Short answer: In four 12-week placebo-controlled trials, the most common Intrarosa side effect was vaginal discharge: 5.71% of women on Intrarosa vs 3.66% on placebo. In a 52-week open-label trial, vaginal discharge was 14.2% and abnormal Pap smear 2.1%. Intrarosa has no boxed warning. Its warning notes that estrogen is a breakdown product of prasterone and it has not been studied after breast cancer.
What Intrarosa is approved for: Intrarosa is a steroid vaginal insert approved to treat moderate to severe dyspareunia (pain during sex), a symptom of vulvar and vaginal atrophy, due to menopause (section 1). Prasterone, also called DHEA, is an inactive steroid that the body converts into androgens and estrogens; how it works for vaginal atrophy is not fully established (section 12.1).
Source
INTRAROSA (prasterone) vaginal inserts, prescribing information, Patient Information and Instructions for Use. Millicent U.S.. DailyMed, version published August 3, 2026. DailyMed setid ada639d4-bac0-2ad0-e053-2a95a90afce7
No. The current Intrarosa label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Intrarosa.
| Trial | Adverse reaction | Intrarosa | Placebo |
|---|---|---|---|
| Four 12-week placebo-controlled trials | Vaginal discharge | 38 of 665 women (5.71 percent) | 17 of 464 women (3.66 percent) |
| 52-week open-label trial | Vaginal discharge | 74 of 521 women (14.2 percent) | No placebo group |
| 52-week open-label trial | Abnormal Pap smear at 52 weeks | 11 of 521 women (2.1 percent) | No placebo group |
The label gives these as cases and percentages in its text, not as a table. The 52-week trial had no placebo group.
The 11 abnormal Pap smears at 52 weeks were 1 low-grade squamous intraepithelial lesion (LSIL) and 10 atypical cells of undetermined significance (ASCUS).
After 7 days of daily use, average peak prasterone was 4.42 ng/mL on Intrarosa vs 1.60 on placebo. Peak testosterone was 0.15 vs 0.12 ng/mL and peak estradiol 5.04 vs 3.33 pg/mL (Table 1).
Over 12 weeks of daily use in the two main trials, trough blood levels of prasterone, testosterone and estradiol rose 47%, 21% and 19% from baseline.
Of 1522 women given prasterone in the trials, 19% in the 12-week trials and 11% in the 52-week trial were 65 or older.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Who should not use it. Women with undiagnosed abnormal genital bleeding. Any postmenopausal woman with undiagnosed, persistent or recurring genital bleeding is evaluated for the cause before Intrarosa is considered.
Current or past breast cancer. Estrogen is a breakdown product (metabolite) of prasterone, and 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.
Pregnancy and breastfeeding. Intrarosa is indicated only for postmenopausal women. There are no data on use in pregnancy and no information on prasterone in breast milk (sections 8.1, 8.2).
Kidney and liver impairment. The effect of kidney or liver impairment on prasterone levels has not been studied (sections 8.6, 8.7).
From the Patient Information that comes with Intrarosa:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.