What the label lists and what reports show
Ulipristal side effects
Ulipristal's FDA label: “The most common adverse reactions (≥ 5%) in the clinical trials were headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%) and dizziness (5%).” FAERS holds 504 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is unintended pregnancy (149 reports).
- No generic listed
Check it at the source: the ulipristal FDA label on DailyMed (effective July 20, 2026, PMI Branded Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ella?● Pregnancy outside of the womb (ectopic pregnancy). If you have severe lower stomach (abdominal) pain about 3 to 5 weeks after taking ella, you may have a pregnancy outside of the uterus (womb), which is called an ectopic or tubal pregnancy. An ectopic pregnancy is a serious condition that needs medical treatment right away. Call your healthcare provider or go to the nearest emergency room right away if you think you may have an ectopic pregnancy. ● Changes in menstrual cycle. Some women taking ella may have their next period earlier or later than expected. If your period is more than a week late, you should take a pregnancy test and follow up with your healthcare provider. […]
Source: FDA drug label, PMI Branded Pharmaceuticals, Inc., effective July 20, 2026 (SPL set 2bf93d23-cddd-4613-9066-5b5fa090404b), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 5%) in the clinical trials were headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%) and dizziness (5%).
Table 1: Adverse Reactions in ≥ 5% of Women (%) Receiving a Single Dose of ella (30 mg Ulipristal Acetate)
| Most Common Adverse Reactions | Open-Label Study N = 1,533 | Single-Blind Comparative Study N = 1,104 |
|---|---|---|
| Headache | 18 | 19 |
| Nausea | 12 | 13 |
| Abdominal and upper abdominal pain | 15 | 8 |
| Dysmenorrhea | 7 | 13 |
| Fatigue | 6 | 6 |
| Dizziness | 5 | 5 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common adverse reactions (≥ 5%) in the clinical trials were headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%) and dizziness (5%). ( 6 )To report SUSPECTED ADVERSE REACTIONS, contact HRA Pharma America Inc., at 844-994-0329 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 clinical practice. Ella was studied in an open-label multicenter trial (Open-Label Study) and in a comparative, randomized, single-blind, multicenter trial (Single-Blind Comparative Study). In these studies, a total of 2,637 (1,533 + 1,104) women in the 30 mg ulipristal acetate groups were included in the safety analysis. The mean age of women who received ulipristal acetate was 24.5 years and the mean body mass index (BMI) was 25.3. The racial demographics of those enrolled were 67% Caucasian, 20% Black or African American, 2% Asian, and 12% other. The most common adverse reactions (≥ 10%) in the clinical trials for women receiving ella were headache (18% overall), nausea (12% overall) and abdominal and upper abdominal pain (12% overall). …
Source: FDA drug label, PMI Branded Pharmaceuticals, Inc., effective July 20, 2026 (SPL set 2bf93d23-cddd-4613-9066-5b5fa090404b), via openFDA; the full label on DailyMed
What do FAERS reports show?
504 reports list ulipristal among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 69 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ulipristal: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions