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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.

DROSPIRENONE\ETHINYL ESTRADIOL: 6,360 Adverse Event Reports & Safety Profile

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6,360
Total FAERS Reports
212 (3.3%)
Deaths Reported
2,702
Hospitalizations
6,360
As Primary/Secondary Suspect
410
Life-Threatening
308
Disabilities

First Report: 1992 · Latest Report: 20250927

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

#1 Most Reported
Pulmonary embolism
1,295 reports (20.4%)
#2 Most Reported
Pain
1,286 reports (20.2%)
#3 Most Reported
Injury
1,266 reports (19.9%)

All DROSPIRENONE\ETHINYL ESTRADIOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pulmonary embolism 1,295 20.4% 105 997
Pain 1,286 20.2% 29 853
Injury 1,266 19.9% 26 855
Deep vein thrombosis 1,139 17.9% 25 714
Emotional distress 742 11.7% 7 475
Anxiety 623 9.8% 16 418
Cerebrovascular accident 528 8.3% 6 435
General physical health deterioration 498 7.8% 6 369
Thrombosis 403 6.3% 15 248
Headache 393 6.2% 6 188
Off label use 363 5.7% 6 120
Dyspnoea 343 5.4% 22 245
Nausea 343 5.4% 7 111
Abdominal pain 280 4.4% 2 187
Depression 272 4.3% 3 132
Pain in extremity 270 4.3% 6 164
Embolism arterial 235 3.7% 7 183
Chest pain 233 3.7% 16 165
Product use in unapproved indication 218 3.4% 2 59
Dizziness 217 3.4% 23 91

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

Gender: 99.8% female, 0.2% male. Average age: 31.7 years. Most reports from: US. View detailed demographics →

Is DROSPIRENONE\ETHINYL ESTRADIOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 4 0 1
2001 17 0 8
2002 44 0 30
2003 69 2 44
2004 98 1 77
2005 129 5 93
2006 197 4 124
2007 223 5 155
2008 281 8 209
2009 326 10 240
2010 250 11 178
2011 290 5 207
2012 316 16 243
2013 122 7 67
2014 192 3 68
2015 212 8 62
2016 212 5 63
2017 241 8 77
2018 210 3 60
2019 233 6 55
2020 150 3 51
2021 148 3 47
2022 115 0 37
2023 100 2 45
2024 87 2 35
2025 58 2 23

View full timeline →

What Is DROSPIRENONE\ETHINYL ESTRADIOL Used For?

IndicationReports
Contraception 1,633
Product used for unknown indication 371
Acne 342
Oral contraception 313
Dysmenorrhoea 301
Premenstrual syndrome 267
Menstrual cycle management 194
Polycystic ovaries 161
Menstruation irregular 138
Premenstrual dysphoric disorder 124

DROSPIRENONE\ETHINYL ESTRADIOL vs Alternatives: Which Is Safer?

DROSPIRENONE\ETHINYL ESTRADIOL vs DROSPIRENONE\ETHINYL ESTRADIOL\LEVOMEFOLATE DROSPIRENONE\ETHINYL ESTRADIOL vs DROTAVERINE DROSPIRENONE\ETHINYL ESTRADIOL vs DROXIDOPA DROSPIRENONE\ETHINYL ESTRADIOL vs DULAGLUTIDE DROSPIRENONE\ETHINYL ESTRADIOL vs DULERA DROSPIRENONE\ETHINYL ESTRADIOL vs DULOXETINE DROSPIRENONE\ETHINYL ESTRADIOL vs DUPILUMAB DROSPIRENONE\ETHINYL ESTRADIOL vs DURAGESIC DROSPIRENONE\ETHINYL ESTRADIOL vs DUROGESIC DROSPIRENONE\ETHINYL ESTRADIOL vs DUROTEP MT

Official FDA Label for DROSPIRENONE\ETHINYL ESTRADIOL

Official prescribing information from the FDA-approved drug label.