What the label lists and what reports show
Estradiol and norethindrone and relugolix side effects
Estradiol and norethindrone and relugolix's FDA label: “In women with heavy menstrual bleeding associated with uterine fibroids, most common adverse reactions (incidence ≥ 3%) are vasomotor symptoms, uterine bleeding, alopecia, and decreased libido.” FAERS holds 1,495 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is intermenstrual bleeding (118 reports).
- 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 FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of MYFEMBREE?MYFEMBREE may cause serious side effects including: See “ What is the most important information I should know about MYFEMBREE? ” suicidal thoughts, suicidal behavior, and worsening of mood. Call your healthcare provider or get emergency medical help right away if you have any of these symptoms, especially if they are new, worse, or bother you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety other unusual changes in behavior or mood Pay attention to any changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. abnormal liver tests. […]
Source: FDA drug label, 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 label list?
From the label: adverse reactionsIn women with heavy menstrual bleeding associated with uterine fibroids, most common adverse reactions (incidence ≥ 3%) are vasomotor symptoms, uterine bleeding, alopecia, and decreased libido.
Table 4: Adverse Reactions Occurring in 3% or More of Women with Moderate to Severe Pain Associated with Endometriosis Treated with MYFEMBREE
| Adverse Reaction | MYFEMBREE (N = 418) % | Placebo (N = 416) % |
|---|---|---|
| Headache | 33.0 | 26.4 |
| Vasomotor symptoms 1 | 13.2 | 7.2 |
| Mood disorders 2 | 9.1 | 7.2 |
| Abnormal uterine bleeding 3 | 6.7 | 4.6 |
| Nausea | 6.0 | 4.1 |
| Toothache | 5.5 | 2.4 |
| Back pain | 4.8 | 2.9 |
| Decreased sexual desire and arousal 4 | 4.3 | 1.2 |
| Arthralgia | 3.6 | 2.2 |
| Fatigue | 3.1 | 2.4 |
| Dizziness | 3.1 | 1.2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed elsewhere in the labeling: Thromboembolic Disorders and Vascular Events [see Warnings and Precautions ( 5.1 )] Bone Loss [see Warnings and Precautions ( 5.2 )] Suicidal Ideation and Mood Disorders (Including Depression) [see Warnings and Precautions ( 5.4 )] Hepatic Impairment and Transaminase Elevations [see Warnings and Precautions ( 5.5 )] Elevated Blood Pressure [see Warnings and Precautions ( 5.7 )] Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy [see Warnings and Precautions ( 5.8 )] Uterine Fibroid Prolapse or Expulsion [see Warnings and Precautions ( 5.10 )] Alopecia [see Warnings and Precautions ( 5.11 )] Effects on Carbohydrate and Lipid Metabolism [see Warnings and Precautions ( 5.12 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.14 )] In women with heavy menstrual bleeding associated with uterine fibroids, most common adverse reactions (incidence ≥ 3%) are vasomotor symptoms, uterine bleeding, alopecia, and decreased libido. In women with moderate to severe pain associated with endometriosis, most common adverse reactions (incidence ≥ 3%) are headache, vasomotor symptoms, mood disorders, abnormal uterine bleeding, nausea, toothache, back pain, decreased sexual desire and arousal, arthralgia, fatigue, and dizziness.
Source: FDA drug label, Sumitomo Pharma America, Inc, effective September 4, 2025 (SPL set fc3feb73-cc84-43a8-aa32-b262460495e8), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,495 reports list estradiol and norethindrone and relugolix among the medicines taken, 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. Of the 20 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Estradiol and norethindrone and relugolix: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions