Skip to the answer

Prasterone Vaginal

Prasterone vaginal is a steroid used to treat moderate to severe painful intercourse caused by vaginal and vulvar tissue changes due to menopause.

Brand name Intrarosa
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 1 clinical label set 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 7, 2026
Prasterone Vaginal at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Prasterone (Intrarosa) is a nightly vaginal insert for moderate to severe pain during sex caused by vaginal thinning after menopause. Vaginal tissue converts it into both estrogens and androgens (hormones women also make), and it is usually considered an alternative to vaginal estrogen, on the market since about 2020 and not available as a generic. Most women tolerate it well. Vaginal discharge is the side effect people notice, and abnormal Pap smear results are also reported. Unexplained or recurring vaginal bleeding must be checked before starting, and any breast cancer history deserves a talk with your prescriber first, since some of it becomes estrogen and it has not been studied in those women.

Clinical pearls

  • Insert it at bedtime so you lie down while it melts, and a panty liner handles the discharge that follows.
  • It is a nightly treatment, and relief builds gradually over weeks, so skipping nights or stopping early undercuts it.
  • Tell whoever does your Pap smear that you use Intrarosa, since abnormal Pap results are among its reported side effects.
  • Report any new vaginal bleeding during treatment too, not just before starting, because it still needs a doctor's evaluation.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asVaginal insert
Earliest FDA record2016
Companies listing it with the FDA1
FDA label last updatedJul 17, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Prasterone Vaginal, written from its FDA label.

What Prasterone Vaginal is used for

▾

Prasterone vaginal is approved for use in postmenopausal women for the following condition:

  • Intrarosa vaginal insert is indicated for the treatment of moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy caused by menopause.

How Prasterone Vaginal works

▾

Prasterone is a steroid that is naturally present in the body but is inactive on its own. After the vaginal insert is placed, the body's own enzymes — including hydroxysteroid dehydrogenases, 5α-reductases, and aromatases — convert prasterone into active sex hormones: androgens and estrogens. These hormones are thought to support the health of vaginal and vulvar tissues. The exact mechanism by which Intrarosa reduces pain during sex has not been fully established.

Prasterone Vaginal dosage

▾

Intrarosa vaginal insert is used once daily, inserted vaginally at bedtime using the applicator provided in the package. There are no food restrictions associated with its use. Always follow your prescriber's specific instructions, and read the directions on your packaging carefully.

Dosing details from the FDA-approved label

From the Prasterone Vaginal 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.

  • Dosing text does not name an indication or patient group
    • One INTRAROSA vaginal insert once daily at bedtime, using the provided applicator
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Administer one INTRAROSA vaginal insert once daily at bedtime, using the provided applicator. One vaginal insert, once daily at bedtime. ( 2 )

Read the full Dosage and Administration section on DailyMed →

Prasterone Vaginal side effects

▾

The most commonly reported side effects with Intrarosa include:

Common side effects

  • Vaginal discharge
  • Abnormal Pap smear results

When to get medical help

  • Tell your doctor right away if you have any unexplained or recurring vaginal bleeding — this must be evaluated before or during treatment.
  • Talk to your doctor before using Intrarosa if you have a current or past history of breast cancer, since estrogen — a byproduct of this medication — is generally not recommended in women with breast cancer history.

Tell your doctor about any new or unusual vaginal bleeding — this is important and should be evaluated promptly. Report any side effects that concern you or don't go away.

Prasterone Vaginal warnings and precautions

▾
  • Breast cancer history: Because prasterone is converted into estrogen in the body, women with a known or suspected history of breast cancer should consult their doctor before use. Intrarosa has not been studied in this population, and estrogen-containing products are generally contraindicated in women with breast cancer history.
  • Unexplained genital bleeding: Any postmenopausal woman with unexplained, persistent, or recurring vaginal bleeding must be evaluated by a doctor to determine the cause before starting Intrarosa.

Prasterone Vaginal interactions

▾

The Intrarosa prescribing information does not identify specific drug, food, or supplement interactions.

    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.

