FDA-filed SPL labeling · retrieved through openFDA

Ulipristal

Ulipristal (ella) is an emergency contraceptive taken orally to help prevent pregnancy after unprotected intercourse or contraceptive failure.

Brand name Ella
Drug class Progesterone Agonist/antagonist
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJul 20, 2026
Clinical labels in scope 4
AvailabilityRx
Earliest approval/marketing year 2010
FDA-listed product records 14
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Ulipristal at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Ella (ulipristal acetate) is a single-dose emergency contraceptive tablet that can reduce the chance of pregnancy when taken within 5 days of unprotected sex or contraceptive failure — the sooner, the better. It is not a regular form of birth control, and it does not protect against sexually transmitted infections. Always follow up with your healthcare provider, especially if your period is late or you have lower abdominal pain after taking it.

📖 Ulipristal: Patient Information Guide

A plain-language walkthrough of Ulipristal — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Ulipristal acetate is approved for use in one product, ella, as an oral emergency contraceptive.

  • Ella is used to prevent pregnancy following unprotected intercourse or known or suspected contraceptive failure, taken within 120 hours (5 days) of the event
  • Ella is not intended for routine or repeated use as an ongoing method of contraception
⚙️How it works

Ulipristal acetate blocks the progesterone receptor — the site in the body that normally responds to the hormone progesterone. By occupying that receptor, it prevents progesterone from sending its usual signal. The primary effect is delaying or preventing ovulation (egg release). When taken before the surge of luteinizing hormone (LH) that triggers ovulation, ella can postpone follicular rupture (the moment the egg is released) by at least 5 days in most cases. Changes to the thickness of the uterine lining may also contribute to its effectiveness.

Importantly, ella was not effective at postponing ovulation when taken on the exact day the LH surge peaked, so timing matters. It works best the sooner it is taken.

💊How it's taken

Ella is taken as a single tablet by mouth — one dose only. Take it as soon as possible, at any time during the menstrual cycle, within 5 days (120 hours) of unprotected intercourse. It can be taken with or without food. If vomiting occurs within 3 hours of taking ella, the dose may need to be repeated.

  • After taking ella, wait at least 5 full days before starting or resuming any hormonal contraceptive
  • Use a reliable barrier method (such as a condom) for any sex after taking ella until your next period arrives
🤒Side effects — in detail

The most common side effects reported in clinical trials of ella include:

  • Headache (most common, reported by about 1 in 5 users)
  • Nausea
  • Abdominal or upper abdominal pain
  • Painful periods (dysmenorrhea)
  • Fatigue
  • Dizziness
  • Spotting between periods

Your next period may come a few days earlier or later than expected — this is common. However, get medical attention right away if you develop severe lower abdominal pain (which could signal an ectopic pregnancy) or signs of an allergic reaction such as hives, swelling, or difficulty breathing.

⚠️Warnings & precautions
  • Not for use in existing pregnancy: Ella will not end an established pregnancy and must not be taken if you are already pregnant.
  • Ectopic pregnancy risk: If you develop lower abdominal pain or a positive pregnancy test after taking ella, see a provider right away — a pregnancy outside the uterus (ectopic pregnancy) is a medical emergency.
  • Quick return of fertility: Fertility comes back rapidly after taking ella. Use a barrier method for all subsequent sex until your next period.
  • Menstrual cycle changes: Your period may shift by several days. If it's more than a week late, take a pregnancy test.
  • No STI protection: Ella does not protect against HIV or any other sexually transmitted infection.
  • Repeated use: Using ella more than once in the same menstrual cycle is not recommended — safety and effectiveness in that situation have not been studied.
  • Drug interactions: Several medications and herbal supplements (see Interactions) can significantly lower ella's effectiveness. Do not take it alongside CYP3A4 inducers like rifampin or St. John's Wort.
🔀What it interacts with

Ella is broken down primarily by a liver enzyme called CYP3A4, which makes it vulnerable to several interactions:

  • CYP3A4 inducers (reduce ella's effectiveness — avoid): rifampin, barbiturates, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, topiramate, bosentan, and St. John's Wort
  • CYP3A4 inhibitors (raise ella's blood levels): strong antifungals such as itraconazole and ketoconazole — use with caution
  • Progestin-containing hormonal contraceptives: starting these too soon after ella may reduce ella's ability to delay ovulation; conversely, ella may affect how progestin-based contraceptives work — wait at least 5 days and use a barrier method until your next period

