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Orilissa Side Effects

Generic Name: elagolix

Note: This document contains side effect information about elagolix. Some of the dosage forms listed on this page may not apply to the brand name Orilissa.

For the Consumer

Applies to elagolix: oral tablet

Side effects requiring immediate medical attention

Along with its needed effects, elagolix (the active ingredient contained in Orilissa) 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:

Orilissa may cause suicidal thoughts or actions.

Call your healthcare provider right away or call 911 if an emergency, if you have any of the following symptoms, especially if they are new, worse, or bother you:

  • thoughts about suicide or dying;

  • try to commit suicide;

  • new or worse depression;

  • new or worse anxiety; or

  • 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.

Call your healthcare provider right away if you have any of these signs and symptoms of liver problems:

  • yellowing of the skin or the whites of the eyes (jaundice);

  • dark amber-colored urine;

  • feeling tired (fatigue or exhaustion);

  • nausea and vomiting;

  • generalized swelling;

  • right upper stomach area (abdomen) pain; or

  • bruising easily.

For Healthcare Professionals

Applies to elagolix: oral tablet

General

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

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.

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

Genitourinary

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.

Very common (10% or more): Amenorrhea (up to 57%)

Frequency not reported: Reduction in mean number of bleeding and spotting days and bleeding intensity

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

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.

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

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

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.

References

1. Aleksandrowicz Z "Mitochondrial adenosine triphosphatase from human placenta--effects of adenylyl and guanylyl imidodiphosphate." Int J Biochem 17 (1985): 229-34

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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