell your healthcare provider about all of your medical problems and the medicines you take, if you are going to have surgery or will be on bed rest, and if you are breastfeeding.

Call your healthcare provider right away if you get any of the following symptoms: new breast lumps, unusual vaginal bleeding, changes in vision or speech, sudden new severe headaches, or severe pains in your chest or legs with or without shortness of breath, weakness and fatigue.

Common side effects that may occur with Divigel® include headache; breast pain; irregular vaginal bleeding or spotting; stomach or abdominal cramps, bloating; nausea and vomiting; hair loss; fluid retention and vaginal yeast infection.

Serious but less common side effects include heart attack, stroke, blood clots, dementia, breast cancer, cancer of the uterus, ovarian cancer, high blood pressure, high blood sugar, gallbladder disease, liver problems, and enlargement of benign uterus tumors (“fibroids”).

Alcohol-based gels are flammable. Avoid fire, flame or smoking until the gel has dried.

Please see Patient Information for Divigel® and talk to your healthcare provider. For more information, call 732-721-0070 or visit www.divigel.com.

You are encouraged to report negative side effects to Vertical Pharmaceuticals, LLC at 1-877-95-VERTI (1-877-958-3784), or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.