    🌿63 supplements and herbs with documented Prasterone Vaginal interactions, ranked by severity Check Prasterone Vaginal against a supplement or herb →

    Before taking Prasterone Vaginal

    ▾
    • Do not use Intrarosa if you have unexplained or recurring genital bleeding that has not been evaluated by a doctor.
    • If you have a current or past history of breast cancer, talk to your doctor before use — this medication produces estrogen as a byproduct and has not been studied in women with breast cancer history.
    • Intrarosa is for postmenopausal women only. It is not intended for use during pregnancy or while breastfeeding.
    • Safety and effectiveness in children have not been established.
    • If you have kidney or liver disease, ask your doctor — studies on how these conditions affect prasterone in the body have not been conducted.

    How your body processes Prasterone Vaginal

    ▾

    After daily use of the Intrarosa vaginal insert, prasterone is absorbed and reaches measurable levels in the bloodstream. At Day 7 of once-daily use, blood levels of prasterone were significantly higher than in women using placebo. Small but measurable increases in the hormone metabolites testosterone and estradiol were also seen. Over 12 weeks of daily use, levels of prasterone and its metabolites testosterone and estradiol increased from baseline by roughly 47%, 21%, and 19%, respectively. Prasterone is broken down by the body using the same enzymes that process naturally produced prasterone, converting it into androgens and estrogens.

    How to store Prasterone Vaginal

    ▾

    Store at 41°F to 86°F (5°C to 30°C). stored at room temperature or in the refrigerator.

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

    63

    Supplements & herbs that interact with Prasterone Vaginal

    63 supplements and herbal products have documented interactions with Prasterone Vaginal in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

    Severity mix
    • Major · 1
    • Moderate · 56
    • Minor · 6
    GRAPEFRUIT Major ALETRIS Moderate ALFALFA Moderate ANDROSTENEDIOL Moderate ANDROSTENEDIONE Moderate ANISE Moderate BAIKAL SKULLCAP Moderate BLACK COHOSH Moderate +55 more
    Every supplement checked against Prasterone Vaginal — ranked by severity The full interaction hub: 1 major · 56 moderate · 6 minor · every one linked to its full report. Check Prasterone Vaginal against your exact supplements

    Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

    5

    Nutrient depletion considerations

    Prasterone Vaginal has been associated with lower levels of 5 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

    Evidence & significance mix
    • Higher significance · 3
    • Moderate · 2
    VITAMIN B6 Insignificant Depletion VITAMIN C Insignificant Depletion ZINC Insignificant Depletion FOLIC ACID Moderate Depletion MAGNESIUM Moderate Depletion
    See the full Prasterone Vaginal nutrient depletion report

    Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

    Prasterone Vaginal: pharmacist answers to common questions

    Quick, plain-English answers to the questions patients ask most about Prasterone Vaginal — the kind of thing our pharmacy team would talk through with you at the counter.

    What exactly is Intrarosa used for?

    ▾
    Intrarosa is used to treat moderate to severe pain during sex that's caused by vaginal and vulvar tissue changes that happen after menopause. Those changes — thinning, drying, and irritation of vaginal tissues — are very common after menopause, and Intrarosa is specifically approved to address the pain during intercourse that can come with them.

    How do I use Intrarosa — is it complicated?

    ▾
    It's pretty straightforward. You insert one vaginal insert once a day at bedtime, using the applicator that comes in the package. Bedtime is recommended so you can stay lying down and let the medication stay in place. Just follow the step-by-step instructions included with your prescription.

    What side effects should I expect?

    ▾
    The most common side effect is vaginal discharge — it was reported in a small percentage of women in clinical trials, so it's something to be aware of but not a cause for alarm in most cases. With longer-term use, some women had slightly abnormal Pap smear results, so keeping up with your regular gynecological exams is a good idea. If you notice anything unexpected or concerning, let your doctor know.

    I had breast cancer in the past — can I still use this?

    ▾
    This is a really important question to bring to your doctor before starting Intrarosa. The medication gets converted into estrogen inside the body, and estrogen-based products are generally not recommended for women with a history of breast cancer. Intrarosa hasn't been specifically studied in women with a breast cancer history, so your doctor needs to weigh that for your individual situation.