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Known or suspected pregnancy: Ella is contraindicated — do not take it if you are already pregnant
  • History of ectopic pregnancy: Not an automatic reason to avoid ella, but tell your provider so they can monitor you
  • Breastfeeding: Small amounts of ulipristal pass into breast milk; discuss timing with your healthcare provider
  • Adolescents: Ella has been studied in teens and found to have a similar safety and efficacy profile as in adults; it is not indicated before the first menstrual period
  • Postmenopausal women: Ella is not intended for use after menopause
  • Liver or kidney disease: No studies have been conducted in people with liver or kidney impairment — discuss with your provider
  • Medications and supplements: Share a full medication list with your provider or pharmacist, especially seizure medications, antibiotics, antifungals, or herbal supplements
🚑If you take too much

Experience with ella overdose is limited. In a clinical study, doses up to four times the standard amount were given to a small number of people without serious adverse reactions being reported. If you think you or someone else has taken too much, contact a poison control center or seek medical care promptly.

📡Pharmacodynamics — effects in the body

Ulipristal acetate selectively binds to the progesterone receptor and blocks progesterone from attaching there. Taken in the late follicular phase (just before ovulation), it delayed follicular rupture (egg release) for at least 5 days in all subjects who took it before the LH surge, and in most who took it just as the LH surge was beginning. In the early luteal phase, it decreases the thickness of the uterine lining slightly but does not significantly delay its maturation. It was not effective at postponing follicular rupture when taken on the day the LH surge peaked.

🔬Pharmacokinetics — how your body processes it

After a single oral dose taken on an empty stomach, ella reaches peak blood levels in less than 1 hour. Its active metabolite (monodemethyl-ulipristal acetate) peaks around the same time. The drug's half-life — the time for blood levels to drop by half — is approximately 32 hours, meaning it stays active in the body for a day or more. Ella is metabolized primarily by the liver enzyme CYP3A4. Food does not significantly affect how well ella works, so it can be taken with or without a meal.

📦How to store it

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) Keep the blister in the outer carton in order to protect from light. Keep out of reach of children .

📄 Written from Ulipristal’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

158

Supplements & herbs that interact with Ulipristal

158 supplements and herbal products have documented interactions with Ulipristal in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 107
  • Minor · 48
Every supplement checked against Ulipristal — ranked by severity The full interaction hub: 3 major · 107 moderate · 48 minor · every one linked to its full report. Check Ulipristal against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

2

Nutrient depletion considerations

Ulipristal has been associated with lower levels of 2 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Ulipristal nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Ulipristal — the kind of thing our pharmacy team would talk through with you at the counter.

How quickly do I need to take ella after unprotected sex?
Take it as soon as possible — the sooner, the better. Ella is effective up to 5 days (120 hours) after unprotected sex or contraceptive failure, but it works best the earlier you take it. Don't wait and hope; get it right away if you can.
Will ella make me feel sick or cause any side effects?
Some people do feel some side effects after taking ella. The most common ones are headache, nausea, abdominal pain, fatigue, and dizziness. Most of these are mild and temporary. One important note: if you vomit within 3 hours of taking ella, you may need to take another dose, so contact your pharmacist or provider right away if that happens.
When will I get my next period after taking ella?
Your next period may come a few days earlier or later than usual — that's a normal effect of the medication. In studies, most cycles returned to normal the following month. If your period is more than a week late, take a pregnancy test and check in with your healthcare provider.
Can I start my birth control pill right after taking ella?
Not right away. You should wait at least 5 full days before starting or restarting any hormonal contraceptive (pill, patch, ring, etc.). Starting too soon can actually reduce how well ella works. In the meantime, use a barrier method like a condom for any sex, and keep using one until your next period begins.
Does ella protect me against STIs or HIV?
No — ella only helps prevent pregnancy. It offers no protection at all against sexually transmitted infections, including HIV. If STI protection is a concern, a condom is the right tool for that.
Are there any medications I should avoid around the time I take ella?
Yes — a few common ones can make ella much less effective. These include certain seizure medications (like carbamazepine or phenytoin), the antibiotic rifampin, and the herbal supplement St. John's Wort. If you take any of these regularly, let your pharmacist know before taking ella so they can advise you on your options.
Is Ulipristal available over the counter?
Ulipristal is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Ulipristal first available?
Ulipristal has been available in the United States since at least 2010, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Ulipristal?
Ulipristal is supplied by 8 manufacturers listed in the FDA NDC Directory, including A-S Medication Solutions, HRA Pharma America, Inc., Industriale Chimica s.r.l..

