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Frequently Asked Questions

Click here to view the Patient Information leaflet.

What is Divigel®?
Divigel® is a once-a-day medicine that contains a plant-based bioidentical estrogen hormone called estradiol. It’s 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.2
What is Divigel® used for?
Divigel® is approved by the FDA to relieve moderate to severe hot flashes, including night sweats associated with menopause.2 
Who should not take Divigel®?
Do not start using Divigel® if you2:
  • 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 in the past year
  • Currently have or have had blood clots
  • Currently have or have had liver problems
  • Are allergic to Divigel® or any of its ingredients
  • Think you may be pregnant
How does the estrogen in Divigel® compare to the estrogen produced naturally in a woman’s body?
  • The estrogen hormone in Divigel® is called estradiol2 
  • The estradiol in Divigel® is bioidentical, derived from plants, unlike other estrogen therapies that are derived from animal sources (horse urine)2,12,13 
  • Estradiol is a bioidentical estrogen. This means that it is chemically identical to an estrogen women make in their bodies before menopause20 
How long do I have to use Divigel® before I get relief?
It’s important to apply Divigel® around the same time each day. This will help your body sustain the consistent levels of estrogen it needs to help relieve your symptoms. As with all estrogen products, it will take some time before the full effect of Divigel® is seen.2,11,14
  • In a clinical study, the highest dose of Divigel® significantly reduced the number of hot flashes after just 2 weeks vs placebo
  • Treatment with the lowest dose of Divigel® significantly reduced the number of hot flashes after 5 weeks vs placebo 
  • While Divigel® may take effect in as little as 2 weeks, you can expect to see your symptoms improve even more over time, typically 8 to 12 weeks of treatment
  • Patients also noticed that the severity of their hot flashes was reduced, along with the number of hot flashes that they experienced each day 
  • Divigel® has been used by thousands of women in the United States
  • In the Divigel® clinical trials the vast majority of women responded positively to their treatment

So, for best results, remember to apply Divigel® every day at the same time. The relief will be worth the effort.
How long will treatment with Divigel® last?
Estrogen therapies such as Divigel® should be used for the shortest amount of time necessary.7 Yet, because each woman’s symptoms and response to treatment will be different, there is no set time limit.

Talk with your healthcare professional every 3 to 6 months about whether you still need treatment with Divigel®.
What dose of Divigel® is right for me?
Because every woman is different, one dose will not fit all. 

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

Generally, women should be started on the lowest effective dose possible to meet their treatment goals.7
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.2

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.2
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 on an every-other-day basis to minimize the chance of a sensitive skin reaction.2
  • 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 avoided2
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 or let the area get wet for at least 1 hour after application.2

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.2
Will Divigel® irritate my skin?
In clinical studies of Divigel®, most patients did not experience skin irritation.2
  • Divigel® is very skin-friendly. In fact, less than 1% of all the patients in a clinical trial experienced some form of skin irritation from Divigel®2
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 progestogen1
  • If you have had a hysterectomy (removal of the uterus), then the answer is no. After a hysterectomy, your healthcare professional may recommend that you take estrogen therapy without progestogen1
  • 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 cause1
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 from the skin into
the body.2

The effect of applying sunscreen and Divigel® to the same application site has not been clinically evaluated.2

Using creams or lotions on other parts of the body should not change the absorption of Divigel® at the application site.
Are there any potentially serious side effects with estrogen therapy?
See your healthcare professional right away if you experience breast lumps, unusual vaginal bleeding, dizziness and faintness, changes in speech, severe headaches, chest pain, shortness of breath, pains in your legs, changes in vision, or vomiting. These can be warning signs of serious side effects.2

The most common side effects for all estrogen products are headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating, nausea and vomiting, and hair loss.2

Less common but serious side effects include breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease, and ovarian cancer.2

These are not all the potential side effects. For more information, please see the full Prescribing Information or speak with your healthcare professional.
What are the most common side effects associated with Divigel®?
In clinical trials of Divigel®, the most common side effects were inflammation of the nasal passages and pharynx, upper respiratory tract infection, vaginal yeast infection, breast tenderness, and vaginal bleeding.2

These are not all the potential side effects. For more information, please see the full Prescribing Information or speak with your healthcare professional.
Can I take other medications while also using Divigel®?
Divigel® may interact with certain medications, herbal supplements, or other products that you take by mouth. These include the antibiotic erythromycin, the herbal supplement Saint-John’s-wort, and some epilepsy medications, such as phenobarbital. For a complete list, please see the full Prescribing Information for Divigel®.2

Before using Divigel®, talk to your healthcare professional about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Based on this information, he or she can tell you if Divigel® is an appropriate option.
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.2
Can Divigel® be used for the prevention of other conditions, such as heart disease or dementia?
No. Divigel® has been studied and approved only for the relief of disruptive hot flashes, including night sweats associated with menopause.2

Do not use estrogens, including Divigel®, with or without progestins, to prevent heart disease, heart attacks, strokes, or dementia. Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, blood clots, or dementia.2
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-based medications can also cause blood clots.2,15

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.2
How should Divigel® be stored?
Divigel® should be stored at room temperature, between 68°F and 77°F.2 
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. If you would like to view the Patient Information now, click on the link below. And please be sure to speak with your healthcare professional regarding other questions about Divigel®.

Click here to view the Patient Information now.
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Important Safety Information for Patients

The following are not all the possible risks for Divigel®. Please read the full Patient Information leaflet and talk to your healthcare provider.

Estrogens increase the chance of getting cancer of the uterus. 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 (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.

Do not use estrogens, with or without progestins, to prevent heart disease, heart attacks, or strokes. Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots.

Do not use estrogens, with or without progestins, to prevent dementia. Using estrogens, with or without progestins, may increase your risk of dementia.

Do not use estrogen products, including Divigel®, if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to any Divigel® ingredients, or think you may be pregnant.

The most common side effects for all estrogen products are headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating, nausea and vomiting, and hair loss. The less common but serious side effects include breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease, and ovarian cancer.

In Divigel® clinical trials, the most common side effects were inflammation of the nasal passages and pharynx, upper respiratory tract infection, vaginal yeast infection, breast tenderness and vaginal bleeding. Call your healthcare provider right away if you have any symptoms that concern you.

Estrogen products should be used at the lowest dose possible for your treatment and only as long as needed. You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, call 1-800-654-2299.

©2010 Upsher-Smith Laboratories, Inc., Maple Grove, MN 55369

*Once-daily dosing of estradiol.