ESTRADIOL\NORETHINDRONE\RELUGOLIX: 1,636 Adverse Event Reports & Safety Profile

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1,636

Total FAERS Reports

2 (0.1%)

Deaths Reported

Hospitalizations

1,636

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Active Ingredient: ESTRADIOL HEMIHYDRATE\NORETHINDRONE ACETATE\RELUGOLIX ·

First Report: 202106 · Latest Report: 20250906

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

#1 Most Reported

Therapy interrupted

467 reports (28.5%)

#2 Most Reported

Heavy menstrual bleeding

243 reports (14.9%)

#3 Most Reported

Intermenstrual bleeding

115 reports (7.0%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Therapy interrupted	467	28.6%	0	4
Heavy menstrual bleeding	243	14.9%	1	8
Intermenstrual bleeding	115	7.0%	0	2
Headache	89	5.4%	0	3
Off label use	72	4.4%	0	0
Hot flush	67	4.1%	0	0
Alopecia	66	4.0%	0	0
Nausea	63	3.9%	0	0
Dysmenorrhoea	62	3.8%	0	1
Menstruation irregular	61	3.7%	0	1
Depression	48	2.9%	0	1
Pain	47	2.9%	0	4
Drug ineffective	38	2.3%	0	1
Migraine	37	2.3%	0	4
Fatigue	35	2.1%	0	1
Dizziness	34	2.1%	0	2
Inappropriate schedule of product administration	31	1.9%	0	0
Suicidal ideation	31	1.9%	0	0
Weight increased	30	1.8%	0	0
Mood swings	29	1.8%	0	0

Gender: 100.0% female, 0.0% male. Average age: 40.6 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2021	40	0	2
2022	154	0	7
2023	270	0	8
2024	126	1	19
2025	49	0	11

Indication	Reports
Uterine leiomyoma	667
Product used for unknown indication	493
Endometriosis	306
Heavy menstrual bleeding	239
Abnormal uterine bleeding	29
Vaginal haemorrhage	26
Polymenorrhoea	23
Uterine haemorrhage	21
Adenomyosis	18
Menstruation irregular	15

Official prescribing information from the FDA-approved drug label.