Compounded by a pharmacy, so it is not FDA-approved. The FDA does not review a compounded preparation before it is dispensed, and a combination does not inherit the approval of any ingredient in it.
Estradiol, taken by mouth
A tablet containing estradiol, the main estrogen the ovaries make before menopause. It is taken to relieve menopausal symptoms.
Not for
Anyone with undiagnosed abnormal genital bleeding.
Anyone with a history of, or suspected, breast cancer, or another estrogen-dependent cancer.
Anyone with active or past blood clots in the legs or lungs, or a clotting disorder.
Anyone with active or recent arterial disease, including stroke or heart attack.
Anyone with liver impairment or disease.
Anyone who is pregnant, or who may be pregnant.
Common effects
Headache, breast pain or tenderness, irregular vaginal bleeding or spotting.
Nausea, abdominal cramps, bloating, and fluid retention.
Mood changes and, for some, worsened migraine.
Serious effects
Blood clots in the legs or lungs, stroke, and heart attack.
Endometrial cancer, where estrogen is taken without adequate progestogen and the uterus is present.
Breast cancer, reported with estrogen plus progestin.
Gallbladder disease, and, rarely, severe high blood calcium in cancer that has spread to bone.
Get medical help if
Sudden shortness of breath, chest pain, or coughing blood.
Pain, swelling, warmth or redness in one leg.
Sudden weakness or numbness on one side, trouble speaking, or a sudden severe headache.
Any vaginal bleeding that is new, heavy, or continues.
A new breast lump.
Tell your provider
Whether you still have a uterus. If you do, estrogen on its own raises the risk of endometrial cancer and a progestogen is usually added.
Every medicine and supplement you take. Thyroid medicine, some seizure medicines, rifampin and St John's wort all interact with estrogen.
If you smoke. Smoking raises the clot and cardiovascular risks of estrogen, particularly over 35.
Any personal or family history of breast cancer, blood clots, stroke or liver disease.
Sources
Estradiol tablets prescribing information, Indications and Usage. US Food and Drug Administration. FDA-approved labeling
Estradiol tablets prescribing information, Boxed Warning. US Food and Drug Administration. FDA-approved labeling
Estradiol tablets prescribing information, Warnings and Precautions. US Food and Drug Administration. FDA-approved labeling
Estradiol, applied to the skin
Estradiol in a cream absorbed through the skin rather than swallowed. It still reaches the bloodstream, so the systemic cautions apply.
Not for
Anyone with undiagnosed abnormal genital bleeding.
Anyone with a history of, or suspected, breast cancer, or another estrogen-dependent cancer.
Anyone with active or past blood clots, or a clotting disorder.
Anyone with active or recent stroke or heart attack, or liver disease.
Anyone who is pregnant, or who may be pregnant.
Handling
Hormone cream transfers by skin contact. Let the site dry, wash your hands, and keep the treated skin covered around children, other adults and pets.
A compounded cream's absorption has not been characterized the way an approved product's has, so how much reaches the bloodstream is less predictable.
Common effects
Skin irritation or redness where it is applied.
Breast tenderness, headache, irregular bleeding or spotting, and mood changes.
Serious effects
Blood clots in the legs or lungs, stroke, and heart attack.
Endometrial cancer, where estrogen is used without adequate progestogen and the uterus is present.
Breast cancer.
Get medical help if
Sudden shortness of breath, chest pain, or coughing blood.
Pain, swelling, warmth or redness in one leg.
Sudden weakness or numbness on one side, or trouble speaking.
New, heavy or continuing vaginal bleeding, or a new breast lump.
Tell your provider
Whether you still have a uterus.
Who else has skin contact with you, particularly children.
Every medicine and supplement you take.
Sources
Estradiol tablets prescribing information, Boxed Warning. US Food and Drug Administration. FDA-approved labeling
The Clinical Utility of Compounded Bioidentical Hormone Therapy, dosing and absorption. National Academies of Sciences, Engineering, and Medicine. NASEM consensus study report, 2020
The Clinical Utility of Compounded Bioidentical Hormone Therapy. National Academies of Sciences, Engineering, and Medicine. NASEM consensus study report, 2020
Estriol
A weaker estrogen, used in compounded 'Biest' creams alongside estradiol. Estriol is not an FDA-approved drug in the United States.
Not for
Anyone with undiagnosed abnormal genital bleeding.
Anyone with a history of, or suspected, breast cancer, or another estrogen-dependent cancer.
Anyone with active or past blood clots, or a clotting disorder.
Anyone who is pregnant, or who may be pregnant.
Handling
Hormone cream transfers by skin contact. Let the site dry, wash your hands, and keep it covered around others.
Common effects
Skin irritation where applied, breast tenderness, headache, spotting.
Serious effects
Estriol is an estrogen, so the class risks in the boxed warning are taken to apply to it. Because it is not FDA-approved, it has no approved labeling of its own that quantifies them.
Get medical help if
New, heavy or continuing vaginal bleeding, or a new breast lump.
