Elagolix, Estradiol, and Norethindrone
Oriahnn (elagolix, estradiol, and norethindrone) is a prescription combination capsule used to reduce heavy menstrual bleeding caused by uterine fibroids in premenopausal women.
🧬 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 →
Oriahnn is a newer, nonsurgical option for heavy periods caused by uterine fibroids (noncancerous growths in the uterus) in premenopausal women, usually prescribed by a gynecologist; elagolix lowers estrogen and progesterone, and added estradiol and norethindrone protect bone and the uterine lining. Most women tolerate it reasonably well; hot flushes, headache, tiredness and irregular spotting are what people notice most. Its boxed warning is for blood clots, stroke and heart attack, so it is off-limits if you have had a clot, have uncontrolled high blood pressure, or are over 35 and smoke. Because it causes bone loss that may not fully reverse, treatment stops at 24 months.
Clinical pearls
- Use condoms or another non-hormonal birth control during treatment and for 28 days after, since Oriahnn can make pregnancy hard to spot.
- The morning and evening capsules are different; if you are more than 4 hours late, skip that dose rather than doubling up.
- Cyclosporine and certain cholesterol drugs can push elagolix to unsafe levels, so every new prescriber needs to know you take Oriahnn.
- Depression and suicidal thoughts are a labeled risk with this combination, so report new low mood to your doctor right away.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Oriahnn carries a serious "black box" warning about blood clots and major cardiovascular events. Because it contains estrogen and progestin, Oriahnn increases the risk of dangerous blood clots in the legs or lungs, stroke, and heart attack. This risk is highest in certain women — particularly women over 35 who smoke and women with uncontrolled high blood pressure. Oriahnn must NOT be used by women who currently have, or have a history of, blood clots, vascular disease, or related conditions. Watch for warning signs like sudden chest pain, shortness of breath, leg pain and swelling, or sudden numbness or trouble speaking — and seek emergency care immediately if any of these occur.
Patient information guide A plain-language walkthrough of Elagolix, Estradiol, and Norethindrone, written from its FDA label.
What Elagolix, Estradiol, and Norethindrone is used for
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Oriahnn is approved for one specific condition in premenopausal women:
- Heavy menstrual bleeding caused by uterine leiomyomas (fibroids) — noncancerous growths in the uterus that cause abnormally heavy periods
It is not approved for other causes of heavy bleeding, and it should be used for no longer than 24 months.
How Elagolix, Estradiol, and Norethindrone works
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Oriahnn works through three ingredients acting together. Elagolix blocks GnRH receptors — hormone-signaling docks in the pituitary gland — which dials down the body's production of estrogen and progesterone. Lower hormone levels shrink fibroid activity and reduce heavy bleeding. Because this estrogen drop can weaken bones and trigger menopause-like symptoms, the morning capsule adds a low dose of estradiol (estrogen) to offset bone loss and a progestin called norethindrone acetate to protect the uterine lining from estrogen's unchecked effects.
The result is a carefully balanced hormonal environment: enough elagolix to reduce bleeding, with just enough estrogen and progestin added back to limit side effects.
Elagolix, Estradiol, and Norethindrone dosage
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Oriahnn is taken as two capsules daily — one in the morning and one in the evening. Both can be taken with or without food. Take them at roughly the same times each day for consistency.
- Missed dose: If less than 4 hours have passed, take it right away. If more than 4 hours have passed, skip it and resume your next regular dose — never take two at once.
- Duration: Do not use for more than 24 months total due to bone loss risk.
- Confirm you are not pregnant before starting, or begin within 7 days of the start of your period.
Dosing details from the FDA-approved label
From the Elagolix, Estradiol, and Norethindrone 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.
One capsule (elagolix 300 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) in the morning and one capsule (elagolix 300 mg) in the evening for up to 24 months.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION One capsule (elagolix 300 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) in the morning and one capsule (elagolix 300 mg) in the evening for up to 24 months. ( 2.1 ) 2.1 Important Dosing Information Exclude pregnancy before starting ORIAHNN or start ORIAHNN within 7 days from the onset of menses [see Use in Specific Populations ( 8.1 ) and ( 8.3 ) ] . The recommended dosage of ORIAHNN is: ○ One elagolix 300 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg capsule in the morning (AM), and ○ One elagolix 300 mg capsule in the evening (PM). Take the morning and evening capsules at approximately the same time each day, with or without food. The recommended duration of treatment with ORIAHNN is 24 months [see Warnings and Precautions ( 5.2 ) ] . 2.2 Missed Dose Instruct the patient to take the missed dose of ORIAHNN within 4 hours of the time that it was supposed to be taken and then the next dose at the usual time. If more than 4 hours have passed since a capsule is usually taken, instruct the patient not to take the missed dose and take the next dose at the usual time. Take only one morning capsule and one evening capsule per day.
