Elagolix
Pronunciation: el-AG-oh-liks.
- Generic name
- elagolix
- Drug class
- Gonadotropin-releasing hormone (GnRH) receptor antagonist
- Form
- Film-coated tablet (150 mg, 200 mg)
- Route
- Oral
- Legal status
- Prescription-only
Availability and supply rules vary by country
Trade names by country: United States · Canada
Australia: · Full directory
What elagolix is and how it works
Elagolix is a prescription medicine taken by mouth that blocks GnRH receptors, reducing the hormones (estradiol and progesterone) that drive endometriosis-related pain. It is used specifically for moderate to severe pain associated with endometriosis. (1) (2)
Elagolix has no FDA boxed warning, but it carries a genuinely serious warning about bone mineral density (BMD) loss that gets worse the longer it is used and may not fully reverse after stopping -- this is why the approved dose and maximum treatment length are tied together, and why the maximum allowed length of the 150 mg dose is not the same in every country (24 months in the US, 12 months in Canada). It also carries real warnings about mood changes/suicidal thoughts and liver enzyme changes. Never take elagolix for longer than your prescriber directs, and never start or stop it without medical guidance.
Mechanism of action: how elagolix works
Elagolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist that competitively binds pituitary GnRH receptors, producing dose-dependent suppression of luteinising hormone (LH) and follicle-stimulating hormone (FSH), which decreases estradiol and progesterone. Ovulation rates and estradiol suppression are dose-dependent (approximately 50% ovulation and greater estradiol reduction at 150 mg once daily versus approximately 32% ovulation and lesser estradiol reduction at 200 mg twice daily, reflecting different suppression profiles at each dose). (1) (2)
What elagolix is used for
Moderate to severe endometriosis pain
Used to manage moderate to severe pain (including painful periods, non-menstrual pelvic pain, and pain with intercourse) associated with endometriosis in premenopausal women. (1)
Before taking elagolix
Do not take / not appropriate for
- Do not take elagolix if you are pregnant or could become pregnant without using non-hormonal contraception -- exposure early in pregnancy may increase the risk of early pregnancy loss. (all confirmed countries) (1)
- Do not take elagolix if you have known osteoporosis. (all confirmed countries) (1)
- Do not take elagolix if you have severe hepatic (liver) impairment. (all confirmed countries) (1)
- Do not take elagolix together with medicines that significantly raise elagolix blood levels through OATP1B1 inhibition, unless your prescriber has specifically reviewed this. (all confirmed countries) (1)
- Do not take elagolix if you have a known hypersensitivity to it (reactions have included anaphylaxis and angioedema). (all confirmed countries) (1)
Tell your clinician about
- Any history of low bone density, osteoporosis, low-trauma fracture, or other bone-loss risk factors.
- Any history of depression, suicidal thoughts, or other mood disorders.
- Any history of liver problems.
- All other medicines, especially hormonal contraceptives, and anything affecting CYP3A or OATP1B1.
- Whether you are pregnant, planning pregnancy, or breastfeeding, and what non-hormonal contraception you plan to use during treatment and for 28 days after stopping.
How to take elagolix
- Take at approximately the same time each day, with or without food.
- Exclude pregnancy before starting, or begin treatment within 7 days of the onset of menses.
- Use effective non-hormonal contraception during treatment and for 28 days after stopping -- combined hormonal contraceptives are not recommended with elagolix.
- Never continue elagolix beyond the maximum duration your prescriber sets for your dose and country -- this limit exists specifically because of the bone mineral density risk.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3)
Missed dose
If you miss a dose, do not double up -- take no more than the prescribed number of tablets for that day (one tablet for 150 mg once daily; no more than two tablets for 200 mg twice daily) and contact your prescriber if you are unsure.
Overdose
Seek medical attention if you think you have taken too much elagolix. There is no specific antidote; treatment is supportive and based on your symptoms. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Hot flushes and night sweats (dose-related: about 24% at 150 mg, 46% at 200 mg twice daily, versus 9% with placebo).
What to notice: Hot flushes and night sweats (dose-related: about 24% at 150 mg, 46% at 200 mg twice daily, versus 9% with placebo).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Headache.
What to notice: Headache.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Nausea.
What to notice: Nausea.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Insomnia.
What to notice: Insomnia.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Amenorrhea (absence of periods), anxiety, joint pain (arthralgia), and mood changes including depression-related symptoms.
What to notice: Amenorrhea (absence of periods), anxiety, joint pain (arthralgia), and mood changes including depression-related symptoms.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Serious warnings
Signs of worsening bone health — serious, dose- and duration-dependent
Symptoms: No specific symptoms occur early on -- bone mineral density loss is typically detected by DXA (bone density) scan, not by how you feel. Long-term fracture risk is not fully known.
