Important Safety Information for Estriol/Estradiol Cream
Estriol / Estradiol Cream is a compounded prescription medication that should only be used under the supervision of a licensed healthcare provider.
Important Notice About Compounded Medications
Compounded Estriol / Estradiol Cream is not FDA-approved. Compounded medications are prepared by licensed pharmacies for individual patient needs and are not reviewed by the FDA for safety, effectiveness, or quality before dispensing.
Important Safety Warning
Estrogen-containing therapies may increase the risk of:
- Blood clots
- Stroke
- Heart attack
- Endometrial cancer in women with a uterus
- Certain hormone-sensitive cancers
- Dementia in certain postmenopausal women
Hormone therapy should be used at the lowest effective dose and for the shortest duration consistent with treatment goals.
Do Not Use Estriol / Estradiol Cream If You:
- Have abnormal or unexplained vaginal bleeding
- Have a history of breast cancer or estrogen-dependent cancer unless specifically approved by your healthcare provider
- Have active or past blood clots, deep vein thrombosis (DVT), or pulmonary embolism
- Have had a stroke or heart attack
- Have liver disease
- Are pregnant or may become pregnant
- Have a known allergy to estriol, estradiol, or any ingredient in the formulation
Before Using Estriol / Estradiol Cream
Tell your healthcare provider if you:
- Have high blood pressure
- Have heart disease
- Have diabetes
- Have elevated cholesterol or triglycerides
- Have a history of migraines
- Have asthma
- Have epilepsy or seizure disorders
- Have lupus
- Have thyroid disorders
- Have endometriosis
- Have uterine fibroids
- Smoke or use tobacco products
- Are taking prescription medications, supplements, or hormone therapies
Common Side Effects
Possible side effects may include:
- Breast tenderness or breast pain
- Headache
- Nausea
- Abdominal bloating
- Fluid retention
- Mood changes
- Vaginal irritation, itching, or discharge
- Application-site irritation or redness
Serious Side Effects
Seek medical attention immediately if you experience:
- Unusual vaginal bleeding
- Signs of a blood clot, including leg pain, swelling, chest pain, or shortness of breath
- Signs of a stroke, including weakness on one side of the body or difficulty speaking
- Sudden vision changes or vision loss
- Severe headache
- Yellowing of the skin or eyes (possible liver problems)
- Signs of a serious allergic reaction, including rash, swelling, or difficulty breathing
Additional Safety Information
- Use exactly as prescribed by your healthcare provider.
- Apply only as directed and do not exceed the prescribed dosage.
- Wash hands after application.
- Avoid contact with the eyes and other sensitive areas.
- Attend recommended follow-up appointments and laboratory monitoring.
- Perform regular breast self-examinations and follow recommended mammogram schedules.
- Inform all healthcare providers that you are using hormone therapy.
- Keep out of reach of children.
Disclaimer
Results vary by individual. Compounded Estriol / Estradiol Cream is prescribed only after evaluation by a licensed healthcare provider. This information does not replace professional medical advice. Consult your healthcare provider regarding the risks, benefits, and whether this treatment is appropriate for you.
