Estradiol Topical (Dotti): Uses, Side Effects and Dosage

What is estradiol gel?

Estradiol gel is a prescription medicine that contains estradiol (an estrogen hormone). Estradiol gel is a clear, colorless, smooth gel that is odorless when dry. When applied to the skin, estradiol is absorbed through the skin into the bloodstream.

What is estradiol gel used for?

Estradiol gel is used after menopause to:

• Reduce moderate to severe hot flashes

Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 to 55 years old. This drop in body estrogen levels causes the "change of life" or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes "surgical menopause."

When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating ("hot flashes" or "hot flushes"). In some women, the symptoms are mild, and they will not need estrogens. In other women, symptoms can be more severe.

Who should not use estradiol gel?

Do not start using estradiol gel if you:

• have any unusual vaginal bleeding

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.

• have been diagnosed with a bleeding disorder
• 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 (womb). If you have or have had cancer, talk with your healthcare provider about whether you should use estradiol gel.

• had a stroke or heart attack
• currently have or have had blood clots
• currently have or have had liver problems
• are allergic to estradiol gel or any of its ingredients

See the list of ingredients in estradiol gel at the end of this leaflet.

Before you use estradiol gel, tell your healthcare provider about all of your medical conditions, including if you:

• have any unusual vaginal bleeding

  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.

• have any other medical conditions that may become worse while you are using estradiol gel

  Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraines, endometriosis, lupus, angioedema (swelling of face and tongue), problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.

• are going to have surgery or will be on bedrest

Your healthcare provider will let you know if you need to stop using estradiol gel.

• are pregnant or think you may be pregnant

Estradiol gel is not for pregnant women.

• are breastfeeding

The hormone in estradiol gel can pass into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how estradiol gel works. Estradiol gel may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get new medicine.

How should I use estradiol gel?

• Take the dose recommended by your healthcare provider and talk to him or her about how well that dose is working for you.
• Estrogens 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 (for example, every 3 to 6 months) about the dose you are using and whether you still need treatment with estradiol gel.

How should estradiol gel be applied?

• Estradiol gel should be applied 1-time a day, around the same time each day.
• Apply estradiol gel to clean, dry, and unbroken (without cuts or scrapes) skin. If you take a bath or shower, be sure to apply your estradiol gel after your skin is dry. The application site should be completely dry before dressing or swimming.
• Apply estradiol gel to either your left or right upper thigh. Change between your left and right upper thigh each day to help prevent skin irritation.

TO APPLY:

Step 1: Wash and dry your hands thoroughly.

Step 2: Sit in a comfortable position.

Step 3: Cut or tear the estradiol gel packet as shown in Figure A.

Figure A

Step 4: Using your thumb and pointer (index) finger, squeeze the entire contents of the estradiol gel packet onto the skin of the upper thigh as shown in Figure B.

Figure B

Step 5: Gently spread the gel in a thin layer on your upper thigh over an area of about 5 by 7 inches, or two palm prints as shown in Figure C. It is not necessary to massage or rub in estradiol gel.

Figure C

Step 6: Allow the gel to dry completely before dressing.

Step 7: Throw away (dispose) of the empty estradiol gel packet in the trash.

Step 8: Wash your hands with soap and water immediately after applying estradiol gel to remove any remaining gel and reduce the chance of transferring estradiol gel to other people.

Important things to remember when using estradiol gel

• Allow the gel to dry before dressing. Try to keep the area dry for as long as possible.
• Do not allow another person to come in contact with the area of skin where you applied the gel for at least 1 hour after you apply estradiol gel.
• You should not have another person to apply the gel for you. However, if you need to have another person help you, have that person wear a disposable plastic glove to avoid direct contact with estradiol gel.
• Do not apply estradiol gel to your face, breast, or irritated skin.
• Never apply estradiol gel in or around the vagina.
• Estradiol gel contains alcohol. Alcohol based gels are flammable. Avoid fire, flame or smoking until the gel has dried.

What should I do if I miss a dose?

