intrarosa
Intrarosa (Prasterone) is a medication used to treat Adrenal Insufficiency, Dyspareunia, Lupus Vulgaris, Sexual and Gender Disorders.
Prasterone · by Millicent
Key facts
- Active ingredient
- Prasterone
- Form
- Insert
- Strength
- Prasterone 6.5MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- adrenal insufficiency, dyspareunia, lupus vulgaris
- Manufacturer
- Millicent
- FDA application
- NDA208470
What is Intrarosa?
From the FDA label:INTRAROSA (prasterone) vaginal insert is a vaginally administered steroid. Prasterone is identified chemically as 3β-hydroxyandrost-5-en-17-one. It has the empirical formula C 19 H 28 O 2 with a molecular weight of 288.424 g/mol. Prasterone is a white to off-white crystalline powder insoluble in water and soluble in sodium lauryl sulfate (SLS). The structural formula is: Each INTRAROSA (prasterone) vaginal insert contains 6.5 mg of prasterone in 1.3 ml of off-white hard fat (Witepsol). Prasterone
How to use
Administer one INTRAROSA vaginal insert once daily at bedtime, using the provided applicator. One vaginal insert, once daily at bedtime. ( 2 )
Side effects
In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥ 2 percent was vaginal discharge. ( 6.1 ) In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥ 2 percent were vaginal discharge and abnormal Pap smear. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Millicent U.S. Inc at 1-877-810-2101 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In four (4) placebo-controlled, 12-week clinical trials [91% - White Caucasian non-Hispanic women, 7% - Black or African American women, and 2% - "Other" women, average age 58.8 years of age (range 40 to 80 years of age)], vaginal discharge is the most frequently reported treatment-emergent adverse reaction in the INTRAROSA treatment group with an incidence of ≥ 2 percent and greater than reported in the placebo treatment group. There were 38 cases in 665 participating postmenopausal women (5.71 percent) in the INTRAROSA treatment group compared to 17 cases in 464 participating postmenopausal women (3.66 percent) in the placebo treatment…
Warnings
Important safety information
Current or Past History of Breast Cancer. ( 5.1 ) 5.1 Current or Past History of Breast Cancer Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer. 5.1 Current or Past History of Breast Cancer Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer.
Who should not take Intrarosa
Undiagnosed abnormal genital bleeding: Any postmenopausal woman with undiagnosed, persistent or recurring genital bleeding should be evaluated to determine the cause of the bleeding before consideration of treatment with INTRAROSA. Undiagnosed abnormal genital bleeding. ( 4 )
May treat (source: NIH RxClass)
Dosage forms
Insert
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Intrarosa treat?
- Intrarosa (Prasterone) may be used to treat adrenal insufficiency, dyspareunia, lupus vulgaris, sexual and gender disorders, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Intrarosa?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Intrarosa. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Intrarosa?
- Intrarosa is marketed by Millicent. You can see Millicent's full profile, rating, and other products on pharmaranks.
- Is Intrarosa a brand-name or generic drug?
- Intrarosa is a brand-name product with the active ingredient Prasterone.
- Is Intrarosa available over the counter?
- No. Intrarosa is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Intrarosa come in?
- Intrarosa is currently marketed as insert, per the FDA's National Drug Code Directory.
- Is Intrarosa FDA-registered?
- Intrarosa is on record with the U.S. FDA under application number NDA208470. You can verify this on its official FDA label.
- Is Intrarosa safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Intrarosa. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Intrarosa?
- Intrarosa's side effects are taken directly from its FDA label. From the label: In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥ 2 percent was vaginal discharge. ( 6.1 ) In one 52-week open-label clinical trial,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about PRASTERONE
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,190 reports naming PRASTERONE — the active ingredient in Intrarosa, and the FDA flagged 64% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fatigue139 reports
- headache126 reports
- nausea108 reports
- dizziness76 reports
- rash67 reports
- diarrhoea65 reports
- dyspnoea65 reports
- asthenia57 reports
Read these as a signal, not a rate. A report does not mean PRASTERONE caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 26, 2026.
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