Estradiol / Progesterone
Estradiol and progesterone is a combination hormone therapy used to treat moderate to severe hot flashes and night sweats caused by menopause.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Estradiol / Progesterone: Patient Information Guide
A plain-language walkthrough of Estradiol / Progesterone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Estradiol and progesterone combination therapy is approved to relieve moderate to severe menopausal symptoms in women who still have a uterus.
- Bijuva (oral capsule): Treatment of moderate to severe vasomotor symptoms — hot flashes and night sweats — due to menopause, in women with a uterus
⚙️How it works▾
Estradiol is the most potent form of estrogen made by the body, and its levels fall sharply after menopause. This drop triggers the brain signals responsible for hot flashes. By replacing estradiol, Bijuva helps reduce how often and how intensely those symptoms occur. Progesterone is added because estrogen used alone can cause the uterine lining (endometrium) to overgrow; progesterone transforms that lining into a stable, secretory state and generally opposes estrogen's stimulating effects on the uterus, reducing that risk.
💊How it's taken▾
Bijuva is taken as a single oral capsule every evening. It must be taken with food — eating significantly boosts how much progesterone your body absorbs from the capsule. Treatment typically starts at the lower strength, with the dose adjusted based on how your symptoms respond.
- Take one Bijuva capsule orally each evening with food
- Do not skip food — it meaningfully affects how the progesterone is absorbed
- Your doctor will reassess your need for Bijuva every 3 to 6 months and may gradually reduce or stop the dose
If you miss a dose, follow your prescriber's or pharmacist's guidance — do not double up the next day without asking first.
🤒Side effects — in detail▾
The most common side effects reported with Bijuva in clinical trials include:
- Breast tenderness
- Headache
- Nausea
- Vaginal bleeding or spotting
- Vaginal discharge
- Pelvic pain
- Dizziness or drowsiness
- Abdominal discomfort or bloating
- Fluid retention
- Fatigue
More serious reactions — including blood clots, stroke, heart attack, and breast changes — require immediate medical attention. Stop Bijuva and contact your doctor or emergency services right away if you develop chest pain, sudden shortness of breath, severe headache, sudden vision loss, or leg swelling and pain.
⚠️Warnings & precautions▾
- Blood clots, stroke, and heart attack: Estrogen plus progestin therapy increases the risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, and heart attack. Stop Bijuva immediately if any of these occur. Plan to stop it at least 4–6 weeks before major surgery or prolonged bed rest.
- Breast cancer: Long-term use of estrogen plus progestin is associated with an increased risk of breast cancer. Get regular breast exams and mammograms. Stop Bijuva if a hormone-sensitive cancer is diagnosed.
- Gallbladder disease: Estrogen therapy is associated with a 2- to 4-fold increase in the risk of gallbladder disease requiring surgery.
- Dementia (women 65+): Women 65 and older had a higher risk of developing dementia in studies of estrogen plus progestin. The safety and effectiveness of Bijuva for dementia prevention has not been established.
- High triglycerides: If you already have high triglycerides, estrogen can raise them further and may trigger pancreatitis. Stop Bijuva if pancreatitis develops.
- Liver disease: Bijuva is contraindicated if you have liver impairment or disease. Estrogens are metabolized in the liver, and poor metabolism can increase risk.
- Vision changes: Retinal blood clots have been reported. Stop Bijuva and see a doctor promptly for sudden vision loss or changes.
- Fluid retention: Monitor closely if you have heart or kidney problems, as Bijuva may worsen fluid retention.
🔀What it interacts with▾
Bijuva's hormones are broken down by a liver enzyme called CYP3A4, so drugs and supplements that affect this enzyme can change hormone levels in your blood.
- St. John's Wort (herbal supplement): Speeds up hormone breakdown, potentially lowering Bijuva's effectiveness
- Phenobarbital, carbamazepine (seizure medications): Can reduce hormone levels and effectiveness
- Rifampin (antibiotic): Can significantly lower estrogen and progesterone levels
- Erythromycin, clarithromycin (antibiotics): Can raise hormone levels, increasing risk of side effects
- Ketoconazole, itraconazole (antifungals): May increase hormone concentrations and side effects
- Ritonavir (HIV medication): May raise hormone levels and increase side effects
- Grapefruit juice: May increase estradiol or progesterone absorption
- Thyroid replacement medications: Bijuva raises thyroid-binding protein levels, so women on thyroid hormone may need a dose adjustment — thyroid function should be monitored
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not take Bijuva if you have or have ever had breast cancer, or any estrogen-sensitive cancer
- Do not take it if you have active blood clots in the legs (DVT) or lungs (PE), or a history of these
- Do not take it if you have had a stroke or heart attack, or currently have active arterial blood clot disease
- Do not take it if you have known clotting disorders such as protein C, protein S, or antithrombin deficiency
- Do not take it if you have unexplained vaginal bleeding — the cause must be found first
- Do not take it if you have liver disease or impairment
- Do not take it if you have had a severe allergic reaction (anaphylaxis or angioedema) to Bijuva
- Tell your doctor if you have high triglycerides, asthma, migraines, epilepsy, diabetes, lupus, or porphyria — Bijuva may worsen these conditions
- Tell your doctor if you have hereditary angioedema — estrogen can trigger dangerous swelling episodes
- Tell your doctor if you have hypoparathyroidism (low parathyroid gland function) — estrogen can lower calcium levels
- Bijuva is not for use during pregnancy. It is also present in breast milk and may reduce milk supply; discuss with your doctor before breastfeeding
- Bijuva is not approved for use in children
- Women over 65 should discuss carefully with their doctor — studies show higher risks of stroke and dementia in this age group with estrogen plus progestin therapy
🚑If you take too much▾
Taking too much Bijuva may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness, fatigue, and possibly vaginal bleeding. If an overdose is suspected, stop taking the medication and seek appropriate medical care. There is no specific antidote — treatment focuses on managing symptoms.
