Prasterone: uses, dosing, side effects & brands
Prasterone is a medicine sold in the U.S. under one brand, for adrenal insufficiency, dyspareunia and lupus vulgaris. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Adrenal Insufficiency, Dyspareunia and Lupus Vulgaris
- Available as
- Insert
- Sold as
- Intrarosa
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How prasterone is dosed
From the FDA label for Intrarosa (application NDA208470). Other prasterone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer one INTRAROSA vaginal insert once daily at bedtime, using the provided applicator. One vaginal insert, once daily at bedtime. ( 2 )
Prasterone 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…
Who shouldn’t take prasterone
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 )
Every prasterone product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Intrarosa.
How long prasterone keeps
No prasterone label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
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, 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.
Related calculators
Frequently asked questions
What is prasterone?
Intrarosa (Prasterone) is a medication used to treat Adrenal Insufficiency, Dyspareunia, Lupus Vulgaris, Sexual and Gender Disorders.
Can you take prasterone with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run prasterone against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does prasterone come in?
Across the brands we track, prasterone is currently marketed as insert, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic prasterone?
We do not currently list a generic-labelled prasterone product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Prasterone: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/prasterone
- MLA
- “Prasterone: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/prasterone.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for prasterone on DailyMed (NIH) ↗.