Elagolix
Elagolix is a once- or twice-daily pill that lowers ovarian hormone levels to manage moderate to severe pain from endometriosis.
🧬 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 1 clinical label set 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 →
Elagolix (Orilissa) is a tablet for moderate to severe endometriosis pain that blocks the brain's hormone signal (GnRH) to the ovaries, so they make less estrogen and progesterone; on the market since about 2018, it is usually a gynecologist's choice after pain relievers and hormonal birth control have not done enough. Most people tolerate it reasonably well, though hot flushes, night sweats, headache and lighter or missed periods are common. The biggest concern is bone loss that may not fully reverse, which is why the course is time-limited, along with mood changes, including depression or suicidal thoughts. Report yellowing of the skin or eyes promptly, since it can affect the liver.
Clinical pearls
- Use non-hormonal birth control, such as condoms or a copper IUD, during treatment and for 28 days after stopping.
- Since periods often lighten or stop, test for pregnancy if you suspect it instead of waiting for a missed period.
- Tell every prescriber you take it, since it raises digoxin and omeprazole levels and lowers rosuvastatin and midazolam levels.
- Ask whether calcium, vitamin D and weight-bearing exercise make sense, especially with a past low-trauma fracture or other bone-loss risks.
Patient information guide A plain-language walkthrough of Elagolix, written from its FDA label.
What Elagolix is used for
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Elagolix is used for one condition.
- Orilissa (elagolix tablets) is used to manage moderate to severe pain associated with endometriosis.
How Elagolix works
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Elagolix is a GnRH receptor antagonist. It competitively binds GnRH receptors in the pituitary gland and blocks the body's own GnRH signal.
This lowers LH and FSH, which in turn lowers the ovarian hormones estradiol and progesterone. The effect depends on the dose.
Elagolix dosage
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Orilissa is a tablet taken by mouth, once or twice daily depending on the regimen your prescriber chooses.
- Take it at about the same time each day, with or without food.
- Pregnancy should be ruled out first, or you should start within 7 days of the start of your period.
- If you miss a dose, take it the same day as soon as you remember, then resume your usual schedule.
- Never take more than your prescribed daily number of tablets.
- Treatment length is limited because of bone loss.
Dosing details from the FDA-approved label
From the Elagolix prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Normal liver function or mild hepatic impairment (Child-Pugh A), no coexisting condition
- Initiate treatment with ORILISSA 150 mg once daily
- Consider initiating treatment with ORILISSA 200 mg twice daily
- Maximum: 150 mg once daily: 24 months; 200 mg twice daily: 6 months
- Exclude pregnancy before starting or start within 7 days from the onset of menses; take at approximately the same time each day, with or without food
- Dyspareunia
- Initiate treatment with ORILISSA 150 mg once daily
- Use of 200 mg twice daily is not recommended
- Maximum: 6 months
- Use the lowest effective dose; limit duration because of bone loss
- Moderate hepatic impairment (Child-Pugh Class B)
- ORILISSA 150 mg once daily
- Use of 200 mg twice daily is not recommended
- Maximum: 6 months
- Moderate impairment had approximately 3-fold higher elagolix exposures
- Severe hepatic impairment (Child-Pugh C)
- Contraindicated
- Approximately 7-fold higher elagolix exposures
- Missed dose
- Take a missed dose on the same day as soon as she remembers and then resume the regular dosing schedule
- Maximum: 150 mg once daily: no more than 1 tablet each day; 200 mg twice daily: no more than 2 tablets each day