📡Pharmacodynamics — effects in the body▾
Blood estrogen levels measured by a lab test do not reliably predict how well Bijuva will work for an individual woman, nor do they predict her personal risk for side effects. Because of this, Bijuva's effects can't simply be compared to other estrogen products by looking at hormone levels alone. Your doctor will gauge effectiveness by how your symptoms respond rather than by lab numbers.
🔬Pharmacokinetics — how your body processes it▾
When Bijuva is taken with food, estradiol reaches peak blood levels in about 3 to 6 hours, and progesterone peaks around 3 hours after the dose. Food has a large effect on progesterone absorption — taking Bijuva with a meal significantly increases how much progesterone gets into the bloodstream. Both hormones reach a stable steady-state level in the blood within about 7 days of daily use. Estradiol has a half-life (the time for blood levels to fall by half) of roughly 26 to 28 hours, while progesterone clears faster, with a half-life of about 9 to 10 hours. Both hormones are metabolized primarily in the liver and are extensively bound to proteins in the blood.
📦How to store it▾
Store at 20°C to 25ºC (68°F to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).
📄 Written from Estradiol / Progesterone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Estradiol / Progesterone — the kind of thing our pharmacy team would talk through with you at the counter.
Why does my doctor want me on both estrogen and progesterone? Can't I just take estrogen? ▾
Does it matter when I take Bijuva, and do I really need food? ▾
What side effects are most common with Bijuva, and which ones should prompt me to call the doctor? ▾
I've heard hormone therapy can raise my risk of breast cancer. How worried should I be? ▾
Are there any supplements or common medications I should avoid while taking Bijuva? ▾
How long will I need to stay on Bijuva? ▾
Is Estradiol / Progesterone available over the counter? ▾
When was Estradiol / Progesterone first available? ▾
Who makes Estradiol / Progesterone? ▾
💬 Answers drafted from Estradiol / Progesterone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Estradiol / Progesterone comes
Estradiol / Progesterone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Bijuva is used to treat moderate to severe hot flashes and night sweats (vasomotor symptoms) due to menopause in women who have a uterus
- Bijuva is taken as one capsule by mouth each evening
- Bijuva should always be taken with food — food significantly increases the amount of progesterone absorbed
- Bijuva is generally started at the lower strength; your prescriber adjusts the dose based on your response
- Your doctor will review whether to taper or stop Bijuva every 3 to 6 months
📊 Estradiol / Progesterone across the U.S. market
How Estradiol / Progesterone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Estradiol / Progesterone is used
A general measure of how commonly Estradiol / Progesterone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Estradiol / Progesterone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Estradiol / Progesterone prescribed? Of the 1,596 medications we measure, Estradiol / Progesterone ranks #1,187 by Medicaid prescriptions — more than 26% of them.
Utilization by Estradiol / Progesterone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
estradiol 1 MG / progesterone 100 MG Oral Capsule Most dispensed
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2108924
estradiol 0.5 MG / progesterone 100 MG Oral Capsule
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2632844
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Estradiol / Progesterone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 11 listed Estradiol / Progesterone NDCs with Medicaid activity.
🔍 Compare Estradiol / Progesterone products
A representative set of FDA-listed product records for Estradiol / Progesterone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 1; 100 mg/1; mg | Oral | Amneal Pharmaceuticals NY LLC × 2 listings | ANDA | View NDC → |
| ESTRADIOL 0.5 mg/1; PROGESTERONE 100 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| ESTRADIOL 1 mg/1; PROGESTERONE 100 mg | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| ESTRADIOL 0.5 mg/1; PROGESTERONE 100 mg | Oral | Mayne Pharma | NDA | View NDC → |
| ESTRADIOL 1 mg/1; PROGESTERONE 100 mg | Oral | Mayne Pharma | NDA | View NDC → |
| 0.5; 100 mg/1; mg | Oral | Mayne Pharma | NDA | View NDC → |
| 1; 100 mg/1; mg | Oral | Mayne Pharma | NDA | View NDC → |
| ESTRADIOL 0.5 mg/1; PROGESTERONE 100 mg | Oral | Mayne Pharma LLC | NDA | View NDC → |
| ESTRADIOL 1 mg/1; PROGESTERONE 100 mg | Oral | Mayne Pharma LLC | NDA | View NDC → |
| 0.5; 100 mg/1; mg | Oral | Mayne Pharma LLC | NDA | View NDC → |
| 1; 100 mg/1; mg | Oral | Mayne Pharma LLC | NDA | View NDC → |
| 1; 100 mg/1; mg | Oral | TherapeuticsMD, Inc. | NDA | View NDC → |
Showing 13 of 13 products — FDA National Drug Code Directory. See every product, package size and price: browse all 13 Estradiol / Progesterone NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Estradiol / Progesterone — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Estradiol / Progesterone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Estradiol / Progesterone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 815024 2 dose forms · 4 strengths
-
Dose form (SCDF) Drug Implant RxCUI 1648168No current FDA listingClinical drug / strength (SCD) estradiol 3-benzoate 10 MG / progesterone 100 MGRxCUI 1648169estradiol 3-benzoate 20 MG / progesterone 200 MGRxCUI 2612081 -
Dose form (SCDF) Oral Capsule RxCUI 2108923In current FDA listingsClinical drug / strength (SCD) estradiol 0.5 MG / progesterone 100 MGRxCUI 2632844estradiol 1 MG / progesterone 100 MGRxCUI 2108924
Look up RxCUI 815024 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Estradiol / Progesterone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Estradiol / Progesterone belongs to the Radioactive Diagnostic Agent class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Mayne Pharma is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.