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Estradiol / Progesterone

Estradiol / Progesterone is a combination of an estrogen and a progestogen hormone, used to treat moderate to severe hot flashes and similar symptoms of menopause in women who still have a uterus.

Drug classes Estrogen
Rx
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from

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 →

✓No current FDA shortage listed · checked Oct 8, 2026
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Bijuva pairs estradiol, to replace the estrogen lost at menopause, with progesterone, to counter estrogen’s effect on the uterine lining, for moderate to severe hot flashes in women with a uterus; it is hormone therapy, the most effective treatment for hot flashes, on the market since about 2019 and available generically. Most women tolerate it reasonably well, with breast tenderness, headache or spotting the usual complaints. The main concern is a higher risk of blood clots, stroke, heart attack and breast cancer, so get emergency help for chest pain, a swollen, painful leg or stroke signs. Keep up with mammograms and ask every few months whether you need it.

Clinical pearls

  • Take the capsule each evening with food, at about the same time, rather than on an empty stomach.
  • Tell your surgeon you take Bijuva, since it should ideally stop 4 to 6 weeks before surgery that raises clot risk.
  • Skip grapefruit juice and St. John’s wort, because one raises hormone levels and the other lowers them and weakens the effect.
  • If you take thyroid replacement, ask for a thyroid blood test after starting, since your dose may need to go up.
How we write & review this content — our editorial policy →
How you get itPrescription only
Earliest FDA record2019
FDA label last updatedApr 24, 2026
FDA’s strongest warning (boxed)None on the label

Patient Information Guide A plain-language walkthrough of Estradiol / Progesterone, written from its FDA label.

What Estradiol / Progesterone Is Used For

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Estradiol / Progesterone is used for symptoms of menopause.

  • Bijuva (oral capsule) treats moderate to severe vasomotor symptoms (hot flashes and related symptoms) due to menopause in women with a uterus.

How Estradiol / Progesterone Works

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Estradiol is the main estrogen the body makes, and it acts by binding to estrogen receptors in tissues. After menopause, the body makes much less of it. Estrogen also helps lower the raised LH and FSH levels seen after menopause.

Progesterone is included alongside the estrogen. It changes the uterine lining and generally opposes estrogen's effects by lowering estrogen receptor levels and increasing the breakdown of estrogen into less active forms.

Estradiol / Progesterone Dosage

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Bijuva is taken by mouth, one capsule each evening with food. Your prescriber usually starts with the lower-strength capsule and adjusts it based on your response.

  • The label advises trying to taper or stop every 3 to 6 months.
  • Follow your prescriber's directions and the label.

Dosing details from the FDA-approved label

From the Estradiol / Progesterone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Bijuva (estradiol/progesterone) therapy, general dosing
    • Take a single BIJUVA capsule orally each evening with food
    • Generally, start therapy with BIJUVA 0.5 mg estradiol/100 mg progesterone dosage strength
    • Make dosage adjustment based on the clinical response
    • Attempt to taper or discontinue BIJUVA at 3 to 6 month intervals
    • Take with food; consider initiating in women < 60 years old or < 10 years from onset of menopause
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION The timing of BIJUVA initiation can affect the overall risk-benefit profile. Consider initiating BIJUVA in women < 60 years old or < 10 years from onset of menopause [see Warnings and Precautions (5) , Adverse Reactions (6.1) , Use in Specific Populations (8.5) and Clinical Studies (14) ] . Take a single BIJUVA capsule orally each evening with food. Generally, start therapy with BIJUVA 0.5 mg estradiol/100 mg progesterone dosage strength. Make dosage adjustment based on the clinical response. Attempt to taper or discontinue BIJUVA at 3 to 6 month intervals. One capsule orally each evening with food. (2.1)

Read the full Dosage and Administration section on DailyMed →

Estradiol / Progesterone Side Effects

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The most common side effects seen with Bijuva in studies were:

Common side effects

  • Breast tenderness
  • Headache
  • Nausea
  • Vaginal bleeding
  • Vaginal discharge
  • Pelvic pain

When to get medical help

  • Get emergency help for signs of a blood clot, stroke or heart attack. Bijuva should be stopped right away if one occurs or is suspected.
  • Call your doctor right away about sudden partial or complete vision loss, bulging eyes, double vision or sudden migraine.
  • Call your doctor if you have severe stomach pain, which may signal pancreatitis (inflammation of the pancreas), especially if you have high triglycerides.
  • Tell your doctor about yellowing of the skin or eyes (cholestatic jaundice) if it comes back.
  • Report unusual swelling or fluid retention that concerns you.
  • Report any new breast lumps or changes, and keep up with breast exams and mammograms.

