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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ELAGOLIX\ESTRADIOL\NORETHINDRONE: 662 Adverse Event Reports & Safety Profile

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662
Total FAERS Reports
1 (0.2%)
Deaths Reported
56
Hospitalizations
662
As Primary/Secondary Suspect
5
Life-Threatening

Active Ingredient: ELAGOLIX SODIUM\ESTRADIOL\NORETHINDRONE ·

First Report: 20181211 · Latest Report: 20250801

What Are the Most Common ELAGOLIX\ESTRADIOL\NORETHINDRONE Side Effects?

#1 Most Reported
Alopecia
76 reports (11.5%)
#2 Most Reported
Heavy menstrual bleeding
67 reports (10.1%)
#3 Most Reported
Headache
54 reports (8.2%)

All ELAGOLIX\ESTRADIOL\NORETHINDRONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Alopecia 76 11.5% 0 1
Heavy menstrual bleeding 67 10.1% 0 8
Headache 54 8.2% 0 2
Nausea 51 7.7% 0 3
Abnormal uterine bleeding 34 5.1% 0 3
Uterine leiomyoma 33 5.0% 0 7
Hot flush 32 4.8% 0 0
Bone density decreased 30 4.5% 0 0
Haemorrhage 29 4.4% 0 6
Surgery 29 4.4% 0 1
Fatigue 28 4.2% 0 0
Intermenstrual bleeding 27 4.1% 0 0
Vaginal haemorrhage 26 3.9% 0 1
Hysterectomy 25 3.8% 0 1
Depression 24 3.6% 0 0
Vomiting 24 3.6% 0 5
Menstruation irregular 21 3.2% 0 0
Drug ineffective 20 3.0% 0 2
Pain 20 3.0% 0 3
Amenorrhoea 19 2.9% 0 1

Who Reports ELAGOLIX\ESTRADIOL\NORETHINDRONE Side Effects? Age & Gender Data

Gender: 100.0% female, 0.0% male. Average age: 42.9 years. Most reports from: US. View detailed demographics →

Is ELAGOLIX\ESTRADIOL\NORETHINDRONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2018 1 0 1
2019 3 0 2
2020 66 0 8
2021 133 0 10
2022 103 0 9
2023 13 0 2
2024 4 0 0
2025 1 0 0

View full timeline →

What Is ELAGOLIX\ESTRADIOL\NORETHINDRONE Used For?

IndicationReports
Uterine leiomyoma 367
Product used for unknown indication 261
Heavy menstrual bleeding 50
Endometriosis 11
Menorrhagia 9
Uterine haemorrhage 9
Abnormal uterine bleeding 6

ELAGOLIX\ESTRADIOL\NORETHINDRONE vs Alternatives: Which Is Safer?

ELAGOLIX\ESTRADIOL\NORETHINDRONE vs ELAPEGADEMASE-LVLR ELAGOLIX\ESTRADIOL\NORETHINDRONE vs ELASOMERAN ELAGOLIX\ESTRADIOL\NORETHINDRONE vs ELBASVIR ELAGOLIX\ESTRADIOL\NORETHINDRONE vs ELBASVIR\GRAZOPREVIR ELAGOLIX\ESTRADIOL\NORETHINDRONE vs ELDECALCITOL ELAGOLIX\ESTRADIOL\NORETHINDRONE vs ELECTROLYTES NOS ELAGOLIX\ESTRADIOL\NORETHINDRONE vs ELECTROLYTES NOS\MINERALS ELAGOLIX\ESTRADIOL\NORETHINDRONE vs ELETRIPTAN ELAGOLIX\ESTRADIOL\NORETHINDRONE vs ELETRIPTAN HYDROBROMIDE ELAGOLIX\ESTRADIOL\NORETHINDRONE vs ELEXACAFTOR\IVACAFTOR\TEZACAFTOR

Official FDA Label for ELAGOLIX\ESTRADIOL\NORETHINDRONE

Official prescribing information from the FDA-approved drug label.