What the label lists and what reports show
Elagolix and estradiol and norethisterone side effects
Elagolix and estradiol and norethisterone's FDA label: “Most common adverse reaction (>5%) in clinical trials were hot flushes, headache, fatigue, metrorrhagia.” FAERS holds 600 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 alopecia (71 reports).
- No generic listed
- Boxed warning
Check it at the source: the elagolix and estradiol and norethisterone FDA label on DailyMed (effective December 19, 2025); 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 ORIAHNN?ORIAHNN may cause serious side effects including: See “What is the most important information I should know about ORIAHNN?” suicidal thoughts, suicidal behavior, and worsening of mood. ORIAHNN may cause suicidal thoughts or actions. 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, AbbVie Inc., effective December 19, 2025 (SPL set 99f6eee7-7e52-6999-7eb8-488d06dd1710), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reaction (>5%) in clinical trials were hot flushes, headache, fatigue, metrorrhagia.
Table 1. Adverse Reactions that Occurred in at Least 5% of Women with Uterine Fibroids Who Received ORIAHNN in Studies UF-1 and UF-2 and at a Greater Incidence Than Placebo
| Adverse Reaction | ORIAHNN N=395 | Placebo N=196 |
|---|---|---|
| Hot flush | 22% | 9% |
| Headache | 9% | 7% |
| Fatigue | 6% | 4% |
| Metrorrhagia | 5% | 1% |
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 serious adverse reactions are discussed elsewhere in labeling: Thromboembolic Disorders and Vascular Events [see Warnings and Precautions ( 5.1 ) ] Bone Loss [see Warnings and Precautions ( 5.2 ) ] Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders [see Warnings and Precautions ( 5.4 ) ] Hepatic Transaminase Elevations [see Warnings and Precautions ( 5.5 ) ] Elevated Blood Pressure [see Warnings and Precautions ( 5.6 ) ] Effects on Carbohydrate and Lipid Metabolism [see Warnings and Precautions ( 5.9 ) ] Alopecia [see Warnings and Precautions ( 5.10 ) ] Most common adverse reaction (>5%) in clinical trials were hot flushes, headache, fatigue, metrorrhagia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1–800–633–9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Figure 1. Mean Percent Change From Baseline in Lumbar Spine BMD in Women Who Received 12 Months of ORIAHNN (On-Treatment) and 12 Months of Follow Up (Off Treatment) 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. …
Source: FDA drug label, 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?
600 reports list elagolix and estradiol and norethisterone among the medicines taken, 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. Of the 22 reactions below, 8 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?
- Elagolix and estradiol and norethisterone: 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