Reports after approval also include fatigue, dizziness, trouble sleeping, weight gain, fluid retention and night sweats. Seek help for signs of a blood clot, stroke, heart attack, sudden vision changes, or yellowing of the skin or eyes.

Estradiol / Progesterone Warnings and Precautions

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  • Blood clots, stroke and heart attack: Estrogen plus progestin therapy has been linked to higher risk. Stop Bijuva right away if one occurs or is suspected.
  • Breast cancer: Risk is higher with estrogen plus progestin therapy. Get breast exams and mammograms.
  • Gallbladder disease: Estrogens raise the risk, in some cases requiring surgery.
  • Vision problems: Stop Bijuva and be examined if you suddenly lose vision or develop double vision or migraine.
  • Other conditions: Estrogens may worsen high triglycerides, hypothyroidism, fluid retention, low calcium, hereditary angioedema, asthma, diabetes, epilepsy, migraine, lupus and others.
  • Bijuva has not been shown to prevent heart disease or dementia.

Estradiol / Progesterone Interactions

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Some medicines and foods change how your body handles these hormones through the CYP3A4 enzyme.

  • St. John’s wort, phenobarbital, carbamazepine, rifampin: may lower hormone levels, reducing effect or changing bleeding.
  • Erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice: may raise hormone levels and cause side effects.
  • Thyroid replacement medicine: you may need a higher dose and monitoring.

Interactions listed in the FDA-approved label

From the Estradiol / Progesterone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Inducers of CYP3A4 (St. John's wort preparations, phenobarbital, carbamazepine, rifampin): May reduce plasma concentrations of estrogens and progestins, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile.
  • Inhibitors of CYP3A4 (erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice): May increase plasma concentrations of the estrogen or the progestin or both and may result in adverse reactions.
Read the label’s full interactions text

7 DRUG INTERACTIONS In-vitro and in-vivo studies have shown that estrogens and progestins are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen and progestin drug metabolism. Inducers of CYP3A4 such as St. John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens and progestins, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4, such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice, may increase plasma concentrations of the estrogen or the progestin or both and may result in adverse reactions. Inducers and inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentration. ( 7 )

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Estradiol / Progesterone against a supplement or herb →

Before Taking Estradiol / Progesterone

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  • Do not use with unexplained vaginal bleeding, breast cancer or a history of it, or estrogen-dependent tumors.
  • Do not use with a current or past blood clot, stroke or heart attack.
  • Do not use with liver disease, a clotting disorder, or a known allergy to Bijuva.
  • Not for use in pregnancy or in children.
  • It can pass into breast milk and reduce milk production.
  • Women over 65 may face higher risks of stroke, breast cancer and dementia, based on related studies.

Estradiol / Progesterone Overdose

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Too much may cause nausea, vomiting, breast tenderness, stomach pain, drowsiness and fatigue. Withdrawal bleeding may occur. Treatment is to stop Bijuva and treat symptoms as needed.

What Estradiol / Progesterone Does in the Body

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Blood estrogen levels do not reliably predict how well Bijuva works for you or your risk of side effects. Comparing hormone levels between different estrogen products also may not be valid.

How Your Body Processes Estradiol / Progesterone

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Both hormones are partly broken down on their first pass through the liver after being swallowed. Estradiol peaks about 3 to 6 hours after a dose and progesterone about 3 hours after. Steady levels build up within seven days.

Food raises the amount of progesterone absorbed. Estradiol is processed mainly in the liver. Its half-life is roughly 26 to 28 hours, and progesterone's is roughly 9 to 10 hours.

How to Store Estradiol / Progesterone

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Store at 20°C to 25ºC (68°F to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Estradiol / Progesterone: Pharmacist Answers to Common Questions

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.

What is this medicine for?

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Bijuva treats moderate to severe hot flashes and related symptoms of menopause. It is for women who still have a uterus. It combines an estrogen with progesterone.

How and when should I take it?

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Take one capsule by mouth each evening with food. Your prescriber will usually start you on the lower strength and adjust if needed. Plan to talk with them every 3 to 6 months about whether you can taper or stop.

What side effects should I expect?

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The most common are breast tenderness, headache, nausea, vaginal bleeding, vaginal discharge and pelvic pain. Tell your prescriber if they bother you or don't settle down.

When should I call my doctor or get emergency help?

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Get help right away for signs of a blood clot, stroke or heart attack, or sudden vision loss or double vision. Also call about severe stomach pain, yellowing of your skin or eyes, or new breast changes. These need prompt attention.

