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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.

ESTRADIOL\NORETHINDRONE: 4,280 Adverse Event Reports & Safety Profile

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4,280
Total FAERS Reports
27 (0.6%)
Deaths Reported
275
Hospitalizations
4,280
As Primary/Secondary Suspect
44
Life-Threatening
35
Disabilities

Active Ingredient: ESTRADIOL\NORETHINDRONE ACETATE ·

First Report: 1998 · Latest Report: 20250918

What Are the Most Common ESTRADIOL\NORETHINDRONE Side Effects?

#1 Most Reported
Product adhesion issue
734 reports (17.1%)
#2 Most Reported
Product storage error
698 reports (16.3%)
#3 Most Reported
Off label use
585 reports (13.7%)

All ESTRADIOL\NORETHINDRONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Product adhesion issue 734 17.2% 0 7
Product storage error 698 16.3% 0 3
Off label use 585 13.7% 0 33
Application site erythema 533 12.5% 0 0
No adverse event 508 11.9% 0 0
Application site pruritus 463 10.8% 0 0
Wrong technique in product usage process 428 10.0% 0 5
Application site irritation 341 8.0% 0 0
Hot flush 307 7.2% 0 6
Product quality issue 263 6.1% 0 2
Drug ineffective 247 5.8% 0 9
Vaginal haemorrhage 230 5.4% 0 9
Drug dose omission 199 4.7% 2 2
Device issue 185 4.3% 0 3
Application site pain 173 4.0% 0 0
Application site rash 170 4.0% 0 0
Headache 165 3.9% 2 6
Product administered at inappropriate site 154 3.6% 0 0
Therapeutic product ineffective 132 3.1% 0 1
Therapy cessation 116 2.7% 0 2

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

Gender: 99.8% female, 0.2% male. Average age: 54.1 years. Most reports from: US. View detailed demographics →

Is ESTRADIOL\NORETHINDRONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 3 0 2
2001 4 0 1
2002 5 0 0
2003 1 0 0
2004 7 0 1
2005 5 0 2
2006 7 0 4
2007 1 0 1
2008 2 0 0
2009 6 0 1
2010 15 0 2
2011 11 0 5
2012 11 0 0
2013 32 0 1
2014 108 0 7
2015 154 0 5
2016 244 0 13
2017 203 2 33
2018 206 5 39
2019 191 1 37
2020 197 2 27
2021 195 1 13
2022 215 0 6
2023 218 0 7
2024 218 0 4
2025 141 2 0

View full timeline →

What Is ESTRADIOL\NORETHINDRONE Used For?

IndicationReports
Product used for unknown indication 1,556
Hot flush 866
Menopause 505
Menopausal symptoms 483
Night sweats 457
Hormone replacement therapy 416
Uterine leiomyoma 142
Off label use 83
Endometriosis 72
Osteoporosis 50

ESTRADIOL\NORETHINDRONE vs Alternatives: Which Is Safer?

ESTRADIOL\NORETHINDRONE vs ESTRADIOL\NORETHINDRONE\RELUGOLIX ESTRADIOL\NORETHINDRONE vs ESTRADIOL\PROGESTERONE ESTRADIOL\NORETHINDRONE vs ESTRAMUSTINE ESTRADIOL\NORETHINDRONE vs ESTRING ESTRADIOL\NORETHINDRONE vs ESTRIOL ESTRADIOL\NORETHINDRONE vs ESTROGENS ESTRADIOL\NORETHINDRONE vs ESTROGENS, CONJUGATED ESTRADIOL\NORETHINDRONE vs ESTROGENS, CONJUGATED\MEDROXYPROGESTERONE ESTRADIOL\NORETHINDRONE vs ESTROGENS, ESTERIFIED ESTRADIOL\NORETHINDRONE vs ESZOPICLONE

Official FDA Label for ESTRADIOL\NORETHINDRONE

Official prescribing information from the FDA-approved drug label.