estradiol vaginal (systemic)

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Pronunciation: ES tra DYE ole VA jin ul (sis TEM ik)

Brand: Femring

What is the most important information I should know about estradiol vaginal?

You should not use this medicine if you have: undiagnosed vaginal bleeding, liver disease, a bleeding disorder, if you have major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. Estradiol should not be used to prevent heart disease, stroke, or dementia. Long-term use may increase your risk of cancer of the breast, uterus, or ovaries.

What is estradiol vaginal (systemic)?

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Some estradiol products placed directly into the vagina are used for "local" treatment of vaginal menopause symptoms (such as dryness, burning, and irritation). Other vaginal estradiol products are used for treating vaginal menopause symptoms and symptoms that affect other parts of the body (such as hot flashes). This type of vaginal estradiol has "systemic" effects, meaning that it can affect parts of the body other than where the medicine is directly applied.

This medication guide provides information about estradiol vaginal for systemic treatment of certain symptoms of menopause, including hot flashes and vaginal dryness, burning, or irritation.

Estradiol vaginal (systemic) may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using estradiol vaginal?

You should not use estradiol if you are allergic to it, or if you have:

  • unusual vaginal bleeding that has not been checked by a doctor;
  • liver disease;
  • a history of heart attack, stroke, or blood clot;
  • an increased risk of having blood clots due to a heart problem or a hereditary blood disorder; or
  • a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Do not use estradiol if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • heart disease;
  • liver problems, or jaundice caused by pregnancy or taking hormones;
  • kidney disease;
  • gallbladder disease;
  • asthma;
  • epilepsy or other seizure disorder;
  • migraines;
  • lupus;
  • endometriosis or uterine fibroid tumors;
  • hereditary angioedema (an autoimmune disorder);
  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
  • a thyroid disorder; or
  • high levels of calcium in your blood.

Long-term use of estradiol may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Estradiol lowers the hormone needed to produce breast milk and can slow breast milk production. Tell your doctor if you are breast-feeding.

How should I use estradiol vaginal?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after inserting the vaginal ring.

You should not be able to feel the vaginal ring once it is in place. Leave the vaginal ring in place for 90 days, then remove it. Your doctor may want you to replace it with a new ring. The ring does not need to be removed during sexual intercourse. If the ring is bothersome, you may remove it, rinse it with warm water, and reinsert it after intercourse.

To remove the ring, loop a finger through the ring and gently pull it from the vagina. Call your doctor if you have trouble removing a vaginal ring.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Call your doctor at once if you have any unusual vaginal bleeding while using this medicine.

Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. Self-examine your breasts for lumps on a monthly basis and have a mammogram every year while using estradiol.

If you need major surgery with long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using estradiol.

Keep the vaginal ring in its protective pouch until you are ready to use it. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Remove the vaginal ring and insert a new one as soon as you remember. Do not use an extra vaginal ring to make up the missed wearing time.

If a vaginal ring falls out, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use your finger to push it in farther.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using estradiol vaginal?

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using estradiol.

Avoid using other vaginal products without your doctor's advice.

Grapefruit and grapefruit juice may interact with estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

What are the possible side effects of estradiol vaginal?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Remove the vaginal ring and seek emergency medical attention if you have: fever with nausea, vomiting, diarrhea, muscle pain, dizziness, fainting, and/or sunburn-like skin rash. These may be signs of a life-threatening disease called toxic shock syndrome.

Call your doctor at once if you have:

  • heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot --sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • swelling or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes);
  • memory problems, confusion, unusual behavior;
  • unusual vaginal bleeding, pelvic pain;
  • a lump in your breast; or
  • high levels of calcium in your blood --nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

  • nausea, vomiting, bloating, stomach cramps;
  • headache;
  • breast pain or tenderness;
  • swelling in your hands or feet, weight gain;
  • thinning scalp hair; or
  • vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect estradiol vaginal?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with estradiol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about systemic vaginal estradiol.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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