Uses of Estradiol Gel:

• It is used to prevent or lower the signs of the change of life (menopause).
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Estradiol Gel?

• If you are allergic to estradiol gel (estroGel); any part of estradiol gel (estroGel); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have ever had a very bad or life-threatening reaction called angioedema. Signs may be swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; unusual hoarseness.
• If you have had any of these health problems: Bleeding disorder, blood clots, a higher risk of having a blood clot, breast cancer, liver problems or liver tumor, heart attack, stroke, or a tumor where estrogen makes it grow.
• If you have eyesight problems like loss of eyesight from blood vessel problems in the eye.
• If you have thickening of the endometrium (lining of the uterus).
• If you have unexplained vaginal bleeding.
• If you are pregnant or may be pregnant. Do not take estradiol gel (estroGel) if you are pregnant.

This is not a list of all drugs or health problems that interact with estradiol gel (estroGel).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take estradiol gel (estroGel) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Estradiol Gel?

• Tell all of your health care providers that you take estradiol gel (estroGel). This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
• Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams as you have been told.
• High calcium levels have happened with drugs like this one in some people with cancer. Call your doctor right away if you have signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach or throwing up, constipation, or bone pain.
• High triglyceride levels have happened with estradiol gel (estroGel). Tell your doctor if you have ever had high triglyceride levels.
• This medicine may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take estradiol gel (estroGel).
• Do not smoke. Smoking raises the chance of heart disease. Talk with your doctor.
• Limit your drinking of alcohol.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Talk with your doctor before you use other drugs or products on your skin.
• Do not use sunscreen before using gel or soon after using gel.
• Do not use sunscreen on gel part for 7 days in a row.
• If you are 65 or older, use estradiol gel (estroGel) with care. You could have more side effects.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Estradiol Gel) best taken?

Use estradiol gel (estroGel) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take estradiol gel (estroGel) by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Use estradiol gel (estroGel) at the same time of day.
• Wash your hands before and after use.
• Put on clean, dry, healthy skin of 1 arm from the wrist to the shoulder.
• Do not use on skin that has any problems.
• Do not put on the face, breast, or vagina.
• Prime pump before first use.
• Do not let any other person touch the gel, solution, or the treated part of your skin.
• Avoid fire, flames, or smoking until dry.
• Let dry before covering with clothing.
• Do not bathe, shower, or swim right after putting on.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is less than 12 hours until the next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or very upset stomach or throwing up.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Eyesight changes or loss, bulging eyes, or change in how contact lenses feel.
• A lump in the breast, breast pain or soreness, or nipple discharge.
• Vaginal itching or discharge.
• Vaginal bleeding that is not normal.
• Depression or other mood changes.
• Memory problems or loss.
• Fever.
• Not able to pass urine or change in how much urine is passed.
• Pain when passing urine.
• Swelling.

What are some other side effects of Estradiol Gel?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Hair loss.
• Upset stomach or throwing up.
• Constipation.
• Stomach cramps.
• Bloating.
• Enlarged breasts.
• Tender breasts.
• Vaginal bleeding or spotting.
• Painful periods.
• Signs of a common cold.
• Nose or throat irritation.
• Weight gain or loss.
• Joint pain.
• Leg cramps.
• Change in sex interest.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Estradiol Gel?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Protect from heat or open flame.
• If you are using a pump, throw away any part not used after labeled number of doses are used.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about estradiol gel (estroGel), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.