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Compounded, not FDA approved

Estradiol Cream

Compounded estrogen cream for hormone therapy

A compounded estradiol cream that a licensed provider may prescribe as part of a hormone therapy plan after an evaluation that includes your health history. It is not FDA approved.

Compounded drugs are not FDA approved. FDA does not review compounded drugs for safety, effectiveness, or quality before marketing.

Prescription medication. Medication availability, formulation, packaging and pharmacy fulfillment vary based on the patient's prescription and location.
Estradiol Cream
At a glance
Dosing and schedule are set by your provider
Form and route
Cream, applied as directed by your prescriber
Frequency
As directed by your prescriber
Storage
As directed on your pharmacy label
Category
Gallery

See it before your first visit

Photographs of the medication as dispensed.

Overview

What it is

Estradiol is a form of estrogen, a hormone. Estradiol cream is a compounded medication that a licensed provider may prescribe as part of a hormone therapy plan after reviewing your symptoms, health history, medications, and any lab work.

It is a compounded medication. It is prepared by a licensed pharmacy for an individual patient based on a prescription. It is not FDA approved, and the FDA has not evaluated it for safety, effectiveness, or quality. The strength, where and how to apply it, and how often are set by your prescriber and printed on your pharmacy label.

Mechanism

How it works

Estradiol replaces estrogen in the body. When applied as directed, it is absorbed through the skin or tissue where it is applied. Your provider decides whether estrogen therapy is appropriate, selects the strength and schedule, and adjusts the plan based on your symptoms and how you respond.

The program

What to expect

Treatment starts with an evaluation by a licensed provider, which may include a physical exam, lab work, and a review of your personal and family history. Your provider will explain how much to use, where to apply it, and how often. Follow-up visits are part of treatment, and your provider will usually aim to use the lowest dose that meets your needs for the shortest time that is appropriate.

If you have a uterus, your provider may talk with you about adding a progestogen to protect the lining of the uterus. Tell your provider right away about any unusual vaginal bleeding. Individual responses vary, and results are not guaranteed.

Candidacy

Who it is for

Whether estradiol is appropriate for you is a decision made by a licensed provider based on your symptoms, examination, and health history. It is not right for everyone and carries serious risks.

Tell your provider if you have or have had breast cancer or other estrogen-sensitive cancers, blood clots, stroke, heart attack, liver disease, unexplained vaginal bleeding, migraine with aura, or a family history of these conditions. Tell your provider if you are pregnant or breastfeeding, and share every medication and supplement you take.

This page is general information and is not medical advice.

Tolerability

Side effects

Commonly reported side effects include breast tenderness, headache, bloating, nausea, spotting or breakthrough bleeding, mood changes, and skin irritation where the cream is applied.

Serious risks include blood clots, stroke, heart attack, breast cancer, endometrial cancer, gallbladder disease, high blood pressure, and probable dementia in older women. Seek urgent care for chest pain, sudden shortness of breath, sudden weakness or numbness on one side, trouble speaking, severe headache, vision changes, or leg swelling and pain. Call your provider about unusual vaginal bleeding or a breast lump.

Safety information and disclosures

Read this before you start

Compounded, not FDA approved
Prescription only
Provider supervision required

Compounded drugs are not FDA approved. FDA does not review compounded drugs for safety, effectiveness, or quality before marketing.

Medication availability, formulation, packaging and pharmacy fulfillment vary based on the patient's prescription and location.

Compounded medication. This medication is compounded by a licensed pharmacy and is not FDA approved. The FDA has not evaluated compounded medications for safety, effectiveness, or quality. It is prescribed for an individual patient by a licensed provider.

Boxed warning, estrogens. Estrogen-containing medicines carry boxed warnings for endometrial cancer, cardiovascular disorders including stroke and blood clots, breast cancer, and probable dementia. Estrogens, with or without progestogens, should not be used to prevent heart disease or dementia. Use the lowest effective dose for the shortest duration consistent with treatment goals.

Who should not use it. Do not use estradiol if you have undiagnosed abnormal vaginal bleeding, known or suspected breast cancer or other estrogen-dependent cancer, active or past blood clots, stroke or heart attack, liver disease, a known clotting disorder, or if you are pregnant.

Exposure of others. Estrogen can transfer from your skin to other people through contact. Children and pets should not touch the treated area. Wash your hands after applying and follow your provider's directions on where to apply.

Monitoring. Your provider should review your health regularly, including breast exams, mammograms as recommended, and blood pressure.

Not medical advice. The information on this page is general and educational. It does not establish a provider relationship and does not replace a consultation with a licensed provider.

If you are having a medical emergency, call 911. The information on this page is general and educational. It does not establish a provider relationship, does not replace a consultation, and should not be used to diagnose or treat any condition.
Questions

Common questions

Is compounded estradiol cream FDA approved?

No. This medication is compounded by a licensed pharmacy, and compounded medications are not FDA approved. The FDA has not evaluated them for safety, effectiveness, or quality.

Do I need a prescription for estradiol cream?

Yes. A licensed provider must evaluate you and write the prescription before a pharmacy prepares it.

What are the risks of estrogen therapy?

Estrogens carry boxed warnings for endometrial cancer, stroke, blood clots, breast cancer, and probable dementia. Your provider will review your personal risks with you.

Do I need a progestogen with estradiol?

If you have a uterus, estrogen alone can increase the risk of endometrial cancer, so your provider may recommend adding a progestogen. This is a decision for your provider.

Can estradiol cream affect other people?

It can transfer through skin contact. Keep children and pets away from the treated area, wash your hands after applying, and follow your provider's instructions.

Who should not use estradiol?

People with unexplained vaginal bleeding, a history of breast cancer or other estrogen-sensitive cancers, blood clots, stroke, heart attack, or liver disease, and people who are pregnant, should not use it.

How long will I use it?

Your provider will use the lowest effective dose for the shortest time that is appropriate and will review the plan with you regularly.