Ulipristal

When taken immediately before ovulation is to occur, ella postpones follicular rupture. The likely primary mechanism of action of ulipristal acetate for emergency contraception is therefore inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also contribute to efficacy.

• Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure [see Dosage and Administration (2.1) ] . Ella is not intended for routine use as a contraceptive.ICD-10: Z30.9

• Ella is contraindicated for use in the case of known or suspected pregnancy [see Use in Specific Populations (8.1) ].contraindicated

Take one tablet orally as soon as possible, within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. Take with or without food. Take at any time during the menstrual cycle. ( 2.1 ) After ella use, initiate or resume hormonal contraception no sooner than 5 days after the intake of ella and use a reliable barrier method until the next menstrual period. ( 2.2 ) If vomiting occurs within 3 hours of taking ella , consider repeating the dose. ( 2.3 ) 2.1 Recommended Dosage and Administration Take one tablet of ella orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. Take ella with or without food. Take ella at any time during the menstrual cycle. 2.2 Recommendations Regarding Use with Hormonal Contraception After ella use, initiate or resume hormonal contraception no sooner than 5 days after the intake of ella and use a reliable barrier method until the next menstrual period. For known or suspected failure of hormonal contraception refer to the hormonal contraceptive’s prescribing information for instructions on what to do [see Warnings and Precautions (5.5) , Drug Interactions (7.1) and Clinical Pharmacology (12.2 )] . 2.3 Recommendation in Case of Gastrointestinal Disturbances If vomiting occurs within 3 hours of taking ella , consider repeating the dose.

Existing Pregnancy: ella is not indicated for termination of an existing pregnancy. ( 5.1) Ectopic pregnancy: Evaluate women who become pregnant or complain of lower abdominal pain after taking ella for ectopic pregnancy. ( 5.2 ) Fertility Following Use : Rapid return of fertility is likely. Subsequent acts of intercourse should be protected by a reliable barrier method of contraception until the next menstrual period. ( 5.5 ) Effect on Menstrual Cycle: ella may alter the next expected menses. If menses is delayed beyond 1 week, rule out pregnancy. ( 5.6 ) Ella does not protect against STI/HIV. ( 5.7 ) 5.1 Existing Pregnancy Ella is not indicated for termination of an existing pregnancy. 5.2 Ectopic Pregnancy A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Healthcare providers, however, should consider the possibility of ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking ella . A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking ella . 5.3 Repeated Use Ella is for occasional use as an emergency contraceptive. It should not replace a regular method of contraception. Repeated use of ella within the same menstrual cycle is not recommended, as safety and efficacy of repeat use within the same cycle has not been evaluated. 5.4 CYP3A4 Inducers A CYP3A4 inducer, rifampin, decreases the plasma concentration of ella significantly.

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%). ( 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). Table 1 lists those adverse reactions that were reported in ≥ 5% of subjects in the clinical studies ( 14 ).

8.1 Pregnancy Risk Summary Ella is contraindicated for use during an existing or suspected pregnancy. No signal of concern regarding pregnancy complications was found in postmarketing studies [see Data ]. Isolated cases of major malformations in ella- exposed pregnancies were identified; however, the data are not sufficient to determine a risk for birth defects with inadvertent use of ella during pregnancy. Miscarriage was reported in 14% of the known pregnancy outcomes; a rate that is similar to the U.S. background rate for miscarriage. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. In animal reproduction studies, no malformations were observed during repeated administration of ulipristal acetate to pregnant rats, rabbits and monkeys at daily drug exposures ⅓, ½, and 3 times respectively, the human exposure at a dose of 30 mg [ see Data ] . Data Human Data Ella pregnancy exposure data was collected in the U.S. and Europe from 1999 to 2015 and analyzed post-marketing using data from interventional clinical trials, observational studies and pharmacovigilance reports. Known pregnancy outcomes were available for 462/784 pregnancies in which women received ella at doses of 30 mg or greater during the conception cycle or during pregnancy.

Metabolism

Absorption Following a single dose administration of ella in 20 women under fasting conditions, maximum plasma concentrations of ulipristal acetate and the active metabolite, monodemethyl-ulipristal acetate, were 176 and 69 ng/ml and were reached at 0.9 and 1 hour, respectively.

