Drug · FAERS side-effect profile with label screen
Prasterone side effects: what 2,672 FDA adverse event reports show
Drug class
Steroid
FDA label, Indications wording
Brand names
Intrarosa
openFDA label
Who reports
2,672 reports · 32% serious · 46 with death outcome · 89% female
openFDA FAERS counts, all years, deduplication not applied
Used for
INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1 )
FDA label, Indications and Usage
What it is
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.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 1Likely indication confounding 1Reporting / coding artifact 9Not in label — unassessed 29
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 77 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Vaginal discharge | 84 | 66.2 53.6–81.8ROR 68.3 · χ² 5,286 / p <1e-300 | 64.7 EB05 53.9 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=3 · 73% consumer | no trial data cached |
| Poor quality product administered | 45 | 34.7 26.0–46.4ROR 35.3 · χ² 1,434 / p <1e-300 | 34.1 EB05 26.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | 91% consumer | no trial data cached |
| Product packaging issue | 29 | 24.6 17.1–35.4ROR 24.9 · χ² 632 / p 1e-139 | 24.2 EB05 17.7 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious n=2 · 93% consumer | no trial data cached |
| Product administration error | 57 | 22.5 17.4–29.1ROR 22.9 · χ² 1,146 / p 1e-251 | 22.3 EB05 17.8 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 92% consumer | no trial data cached |
| Product physical issue | 51 | 20.1 15.3–26.4ROR 20.5 · χ² 907 / p 2e-199 | 20.0 EB05 15.7 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=2 · 94% consumer | no trial data cached |
| Head discomfort | 29 | 12.9 9.0–18.6ROR 13.1 · χ² 308 / p 4e-69 | 12.5 EB05 8.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 38.0 | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 27 | 12.9 8.9–18.8ROR 13.0 · χ² 284 / p 4e-64 | 12.4 EB05 8.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 34.9 | no trial data cached |
| Micturition urgency | 17 | 11.8 7.3–18.9ROR 11.9 · χ² 157 / p 2e-36 | 10.7 EB05 6.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Therapeutic response unexpected | 60 | 10.5 8.2–13.5ROR 10.7 · χ² 505 / p 4e-112 | 10.2 EB05 8.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 | no trial data cached |
| Arteriosclerosis | 11 | 9.2 5.1–16.5ROR 9.2 · χ² 72 / p 1e-17 | 7.3 EB05 4.1 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 | no trial data cached |
| Insurance issue | 17 | 9.0 5.6–14.4ROR 9.0 · χ² 113 / p 1e-26 | 7.8 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 31.1 | no trial data cached |
| Vaginal haemorrhage | 48 | 8.9 6.7–11.7ROR 9.0 · χ² 327 / p 2e-73 | 8.4 EB05 6.5 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.2 · 76% consumer | no trial data cached |
| Seasonal allergy | 15 | 8.3 5.0–13.8ROR 8.4 · χ² 90 / p 1e-21 | 7.0 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Dermatitis contact | 12 | 8.3 4.7–14.6ROR 8.3 · χ² 70 / p 3e-17 | 6.7 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Infusion site pain | 12 | 7.4 4.2–13.0ROR 7.4 · χ² 60 / p 5e-15 | 6.0 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Off label use (used outside approved label) | 793 | 7.2 6.8–7.6ROR 9.8 · χ² 4,389 / p <1e-300 | 7.1 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 72% consumer | no trial data cached |
| Product use complaint | 14 | 7.1 4.2–12.0ROR 7.1 · χ² 67 / p 1e-16 | 5.9 EB05 3.7 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious n=6 | no trial data cached |
| Contraindicated product administered | 27 | 7.0 4.8–10.2ROR 7.1 · χ² 134 / p 3e-31 | 6.4 EB05 4.6 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 0.6 · 92% consumer | no trial data cached |
| Brain fog | 13 | 7.0 4.1–12.0ROR 7.0 · χ² 61 / p 3e-15 | 5.8 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 | no trial data cached |
| Tinnitus (ringing in the ears) | 41 | 7.0 5.2–9.5ROR 7.1 · χ² 205 / p 8e-47 | 6.6 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 | no trial data cached |
| Restless legs syndrome | 14 | 6.0 3.6–10.2ROR 6.1 · χ² 54 / p 1e-13 | 5.1 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 | no trial data cached |
| Hot flush (hot flashes) | 54 | 5.6 4.3–7.3ROR 5.7 · χ² 201 / p 5e-46 | 5.4 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 · 80% consumer | no trial data cached |
| Pelvic pain | 13 | 5.6 3.3–9.7ROR 5.6 · χ² 45 / p 1e-11 | 4.8 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Night sweats | 22 | 5.4 3.5–8.1ROR 5.4 · χ² 74 / p 4e-18 | 4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Lower limb fracture | 13 | 5.3 3.1–9.2ROR 5.4 · χ² 42 / p 5e-11 | 4.6 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Sleep apnoea syndrome | 13 | 5.3 3.1–9.2ROR 5.4 · χ² 42 / p 6e-11 | 4.6 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Deafness | 17 | 5.1 3.2–8.2ROR 5.1 · χ² 52 / p 3e-13 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Underdose | 47 | 5.1 3.8–6.7ROR 5.1 · χ² 149 / p 1e-34 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | 74% consumer | no trial data cached |