If you miss a dose, do not double the dose on the next day to catch up. If your next dose is less than 12 hours away, it is best just to wait and apply your normal dose the next day. If it is more than 12 hours until the next dose, apply the dose you missed and resume your normal dosing the next day. Do not apply estradiol gel more than 1-time each day. If you accidentally spill some of the contents of an estradiol gel packet, do not open a new estradiol gel packet. Wait and apply your normal dose the next day.

What should I do if someone else is exposed to estradiol gel?

To reduce the chance of transfer to another person (or pet) let the estradiol gel dry completely. Wash your hands with soap and water after application. If someone else is exposed to estradiol gel by direct contact with the wet gel, have that person wash the area of contact with soap and water right away. This is especially important for men and children. The longer the gel is in contact with the skin before washing, the greater the chance that the other person (or pet) will absorb some of the estrogen hormone. This may harm them. In case of any signs or symptoms of estrogen exposure in the other person (or pet), contact your healthcare provider (or veterinarian, if appropriate).

What should I do if I get estradiol gel in my eyes?

If you get estradiol gel in your eyes, flush your eyes right away with lukewarm tap water. If you have concerns, contact your healthcare provider.

What are the possible side effects of estradiol gel?

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

• heart attack
• stroke
• blood clots
• breast cancer
• cancer of the lining of the uterus (womb)
• cancer of the ovary
• dementia
• high or low blood calcium (hypercalcemia)
• gall bladder disease
• visual abnormalities
• high blood pressure
• high levels of fat (triglycerides) in your blood
• liver problems
• changes in your thyroid hormone levels
• fluid retention
• cancer change of endometriosis
• enlargement of benign tumors of the uterus (“fibroids”)
• worsening swelling of face and tongue (angioedema)
• changes in certain laboratory test results such as high blood sugar

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

• 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
• swelling of face, lips, and tongue with or without red, itchy bumps

The most common side effects of estradiol gel include:

• irregular vaginal bleeding or spotting
• breast tenderness
• vaginal yeast infection
• upper respiratory tract (nose, sinuses, pharynx or larynx) infection

These are not all the possible side effects of estradiol gel. For more information, ask your healthcare provider or pharmacist for advice about side effects. Tell your healthcare provider if you have any side effects that bother you or do not go away. You may report side effects to FDA at 1-800-FDA-1088 or Trigen Laboratories, LLC at 1-800-541-4802.

What can I do to lower my chances of a serious side effect with estradiol gel?

• Talk with your healthcare provider regularly about whether you should continue using estradiol gel.
• If you have a uterus, talk to your healthcare provider about whether the addition of a progestogen is right for you.
• See your healthcare provider right away if you get vaginal bleeding while using estradiol gel.
• Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else.
• If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances of getting heart disease.

Ask your healthcare provider for ways to lower your chances of getting heart disease.

How should I store estradiol gel?

Store estradiol gel packets at room temperature, 68 to 77°F (20 to 25°C).

Keep estradiol gel and all medicines out of the reach of children.

General information about safe and effective use of estradiol gel.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use estradiol gel for a condition for which it was not prescribed. Do not give estradiol gel to other people, even if they have the same symptoms that you have. It may harm them.

This leaflet provides a summary of the most important information about estradiol gel. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about estradiol gel that is written for health professionals.

What are the ingredients in estradiol gel?

Active ingredient: estradiol.

Inactive ingredients: carbomer, ethanol, propylene glycol, purified water, and triethanolamine.

Contains: 56% alcohol.

How is estradiol gel supplied?

Estradiol gel is supplied in individual foil packets, each one containing a single day's dose.

Manufactured by:

Orion Corporation

Orion Pharma

Tengströminkatu 8

FI-20360 Turku

Finland

Manufactured for:

Trigen Laboratories, LLC

Alpharetta, GA 30005 USA

1-800-541-4802

Product of Finland

155330-12

Revised 02/2026

This Patient Information has been approved by the U.S. Food and Drug Administration.