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.
Applies to elagolix: oral tablet
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:
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:
Applies to elagolix: oral tablet
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.
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
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.
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).
Common (1% to 10%): ALT elevations
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.
Very common (10% or more): Headache (up to 20%)
Common (1% to 10%): Dizziness
Very common (10% or more): Hot flush or night sweats (up to 46%)
Very common (10% or more): Nausea (up to 16%)
Common (1% to 10%): Abdominal pain, diarrhea, constipation
Uncommon (0.1% to 1%): Appendicitis
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%).
Common (1% to 10%): Non-serious reactions including rash
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.
Common (1% to 10%): Arthralgia, weight gain, bone loss
Uncommon (0.1% to 1%): Back pain
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Orilissa