💬 Answers drafted from Ulipristal’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Ulipristal comes

Ulipristal is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Ella
How this form is used
What it may be used for
  • Ella is used to prevent pregnancy after unprotected intercourse or known or suspected contraceptive failure
  • Ella must be taken within 120 hours (5 days) of unprotected sex
  • Ella is for emergency, occasional use only — not as a routine contraceptive
Important instructions
  • Ella: take one tablet by mouth as soon as possible, within 120 hours (5 days) of unprotected intercourse
  • Ella can be taken with or without food
  • Ella: if you vomit within 3 hours of taking the tablet, consider repeating the dose
  • Ella: after taking it, wait at least 5 days before starting or resuming hormonal contraception and use a barrier method until your next period
Available strengths 1 strength
11 FDA-listed product records

📊 Ulipristal across the U.S. market

How Ulipristal appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
8
Manufacturers
1
Brand names
14
FDA-listed product records
2010
First marketed

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions21%
HRA Pharma America, Inc.21%
Industriale Chimica s.r.l.14%
RPK Pharmaceuticals, Inc.14%
Afaxys Pharma LLC7%
PMI Branded Pharmaceuticals, Inc.7%
Other makers14%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Ulipristal is used

A general measure of how commonly Ulipristal is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Ulipristal is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

93,222
Medicaid prescriptions filled (Q1–Q4 2025)
$5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ulipristal prescribed? Of the 1,596 medications we measure, Ulipristal ranks #522 by Medicaid prescriptions — more than 67% of them.

Where Ulipristal ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Ulipristal product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

ulipristal acetate 30 MG Oral Tablet

93,222 Medicaid prescriptions (Q1–Q4 2025) 100% of Ulipristal prescriptions shown $5M gross reimbursement (before rebates) ≈ $53 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1005924

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ulipristal, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 6 listed Ulipristal NDCs with Medicaid activity.

🔍 Compare Ulipristal products

A representative set of FDA-listed product records for Ulipristal — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Tablet
30 mg Oral A-S Medication Solutions × 3 listings NDA View NDC →
30 mg Oral Afaxys Pharma LLC NDA Find on DailyMed
30 mg Oral Hra Pharma America, Inc. × 3 listings NDA View NDC →
30 mg Oral PMI Branded Pharmaceuticals, Inc. NDA View NDC →
30 mg Oral RedPharm Drug, Inc NDA View NDC →
30 mg Oral RPK Pharmaceuticals, Inc. × 2 listings NDA View NDC →
💊Bulk drug substance
1 kg/kg Industriale Chimica s.r.l. × 2 listings BULK INGREDIENT View NDC →
100 kg/100 kg Sicor S.r.l. BULK INGREDIENT View NDC →

Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Ulipristal NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Ulipristal RxCUI 1005921 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 1005923 In current FDA listings
    Clinical drug / strength (SCD) acetate 30 MG RxCUI 1005924 acetate 5 MG RxCUI 1546350

Look up RxCUI 1005921 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Ella

🏭 Manufacturers & labelers

A-S Medication Solutions 3 HRA Pharma America, Inc. 3 Industriale Chimica s.r.l. 2 RPK Pharmaceuticals, Inc. 2 Afaxys Pharma LLC 1 PMI Branded Pharmaceuticals, Inc. 1 RedPharm Drug, Inc 1 Sicor S.r.l. 1

RxNorm drug class

Ulipristal belongs to the Progesterone Agonist/Antagonist class.

Pharmacologic class Progesterone Agonist/Antagonist
Drug family (ATC) Emergency contraceptives, Progesterone receptor modulators
How it works Selective Progesterone Receptor Modulators

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 20, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ulipristal.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ulipristal after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
4
NDC products indexed
14
Distinct labelers/manufacturers represented
8
Linked representative label
Hra Pharma America, Inc.
Linked label effective
Jul 20, 2026
Composite sections available
21
Linked SPL Set ID
2bf93d23-cddd-4613-9066-5b5fa090404b
Linked SPL Document ID
30e0d760-1e27-456f-8420-ad1c219f49f7
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 4 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Hra Pharma America, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.