Drug · FAERS side-effect profile with label screen

Ulipristal side effects: what 504 FDA adverse event reports show

Ulipristal Acetate · 17 reaction terms · 449 drug–reaction co-reports · data 2026-09-14

Drug class

Progesterone agonist/antagonist emergency contraceptive

FDA label, Indications wording of the closest related product

Label matched

Ulipristal Acetate (Ella)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

504 reports · 89% serious · 2 with death outcome · 98% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure . Ella is not intended for routine use as a contraceptive.

FDA label, Indications and Usage

What it is

The ella (ulipristal acetate) tablet for oral use contains 30 mg of a single active steroid ingredient, ulipristal acetate [17α-acetoxy-11β-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione], a synthetic progesterone agonist/antagonist.

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 12 strongest signals

Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 7

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 5 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Unintended pregnancy	149	601.2 524.6–688.8ROR 853.0 · χ² 87,439 / p <1e-300	550.4 EB05 480.1 · IC025 +7.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 425.0 · 71% consumer	no trial data cached
Abortion spontaneous	108	112.0 94.7–132.4ROR 142.2 · χ² 11,758 / p <1e-300	109.6 EB05 93.3 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 72.4 · 78% consumer	no trial data cached
Abortion induced	21	92.9 61.1–141.3ROR 96.9 · χ² 1,815 / p <1e-300	85.7 EB05 59.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 56.3	no trial data cached
Vaginal haemorrhage	74	72.4 58.7–89.4ROR 84.7 · χ² 5,143 / p <1e-300	71.0 EB05 58.5 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 95.6 · 75% consumer	no trial data cached
Menstruation delayed	10	40.1 21.7–74.1ROR 40.9 · χ² 343 / p 8e-77	37.4 EB05 21.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Pharyngeal swelling	8	34.8 17.5–69.2ROR 35.3 · χ² 230 / p 3e-52	32.2 EB05 17.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Blood calcium decreased	7	25.8 12.4–53.9ROR 26.2 · χ² 143 / p 3e-33	23.6 EB05 11.1 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 20.8	no trial data cached
Pelvic pain	10	22.9 12.4–42.3ROR 23.3 · χ² 188 / p 4e-43	21.7 EB05 12.0 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 22.4	no trial data cached
Dysmenorrhoea	6	19.1 8.6–42.3ROR 19.3 · χ² 86 / p 1e-20	15.9 EB05 5.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Exposure during pregnancy	24	16.1 10.9–23.7ROR 16.8 · χ² 325 / p 6e-73	15.7 EB05 10.8 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 15.6	no trial data cached
Premature delivery	5	13.0 5.4–31.1ROR 13.1 · χ² 44 / p 2e-11	8.7 EB05 3.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.6	no trial data cached
Mood swings	9	11.7 6.1–22.4ROR 11.9 · χ² 78 / p 5e-19	9.4 EB05 4.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 11.8	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
Unintended pregnancy	149	601.2 524.6–688.8ROR 853.0 · χ² 87,439 / p <1e-300	550.4 EB05 480.1 · IC025 +7.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 425.0 · 71% consumer	no trial data cached
Abortion spontaneous	108	112.0 94.7–132.4ROR 142.2 · χ² 11,758 / p <1e-300	109.6 EB05 93.3 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 72.4 · 78% consumer	no trial data cached
Vaginal haemorrhage	74	72.4 58.7–89.4ROR 84.7 · χ² 5,143 / p <1e-300	71.0 EB05 58.5 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 95.6 · 75% consumer	no trial data cached
Exposure during pregnancy	24	16.1 10.9–23.7ROR 16.8 · χ² 325 / p 6e-73	15.7 EB05 10.8 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 15.6	no trial data cached
Abortion induced	21	92.9 61.1–141.3ROR 96.9 · χ² 1,815 / p <1e-300	85.7 EB05 59.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 56.3	no trial data cached
Pelvic pain	10	22.9 12.4–42.3ROR 23.3 · χ² 188 / p 4e-43	21.7 EB05 12.0 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 22.4	no trial data cached
Menstruation delayed	10	40.1 21.7–74.1ROR 40.9 · χ² 343 / p 8e-77	37.4 EB05 21.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Mood swings	9	11.7 6.1–22.4ROR 11.9 · χ² 78 / p 5e-19	9.4 EB05 4.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 11.8	no trial data cached
Pharyngeal swelling	8	34.8 17.5–69.2ROR 35.3 · χ² 230 / p 3e-52	32.2 EB05 17.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Blood calcium decreased	7	25.8 12.4–53.9ROR 26.2 · χ² 143 / p 3e-33	23.6 EB05 11.1 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 20.8	no trial data cached
Dysmenorrhoea	6	19.1 8.6–42.3ROR 19.3 · χ² 86 / p 1e-20	15.9 EB05 5.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Premature delivery	5	13.0 5.4–31.1ROR 13.1 · χ² 44 / p 2e-11	8.7 EB05 3.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.6	no trial data cached
Amenorrhoea (missed periods)	4	10.0 3.8–26.5ROR 10.0 · χ² 24 / p 5e-7	5.8 EB05 2.2 · IC025 +0.6 3/3 methods agree	Not in label — unassessed	serious PRR 14.7	no trial data cached
Breast pain	4	15.6 5.9–41.5ROR 15.7 · χ² 41 / p 7e-11	9.9 EB05 3.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Vaginal discharge	4	16.6 6.2–44.0ROR 16.7 · χ² 44 / p 2e-11	10.7 EB05 3.2 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious n=4	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.

Abortion induced — n=21, PRR 92.9
Vaginal haemorrhage — n=74, PRR 72.4

✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.

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 Ulipristal?

In FDA FAERS, the most frequently co-reported reaction terms for Ulipristal are unintended pregnancy, abortion spontaneous, vaginal haemorrhage, abortion induced, pelvic pain, menstruation delayed. 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 Ulipristal have an FDA boxed warning?

No. The FDA label retrieved for Ulipristal has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Ulipristal 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 2bf93d23-cddd-4613-9066-5b5fa090404b, effective 20260720; matched on openfda.generic_name.exact:"ULIPRISTAL ACETATE")
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, field patient.drug.openfda.generic_name.exact, 17 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.