Are there medicines or foods I should avoid?

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Tell me about St. John’s wort, carbamazepine, phenobarbital, rifampin, certain antibiotics and antifungals, ritonavir, and thyroid medicine. Grapefruit juice can also raise hormone levels. These can change how well the medicine works or increase side effects.

Can I take it if I might be pregnant or am breastfeeding?

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Bijuva is not for use in pregnancy. Estrogen plus progestogen passes into breast milk and can lower milk production, so talk with your prescriber if you are breastfeeding.

Is Estradiol / Progesterone available over the counter?

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No. Estradiol / Progesterone is a prescription medicine: every Estradiol / Progesterone product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Estradiol / Progesterone first available?

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The earliest FDA record we hold for Estradiol / Progesterone is from 2019: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Estradiol / Progesterone was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More About Estradiol / Progesterone on HelloPharmacist

🌿Drug & Supplement CheckerEstradiol / Progesterone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Estradiol / Progesterone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed Data & References for Estradiol / Progesterone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Estradiol / Progesterone on the U.S. Market: Products, Makers and Brands

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.

The FDA lists Estradiol / Progesterone products; the earliest marketing or approval year on record is 2019.

2019
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Unfinished capsule (2) — bulk drug substance and unfinished product sold to compounders and other manufacturers to finish, and multi-item kits. These aren’t counted in the dose-form total above.

How Widely Estradiol / Progesterone Is Used (Medicaid Data)

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.

2,044
Medicaid prescriptions filled (Q1–Q4 2025)
$737,965 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Estradiol / Progesterone prescribed? Of the 1,603 medications we measure, Estradiol / Progesterone ranks #1,190 by Medicaid prescriptions — more than 26% of them.

Where Estradiol / Progesterone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,190 of 1,603
#1,185 Menthol 2,137 Rx #1,186 Iopamidol 2,104 Rx #1,187 Aclidinium Oral Inhala... 2,081 Rx #1,188 Triptorelin Injection 2,066 Rx #1,189 Rilonacept Injection 2,050 Rx #1,190 Estradiol / Progestero... 2,044 Rx #1,191 Lenacapavir Injection 2,031 Rx #1,192 Bendamustine Injection 2,007 Rx #1,193 Bendamustine 2,007 Rx #1,194 Butenafine 1,979 Rx #1,195 Butorphanol Nasal Spra... 1,967 Rx

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.

The 1 mg / 100 mg oral capsule is the most-dispensed Estradiol / Progesterone product — about 59% of these Medicaid prescriptions.

estradiol 1 MG / progesterone 100 MG Oral Capsule Most dispensed

1,204 Medicaid prescriptions (Q1–Q4 2025) 59% of Estradiol / Progesterone prescriptions shown $448,848 gross reimbursement (before rebates) ≈ $373 per prescription (gross)

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

840 Medicaid prescriptions (Q1–Q4 2025) 41% of Estradiol / Progesterone prescriptions shown $289,117 gross reimbursement (before rebates) ≈ $344 per prescription (gross)

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.

Estradiol / Progesterone 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.

The FDA’s enforcement reports list no Estradiol / Progesterone recalls since July 2021.

✅No Estradiol / Progesterone recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.

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.

Multiple ingredients (MIN) Estradiol / Progesterone RxCUI 815024 2 dose forms · 4 strengths
  1. Dose form (SCDF) Drug Implant RxCUI 1648168 No current FDA listing
    Clinical drug / strength (SCD) estradiol 3-benzoate 10 MG / progesterone 100 MG RxCUI 1648169 estradiol 3-benzoate 20 MG / progesterone 200 MG RxCUI 2612081

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.

Estradiol / Progesterone Drug Class (RxNorm)

Estradiol / Progesterone belongs to the Radioactive Diagnostic Agent class.

Pharmacologic class Radioactive Diagnostic Agent, Estrogen
Drug family (ATC) Natural and semisynthetic estrogens, plain, Progestogens and estrogens, sequential preparations
How it works Positron Emitting Activity, Estrogen Receptor Agonists

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.

Sources for This Estradiol / Progesterone Page

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 24, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Estradiol / Progesterone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Estradiol / Progesterone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Linked representative label ⓘ
Mayne Pharma
Linked label effective
Apr 24, 2026
Composite sections available
23
Linked SPL Set ID
59eadb88-c9f3-4871-b176-7ddd98faf9bc
Linked SPL Document ID
50389c42-cbef-d35d-e063-6394a90a6dcf
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Mayne Pharma is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →