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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.

ETHINYL ESTRADIOL\NORELGESTROMIN: 6,648 Adverse Event Reports & Safety Profile

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6,648
Total FAERS Reports
12 (0.2%)
Deaths Reported
78
Hospitalizations
6,648
As Primary/Secondary Suspect
23
Life-Threatening
25
Disabilities

First Report: 19850924 · Latest Report: 20250820

What Are the Most Common ETHINYL ESTRADIOL\NORELGESTROMIN Side Effects?

#1 Most Reported
Product adhesion issue
3,932 reports (59.1%)
#2 Most Reported
No adverse event
3,014 reports (45.3%)
#3 Most Reported
Product quality issue
691 reports (10.4%)

All ETHINYL ESTRADIOL\NORELGESTROMIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Product adhesion issue 3,932 59.2% 0 0
No adverse event 3,014 45.3% 0 0
Product quality issue 691 10.4% 0 5
Inappropriate schedule of drug administration 563 8.5% 0 5
Drug dose omission 495 7.5% 0 2
Wrong technique in product usage process 366 5.5% 0 0
Wrong technique in drug usage process 349 5.3% 0 0
Product substitution issue 269 4.1% 0 0
Off label use 251 3.8% 0 5
Product use issue 227 3.4% 0 4
Metrorrhagia 220 3.3% 0 0
Application site pruritus 215 3.2% 0 0
Application site rash 163 2.5% 0 2
Application site erythema 149 2.2% 0 0
Application site irritation 139 2.1% 0 0
Vaginal haemorrhage 136 2.1% 0 3
Nausea 115 1.7% 0 4
Application site pain 100 1.5% 0 0
Headache 89 1.3% 0 3
Drug ineffective 74 1.1% 0 2

Who Reports ETHINYL ESTRADIOL\NORELGESTROMIN Side Effects? Age & Gender Data

Gender: 99.8% female, 0.2% male. Average age: 26.4 years. Most reports from: US. View detailed demographics →

Is ETHINYL ESTRADIOL\NORELGESTROMIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 2 0 0
2001 3 0 0
2002 3 0 0
2003 5 0 0
2004 4 0 0
2005 7 0 3
2006 10 0 1
2007 4 0 0
2008 8 1 3
2009 6 0 1
2010 6 0 0
2011 15 0 1
2012 133 1 2
2013 725 0 6
2014 573 0 10
2015 209 0 6
2016 93 0 6
2017 74 0 6
2018 69 0 4
2019 93 0 6
2020 83 2 3
2021 682 0 1
2022 265 0 0
2023 448 0 0
2024 363 0 1
2025 79 0 0

View full timeline →

What Is ETHINYL ESTRADIOL\NORELGESTROMIN Used For?

IndicationReports
Product used for unknown indication 3,568
Contraception 2,489
Menstruation irregular 138
Menstrual cycle management 75
Menstrual disorder 59
Dysmenorrhoea 50
Endometriosis 34
Menorrhagia 27
Hormone level abnormal 26
Ovarian cyst 25

ETHINYL ESTRADIOL\NORELGESTROMIN vs Alternatives: Which Is Safer?

ETHINYL ESTRADIOL\NORELGESTROMIN vs ETHINYL ESTRADIOL\NORETHINDRONE ETHINYL ESTRADIOL\NORELGESTROMIN vs ETHINYL ESTRADIOL\NORGESTIMATE ETHINYL ESTRADIOL\NORELGESTROMIN vs ETHINYL ESTRADIOL\NORGESTREL ETHINYL ESTRADIOL\NORELGESTROMIN vs ETHINYL ESTRADIOL\SEGESTERONE ETHINYL ESTRADIOL\NORELGESTROMIN vs ETHIODIZED OIL ETHINYL ESTRADIOL\NORELGESTROMIN vs ETHIONAMIDE ETHINYL ESTRADIOL\NORELGESTROMIN vs ETHOSUXIMIDE ETHINYL ESTRADIOL\NORELGESTROMIN vs ETHYL ICOSAPENTATE ETHINYL ESTRADIOL\NORELGESTROMIN vs ETHYL LOFLAZEPATE ETHINYL ESTRADIOL\NORELGESTROMIN vs ETHYLENE GLYCOL

Official FDA Label for ETHINYL ESTRADIOL\NORELGESTROMIN

Official prescribing information from the FDA-approved drug label.