Prescription medicine
Elagolix Brand names: Orilissa
Elagolix (Orilissa) is a prescription medicine with an FDA approval on record since 2018. No generic is listed; pharmacies paid $43.81 per Orilissa 150 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the elagolix FDA label on DailyMed (effective December 19, 2025, AbbVie Inc.); the NDA 210450 record on Drugs@FDA; every elagolix label on DailyMed.
Highlights of the record
FDA label of December 19, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageORILISSA is indicated for the management of moderate to severe pain associated with endometriosis.
Forms and strengths
- 150 mg
- 200 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 23, 2018 Orilissa, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 27, 2040 Orilissa tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $43.81 per tablet Orilissa 150 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 3,723 through July 30, 2026
What is elagolix used for?
From the label: indications and usageORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitation s of Use: Limit the duration of use based on the dose and coexisting condition (see Table 1 ) [see D osage and Administration ( 2.1 ) and Warnings and Precautions ( 5.1 ) ]. ORILISSA is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis. ( 1 ) Limitation s of Use: Limit the duration of use based on the dose and coexisting condition (see Table 1 ).
FDA pharmacologic class: Gonadotropin Releasing Hormone Receptor Antagonist.
Source: FDA drug label (Orilissa), AbbVie Inc., effective December 19, 2025 (SPL set a86757b3-09c5-fd3b-1223-244e94f50a66), via openFDA; the full label on DailyMed
What does the patient leaflet for elagolix say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ORILISSA?ORILISSA may cause serious side effects, including: bone loss (decreased bone mineral density). ○ While you are taking ORILISSA, your estrogen levels will be low. Low estrogen levels can lead to bone mineral density loss. ○ If you have bone loss on ORILISSA, your bone density may improve after you stop taking ORILISSA but complete recovery may not occur. It is unknown if these bone changes could increase your risk for broken bones as you age. For this reason, your healthcare provider may limit the length of time you take ORILISSA. ○ Your healthcare provider may advise you to take vitamin D and calcium supplements as part of a healthy lifestyle that promotes bone health. ○ If you have conditions or take other medicines that can cause bone loss, or if you have broken a bone with minimal or no injury, your healthcare provider may order an X-ray test called a DXA scan to check your bone mineral density. effects on pregnancy ○ Do not take ORILISSA if you are trying to become or are pregnant. It may increase the risk of early pregnancy loss. ○ If you think you are pregnant, stop taking ORILISSA right away and call your healthcare provider. ○ ORILISSA may change your menstrual periods (irregular bleeding or spotting, a decrease in menstrual bleeding, or no bleeding at all), making it hard to know if you are pregnant. Watch for other signs of pregnancy such as breast tenderness, weight gain and nausea. ○ ORILISSA does not prevent pregnancy. You will need to use effective methods of birth control while taking ORILISSA and for 28 days after you stop taking ORILISSA. Examples of effective methods can include condoms or spermicide, which do not contain hormones. ○ Birth control pills that contain estrogen may make ORILISSA less effective. […]
From the patient leaflet: How should I store ORILISSA?Store ORILISSA between 36°F to 86°F (2°C to 30°C). Do not keep medicine that is out of date or that you no longer need. Throw away (dispose of) unused medicines through community take-back disposal programs when available. If no community take-back disposal program is available go to www.fda.gov/drugdisposal for more information on how to dispose of ORILISSA the right way. Do not flush ORILISSA down the toilet. Keep ORILISSA and all medicines out of the reach of children.
Source: FDA drug label (Orilissa), AbbVie Inc., effective December 19, 2025 (SPL set a86757b3-09c5-fd3b-1223-244e94f50a66), via openFDA; the full label on DailyMed
Is there a generic for elagolix (Orilissa)?
No generic elagolix is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 9 patents for Orilissa tablets: the compound patent runs to July 23, 2039, and the last listed entry to August 27, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2040 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for elagolix (Orilissa)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $43.81 per Orilissa 150 mg tablet, up 5% from $41.75 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Orilissa 200 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Orilissa 150 mg tablet | Brand | $43.81 per tablet | $1,314.26 | +5% |
| Orilissa 200 mg tablet | Brand | $21.93 per tablet | $657.95 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has elagolix been recalled?
The FDA's Enforcement Report lists 1 recall naming elagolix since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the elagolix label say about other medicines?
The elagolix label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name elagolix. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Digoxin | drug interactions | Concomitant Drug Class/Drug Name: Cardiac glycosides: digoxin; Effect on Plasma Exposure of Concomitant Drug: ↑ digoxin; Clinical Recommendations: Increase monitoring of digoxin concentrations and potential signs and symptoms of clinical toxicity when initiating ORILISSA in patients who are taking digoxin. … |
| Estradiol and levonorgestrel | drug interactions | Combined hormonal contraceptives: oral ethinyl estradiol/levonorgestrel ↑ethinyl estradiol ↓levonorgestrel Advise women to use effective non-hormonal contraception during treatment with ORILISSA and for 28 days after discontinuing ORILISSA. |
| Levonorgestrel | drug interactions | Concomitant Drug Class/Drug Name: Combined hormonal contraceptives: oral ethinyl estradiol/levonorgestrel; Effect on Plasma Exposure of Concomitant Drug: ↑ethinyl estradiol ↓levonorgestrel; Clinical Recommendations: Advise women to use effective non-hormonal contraception during treatment with ORILISSA and for 28 days … |
| Midazolam | drug interactions | Concomitant Drug Class/Drug Name: Benzodiazepines: oral midazolam; Effect on Plasma Exposure of Concomitant Drug: ↓ midazolam; Clinical Recommendations: Consider increasing the dose of midazolam by no more than 2-fold and individualize midazolam therapy based on the patient’s response. |
| Norethindrone | warnings and precautions | Co-administration of ORILISSA with COCs containing norethindrone acetate did not show reduction in plasma concentrations of norethindrone [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )]. |
| Omeprazole | drug interactions | Concomitant Drug Class/Drug Name: Proton pump inhibitors: omeprazole; Effect on Plasma Exposure of Concomitant Drug: ↑ omeprazole; Clinical Recommendations: No dose adjustment needed for omeprazole 40 mg once daily when co-administered with ORILISSA. … |
| Rifampin | drug interactions | Concomitant use of ORILISSA 200 mg twice daily and rifampin is not recommended. |
| Rosuvastatin | drug interactions | Concomitant Drug Class/Drug Name: Statins: rosuvastatin; Effect on Plasma Exposure of Concomitant Drug: ↓ rosuvastatin; Clinical Recommendations: Monitor lipid levels and adjust the dose of rosuvastatin, if necessary. |
Other labels that name elagolix
Source: FDA drug label (Orilissa), AbbVie Inc., effective December 19, 2025 (SPL set a86757b3-09c5-fd3b-1223-244e94f50a66), via openFDA; the full label on DailyMed
What do FAERS reports show for elagolix?
The FDA Adverse Event Reporting System holds 3,723 reports that list elagolix among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 321 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. Reports rose sharply in 2020 (1,090, against a median of 121 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other gonadotropin releasing hormone receptor antagonists
- the pharmacologic class, with prices and generics
- Elagolix side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other