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Elagolix Side Effects

The most commonly reported side effects of elagolix include hot flush, pain, and nausea, based on 4,467 FDA adverse event reports from 2004 to 2025. 6.4% of reports found the drug to be ineffective.

Elagolix side effects

Percentages show how often each reaction appears relative to total reports for elagolix.

1
Hot Flush11.3%503
2
Pain10.2%457
3
Nausea8.7%387
4
Headache7.6%341
5
Endometriosis6.8%305
6
Drug Ineffective6.4%284
7
Depression5.2%234
8
Arthralgia4.7%208
9
Fatigue3.9%174
10
Anxiety3.8%168
11
Surgery3.8%168
12
Alopecia3.7%165
13
Insomnia3.5%158
14
Suicidal Ideation3.4%152
15
Adverse Drug Reaction3.3%148

These are voluntary reports and do not establish that elagolix caused these reactions.

Report severity

35.9%Serious1,602 reports
9.6%Hospitalizations430 reports
0.3%Fatal14 reports

Seriousness is determined by the reporter, not by OpenClaim.

Elagolix drug interactions

Other drugs that appear in adverse event reports alongside elagolix. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Norethindrone5.2%231
2
Estradiol4.9%219
3
Leuprolide3.4%153
4
Dupilumab0.7%32
5
Adalimumab0.4%17
6
Apremilast0.4%16
7
Sodium-oxybate0.3%14
8
Levonorgestrel0.3%13
9
Calcium-oxybate0.2%11
10
Magnesium-oxybate0.2%11
11
Potassium-oxybate0.2%11
12
Acetaminophen0.2%10
13
Certolizumab-pegol0.2%8
14
Medroxyprogesterone-acetate0.2%8
15
Ciprofloxacin0.1%6

Taken alongside

1
Ergocalciferol5.0%223
2
Ibuprofen3.8%168
3
Acetaminophen2.9%128
4
Buspirone-hydrochloride2.4%106
5
Ferrous-sulfate2.1%95
6
Albuterol1.9%84
7
Levothyroxine-sodium1.8%82
8
Norethindrone1.6%72
9
Cetirizine-hydrochloride1.5%65
10
Omeprazole1.4%64
11
Gabapentin1.4%63
12
Montelukast-sodium1.3%57
13
Calcium1.2%54
14
Naproxen1.2%53
15
Metformin1.1%50

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports elagolix side effects

91.7% of elagolix adverse event reports involve female patients and 0.9% involve male patients. The largest age group is adult at 97%. These figures reflect who reports side effects, not underlying risk.

Sex

Female91.7%
Male0.9%
Unknown7.4%

Age group

< 20.5%
2–110.1%
12–171.1%
18–6497.1%
65+1.1%

What is elagolix used for

Conditions and purposes for which patients were taking elagolix when the adverse event was reported.

Abdominal DistensionAbnormal Uterine BleedingAdenomyosisAdnexa Uteri PainAnticoagulant TherapyAstheniaAbdominal PainAbnormal Uterine BleedingAdenomyosisAnaemiaAnxietyArthralgiaAutoimmune DisorderBlood OestrogenBlood Oestrogen Decreased

Showing 15 of 86 indications

Elagolix brand names and reporting trend

Elagolix is sold under brand names including Elagolix, Sheur, Orilissa.

Brand names

Elagolix568
Sheur183
Orilissa9

Quarterly reports (20042025)

2004201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking elagolix with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.