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Normal liver function or mild hepatic impairment : 150 mg once daily for up to 24 months or 200 mg twice daily for up to 6 months. ( 2.1 ) Moderate hepatic impairment : 150 mg once daily for up to 6 months. ( 2.1 ) 2.1 Important Dosing Information Exclude pregnancy before starting ORILISSA or start ORILISSA within 7 days from the onset of menses. Take ORILISSA at approximately the same time each day, with or without food. Use the lowest effective dose, taking into account the severity of symptoms and treatment objectives [see Warnings and Precautions ( 5.1 , 5.3 , 5.4 ) and Clinical Studies ( 14 )] . Limit the duration of use because of bone loss ( Table 1 ) [see Warnings and Precautions ( 5.1 )] . Table 1. Recommended Dosage and Duration of Use Dosing Regimen Maximum Treatment Duration Coexisting Condition Initiate treatment with ORILISSA 150 mg once daily 24 months None Consider initiating treatment with ORILISSA 200 mg twice daily 6 months Dyspareunia Initiate treatment with ORILISSA 150 mg once daily. Use of 200 mg twice daily is not recommended. 6 months Moderate hepatic impairment (Child-Pugh Class B) 2.2 Hepatic Impairment No dosage adjustment of ORILISSA is required in women with mild hepatic impairment (Child-Pugh A). Compared to women with normal liver function, those with moderate hepatic impairment had approximately 3-fold higher elagolix exposures and those with severe hepatic impairment had approximately 7-fold higher elagolix exposures. Because of these increased exposures and risk for bone loss: ORILISSA 150 mg once daily is recommended for women with moderate hepatic impairment (Child-Pugh B) with the duration of treatment limited to 6 months. Use of ORILISSA 200 mg twice daily is not recommended for women with moderate hepatic impairment [see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] . ORILISSA is contraindicated in women with severe hepatic impairment (Child-Pugh C) [see Contraindications ( 4 ), Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] . 2.3 Missed Dose Instruct the patient to take a missed dose of ORILISSA on the same day as soon as she remembers and then resume the regular dosing schedule. 150 mg once daily: take no more than 1 tablet each day. 200 mg twice daily: take no more than 2 tablets each day.
Read the full Dosage and Administration section on DailyMed →
Elagolix side effects
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The most common side effects in clinical trials were:
Common side effects
- Hot flushes and night sweats
- Headache
- Nausea
- Trouble sleeping (insomnia)
- Absence of periods (amenorrhea)
- Anxiety
- Joint pain
- Mood changes or depression-related symptoms
When to get medical help
- Get help right away if you have thoughts of suicide or self-harm.
- Call your doctor if you have new or worsening depression, anxiety, or mood changes.
- Call your doctor if you notice signs of liver injury, such as yellowing of the skin or eyes (jaundice).
- Call your doctor if you think you might be pregnant. Pregnancy testing may be needed.
- Seek emergency care for signs of a serious allergic reaction, such as swelling of the face or throat or trouble breathing.
Nausea and hot flushes were most likely to cause people to stop, mostly within the first 2 months. Seek help for suicidal thoughts, worsening mood, signs of liver injury such as jaundice, or allergic reactions.
Elagolix warnings and precautions
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- Bone loss: bone density drops with higher doses and longer use, and may not fully recover. The long-term effect on fracture risk is unknown.
- Mood and suicidal thoughts: depression, mood changes, and suicidal thoughts occurred in trials, including one completed suicide. Those with a history of depression or suicidality had more depression.
- Liver enzymes: ALT elevations occurred, depending on the dose.
- Pregnancy recognition: bleeding may lessen, making pregnancy harder to notice.
- Birth control: non-hormonal contraception is advised.
Elagolix interactions
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Elagolix can affect and be affected by other medicines.
- Estrogen-containing birth control: raises estrogen exposure with the twice-daily regimen, and may reduce elagolix's effect.
- Progestin-containing birth control pills: may be less effective.
- Strong CYP3A inhibitors: raise elagolix levels, so use is limited.
- Rifampin and strong CYP3A inducers: may lower elagolix levels and its effect.
- OATP1B1 inhibitors that significantly raise elagolix levels: contraindicated.
- Digoxin: levels may rise.
- Midazolam: levels may fall.
- Rosuvastatin: levels may fall.
- Omeprazole: levels may rise.
Interactions listed in the FDA-approved label
From the Elagolix prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Digoxin (cardiac glycosides): Digoxin exposure is increased. Increase monitoring of digoxin concentrations and potential signs and symptoms of clinical toxicity when initiating ORILISSA; if ORILISSA is discontinued, increase monitoring of digoxin concentrations.
- Oral midazolam (benzodiazepines): Midazolam exposure is decreased. Consider increasing the dose of midazolam by no more than 2-fold and individualize midazolam therapy based on the patient's response.
