Elagolix Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on May 8, 2025.

Applies to elagolix: oral capsule, oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) along with your pills. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for at least 28 days after the last dose. If a pregnancy occurs while using the medicine, tell your doctor right away.

Do not use this medicine together with cyclosporine (Neoral®, Sandimmune®) or gemfibrozil (Lopid®).

This medicine can cause your bone mineral density to decrease, which may lead to osteoporosis or weakened bones. Check with your doctor if you have pain in the back, ribs, arms, or legs, or a decrease in your height.

This medicine may cause changes in menstrual bleeding, which may decrease your ability to recognize a pregnancy from occurring. Talk to your doctor if you have concerns.

Elagolix may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of elagolix

Along with its needed effects, elagolix may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking elagolix:

Other side effects of elagolix

Some side effects of elagolix may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to elagolix: oral tablet.

General adverse events

The more commonly reported adverse reactions have included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions, and mood changes.^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia, mood altered, mood swings, depressed mood, depression, depressive symptoms and/or tearfulness, anxiety, decreased libido, irritability
• Uncommon (0.1% to 1%): Completed suicide, suicidal ideation

During clinical trials, a 44-year old woman completed suicide 2 days after finishing a course of 150 mg once a day for 31 days. She was reported to have no relevant past medical history; life stressors were noted. Of the 2090 patients exposed to this drug, there were 4 reports of suicidal ideation, 3 had a history of depression.

Genitourinary

• Very common (10% or more): Amenorrhea (up to 57%)
• Frequency not reported: Reduction in mean number of bleeding and spotting days and bleeding intensity

Dose-dependent reduction in mean number of bleeding and spotting days and bleeding intensity was reported in electronic diaries. Amenorrhea was reported in 6% to 17% of patients receiving 150 mg/day and 13% to 52% of those receiving 200 mg twice a day during the first 6 months of therapy. During the second 6 months the incidence of amenorrhea was 11% to 15% and 46% to 57%, respectively. Six months after stopping therapy (150 mg/day), menses resumed in 59%, 87%, and 95% of women within 1, 2, and 6 months, respectively. After stopping therapy following 6 months at 200 mg twice a day, resumption of menses was reported in 60%, 88%, and 97% of women within 1, 2, and 6 months, respectively.

Hepatic

• Common (1% to 10%): ALT elevations

Dose-dependent asymptomatic elevations of serum ALT to 3 times the upper limit normal occurred at 0.2% and 1.1% of patients receiving 150 mg/day (n=450) and 200 mg twice a day (n=443) respectively; placebo 0.1% (n=696).

Metabolic

• Common (1% to 10%): Increases in total cholesterol, low-density lipoprotein cholesterol, high density lipoprotein cholesterol, and serum triglycerides

During clinical trials, dose dependent increases in total cholesterol, low-density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, and serum triglycerides occurred. Mean changes of LDL at 6 months were 5 and 13 mg/dL in patients receiving 150 mg/day and 200 mg twice a day, respectively. Mean change in HDL was 2 and 4 mg/dL in patients receiving 150 mg/day and 200 mg twice a day, respectively. Mean change in serum triglycerides was less than 1 and 11 mg/dL in patients receiving 150 mg/day and 200 mg twice a day, respectively. Placebo patients had mean changes of -3, 1 and -3 mg/dL for LDL, HDL, and serum triglycerides, respectively. Increases occurred within 1 to 2 months and remained stable after that.

Nervous system

• Very common (10% or more): Headache (up to 20%)
• Common (1% to 10%): Dizziness

Cardiovascular

• Very common (10% or more): Hot flush or night sweats (up to 46%)

Gastrointestinal

• Very common (10% or more): Nausea (up to 16%)
• Common (1% to 10%): Abdominal pain, diarrhea, constipation
• Uncommon (0.1% to 1%): Appendicitis

Hypersensitivity

• Common (1% to 10%): Non-serious reactions including rash
• Postmarketing reports: Hypersensitivity reactions including anaphylaxis, angioedema, and urticaria

Non-serious hypersensitivity reactions including rash occurred in 5.8% of patients (placebo=6.1%). Study discontinuation occurred in 0.4% of drug treated patients (placebo=0.5%).

Musculoskeletal

• Common (1% to 10%): Arthralgia, weight gain, bone loss
• Uncommon (0.1% to 1%): Back pain

During clinical trials, bone loss was assessed by dual-energy X-ray absorptiometry (DXA). One study showed the percent of subjects with greater than an 8% decrease in bone mineral density in lumbar spine, total hip, or femoral neck at any point compared to placebo was 2% and 7% in patients dosed with 150 mg/day and 200 mg twice a day, respectively (placebo: less than 1%). In the blinded extension study in which patients continued treatment for 12 months, these numbers increased to 8% and 21%. In study 2, the percent of subjects with greater than an 8% decrease in BMD was less than 1%, 6%, and 0% in patients dosed with 150 mg/day, 200 mg twice a day, and placebo, respectively. Continued bone loss occurred in the extension study with up to 2% observed in patients receiving 150 mg/day and 21% in patients receiving 200 mg twice a day. Upon completing drug therapy, partial recovery of BMD was observed in those patients who were followed.

See also:

Frequently asked questions

• What types of birth control work with Orilissa?
• Can Elagolix be used for heavy menstrual bleeding in women?

Further information

Elagolix side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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