Prescription medicine
Estradiol and norethindrone and relugolix Brand names: Myfembree
Estradiol and norethindrone and relugolix (Myfembree) is a prescription medicine with an FDA approval on record since 2021. No generic is listed; pharmacies paid $45.25 per Myfembree 40 mg-1 mg-0.5 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the estradiol and norethindrone and relugolix FDA label on DailyMed (effective September 4, 2025, Sumitomo Pharma America, Inc); the NDA 214846 record on Drugs@FDA; every estradiol and norethindrone and relugolix label on DailyMed.
Highlights of the record
FDA label of September 4, 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 MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism (PE), deep vein thrombosis (DVT), stroke and myocardial infarction (MI), especially in women at increased risk for these events [see Warnings and Precautions ( 5.1 )]. MYFEMBREE 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 [see Contraindications ( 4 )]. WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS See full prescribing information for complete boxed warning Estrogen and progestin combinations, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders, especially in women at increased risk for these events. ( 5.1 ) MYFEMBREE 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 usageMYFEMBREE is a combination of relugolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, indicated in premenopausal women for the: management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids).
Forms and strengths
- 40 mg / 1 mg / 0.5 mg
Film-coated tablet.
On the market
- Earliest approval on file
- May 26, 2021 Myfembree, Sumitomo Pharma Am; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- November 5, 2042 Myfembree tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $45.25 per tablet Myfembree 40 mg-1 mg-0.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,495 through July 30, 2026
What is estradiol and norethindrone and relugolix used for?
From the label: indications and usageMYFEMBREE is a combination of relugolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, indicated in premenopausal women for the: management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids). ( 1.1 , 14.1 ) management of moderate to severe pain associated with endometriosis. ( 1.2 , 14.2 ) Limitations of Use Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible. […]
FDA pharmacologic class: Estrogen, Gonadotropin Releasing Hormone Receptor Antagonist and Progestin.
Source: FDA drug label (Myfembree), Sumitomo Pharma America, Inc, effective September 4, 2025 (SPL set fc3feb73-cc84-43a8-aa32-b262460495e8), via openFDA; the full label on DailyMed
What does the patient leaflet for estradiol and norethindrone and relugolix 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 MYFEMBREE?MYFEMBREE may cause serious side effects, including: cardiovascular conditions MYFEMBREE may increase your chances of heart attack, stroke, or blood clots, especially if you are over 35 years of age, smoke, and have uncontrolled high blood pressure. Stop taking MYFEMBREE 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, or 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 MYFEMBREE, your estrogen levels may be low. Low estrogen levels can lead to bone mineral density loss. If you have bone loss on MYFEMBREE, your bone density may improve after you stop taking MYFEMBREE, 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 MYFEMBREE 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 MYFEMBREE and periodically after you start if you have uterine fibroids or annually if you have pain associated with endometriosis. Your healthcare provider may advise you to take vitamin D and/or calcium supplements as part of a healthy lifestyle that promotes bone health. If you are also advised to take iron supplements, they should be taken at least two hours apart from your vitamin D or calcium supplements. effects on pregnancy Do not take MYFEMBREE if you are trying to become pregnant or are pregnant. […]
From the patient leaflet: How should I store MYFEMBREE?Store MYFEMBREE between 59°F to 86°F (15°C to 30°C). 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 MYFEMBREE the right way. Do not flush MYFEMBREE down the toilet. Do not keep medicine that is out of date or that you no longer need. Keep MYFEMBREE and all medicines out of the reach of children.
Source: FDA drug label (Myfembree), Sumitomo Pharma America, Inc, effective September 4, 2025 (SPL set fc3feb73-cc84-43a8-aa32-b262460495e8), via openFDA; the full label on DailyMed
Is there a generic for estradiol and norethindrone and relugolix (Myfembree)?
No generic estradiol and norethindrone and relugolix is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Myfembree tablets: the compound patent runs to September 27, 2033, and the last listed entry to November 5, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for estradiol and norethindrone and relugolix (Myfembree)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $45.25 per Myfembree 40 mg-1 mg-0.5 mg tablet, up 6% from $42.86 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.
- Myfembree 40 mg-1 mg-0.5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Myfembree 40 mg-1 mg-0.5 mg tablet | Brand | $45.25 per tablet | $1,357.54 | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for estradiol and norethindrone and relugolix?
The FDA Adverse Event Reporting System holds 1,495 reports that list estradiol and norethindrone and relugolix 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 35 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?
- Other estrogens
- the pharmacologic class, with prices and generics
- Estradiol and norethindrone and relugolix side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other