    I've had some vaginal bleeding — is it okay to start this medication?

    ▾
    Not until your doctor has checked it out. Any unexplained, persistent, or recurring vaginal bleeding after menopause needs to be evaluated first to find the cause. Once your doctor has assessed it and cleared you, they can let you know whether Intrarosa is appropriate for you.

    Does this medication affect hormones in my whole body, or just locally?

    ▾
    Good question. Intrarosa is a vaginal insert, but some of the medication does get absorbed into the bloodstream and is converted into small amounts of estrogen and testosterone throughout the body. The levels seen in studies were modest, but it's not purely a local effect. That's exactly why your doctor needs to know your full medical history — including any history of breast cancer — before you use it.

    Is Prasterone Vaginal available over the counter?

    ▾
    No. Prasterone Vaginal is a prescription medicine: every Prasterone Vaginal 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 Prasterone Vaginal first available?

    ▾
    The earliest FDA record we hold for Prasterone Vaginal is from 2016: 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 Prasterone Vaginal was first used.

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

    More about Prasterone Vaginal on HelloPharmacist

    📊Prasterone Vaginal supplement interactions63 checked — ranked by severity 🌿Drug & Supplement CheckerPrasterone Vaginal vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Prasterone Vaginal NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
    Detailed data & references for Prasterone Vaginal 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.

    Prasterone Vaginal forms and strengths (how it comes)

    Prasterone Vaginal 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.

    Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Prasterone Vaginal inactive ingredients by manufacturer.

    Vaginal insert

    Vaginal
    Brands Intrarosa
    How this form is used
    What it may be used for
    • Intrarosa vaginal insert is used to treat moderate to severe dyspareunia (pain during sex), a symptom of vulvar and vaginal atrophy due to menopause.
    Important instructions
    • Intrarosa vaginal insert is inserted once daily at bedtime using the provided applicator.
    • Use Intrarosa exactly as your prescriber directs and follow the instructions included with the applicator.
    Available strengths 1 strength
    6.5 mg
    12 FDA-listed product records ⓘ

    Prasterone Vaginal on the U.S. market: products, makers and brands

    How Prasterone Vaginal 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.

    1 company lists 2 Prasterone Vaginal product records with the FDA, mostly as vaginal insert; the earliest marketing or approval year on record is 2016. Brand names on the directory include Intrarosa; the rest are generics.

    1
    Dose forms ⓘ
    1
    Labelers (makers, repackagers, distributors)
    1
    Brand names
    2
    FDA-listed product records ⓘ
    2016
    Earliest FDA record ⓘ

    How widely Prasterone Vaginal is used (Medicaid data)

    A general measure of how commonly Prasterone Vaginal 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 Prasterone Vaginal 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.

    2,624
    Medicaid prescriptions filled (Q1–Q4 2025)
    $812,092 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

    How commonly is Prasterone Vaginal prescribed? Of the 1,601 medications we measure, Prasterone Vaginal ranks #1,150 by Medicaid prescriptions — more than 28% of them.

    Where Prasterone Vaginal ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
    Total prescriptions — #1,150 of 1,601
    #1,145 Ketorolac / Phenylephr... 2,724 Rx #1,146 Ibrutinib 2,698 Rx #1,147 Canagliflozin / Metfor... 2,694 Rx #1,148 Phenol 2,689 Rx #1,149 Dabrafenib 2,673 Rx #1,150 Prasterone Vaginal 2,624 Rx #1,151 Mifepristone (Mifeprex... 2,590 Rx #1,152 Mifepristone (Korlym) 2,590 Rx #1,153 Deferiprone 2,586 Rx #1,154 Calcifediol 2,586 Rx #1,155 Ponatinib 2,562 Rx

    Utilization by Prasterone Vaginal 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.

    prasterone 6.5 MG Vaginal Insert

    2,624 Medicaid prescriptions (Q1–Q4 2025) 100% of Prasterone Vaginal prescriptions shown $812,092 gross reimbursement (before rebates) ≈ $309 per prescription (gross)

    Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1927688

    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 Prasterone Vaginal, 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 1 of 2 listed Prasterone Vaginal NDCs with Medicaid activity.

