ETHINYL ESTRADIOL\LEVONORGESTREL: 4,614 Adverse Event Reports & Safety Profile
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4,614
Total FAERS Reports
104 (2.3%)
Deaths Reported
1,046
Hospitalizations
4,614
As Primary/Secondary Suspect
280
Life-Threatening
154
Disabilities
First Report: 1987 · Latest Report: 20250908
What Are the Most Common ETHINYL ESTRADIOL\LEVONORGESTREL Side Effects?
#1 Most Reported
Product adhesion issue
522 reports (11.3%)
#2 Most Reported
Pulmonary embolism
324 reports (7.0%)
#3 Most Reported
Drug ineffective
269 reports (5.8%)
All ETHINYL ESTRADIOL\LEVONORGESTREL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Product adhesion issue | 522 | 11.3% | 0 | 0 |
| Pulmonary embolism | 324 | 7.0% | 36 | 229 |
| Drug ineffective | 269 | 5.8% | 3 | 21 |
| Headache | 241 | 5.2% | 1 | 92 |
| Deep vein thrombosis | 203 | 4.4% | 4 | 122 |
| Nausea | 201 | 4.4% | 0 | 50 |
| Off label use | 189 | 4.1% | 6 | 57 |
| Anxiety | 178 | 3.9% | 0 | 13 |
| Pain | 168 | 3.6% | 6 | 26 |
| Pregnancy on oral contraceptive | 166 | 3.6% | 0 | 5 |
| Metrorrhagia | 153 | 3.3% | 0 | 7 |
| Vaginal haemorrhage | 146 | 3.2% | 0 | 15 |
| Fatigue | 125 | 2.7% | 2 | 44 |
| Intermenstrual bleeding | 124 | 2.7% | 0 | 4 |
| Emotional distress | 122 | 2.6% | 0 | 5 |
| Product use in unapproved indication | 121 | 2.6% | 4 | 18 |
| Vomiting | 118 | 2.6% | 3 | 56 |
| Dizziness | 116 | 2.5% | 32 | 25 |
| Partner stress | 113 | 2.5% | 0 | 0 |
| Menstrual disorder | 112 | 2.4% | 0 | 2 |
Who Reports ETHINYL ESTRADIOL\LEVONORGESTREL Side Effects? Age & Gender Data
Gender: 99.3% female, 0.7% male. Average age: 30.0 years. Most reports from: US. View detailed demographics →
Is ETHINYL ESTRADIOL\LEVONORGESTREL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 4 | 0 | 0 |
| 2001 | 2 | 0 | 1 |
| 2002 | 2 | 0 | 1 |
| 2003 | 5 | 0 | 2 |
| 2004 | 4 | 0 | 3 |
| 2005 | 1 | 0 | 0 |
| 2006 | 2 | 0 | 1 |
| 2007 | 12 | 2 | 6 |
| 2008 | 7 | 0 | 2 |
| 2009 | 9 | 1 | 5 |
| 2010 | 19 | 0 | 12 |
| 2011 | 22 | 1 | 7 |
| 2012 | 23 | 1 | 17 |
| 2013 | 56 | 0 | 18 |
| 2014 | 174 | 2 | 78 |
| 2015 | 162 | 1 | 61 |
| 2016 | 207 | 2 | 64 |
| 2017 | 179 | 2 | 51 |
| 2018 | 314 | 11 | 143 |
| 2019 | 246 | 6 | 72 |
| 2020 | 186 | 4 | 47 |
| 2021 | 261 | 6 | 84 |
| 2022 | 294 | 1 | 32 |
| 2023 | 212 | 1 | 26 |
| 2024 | 129 | 0 | 25 |
| 2025 | 58 | 0 | 23 |
What Is ETHINYL ESTRADIOL\LEVONORGESTREL Used For?
| Indication | Reports |
|---|---|
| Contraception | 1,968 |
| Product used for unknown indication | 1,064 |
| Oral contraception | 454 |
| Menstrual cycle management | 131 |
| Dysmenorrhoea | 100 |
| Menstruation irregular | 62 |
| Hormonal contraception | 58 |
| Endometriosis | 56 |
| Heavy menstrual bleeding | 44 |
| Menorrhagia | 44 |
ETHINYL ESTRADIOL\LEVONORGESTREL vs Alternatives: Which Is Safer?
ETHINYL ESTRADIOL\LEVONORGESTREL vs ETHINYL ESTRADIOL\NORELGESTROMIN
ETHINYL ESTRADIOL\LEVONORGESTREL vs ETHINYL ESTRADIOL\NORETHINDRONE
ETHINYL ESTRADIOL\LEVONORGESTREL vs ETHINYL ESTRADIOL\NORGESTIMATE
ETHINYL ESTRADIOL\LEVONORGESTREL vs ETHINYL ESTRADIOL\NORGESTREL
ETHINYL ESTRADIOL\LEVONORGESTREL vs ETHINYL ESTRADIOL\SEGESTERONE
ETHINYL ESTRADIOL\LEVONORGESTREL vs ETHIODIZED OIL
ETHINYL ESTRADIOL\LEVONORGESTREL vs ETHIONAMIDE
ETHINYL ESTRADIOL\LEVONORGESTREL vs ETHOSUXIMIDE
ETHINYL ESTRADIOL\LEVONORGESTREL vs ETHYL ICOSAPENTATE
ETHINYL ESTRADIOL\LEVONORGESTREL vs ETHYL LOFLAZEPATE
Official FDA Label for ETHINYL ESTRADIOL\LEVONORGESTREL
Official prescribing information from the FDA-approved drug label.