What the label lists and what reports show
Elagolix side effects
Elagolix's FDA label: “Most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions and mood changes ( 6.1 ).” FAERS holds 3,723 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 hot flush (471 reports).
- No generic listed
Check it at the source: the elagolix FDA label on DailyMed (effective December 19, 2025, AbbVie 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 ORILISSA?ORILISSA may cause serious side effects including: See “What is the most important information I should know about ORILISSA?” suicidal thoughts, suicidal behavior, and worsening of mood. ORILISSA may cause suicidal thoughts or actions. Call your healthcare provider or get emergency medical help right away if you have any of the following 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 You or your caregiver should 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 a86757b3-09c5-fd3b-1223-244e94f50a66), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions and mood changes ( 6.1 ).
Table 2. Percentage of Subjects in Studies EM-1 and EM-2 with Treatment-Emergent Adverse Reactions Occurring in at Least 5% of Subjects (either ORILISSA Dose Group) and at a Greater Incidence than with Placebo
| Reaction | ORILISSA 150 mg Once Daily N=475 % | ORILISSA 200 mg Twice Daily N=477 % | Placebo N=734 % |
|---|---|---|---|
| Hot Flush | 24 | 46 | 9 |
| Headache | 17 | 20 | 12 |
| Nausea | 11 | 16 | 13 |
| Insomnia | 6 | 9 | 3 |
| Mood altered, mood swings | 6 | 5 | 3 |
| Amenorrhea | 4 | 7 | <1 |
| Depressed mood, depression, depressive symptoms and/or tearfulness | 3 | 6 | 2 |
| Anxiety | 3 | 5 | 3 |
| Arthralgia | 3 | 5 | 3 |
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: Bone loss [see Warnings and Precautions ( 5.1 )] Change in menstrual bleeding pattern and reduced ability to recognize pregnancy [see Warnings and Precautions ( 5.2 )] Suicidal ideation, suicidal behavior, and exacerbation of mood disorders [see Warnings and Precautions ( 5.3 )] Hepatic transaminase elevations [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions and mood changes ( 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. Percent Change from Baseline in Lumbar Spine BMD in Subjects Who Received 12 Months of ORILISSA and Had Follow-up BMD 6 Months off Therapy in Studies EM-2/EM-4 Figure 2. …
Source: FDA drug label, AbbVie Inc., effective December 19, 2025 (SPL set a86757b3-09c5-fd3b-1223-244e94f50a66), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,723 reports list elagolix among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 321 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 rose sharply in 2020 (1,090, against a median of 121 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 22 reactions below, 13 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: 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