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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is ESTRADIOL\NORETHINDRONE Used For?
| Indication | Reports |
|---|---|
| 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.