Read the full Dosage and Administration section on DailyMed →
Elagolix, Estradiol, and Norethindrone side effects
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The most common side effects reported in clinical trials include:
Common side effects
- Hot flushes (sudden feelings of warmth or flushing)
- Headache
- Fatigue (tiredness or low energy)
- Metrorrhagia (irregular or unexpected spotting/bleeding between periods)
- Nausea
- Breast tenderness
- Abdominal pain
When to get medical help
- Signs of a blood clot — sudden chest pain, shortness of breath, pain or swelling in a leg: call 911 or go to an ER immediately
- Signs of stroke — sudden numbness, weakness, severe headache, trouble speaking or seeing: call 911
- New or worsening depression, anxiety, or thoughts of suicide or self-harm: contact your doctor right away
- Sudden vision changes, eye pain, or bulging of the eye: stop taking and seek care immediately
- Signs of liver injury — yellowing of the skin or eyes, dark urine, severe stomach pain: contact your doctor
- Significantly rising blood pressure: contact your doctor
- Severe allergic reaction (hives, swelling of the face or throat, trouble breathing): call 911
More serious reactions — including blood clots, mood changes or suicidal thoughts, liver problems, rising blood pressure, and hair loss — require immediate medical attention. Don't wait to call your doctor if something feels off.
Elagolix, Estradiol, and Norethindrone warnings and precautions
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- Blood clots and vascular events: The most critical risk. Oriahnn can cause deep vein thrombosis, pulmonary embolism, stroke, and heart attack. Women over 35 who smoke or have uncontrolled high blood pressure face the highest danger. Stop immediately and seek emergency care if you have chest pain, trouble breathing, sudden vision changes, or leg swelling.
- Bone loss: Oriahnn reduces bone mineral density (BMD) in a way that may not fully reverse after stopping. That's why use is capped at 24 months. Your doctor may check bone density before and during treatment.
- Mood changes and suicidal ideation: New or worsening depression, anxiety, or thoughts of suicide have been reported. Tell your doctor right away.
- Liver injury: Do not use if you have liver disease. Watch for jaundice (yellowing skin or eyes), dark urine, or severe stomach pain.
- Pregnancy risk: Oriahnn must be stopped immediately if pregnancy is confirmed. Taking it early in pregnancy may increase the risk of miscarriage.
- Allergic reactions: The capsule contains FD&C Yellow No. 5 (tartrazine), which can trigger allergic reactions including asthma in some people.
Elagolix, Estradiol, and Norethindrone interactions
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Oriahnn can affect — or be affected by — several other medications. Key ones to know:
- OATP1B1 inhibitors (e.g., cyclosporine): Can dramatically raise elagolix levels — this combination is contraindicated (must not be used together).
- Strong CYP3A inducers (e.g., rifampin, certain seizure drugs): Can lower Oriahnn levels and reduce its effectiveness.
- Digoxin (heart medication): Oriahnn raises digoxin blood levels, increasing toxicity risk — more frequent monitoring needed.
- Midazolam (sedative): Oriahnn lowers midazolam levels; dose adjustment may be needed.
- Rosuvastatin (cholesterol drug): Oriahnn reduces rosuvastatin levels; lipid levels should be monitored.
- Omeprazole (acid reducer): Oriahnn increases omeprazole levels at higher omeprazole doses; dose reduction may be considered.
Interactions listed in the FDA-approved label
From the Elagolix, Estradiol, and Norethindrone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
See full prescribing information for a list of clinically important drug interactions. ( 7 ) 7.1 Potential for ORIAHNN to Affect Other Drugs Elagolix (a component of ORIAHNN) is: A weak to moderate inducer of cytochrome P450 (CYP3A).
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 ORIAHNN to Affect Other Drugs Elagolix (a component of ORIAHNN) is: A weak to moderate inducer of cytochrome P450 (CYP3A). Co-administration with ORIAHNN may decrease plasma concentrations of drugs that are substrates of CYP3A. A weak inhibitor of CYP2C19. Co-administration with ORIAHNN may increase plasma concentrations of drugs that are substrates of CYP2C19 (see Table 3). An inhibitor of efflux transporter P-glycoprotein (P-gp). Co-administration with ORIAHNN may increase plasma concentrations of drugs that are substrates of P-gp (see Table 3). The effects of co-administration of ORIAHNN on concentrations of concomitant drugs and the clinical recommendations for these drug interactions are summarized in Table 3. Table 3. Drug Interactions: Effects of ORIAHNN 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 ORIAHNN in patients who are taking digoxin. If ORIAHNN 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 ORIAHNN. When ORIAHNN is used concomitantly with higher doses of omeprazole, consider dosage reduction of omeprazole. See Tables 6 and 7 [see Clinical Pharmacology ( 12.3 ) ] .
