Prescription medicine
Elagolix and estradiol and norethisterone Brand names: Oriahnn
Elagolix and estradiol and norethisterone (Oriahnn) is a prescription medicine. No generic is listed; pharmacies paid $22.00 per unit (Oriahnn 300-1-0.5 mg/300 mg caps) in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the elagolix and estradiol and norethisterone FDA label on DailyMed (effective December 19, 2025); every elagolix and estradiol and norethisterone 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
THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS.
Estrogen and progestin combinations, including ORIAHNN, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events [see Warnings and Precautions ( 5.1 )]. ORIAHNN is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke and women with uncontrolled hypertension [see Contraindications ( 4 )]. WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS See full prescribing information for complete boxed warning. Estrogen and progestin combinations, including ORIAHNN, increase the risk of thrombotic or thromboembolic disorders, especially in women at increased risk for these events. ( 5.1 ) ORIAHNN is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events including women over 35 years of age who smoke or women with uncontrolled hypertension.
Used for
From the label: indications and usageORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
Forms and strengths
Kit.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $22.00 per unit Oriahnn 300-1-0.5 mg/300 mg caps
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 600 through July 30, 2026
What is elagolix and estradiol and norethisterone used for?
From the label: indications and usageORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitation of Use: Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.2 ) ]. ORIAHNN is a combination of elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. […]
Source: FDA drug label (Oriahnn), AbbVie Inc., effective December 19, 2025 (SPL set 99f6eee7-7e52-6999-7eb8-488d06dd1710), via openFDA; the full label on DailyMed
What does the patient leaflet for elagolix and estradiol and norethisterone 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 ORIAHNN?ORIAHNN may cause serious side effects, including: cardiovascular conditions ○ ORIAHNN may increase your chances of heart attack, stroke, or blood clots, especially if you are over 35 years of age and smoke, have uncontrolled high blood pressure, high cholesterol, diabetes, or are obese. Stop taking ORIAHNN and call your healthcare provider right away or go to the nearest hospital emergency room right away if you have: ■ leg pain or swelling that will not go away ■ sudden shortness of breath ■ double vision, bulging of the eyes, sudden blindness, partial or complete ■ pain or pressure in your chest, arm, or jaw ■ sudden, severe headache unlike your usual headaches ■ weakness or numbness in an arm or leg, or trouble speaking bone loss (decreased bone mineral density) ○ While you are taking ORIAHNN, your estrogen levels may be low. Low estrogen levels can lead to bone mineral density loss. ○ If you have bone loss on ORIAHNN, your bone density may improve after you stop taking ORIAHNN, 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, you should not take ORIAHNN for more than 24 months. ○ Your healthcare provider may order an X-ray test called a DXA scan to check your bone mineral density when you start taking ORIAHNN and periodically after you start. ○ Your healthcare provider may advise you to take vitamin D and calcium supplements as part of a healthy lifestyle that promotes bone health. Iron supplements should not be taken at the same time that you take vitamin D and calcium supplements. effects on pregnancy ○ Do not take ORIAHNN if you are trying to become pregnant or are pregnant. […]
From the patient leaflet: What should I avoid while taking ORIAHNN?Avoid grapefruit and grapefruit juice during treatment with ORIAHNN since they may affect the level of ORIAHNN in your blood, which may increase side effects.
From the patient leaflet: How should I store ORIAHNN?Store ORIAHNN at room temperature between 68°F to 77°F (20°C to 25°C). Do not keep medicine that is out of date or that you no longer need. 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 information on how to dispose of ORIAHNN the right way. Do not flush ORIAHNN down the toilet. Keep ORIAHNN and all medicines out of the reach of children.
Source: FDA drug label (Oriahnn), AbbVie Inc., effective December 19, 2025 (SPL set 99f6eee7-7e52-6999-7eb8-488d06dd1710), via openFDA; the full label on DailyMed
Is there a generic for elagolix and estradiol and norethisterone (Oriahnn)?
No generic elagolix and estradiol and norethisterone is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for elagolix and estradiol and norethisterone (Oriahnn)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $22.00 per unit (Oriahnn 300-1-0.5 mg/300 mg caps), up 6% from $20.79 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.
- Oriahnn 300-1-0.5 mg/300 mg caps (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Oriahnn 300-1-0.5 mg/300 mg caps | Brand | $22.00 per unit | $660.13 | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the elagolix and estradiol and norethisterone label say about other medicines?
The elagolix and estradiol and norethisterone label names 7 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Aspirin | warnings and precautions | Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. |
| 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 ORIAHNN in patients who are taking digoxin. … |
| 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 | drug interactions | Concomitant use of ORIAHNN with: Strong CYP3A inducers may decrease elagolix, estradiol, and norethindrone plasma concentrations and may result in a decrease of the therapeutic effects of ORIAHNN. |
| 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 ORIAHNN. … |
| Rifampin | drug interactions | 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. |
Check elagolix and estradiol and norethisterone against other medicines
Source: FDA drug label (Oriahnn), AbbVie Inc., effective December 19, 2025 (SPL set 99f6eee7-7e52-6999-7eb8-488d06dd1710), via openFDA; the full label on DailyMed
What do FAERS reports show for elagolix and estradiol and norethisterone?
The FDA Adverse Event Reporting System holds 600 reports that list elagolix and estradiol and norethisterone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 46 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 received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Elagolix and estradiol and norethisterone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other