    Compare Prasterone Vaginal products

    A representative set of FDA-listed product records for Prasterone Vaginal — 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
    💊Vaginal insert
    6.5 mg Vaginal Millicent US, Inc. × 2 listings NDA View NDC →

    Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Prasterone Vaginal NDCs →

    Prasterone Vaginal side effects reported to the 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 Prasterone Vaginal — a signal of what to watch for, not proof the drug caused it.

    The effects most often named in FDA reports that mention Prasterone Vaginal are headache, fatigue, nausea; about 33% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

    2,681
    Reports mentioning it
    33%
    Reported as serious
    12
    Distinct effects shown
    Most reported effects
    Headache
    168
    Fatigue
    167
    Nausea
    128
    Application Site Discharge
    114
    Insomnia
    93
    Rash
    93
    Pain
    91
    Dizziness
    88
    Vaginal Discharge
    84
    Pruritus
    82
    Age groups
    Adult · 381Elderly · 274Infant · 1Adolescent · 1

    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 Prasterone Vaginal 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.

    Prasterone Vaginal FDA approval history

    How Prasterone Vaginal went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

    Prasterone Vaginal was first approved by the FDA in 2016 (Brand: INTRAROSA · Millicent). It remains available in U.S. pharmacies today.

    2016
    Brand approved
    Brand: INTRAROSA · Millicent
    2026
    Available today
    Active in U.S. pharmacies

    Source: Drugs@FDA.

    Prasterone Vaginal 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 Prasterone recalls since July 2021.

    ✅No Prasterone recalls on record since July 2021

    Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

    RxNorm Concept Web — From Ingredient to Every Form and Strength

    This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

    Ingredient (IN) Prasterone Vaginal RxCUI 3143 3 dose forms · 10 strengths
    1. Dose form (SCDF) Oral Capsule RxCUI 373558 No current FDA listing
      Clinical drug / strength (SCD) 5 MG RxCUI 1089817 10 MG RxCUI 200089 25 MG RxCUI 242213 50 MG RxCUI 242339 100 MG RxCUI 252733
    2. Dose form (SCDF) Oral Tablet RxCUI 373559 No current FDA listing
      Clinical drug / strength (SCD) 5 MG RxCUI 483555 10 MG RxCUI 483553 25 MG RxCUI 242214 50 MG RxCUI 252734
    3. Dose form (SCDF) Vaginal Insert RxCUI 2109018 In current FDA listings
      Clinical drug / strength (SCD) 6.5 MG RxCUI 1927688

    Look up RxCUI 3143 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.

    💵 What Prasterone Vaginal costs pharmacies (NADAC benchmark)

    The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

    FormStrengthPharmacy acquisition benchmark
    Insert · Vaginal 6.5 mg $10.98 each NDC details & price history
    Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

    Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

    Prasterone Vaginal brand names

    Prasterone Vaginal is sold under one brand name in the FDA directory — Intrarosa. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

    Intrarosa

    Who makes Prasterone Vaginal: manufacturers and labelers

    One company lists Prasterone Vaginal products with the FDA. By number of product records, the largest are Millicent US, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

    Millicent US, Inc. 2

    Prasterone Vaginal drug class (RxNorm)

    Prasterone Vaginal belongs to the Androstan derivatives class.

    Drug family (ATC) Androstan derivatives, Other sex hormones and modulators of the genital system

    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 Prasterone Vaginal 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 Jul 17, 2026
    🏭
    Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Prasterone Vaginal.
    📈
    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 Prasterone Vaginal after exact ingredient or ingredient-combination matching and applicable route/form matching
    Clinical labels in scope
    1
    Finished products in the current FDA directory
    2
    Companies listing them (makers, repackagers, distributors)
    1
    FDA labeler codes behind them ⓘ
    1
    Linked representative label ⓘ
    Millicent US, Inc.
    Linked label effective
    Jul 17, 2026
    Composite sections available
    15
    Linked SPL Set ID
    ada639d4-bac0-2ad0-e053-2a95a90afce7
    Linked SPL Document ID
    35d8836d-d828-4c04-903d-521c6abf9c42
    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. Millicent US, Inc. 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 →