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, Estradiol, and Norethindrone
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- Women over 35 who smoke — the blood clot risk is significantly higher; this combination is contraindicated
- Women with uncontrolled high blood pressure — contraindicated
- Personal or family history of blood clots, stroke, heart attack, or vascular disease
- Known or suspected pregnancy — do not start; confirm negative pregnancy status first
- Known osteoporosis — contraindicated due to further bone loss risk
- History of breast cancer or any hormone-sensitive cancer — contraindicated
- Any liver disease or liver impairment — contraindicated
- Undiagnosed abnormal uterine bleeding — must be evaluated before starting
- History of migraines with aura if over age 35, or headaches with neurological symptoms
- Any known allergy to tartrazine (FD&C Yellow No. 5) or any component of the capsule
Elagolix, Estradiol, and Norethindrone overdose
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Taking too much Oriahnn may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness, fatigue, and unexpected bleeding. There is no specific antidote. If you think you or someone else has taken too much, contact a poison control center or emergency room and let them know what was taken. Treatment is focused on relieving symptoms.
What Elagolix, Estradiol, and Norethindrone does in the body
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Beyond controlling bleeding, the estrogen and progestin components of Oriahnn cause measurable changes in the body's chemistry. They can raise levels of certain blood proteins, including those that bind thyroid hormones — which may affect thyroid test results without actually altering thyroid function in healthy women. They also increase HDL ("good") cholesterol, reduce LDL ("bad") cholesterol, and raise triglyceride levels. Additionally, they influence blood-clotting factors in ways that promote clot formation, which is the biological basis for the cardiovascular warnings associated with this medication.
How your body processes Elagolix, Estradiol, and Norethindrone
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All three active ingredients are absorbed relatively quickly after swallowing, generally reaching peak blood levels within 1–2 hours. Eating a high-fat meal can affect how much of each component is absorbed — it lowers peak elagolix and estradiol levels somewhat, while modestly increasing norethindrone absorption. Each ingredient is broken down primarily by the liver, mainly through an enzyme system called CYP3A, and is cleared from the body within hours to about a day (half-lives range from roughly 6 to 15 hours depending on the ingredient). This liver-based metabolism is why Oriahnn is contraindicated in people with liver disease and why it interacts with drugs that affect the same liver enzymes.
How to store Elagolix, Estradiol, and Norethindrone
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Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15˚C to 30˚C (59˚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, Estradiol, and Norethindrone
161 supplements and herbal products have documented interactions with Elagolix, Estradiol, and Norethindrone 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 · 120
- 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, Estradiol, and Norethindrone: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Elagolix, Estradiol, and Norethindrone — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this medication doing to my body, and will it stop my periods?
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How long can I stay on this medication?
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Do I still need to use birth control while on Oriahnn?
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What are the warning signs I should never ignore while taking this?
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I'm 38 and I smoke — is this medication safe for me?
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What if I miss a dose?
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Is Elagolix, Estradiol, and Norethindrone available over the counter?
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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, Estradiol, and Norethindrone on HelloPharmacist
Elagolix, Estradiol, and Norethindrone on the U.S. market: products, makers and brands
How Elagolix, Estradiol, and Norethindrone 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.
The FDA lists Elagolix, Estradiol, and Norethindrone products. Brand names on the directory include Oriahnn; the rest are generics.
How widely Elagolix, Estradiol, and Norethindrone is used (Medicaid data)
A general measure of how commonly Elagolix, Estradiol, and Norethindrone 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, Estradiol, and Norethindrone 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, Estradiol, and Norethindrone prescribed? Of the 1,601 medications we measure, Elagolix, Estradiol, and Norethindrone ranks #1,362 by Medicaid prescriptions — more than 15% of them.
Utilization by Elagolix, Estradiol, and Norethindrone 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.
Other Elagolix, Estradiol, and Norethindrone products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 2 listed NDC products with Medicaid activity.
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, Estradiol, and Norethindrone, 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 2 listed Elagolix, Estradiol, and Norethindrone NDCs with Medicaid activity.
Elagolix, Estradiol, and Norethindrone 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, Estradiol, and Norethindrone — 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, Estradiol, and Norethindrone 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, Estradiol, and Norethindrone FDA approval history
How Elagolix, Estradiol, and Norethindrone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Elagolix, Estradiol, and Norethindrone 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, Estradiol, and Norethindrone recalls since July 2021.
✅No Elagolix, Estradiol, and Norethindrone recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
Elagolix, Estradiol, and Norethindrone supply and shortage status
Whether Elagolix, Estradiol, and Norethindrone 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.
Elagolix, Estradiol, and Norethindrone brand names
Elagolix, Estradiol, and Norethindrone is sold under one brand name in the FDA directory — Oriahnn. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Elagolix, Estradiol, and Norethindrone drug class (RxNorm)
Elagolix, Estradiol, and Norethindrone 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, Estradiol, and Norethindrone 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 →