Important Safety Information: Estradiol Compounded Estrogen Therapy

What is this?

This Important Safety Information summarizes key warnings and precautions for Estradiol, a form of estrogen used to support women with low estrogen levels, most commonly during perimenopause and menopause. Estradiol may be prescribed to help manage symptoms such as hot flashes, vaginal dryness, and other estrogen-related changes that can impact quality of life. This medication may be provided in oral, topical, or injectable compounded formulations. Compounded estradiol is not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy and should only be used exactly as directed by a licensed healthcare provider. This summary does not include all available information. Always read your medication label and follow your provider’s instructions.

Most Serious Warnings

Product can cause:

• Severe allergic reactions, including anaphylaxis

• Increased risk of blood clots (deep vein thrombosis, pulmonary embolism), stroke, or heart attack

• Increased risk of hormone-sensitive cancers, including breast, uterine, or ovarian cancer

• Worsening of migraine headaches or neurological symptoms

• Fluid retention, swelling, or increased blood pressure

• Abnormal uterine bleeding or endometrial changes

Compounded estradiol may carry sterility, dosing, or formulation risks due to limited FDA oversight.

Who Should NOT Take Estradiol

Do not take this medication if you:

• Have a known allergy to estradiol or any ingredient in the formulation

• Have a history of or current estrogen-dependent cancers (including breast or uterine cancer)

• Have a history of blood clots, stroke, or heart attack without provider clearance

• Have unexplained vaginal bleeding

• Have active liver disease

• Are pregnant or may become pregnant

Before Taking Estradiol, Tell Your Healthcare Provider if You:

• Have a personal or family history of blood clots or cardiovascular disease

• Have high blood pressure, high cholesterol, or diabetes

• Have migraines, seizure disorders, or gallbladder disease

• Have a history of endometriosis or uterine fibroids

• Have been diagnosed with breast lumps or abnormal mammograms

• Take any prescription, over-the-counter, or herbal medications

• Smoke or use nicotine products

• Are breastfeeding or planning pregnancy

Possible Side Effects

Common (mild to moderate):

• Breast tenderness or swelling

• Headache

• Nausea or bloating

• Fluid retention or mild weight changes

• Mood changes or irritability

• Skin irritation at application site (topical formulations)

Serious (seek medical care immediately):

• Rash, hives, swelling of the face or throat, difficulty breathing

• Signs of a blood clot such as leg pain, swelling, warmth, redness, or sudden weakness

• Chest pain or shortness of breath

• Sudden vision changes, severe headache, or confusion

• Unusual or heavy vaginal bleeding

• Yellowing of the skin or eyes (signs of liver problems)

While Taking Estradiol

Tell your healthcare provider immediately if you:

• Develop leg swelling, warmth, or pain

• Experience chest pain, shortness of breath, or sudden weakness

• Notice new breast lumps or changes

• Have persistent headaches, visual changes, or mood changes

• Experience abnormal vaginal bleeding

• Develop symptoms of an allergic reaction

Pregnancy and Fertility

Estradiol should not be used during pregnancy. It is not intended for use in individuals who are pregnant or trying to become pregnant. If pregnancy occurs while taking estradiol, notify your provider immediately. Use only under medical supervision for hormone management purposes.

Overdose

Symptoms of estradiol overdose may include:

• Severe nausea or vomiting

• Heavy vaginal bleeding

• Severe headache or dizziness

• Breast pain or swelling

• Signs of blood clots or cardiovascular events

If overdose is suspected, seek emergency medical attention or contact Poison Control right away.

Missed Dosage

If you miss a scheduled dose:

• Do not double the next dose

• Follow your provider’s instructions for resuming therapy

• Contact your pharmacy or provider if you are unsure how to proceed

Storage

• Store medication at room temperature unless otherwise directed

• Protect from excessive heat and light

• Do not freeze topical or injectable formulations unless instructed

• Keep out of reach of children

• Use only within the beyond-use date listed on your pharmacy label

Medication Disposal

Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication or dispose of it in household drains. Contact your pharmacy for disposal instructions or ask about medication take-back programs.

Provider Oversight and Order Review

This compounded medication requires review and oversight by licensed Superior Health & Wellness providers. Dosing, formulation, and therapy duration are determined based on labs, medical history, symptoms, and individual risk factors. Orders may be adjusted to ensure safety and clinical appropriateness.

Telemedicine Disclosure

This prescription was issued via telemedicine. If you experience any concerning or severe symptoms, contact your prescribing clinician immediately or seek emergency medical care.

Disclaimer

This summary does not include all information about estradiol and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations. This compounded medication has not been evaluated or approved by the FDA for safety or efficacy. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.