Important Safety Information: BIEST (Estradiol/Estriol) HRT Cream | Compounded Topical Hormone Therapy
What is this?
This Important Safety Information summarizes key warnings and precautions for BIEST (Estradiol/Estriol 80:20) Hormone Replacement Therapy Cream. BIEST is a compounded topical estrogen formulation containing estradiol and estriol in an 80:20 ratio. It is commonly prescribed to help reduce symptoms associated with menopause, including hot flashes, vaginal dryness, and hormonal imbalance, and may support bone health in certain patients. This compounded formulation has not been reviewed or approved by the U.S. Food and Drug Administration for safety or efficacy. It 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
Estrogen therapy may increase the risk of serious health conditions.
Product can increase the risk of:
Blood clots, including deep vein thrombosis or pulmonary embolism
Stroke or heart attack
Breast cancer
Endometrial cancer in patients with a uterus when estrogen is used without a progestin
Dementia in women aged 65 years and older
Do not use estrogen therapy to prevent heart disease or dementia. Use the lowest effective dose for the shortest duration consistent with treatment goals. Regular follow up with your healthcare provider is required.
Compounded hormone products may carry formulation or consistency risks due to limited FDA oversight.
Who Should NOT Use BIEST
Do not use this medication if you:
Have a known allergy to estradiol, estriol, or any ingredient in the formulation
Have or have had breast cancer or other estrogen dependent tumors
Have a history of blood clots, stroke, or heart attack
Have liver disease or liver tumors
Have unexplained vaginal bleeding
Have known or suspected pregnancy
Have been diagnosed with thickening of the uterine lining without medical evaluation
Before Using BIEST, Tell Your Healthcare Provider if You:
Have high blood pressure, heart disease, or elevated cholesterol
Have diabetes or high triglycerides
Have a history of migraines or seizure disorders
Have asthma or kidney problems
Have a family history of blood clots or hormone sensitive cancers
Smoke or use tobacco products
Drink alcohol regularly
Are breastfeeding
Take prescription medications, over the counter medications, supplements, or herbal products
Possible Side Effects
Common (mild to moderate):
Breast tenderness
Nausea
Headache
Bloating or fluid retention
Skin irritation at the application site
Mood changes
Serious (seek medical care immediately):
Chest pain, shortness of breath, or coughing up blood
Sudden weakness, numbness, or trouble speaking
Severe headache or vision changes
Swelling, warmth, redness, or pain in a leg
Yellowing of the skin or eyes
Unusual vaginal bleeding
Signs of a severe allergic reaction including rash, swelling of the face or throat, or difficulty breathing
While Using BIEST
Tell your healthcare provider immediately if you:
Develop signs of a blood clot or stroke
Notice new breast lumps or nipple discharge
Experience persistent abnormal vaginal bleeding
Have significant mood changes or memory problems
Develop dark patches on the face or skin sensitivity to sunlight
Regular breast exams, pelvic exams, blood pressure checks, and lab monitoring may be required while on therapy.
Pregnancy and Breastfeeding
Do not use this medication if you are pregnant. Estrogen therapy is not indicated during pregnancy. If you become pregnant while using this medication, contact your provider immediately. Discuss risks and benefits with your provider if you are breastfeeding.
Overdose
Symptoms of overdose may include severe nausea, vomiting, breast tenderness, abdominal pain, or vaginal bleeding. If overdose is suspected, seek emergency medical attention or contact Poison Control immediately.
Missed Dosage
If you miss a dose, apply it as soon as you remember unless it is almost time for your next scheduled dose. Do not apply extra cream to make up for a missed dose. Resume your regular dosing schedule as directed by your provider.
Storage
Store at room temperature unless otherwise directed on the pharmacy label.
Keep tightly closed and protect from excessive heat and light.
Keep out of reach of children and pets.
Medication Disposal
Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication down the drain. Ask your pharmacy about medication take back programs if needed.
Provider Oversight and Order Review
This compounded hormone therapy requires medical supervision. Dosing, duration, and monitoring must be determined by a licensed healthcare provider. Therapy may be adjusted based on symptoms, lab results, and treatment goals.
Telemedicine Disclosure
If prescribed via telemedicine, contact your prescribing clinician immediately if you experience concerning symptoms. Seek emergency medical care for severe reactions.
Disclaimer
This summary is not comprehensive and does not replace medical advice, diagnosis, or treatment from a qualified healthcare provider. Always consult your provider regarding risks, benefits, and potential interactions. This compounded medication has not been evaluated or approved by the U.S. Food and Drug Administration for safety or efficacy.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at or call 1-800-FDA-1088.