Sudden shortness of breath, chest pain, leg pain or swelling.
Sudden weakness, numbness or trouble speaking.
Tell your provider
Whether you still have a uterus.
That a compounded product's dose and absorption are less predictable than an approved one's.
Sources
FDA statements on compounded bioidentical hormone replacement therapy and estriol. US Food and Drug Administration. FDA compounded BHRT communications
Estradiol tablets prescribing information, Boxed Warning. US Food and Drug Administration. FDA-approved labeling
The Clinical Utility of Compounded Bioidentical Hormone Therapy. National Academies of Sciences, Engineering, and Medicine. NASEM consensus study report, 2020
Progesterone
A progestogen. Where estrogen is taken and the uterus is still present, an adequate progestogen is what reduces the raised risk of endometrial cancer.
Not for
Anyone with undiagnosed abnormal genital bleeding.
Anyone with a history of, or suspected, breast cancer.
Anyone with active or past blood clots, or a clotting disorder.
Anyone with liver impairment or disease.
Anyone allergic to peanuts, where the product is formulated in peanut oil, ask which this one is.
Common effects
Drowsiness or dizziness. The oral capsule is usually taken at bedtime for this reason.
Headache, breast tenderness, bloating, mood changes, and irregular bleeding.
Serious effects
Blood clots in the legs or lungs.
Breast cancer, reported for estrogen plus progestin therapy.
Severe allergic reaction, including in anyone with a peanut allergy where the product contains peanut oil.
Get medical help if
Sudden shortness of breath, chest pain, or leg pain and swelling.
Severe dizziness, or fainting.
Swelling of the lips, tongue, face or throat, or trouble breathing.
Tell your provider
Whether you still have a uterus, which is what decides whether you need this.
Any peanut allergy, before the first dose.
Do not drive or operate machinery until you know how it affects you.
Sources
Progesterone capsules prescribing information. US Food and Drug Administration. FDA-approved labeling
Estradiol tablets prescribing information, Warnings and Precautions. US Food and Drug Administration. FDA-approved labeling
DHEA
A hormone precursor the body converts to estrogen and testosterone. It is sold in the United States as a dietary supplement, not as an FDA-approved drug.
Not for
Anyone with a hormone-sensitive cancer, including breast, ovarian or prostate cancer.
Anyone who is pregnant or breastfeeding.
Anyone with liver disease.
Common effects
Acne and oily skin.
Unwanted hair growth, and in some people scalp hair thinning.
A deeper voice, which may not reverse.
Irritability or trouble sleeping.
Serious effects
Because DHEA converts to estrogen and testosterone, it can act on hormone-sensitive tissue, including hormone-sensitive cancers.
Changes in cholesterol, including a fall in HDL.
Liver problems have been reported.
Get medical help if
Yellowing of the skin or eyes, dark urine, or pain in the upper right abdomen.
Chest pain, or an irregular heartbeat.
New, heavy or continuing vaginal bleeding.
Tell your provider
Any personal or family history of hormone-sensitive cancer.
That evidence for DHEA in menopausal symptoms and libido is limited and inconsistent.
Every other supplement you take: supplements are not reviewed by the FDA for effectiveness before sale.
Sources
Dietary supplements: what the FDA does and does not review. US Food and Drug Administration. FDA dietary supplement guidance
The Clinical Utility of Compounded Bioidentical Hormone Therapy. National Academies of Sciences, Engineering, and Medicine. NASEM consensus study report, 2020
Estradiol, applied vaginally
Estradiol in a cream applied in the vagina, used for vaginal dryness, irritation and painful sex after menopause. Some is absorbed into the bloodstream.
Not for
Anyone with undiagnosed abnormal genital bleeding.
Anyone with a history of, or suspected, breast cancer, or another estrogen-dependent cancer.
Anyone with active or past blood clots, or a clotting disorder.
Anyone who is pregnant, or who may be pregnant.
Handling
Hormone cream transfers by skin contact, including to a partner. Wash your hands after applying.
This is a compounded strength, not one of the FDA-approved vaginal cream products, so how much is absorbed is less predictable.
Common effects
Local irritation, itching or discharge.
Headache and breast tenderness.
Serious effects
The systemic risks in the boxed warning apply, because some estrogen is absorbed.
Endometrial cancer, where the uterus is present and estrogen is used without adequate progestogen.
Get medical help if
New, heavy or continuing vaginal bleeding.
Sudden shortness of breath, chest pain, leg swelling or pain.
Sudden weakness, numbness or trouble speaking.
Tell your provider
Whether you still have a uterus.
Any history of breast cancer, clots or stroke.
Sources
Estradiol vaginal cream prescribing information. US Food and Drug Administration. FDA-approved labeling
Estradiol tablets prescribing information, Boxed Warning. US Food and Drug Administration. FDA-approved labeling
Compounding and the FDA: questions and answers. US Food and Drug Administration. FDA drug compounding guidance