- Rosuvastatin (statins): Rosuvastatin exposure is decreased. Monitor lipid levels and adjust the dose of rosuvastatin, if necessary.
- Omeprazole (proton pump inhibitors): Omeprazole exposure is increased. No dose adjustment needed for omeprazole 40 mg once daily; with higher doses of omeprazole, consider dosage reduction of omeprazole.
- Oral ethinyl estradiol/levonorgestrel (combined hormonal contraceptives): Ethinyl estradiol exposure is increased and levonorgestrel exposure is decreased. Advise women to use effective non-hormonal contraception during treatment with ORILISSA and for 28 days after discontinuing ORILISSA.
- Strong CYP3A inhibitors: Elagolix is a CYP3A substrate, so its concentrations may be increased. Concomitant use of ORILISSA 200 mg twice daily for more than 1 month is not recommended; limit concomitant use of ORILISSA 150 mg once daily to 6 months.
- Strong CYP3A inducers, including rifampin: May decrease elagolix plasma concentrations and may result in a decrease of the therapeutic effects of ORILISSA. Concomitant use of ORILISSA 200 mg twice daily and rifampin is not recommended; limit concomitant use of ORILISSA 150 mg once daily and rifampin to 6 months.
- P-gp inhibitors or inducers: The effect on the pharmacokinetics of ORILISSA is unknown.
- OATP1B1 inhibitors: Those known or expected to significantly increase elagolix plasma concentrations raise the risk of elagolix-associated adverse reactions. Contraindicated.
- CYP3A, CYP2C19 and P-gp substrates: Elagolix is a weak to moderate CYP3A inducer (may decrease substrate concentrations), a weak CYP2C19 inhibitor and a P-gp inhibitor (may increase substrate concentrations).
Read the label’s full interactions text
7 DRUG INTERACTIONS See full prescribing information for a list of clinically important drug interactions ( 7 ). 7.1 Potential for ORILISSA to Affect Other Drugs Elagolix is: A weak to moderate inducer of cytochrome P450 (CYP) 3A. Co-administration with ORILISSA may decrease plasma concentrations of drugs that are substrates of CYP3A (see Table 7). A weak inhibitor of CYP 2C19. Co-administration with ORILISSA may increase plasma concentrations of drugs that are substrates of CYP2C19 (see Table 7). An inhibitor of efflux transporter P-glycoprotein (P-gp). Co-administration with ORILISSA may increase plasma concentrations of drugs that are substrates of P-gp (see Table 7). The effects of co-administration of ORILISSA on concentrations of concomitant drugs and the clinical recommendations for these drug interactions are summarized in Table 7. Table 7. Drug Interactions: Effects of ORILISSA on Other Drugs Concomitant Drug Class: Drug Name Effect on Plasma Exposure of Concomitant Drug Clinical Recommendations Cardiac glycosides: digoxin ↑ digoxin Increase monitoring of digoxin concentrations and potential signs and symptoms of clinical toxicity when initiating ORILISSA in patients who are taking digoxin. If ORILISSA is discontinued, increase monitoring of digoxin concentrations. Benzodiazepines: oral midazolam ↓ midazolam Consider increasing the dose of midazolam by no more than 2-fold and individualize midazolam therapy based on the patient’s response. Statins: rosuvastatin ↓ rosuvastatin Monitor lipid levels and adjust the dose of rosuvastatin, if necessary. Proton pump inhibitors: omeprazole ↑ omeprazole No dose adjustment needed for omeprazole 40 mg once daily when co-administered with ORILISSA. When ORILISSA is used concomitantly with higher doses of omeprazole, consider dosage reduction of omeprazole.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Elagolix
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- Do not use if pregnant.
- Do not use with known osteoporosis.
- Do not use with severe liver impairment.
- Moderate liver impairment: only the lower-dose regimen for up to 6 months is recommended.
- Mild liver impairment: no dose change.
- Any kidney impairment, including dialysis: no dose change.
- Known allergy to elagolix: do not use. Reactions have included anaphylaxis and angioedema.
- Breastfeeding: no information on milk transfer; discuss benefits and risks with your doctor.