| Fungal infection | 21 | 5.0 3.2–7.6ROR 5.0 · χ² 62 / p 1e-15 | 4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Cellulitis (skin infection) | 30 | 4.7 3.3–6.7ROR 4.7 · χ² 83 / p 4e-20 | 4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Feeling hot | 36 | 4.6 3.3–6.4ROR 4.7 · χ² 98 / p 2e-23 | 4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 | no trial data cached |
| Sinus disorder | 11 | 4.4 2.4–7.9ROR 4.4 · χ² 25 / p 3e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Application site pain | 12 | 4.3 2.4–7.5ROR 4.3 · χ² 27 / p 1e-7 | 3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Pollakiuria (frequent urination) | 22 | 4.1 2.7–6.3ROR 4.2 · χ² 50 / p 1e-12 | 3.8 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Ear infection | 14 | 4.1 2.5–7.0ROR 4.2 · χ² 30 / p 2e-8 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
| Feeling jittery | 10 | 4.1 2.2–7.6ROR 4.1 · χ² 21 / p 3e-6 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Drug ineffective for unapproved indication | 29 | 4.1 2.8–5.9ROR 4.1 · χ² 65 / p 4e-16 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 1.7 · 77% consumer | no trial data cached |
| Sinusitis | 53 | 4.0 3.1–5.3ROR 4.1 · χ² 119 / p 5e-28 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Swelling face | 32 | 3.9 2.7–5.5ROR 3.9 · χ² 65 / p 3e-16 | 3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Femur fracture | 15 | 3.8 2.3–6.3ROR 3.8 · χ² 28 / p 6e-8 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 793 | 7.2 6.8–7.6ROR 9.8 · χ² 4,389 / p <1e-300 | 7.1 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 72% consumer | no trial data cached |
| Product dose omission issue | 125 | 3.4 2.9–4.1ROR 3.6 · χ² 218 / p 1e-49 | 3.4 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 · 87% consumer | no trial data cached |
| Vaginal discharge | 84 | 66.2 53.6–81.8ROR 68.3 · χ² 5,286 / p <1e-300 | 64.7 EB05 53.9 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=3 · 73% consumer | no trial data cached |
| Alopecia (hair loss) | 81 | 3.2 2.6–4.0ROR 3.3 · χ² 124 / p 5e-29 | 3.2 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · 77% consumer | no trial data cached |
| Inappropriate schedule of product administration | 64 | 2.8 2.2–3.6ROR 2.9 · χ² 75 / p 2e-18 | 2.8 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 · 85% consumer | no trial data cached |
| Therapeutic response unexpected | 60 | 10.5 8.2–13.5ROR 10.7 · χ² 505 / p 4e-112 | 10.2 EB05 8.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 | no trial data cached |
| Product administration error | 57 | 22.5 17.4–29.1ROR 22.9 · χ² 1,146 / p 1e-251 | 22.3 EB05 17.8 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 92% consumer | no trial data cached |
| Hot flush (hot flashes) | 54 | 5.6 4.3–7.3ROR 5.7 · χ² 201 / p 5e-46 | 5.4 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 · 80% consumer | no trial data cached |
| Sinusitis | 53 | 4.0 3.1–5.3ROR 4.1 · χ² 119 / p 5e-28 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Product physical issue | 51 | 20.1 15.3–26.4ROR 20.5 · χ² 907 / p 2e-199 | 20.0 EB05 15.7 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=2 · 94% consumer | no trial data cached |
| Vaginal haemorrhage | 48 | 8.9 6.7–11.7ROR 9.0 · χ² 327 / p 2e-73 | 8.4 EB05 6.5 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.2 · 76% consumer | no trial data cached |
| Underdose | 47 | 5.1 3.8–6.7ROR 5.1 · χ² 149 / p 1e-34 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | 74% consumer | no trial data cached |
| Illness | 45 | 3.5 2.6–4.7ROR 3.6 · χ² 79 / p 3e-19 | 3.4 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 10.1 | no trial data cached |
| Heart rate increased | 45 | 3.6 2.7–4.8ROR 3.6 · χ² 81 / p 1e-19 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 8.0 | no trial data cached |
| Poor quality product administered | 45 | 34.7 26.0–46.4ROR 35.3 · χ² 1,434 / p <1e-300 | 34.1 EB05 26.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | 91% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Poor quality product administered — n=45, PRR 34.7
- Head discomfort — n=29, PRR 12.9
- Photosensitivity reaction — n=27, PRR 12.9
- Tinnitus — n=41, PRR 7.0
- Hot flush — n=54, PRR 5.6
- Night sweats — n=22, PRR 5.4
- Fungal infection — n=21, PRR 5.0
- Cellulitis — n=30, PRR 4.7
- Feeling hot — n=36, PRR 4.6
- Pollakiuria — n=22, PRR 4.1
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Prasterone?
In FDA FAERS, the most frequently co-reported reaction terms for Prasterone are vaginal discharge, alopecia, hot flush, sinusitis, vaginal haemorrhage, heart rate increased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Prasterone have an FDA boxed warning?
No. The FDA label retrieved for Prasterone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Prasterone causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID ada639d4-bac0-2ad0-e053-2a95a90afce7, effective 20260717; matched on
openfda.generic_name.exact:"PRASTERONE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 117 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.