Experience with ulipristal acetate overdose is limited. In a clinical study, single doses equivalent to up to 4 times ella were administered to a limited number of subjects without any adverse reactions.

• Aug 13, 2010NDANDA022474Lab Hra Pharma

1. 1Unintended Pregnancy14930%
2. 2Abortion Spontaneous10721%
3. 3Vaginal Haemorrhage7415%
4. 4Drug Ineffective5411%
5. 5Nausea397.8%
6. 6Pregnancy After Post Coital Contraception346.8%
7. 7Abdominal Pain285.6%
8. 8Headache275.4%
9. 9Dizziness255.0%
10. 10Exposure During Pregnancy244.8%
11. 11Maternal Exposure During Pregnancy224.4%
12. 12Abortion Induced214.2%
13. 13Vomiting193.8%
14. 14Back Pain173.4%
15. 15Off Label Use173.4%

The 10 most recently updated of 98 ClinicalTrials.gov registrations naming Ulipristal as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception
  Recruiting · Phase 3 · Interventional · 980 enrolled · The University of Hong Kong
  NCT06727734updated 2026-05-14
• Mammogram Pretreatment With Ulipristal Acetate
  Not yet recruiting · Phase 2 · Interventional · 26 enrolled · OHSU Knight Cancer Institute
  NCT07434128updated 2026-02-25
• Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2
  Not yet recruiting · Interventional · 560 enrolled · Second Affiliated Hospital, School of Medicine, Zhejiang University
  NCT07306260updated 2025-12-29
• Multicenter Prospective Non-randomized Controlled Study of ALA-PDT for LSIL With HPV16/18 Infection
  Not yet recruiting · Interventional · 225 enrolled · Second Affiliated Hospital, School of Medicine, Zhejiang University
  NCT07306247updated 2025-12-29
• Study of the Safety and Efficacy of Ulipristal Acetate (UPA) Used Daily as a Contraceptive
  Withdrawn · Phase 2 · Interventional · 0 enrolled · Premier Research
  NCT03296098updated 2025-11-20
• Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg
  Terminated · Phase 4 · Interventional · 532 enrolled · Kimberly Myer
  NCT03537768updated 2025-11-20
• Non-interventional Study to Evaluate Long Term Safety, Prescription Management Patterns of Esmya in a Long Term Setting
  Completed · Observational · 1,527 enrolled · PregLem SA
  NCT02748460updated 2025-09-02
• Comfortage - AD Prevention Strategies
  Not yet recruiting · Interventional · 200 enrolled · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  NCT06896201updated 2025-08-26
• PROACT Pilot Trial
  Active not recruiting · Observational · 60 enrolled · University of British Columbia
  NCT06564649updated 2025-06-15
• Korean Vascular Intervention Society Multicenter Registry Study on Outcomes of Endovascular Therapy in Lower Limb Artery Diseases (K-VIS ELLA): (A Retrospective & Prospective Observational Study)
  Recruiting · Observational · 12,000 enrolled · Yonsei University
  NCT02748226updated 2025-04-30

Frequently asked questions

How does Ulipristal work?

When taken immediately before ovulation is to occur, ella postpones follicular rupture. The likely primary mechanism of action of ulipristal acetate for emergency contraception is therefore inhibition or delay of ovulation; however, alterations to the endometrium that may affect implantation may also contribute to efficacy.

What is Ulipristal used for?

According to FDA labeling, Ulipristal carries indications including: Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure [see Dosage and Administration (2.1) ] . Ella is not intended for routine use as a contraceptive.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ulipristal?

Ulipristal is classified as Emergency contraceptives, Progesterone receptor modulators, Progesterone Agonist/Antagonist, Selective Progesterone Receptor Modulators, Decreased Embryonic Implantation, Inhibit Ovulation.

What are the brand names for Ulipristal?

Ulipristal is marketed under brand names including Ella.

What are the contraindications for Ulipristal?

Ulipristal labeling lists contraindications including: Ella is contraindicated for use in the case of known or suspected pregnancy [see Use in Specific Populations (8.1) ].. Always consult the full prescribing information and a clinician.