- Children: safety and effectiveness not established.
Elagolix overdose
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If too much is taken, you should be monitored for signs or symptoms of side effects and given symptom-based treatment as needed. Contact your doctor, pharmacist, or poison control right away.
What Elagolix does in the body
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Elagolix lowers estradiol in a dose-related way. In trials in women with endometriosis, median estradiol fell to about 42 pg/mL on the once-daily regimen and about 12 pg/mL on the twice-daily regimen. In healthy women, ovulation rates were about 50% and 32%, respectively. At a dose far above normal, there was no clinically relevant effect on the heart's QTc interval.
How your body processes Elagolix
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Elagolix reaches peak levels in about 1 hour. A high-fat meal lowers the amount absorbed somewhat. It is about 80% bound to plasma proteins.
It is mainly broken down by the liver enzyme CYP3A, with minor pathways too. Its half-life in the terminal phase is about 4 to 6 hours. People with two reduced-function copies of the SLCO1B1 gene (under 5% in most groups) have about 78% higher levels.
How to store Elagolix
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Store at 2°C to 30°C (36°F to 86°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Elagolix
159 supplements and herbal products have documented interactions with Elagolix in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 118
- Minor · 38
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.
Elagolix: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Elagolix — the kind of thing our pharmacy team would talk through with you at the counter.
What is Orilissa for?
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How should I take it?
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What side effects should I expect?
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Why is there a time limit on how long I can take it?
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Do I still need birth control?
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When should I call my doctor right away?
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Is Elagolix available over the counter?
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When was Elagolix first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Elagolix on HelloPharmacist
Elagolix forms and strengths (how it comes)
Elagolix 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Elagolix inactive ingredients by manufacturer.
Tablet
How this form is used
- Orilissa is used to manage moderate to severe pain associated with endometriosis.
- Orilissa is taken by mouth at about the same time each day, with or without food.
- Orilissa treatment should start only after pregnancy is ruled out, or within 7 days of the start of your period.
- If you miss a dose of Orilissa, take it the same day as soon as you remember, then resume your regular schedule.
Elagolix on the U.S. market: products, makers and brands
How Elagolix 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 company lists 2 Elagolix product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2018. Brand names on the directory include Orilissa; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (11) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Elagolix is used (Medicaid data)
A general measure of how commonly Elagolix 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 Elagolix 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.
How commonly is Elagolix prescribed? Of the 1,601 medications we measure, Elagolix ranks #839 by Medicaid prescriptions — more than 48% of them.
Utilization by Elagolix 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.
elagolix 150 MG Oral Tablet Most dispensed
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2049852
elagolix 200 MG Oral Tablet
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2049860
elagolix 300 MG Oral Capsule
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2371766
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 Elagolix, 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 3 of 10 listed Elagolix NDCs with Medicaid activity.
Compare Elagolix products
A representative set of FDA-listed product records for Elagolix — 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 | ||||
| 150 mg | Oral | AbbVie Inc. | NDA | View NDC → |
| 200 mg | Oral | AbbVie Inc. | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Elagolix NDCs →
Elagolix side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Elagolix — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Elagolix in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Elagolix FDA approval history
How Elagolix went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Elagolix recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Elagolix recalls since July 2021.
✅No Elagolix recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
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.
RxCUI 2049846 2 dose forms · 3 strengths
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Dose form (SCDF) Oral Capsule RxCUI 2371765No current FDA listingClinical drug / strength (SCD) 300 MGRxCUI 2371766 -
Dose form (SCDF) Oral Tablet RxCUI 2049851In current FDA listings
Look up RxCUI 2049846 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.
Elagolix supply and shortage status
Whether Elagolix is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Elagolix costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 150 mg | $43.81 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 200 mg | $21.93 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Elagolix brand names
Elagolix is sold under one brand name in the FDA directory — Orilissa. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Elagolix: manufacturers and labelers
One company lists Elagolix products with the FDA. By number of product records, the largest are AbbVie Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Elagolix drug class (RxNorm)
Elagolix belongs to the Gonadotropin Releasing Hormone Receptor Antagonist class.
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.
Sources for this Elagolix page
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.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. AbbVie Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →