ETHINYL ESTRADIOL\ETONOGESTREL: 11,613 Adverse Event Reports & Safety Profile
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11,613
Total FAERS Reports
130 (1.1%)
Deaths Reported
3,386
Hospitalizations
11,613
As Primary/Secondary Suspect
311
Life-Threatening
576
Disabilities
First Report: 1997 · Latest Report: 20250904
What Are the Most Common ETHINYL ESTRADIOL\ETONOGESTREL Side Effects?
#1 Most Reported
Pulmonary embolism
2,370 reports (20.4%)
#2 Most Reported
Deep vein thrombosis
1,577 reports (13.6%)
#3 Most Reported
Inappropriate schedule of drug administration
1,464 reports (12.6%)
All ETHINYL ESTRADIOL\ETONOGESTREL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pulmonary embolism | 2,370 | 20.4% | 97 | 2,125 |
| Deep vein thrombosis | 1,577 | 13.6% | 39 | 1,220 |
| Inappropriate schedule of drug administration | 1,464 | 12.6% | 2 | 52 |
| No adverse event | 1,280 | 11.0% | 0 | 0 |
| Device expulsion | 986 | 8.5% | 1 | 27 |
| Device breakage | 741 | 6.4% | 0 | 4 |
| Incorrect drug administration duration | 740 | 6.4% | 2 | 58 |
| Unintended pregnancy | 543 | 4.7% | 2 | 87 |
| Headache | 530 | 4.6% | 4 | 288 |
| Depression | 511 | 4.4% | 5 | 343 |
| Anxiety | 483 | 4.2% | 5 | 330 |
| Migraine | 480 | 4.1% | 5 | 309 |
| Off label use | 457 | 3.9% | 10 | 374 |
| Product quality issue | 445 | 3.8% | 0 | 5 |
| Metrorrhagia | 431 | 3.7% | 0 | 57 |
| Nausea | 411 | 3.5% | 1 | 181 |
| Vaginal haemorrhage | 403 | 3.5% | 1 | 64 |
| Menorrhagia | 353 | 3.0% | 0 | 138 |
| Pregnancy with contraceptive device | 334 | 2.9% | 0 | 27 |
| Chest pain | 284 | 2.5% | 1 | 245 |
Who Reports ETHINYL ESTRADIOL\ETONOGESTREL Side Effects? Age & Gender Data
Gender: 99.5% female, 0.5% male. Average age: 29.3 years. Most reports from: US. View detailed demographics →
Is ETHINYL ESTRADIOL\ETONOGESTREL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 3 | 0 | 3 |
| 2001 | 8 | 0 | 6 |
| 2002 | 15 | 0 | 12 |
| 2003 | 62 | 0 | 47 |
| 2004 | 79 | 0 | 64 |
| 2005 | 131 | 1 | 111 |
| 2006 | 258 | 10 | 222 |
| 2007 | 303 | 12 | 260 |
| 2008 | 314 | 10 | 262 |
| 2009 | 372 | 5 | 292 |
| 2010 | 407 | 11 | 327 |
| 2011 | 491 | 10 | 364 |
| 2012 | 604 | 12 | 458 |
| 2013 | 409 | 10 | 269 |
| 2014 | 571 | 2 | 113 |
| 2015 | 793 | 11 | 97 |
| 2016 | 675 | 5 | 101 |
| 2017 | 620 | 4 | 76 |
| 2018 | 444 | 1 | 45 |
| 2019 | 376 | 3 | 35 |
| 2020 | 432 | 2 | 22 |
| 2021 | 280 | 2 | 17 |
| 2022 | 178 | 0 | 7 |
| 2023 | 104 | 1 | 11 |
| 2024 | 80 | 0 | 12 |
| 2025 | 28 | 1 | 10 |
What Is ETHINYL ESTRADIOL\ETONOGESTREL Used For?
| Indication | Reports |
|---|---|
| Contraception | 5,815 |
| Product used for unknown indication | 974 |
| Menstrual cycle management | 275 |
| Menstruation irregular | 163 |
| Menorrhagia | 152 |
| Dysmenorrhoea | 112 |
| Endometriosis | 80 |
| Polycystic ovaries | 61 |
| Menstrual disorder | 49 |
| Ovarian cyst | 47 |
ETHINYL ESTRADIOL\ETONOGESTREL vs Alternatives: Which Is Safer?
ETHINYL ESTRADIOL\ETONOGESTREL vs ETHINYL ESTRADIOL\FERROUS\NORETHINDRONE
ETHINYL ESTRADIOL\ETONOGESTREL vs ETHINYL ESTRADIOL\GESTODENE
ETHINYL ESTRADIOL\ETONOGESTREL vs ETHINYL ESTRADIOL\LEVONORGESTREL
ETHINYL ESTRADIOL\ETONOGESTREL vs ETHINYL ESTRADIOL\NORELGESTROMIN
ETHINYL ESTRADIOL\ETONOGESTREL vs ETHINYL ESTRADIOL\NORETHINDRONE
ETHINYL ESTRADIOL\ETONOGESTREL vs ETHINYL ESTRADIOL\NORGESTIMATE
ETHINYL ESTRADIOL\ETONOGESTREL vs ETHINYL ESTRADIOL\NORGESTREL
ETHINYL ESTRADIOL\ETONOGESTREL vs ETHINYL ESTRADIOL\SEGESTERONE
ETHINYL ESTRADIOL\ETONOGESTREL vs ETHIODIZED OIL
ETHINYL ESTRADIOL\ETONOGESTREL vs ETHIONAMIDE
Official FDA Label for ETHINYL ESTRADIOL\ETONOGESTREL
Official prescribing information from the FDA-approved drug label.