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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\NORGESTIMATE: 4,918 Adverse Event Reports & Safety Profile

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4,918
Total FAERS Reports
17 (0.3%)
Deaths Reported
268
Hospitalizations
4,918
As Primary/Secondary Suspect
97
Life-Threatening
63
Disabilities

First Report: 1984 · Latest Report: 20250721

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

#1 Most Reported
Drug dose omission
950 reports (19.3%)
#2 Most Reported
Inappropriate schedule of drug administration
724 reports (14.7%)
#3 Most Reported
Nausea
315 reports (6.4%)

All ETHINYL ESTRADIOL\NORGESTIMATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug dose omission 950 19.3% 0 2
Inappropriate schedule of drug administration 724 14.7% 0 0
Nausea 315 6.4% 0 11
Vaginal haemorrhage 285 5.8% 0 4
Metrorrhagia 264 5.4% 0 2
Product use issue 257 5.2% 0 7
Anxiety 225 4.6% 1 2
Drug ineffective 225 4.6% 0 3
Headache 202 4.1% 1 16
Pregnancy on oral contraceptive 197 4.0% 1 3
Vomiting 182 3.7% 0 16
Off label use 167 3.4% 1 11
Product dose omission 152 3.1% 0 1
Pain 150 3.1% 0 6
Acne 138 2.8% 0 0
Malaise 137 2.8% 0 5
Product substitution issue 133 2.7% 0 5
Menstruation delayed 130 2.6% 0 0
Menstruation irregular 123 2.5% 0 3
Emotional distress 122 2.5% 0 0

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

Gender: 99.7% female, 0.3% male. Average age: 26.7 years. Most reports from: US. View detailed demographics →

Is ETHINYL ESTRADIOL\NORGESTIMATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 6 0 1
2001 5 0 0
2002 6 0 1
2003 2 0 0
2004 7 0 1
2005 5 0 1
2006 12 0 4
2007 5 0 2
2008 11 0 1
2009 13 0 2
2010 33 0 3
2011 194 0 3
2012 509 2 11
2013 439 0 16
2014 413 4 26
2015 353 2 18
2016 262 0 18
2017 199 0 16
2018 216 4 8
2019 176 1 12
2020 57 0 6
2021 68 0 9
2022 33 0 3
2023 43 0 17
2024 15 1 1
2025 5 0 3

View full timeline →

What Is ETHINYL ESTRADIOL\NORGESTIMATE Used For?

IndicationReports
Contraception 2,235
Product used for unknown indication 1,596
Acne 221
Oral contraception 202
Menstruation irregular 172
Polycystic ovaries 60
Dysmenorrhoea 52
Menstrual cycle management 46
Menorrhagia 33
Ovarian cyst 33

ETHINYL ESTRADIOL\NORGESTIMATE vs Alternatives: Which Is Safer?

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

Official FDA Label for ETHINYL ESTRADIOL\NORGESTIMATE

Official prescribing information from the FDA-approved drug label.