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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\GESTODENE: 160 Adverse Event Reports & Safety Profile

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160
Total FAERS Reports
3 (1.9%)
Deaths Reported
85
Hospitalizations
160
As Primary/Secondary Suspect
16
Life-Threatening
14
Disabilities

First Report: 1994 · Latest Report: 20250517

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

#1 Most Reported
Headache
19 reports (11.9%)
#2 Most Reported
Pain in extremity
18 reports (11.3%)
#3 Most Reported
Pulmonary embolism
17 reports (10.6%)

All ETHINYL ESTRADIOL\GESTODENE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Headache 19 11.9% 0 19
Pain in extremity 18 11.3% 0 15
Pulmonary embolism 17 10.6% 2 13
Cerebral venous thrombosis 16 10.0% 0 15
Product use in unapproved indication 16 10.0% 0 11
Drug interaction 14 8.8% 1 10
Fatigue 13 8.1% 0 13
Nausea 13 8.1% 0 11
Off label use 13 8.1% 0 8
Thrombosis 13 8.1% 0 11
Vomiting 13 8.1% 0 12
Dyspnoea 11 6.9% 0 10
Meningioma 11 6.9% 0 4
Deep vein thrombosis 10 6.3% 1 6
Chest pain 9 5.6% 0 9
Drug abuse 9 5.6% 0 6
Maternal exposure during pregnancy 9 5.6% 0 3
Peripheral swelling 9 5.6% 0 7
Pregnancy on oral contraceptive 9 5.6% 0 2
Dizziness 8 5.0% 1 7

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

Gender: 95.9% female, 4.1% male. Average age: 35.2 years. Most reports from: DK. View detailed demographics →

Is ETHINYL ESTRADIOL\GESTODENE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2003 1 0 0
2005 1 0 0
2007 8 1 4
2009 1 0 0
2010 2 0 2
2011 3 0 3
2012 10 0 7
2013 11 0 10
2014 19 0 13
2015 12 1 7
2016 8 0 5
2017 11 0 7
2018 8 0 4
2019 9 0 1
2021 4 0 3
2022 5 0 1
2023 1 0 1
2024 4 0 2
2025 2 1 0

View full timeline →

What Is ETHINYL ESTRADIOL\GESTODENE Used For?

IndicationReports
Contraception 64
Oral contraception 21
Product used for unknown indication 21
Dysmenorrhoea 5
Hormonal contraception 5

ETHINYL ESTRADIOL\GESTODENE vs Alternatives: Which Is Safer?

ETHINYL ESTRADIOL\GESTODENE vs ETHINYL ESTRADIOL\LEVONORGESTREL ETHINYL ESTRADIOL\GESTODENE vs ETHINYL ESTRADIOL\NORELGESTROMIN ETHINYL ESTRADIOL\GESTODENE vs ETHINYL ESTRADIOL\NORETHINDRONE ETHINYL ESTRADIOL\GESTODENE vs ETHINYL ESTRADIOL\NORGESTIMATE ETHINYL ESTRADIOL\GESTODENE vs ETHINYL ESTRADIOL\NORGESTREL ETHINYL ESTRADIOL\GESTODENE vs ETHINYL ESTRADIOL\SEGESTERONE ETHINYL ESTRADIOL\GESTODENE vs ETHIODIZED OIL ETHINYL ESTRADIOL\GESTODENE vs ETHIONAMIDE ETHINYL ESTRADIOL\GESTODENE vs ETHOSUXIMIDE ETHINYL ESTRADIOL\GESTODENE vs ETHYL ICOSAPENTATE

Official FDA Label for ETHINYL ESTRADIOL\GESTODENE

Official prescribing information from the FDA-approved drug label.