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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\NORETHINDRONE: 4,583 Adverse Event Reports & Safety Profile

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4,583
Total FAERS Reports
85 (1.9%)
Deaths Reported
418
Hospitalizations
4,583
As Primary/Secondary Suspect
189
Life-Threatening
174
Disabilities

Active Ingredient: ETHINYL ESTRADIOL\NORETHINDRONE ACETATE ·

First Report: 10181031 · Latest Report: 20250901

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

#1 Most Reported
Off label use
463 reports (10.1%)
#2 Most Reported
Drug ineffective
364 reports (7.9%)
#3 Most Reported
Metrorrhagia
333 reports (7.3%)

All ETHINYL ESTRADIOL\NORETHINDRONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 463 10.1% 28 41
Drug ineffective 364 7.9% 16 27
Metrorrhagia 333 7.3% 0 9
Nausea 308 6.7% 50 71
Anxiety 294 6.4% 45 58
Headache 279 6.1% 47 70
Amenorrhoea 276 6.0% 0 3
Pain 228 5.0% 49 63
Pregnancy on oral contraceptive 194 4.2% 0 5
Menstruation irregular 185 4.0% 0 1
Vomiting 180 3.9% 51 71
Weight increased 175 3.8% 48 58
Inappropriate schedule of product administration 170 3.7% 3 3
Muscle spasms 165 3.6% 44 50
Vaginal haemorrhage 164 3.6% 0 5
Dizziness 163 3.6% 44 62
Depression 161 3.5% 44 52
Product use in unapproved indication 159 3.5% 10 17
Fatigue 149 3.3% 48 57
Rash 149 3.3% 48 49

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

Gender: 99.7% female, 0.3% male. Average age: 31.4 years. Most reports from: US. View detailed demographics →

Is ETHINYL ESTRADIOL\NORETHINDRONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 1 0 0
2005 4 0 3
2006 3 0 0
2007 6 0 3
2008 5 0 3
2009 2 0 1
2010 9 0 8
2011 10 0 1
2012 24 1 8
2013 37 0 11
2014 114 3 32
2015 167 2 36
2016 236 1 22
2017 285 1 26
2018 261 1 36
2019 205 1 16
2020 144 0 11
2021 119 0 9
2022 70 0 6
2023 65 0 11
2024 57 0 8
2025 23 0 3

View full timeline →

What Is ETHINYL ESTRADIOL\NORETHINDRONE Used For?

IndicationReports
Contraception 1,613
Product used for unknown indication 1,150
Oral contraception 237
Menstruation irregular 121
Dysmenorrhoea 94
Menorrhagia 82
Endometriosis 74
Menstrual cycle management 71
Polycystic ovaries 60
Pregnancy 57

ETHINYL ESTRADIOL\NORETHINDRONE vs Alternatives: Which Is Safer?

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

Official FDA Label for ETHINYL ESTRADIOL\NORETHINDRONE

Official prescribing information from the FDA-approved drug label.