Action: Elagolix causes a dose- and duration-dependent decrease in bone mineral density that may not fully reverse after stopping treatment. This is why the approved dose and maximum treatment length are linked, and why the maximum duration differs by country for the 150 mg dose (24 months in the US, 12 months in Canada). Never continue treatment beyond your prescriber's set limit, and discuss calcium/vitamin D intake and bone density monitoring with your prescriber, especially with any fracture history or osteoporosis risk factors. (1) (2)
Suicidal thoughts, new or worsening depression, or significant mood changes — serious
Symptoms: Thoughts of suicide or self-harm, new or worsening depression, or significant mood or behaviour changes.
Action: Seek immediate medical attention. Suicidal ideation and behavior, including one completed suicide, occurred in people treated with elagolix in clinical trials, with a higher rate of depression and mood changes than placebo, especially in those with a prior history of depression or suicidality. (1)
Signs of liver injury — serious
Symptoms: Yellowing of the skin or eyes (jaundice), dark urine, unusual fatigue, nausea, right-upper abdominal pain, or easy bruising.
Action: Contact your clinician promptly for liver blood tests. Elagolix causes dose-dependent elevations in liver enzymes (ALT) in some people. (1)
Missed or unusual menstrual bleeding while trying to avoid pregnancy — moderate
Symptoms: Lighter, less frequent, or absent periods.
Action: Elagolix can alter menstrual bleeding in a way that may delay recognising a new pregnancy. If pregnancy is suspected, get a pregnancy test and contact your clinician -- elagolix must be stopped if pregnancy is confirmed. (1)
Signs of a serious allergic reaction — emergency
Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives.
Action: Seek emergency medical help immediately. (1)
Interactions
- Combined hormonal contraceptives (containing estrogen) are not recommended with the 200 mg twice-daily dose -- elagolix can raise ethinyl estradiol levels 2.2-fold, increasing thromboembolic/vascular risk, and may also reduce elagolix's own effectiveness. (1)
- Progestin-only contraceptives containing levonorgestrel can have reduced effectiveness (levonorgestrel levels reduced about 27%) with the 200 mg twice-daily dose. (1)
- Strong CYP3A inhibitors or the CYP3A inducer rifampin change how long elagolix can safely be used at each dose -- discuss any new medicine with your prescriber. (1)
- Digoxin levels may rise (elagolix inhibits P-glycoprotein); midazolam and rosuvastatin levels may fall (elagolix is a weak-to-moderate CYP3A inducer); omeprazole levels may rise (elagolix is a weak CYP2C19 inhibitor). (1)
- Medicines that are OATP1B1 inhibitors and significantly raise elagolix blood levels are contraindicated in combination with elagolix. (1)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Contraindicated. Exposure to elagolix early in pregnancy may increase the risk of early pregnancy loss. Effective non-hormonal contraception is required during treatment and for 28 days after stopping. (1) (2) (3)
Breastfeeding
No data on elagolix in human milk or effects on a breastfed infant; discuss the benefits of breastfeeding against the mother's clinical need for treatment with your prescriber. (1) (2) (3)
Children
Safety and effectiveness in children have not been established. (1) (2) (3)
Elderly
Endometriosis affects premenopausal women; no specific elderly-population data is described in the sources reviewed for this dossier. (1) (2) (3)
Hepatic_impairment
Mild impairment: no dose adjustment. Moderate impairment: 150 mg once daily only, maximum 6 months; 200 mg twice daily not recommended. Severe impairment: contraindicated (elagolix exposure is around 7-fold higher). (1) (2) (3)
Renal_impairment
No dose adjustment needed for any degree of renal impairment, including end-stage renal disease/dialysis. (1) (2) (3)
Source_ids
Monitoring
Before starting
- Pregnancy test (or start within 7 days of menses onset)
- Assessment of bone health/fracture history and osteoporosis risk factors
- Liver function assessment where clinically indicated
- Review of current contraceptive method and other medicines
During treatment
- Bone mineral density (DXA) assessment considered for patients with fracture history or osteoporosis risk factors, and specifically recommended in Canada if treatment continues beyond 12 months
- Monitoring for mood changes, depression, or suicidal thoughts throughout treatment
- Liver function tests if signs of liver injury develop
- Ongoing confirmation of non-hormonal contraception use
Storage
Store at 2C to 30C (36F to 86F). Dispose of unused medicine via a community take-back program where available; do not flush down the toilet. Keep out of reach of children.
Professional information
Clinician-facing context only, sourced from the current US FDA prescribing information and Health Canada regulatory decision documents; verify against the current full label before prescribing.
United States
Indication: Moderate to severe endometriosis pain
Dose summary: 150 mg once daily, up to 24 months (normal/mild hepatic function); or 200 mg twice daily, up to 6 months. Moderate hepatic impairment: 150 mg once daily only, 6-month maximum. Severe hepatic impairment: contraindicated.
Renal context: No dose adjustment needed for any degree of renal impairment, including dialysis. (1)
Canada
Indication: Moderate to severe endometriosis pain
Dose summary: 150 mg once daily, up to 12 months maximum (shorter than the US limit for the same dose); 200 mg twice daily, up to 6 months, consistent with the US label.
Renal context: Not separately specified in the sources reviewed for this dossier beyond the US renal-impairment findings. (2)
Hepatic guidance
Contraindicated in severe hepatic impairment (~7-fold exposure increase); moderate impairment limits dosing to 150 mg once daily for a maximum of 6 months (~3-fold exposure increase); mild impairment requires no adjustment.
Overdose note
No specific antidote; manage supportively based on signs/symptoms. (1) (2)
Frequently asked questions
Is elagolix available in the US, UK, Europe, Canada, Australia, and New Zealand?
It is confirmed authorised (as Orilissa) in the United States and Canada. A live UK regulator search found no current UK listing for elagolix. Direct confirmation for the European Union, Australia, and New Zealand could not be completed this session due to technical access issues with those regulators' search tools, so their status is recorded as unable to verify rather than assumed. (1) (2) (3)
Why is there a maximum length of time I can take elagolix, and why does it differ between countries?
Elagolix causes a dose- and duration-dependent decrease in bone mineral density that may not fully reverse after stopping. Regulators in different countries have set different maximum durations for the same 150 mg dose based on their own review of this risk -- 24 months in the United States, but only 12 months in Canada. Always follow the maximum duration your own prescriber sets for you. (1) (2)
Can I use my regular birth control pill while taking elagolix?
Combined hormonal contraceptives are not recommended, especially at the 200 mg twice-daily dose, because elagolix can raise estrogen levels and increase thromboembolic/vascular risk, and hormonal contraceptives may also reduce elagolix's own effectiveness. Effective non-hormonal contraception is required during treatment and for 28 days after stopping. (1)
What is the mechanism of action of elagolix?
Elagolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist that competitively binds pituitary GnRH receptors, producing dose-dependent suppression of luteinising hormone (LH) and follicle-stimulating hormone (FSH), which decreases estradiol and progesterone. Ovulation rates and estradiol suppression are dose-dependent (approximately 50% ovulation and greater estradiol reduction at 150 mg once daily versus approximately 32% ovulation and lesser estradiol reduction at 200 mg twice daily, reflecting different suppression profiles at each dose). (1) (2)
What is the generic name of Elagolix?
The generic name is elagolix. (1)
What class of drug is elagolix?
Elagolix is classed as: Gonadotropin-releasing hormone (GnRH) receptor antagonist. (1)
References
- ORILISSA (elagolix) tablets, for oral use -- full prescribing informationDailyMed (U.S. National Library of Medicine) -- FDA prescribing information · United States · accessed 2026-07-30 · source 1
- Orilissa (elagolix) -- Regulatory Decision Summary (RDS00479) and Summary Basis of Decision (SBD00426); Product Monograph (pdf.hres.ca/dpd_pm/00055319.PDF)Health Canada -- Drug and Health Products Portal (Regulatory Decision Summary / Summary Basis of Decision) and Health Canada-approved Product Monograph · Canada · accessed 2026-07-30 · source 2
- emc.medicines.org.uk search for 'elagolix' -- no resultselectronic medicines compendium (emc), United Kingdom -- product search · United Kingdom · accessed 2026-07-30 · source 3
- EMA medicine search for 'elagolix' -- technical failure (HTTP 404)n/a -- disclosed live-query technical failure, not a confirmed negative or positive result · European Union · accessed 2026-07-30 · source 4
- TGA ARTG search for 'elagolix' -- repeated technical failure (request timeout)n/a -- disclosed live-query technical failure, not a confirmed negative or positive result · Australia · accessed 2026-07-30 · source 5
- Medsafe product/data-sheet search for 'elagolix' -- search tool could not be queried live (search form page returned only, no query executed against the live database)n/a -- disclosed live-query technical failure, not a confirmed negative or positive result · New Zealand · accessed 2026-07-30 · source 6
Brand names by country
Single-ingredient elagolix names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Orilissa150 mg, 200 mg · abbvie inc.
Canada
- Orilissa (2)Health Canada authorised confirmed · 150 mg, 200 mg · AbbVie Corporation