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etonogestrel Side Effects

Also known as: Nexplanon

Analysis of 46,939 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

46,939

Death-Related

94

0.2% of reports

Hospitalizations

1,645

3.5% of reports

Top Indication

Contraception

Most Reported Adverse Reactions

NO ADVERSE EVENT
9,909
PRODUCT QUALITY ISSUE
5,554
COMPLICATION ASSOCIATED WITH DEVICE
5,228
DEVICE DIFFICULT TO USE
4,562
DEVICE BREAKAGE
4,501
INCORRECT PRODUCT ADMINISTRATION DURATION
3,644
UNINTENDED PREGNANCY
3,449
DEVICE DEPLOYMENT ISSUE
3,370
COMPLICATION OF DEVICE REMOVAL
3,270
COMPLICATION OF DEVICE INSERTION
3,249
PREGNANCY WITH IMPLANT CONTRACEPTIVE
3,147
DEVICE DISLOCATION
2,662
IMPLANT SITE PAIN
2,575
MENORRHAGIA
2,443
VAGINAL HAEMORRHAGE
2,280
DEVICE EXPULSION
2,167
MENSTRUATION IRREGULAR
2,008
DEVICE KINK
1,995
WEIGHT INCREASED
1,956
AMENORRHOEA
1,640

Who Reports Side Effects

Gender Distribution

Female 44,403 (98%)
Male 82 (0%)
Unknown 696

Age Distribution

0-17 3,186 (13%)
18-44 21,245 (85%)
45-64 448 (2%)
65-74 4 (0%)
75+ 4 (0%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 94 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 24
FOETAL EXPOSURE DURING PREGNANCY 15
PREMATURE BABY 10
DEATH NEONATAL 8
COMPLETED SUICIDE 7
PULMONARY EMBOLISM 7
CEREBELLAR HAEMORRHAGE 6
HEADACHE 4
MATERNAL DRUGS AFFECTING FOETUS 4
THROMBOSIS 4
VAGINAL HAEMORRHAGE 4
ADVERSE EVENT 3
ANXIETY 3
FOETAL DEATH 3
PREGNANCY WITH CONTRACEPTIVE DEVICE 3
ABORTION INDUCED 2
ABORTION SPONTANEOUS 2
CARDIAC FAILURE 2
CARDIO-RESPIRATORY ARREST 2
CEREBROVASCULAR ACCIDENT 2

Reactions in Hospitalization Reports

Top reactions in 1,645 reports where hospitalization was an outcome.

Reaction Reports
COMPLICATION ASSOCIATED WITH DEVICE 164
UNINTENDED PREGNANCY 139
PREGNANCY WITH IMPLANT CONTRACEPTIVE 129
COMPLICATION OF DEVICE REMOVAL 113
DEVICE DISLOCATION 104
NAUSEA 98
HEADACHE 94
DEPRESSION 85
WEIGHT INCREASED 84
ANXIETY 79
PAIN 75
INCORRECT PRODUCT ADMINISTRATION DURATION 74
VOMITING 74
PULMONARY EMBOLISM 72
VAGINAL HAEMORRHAGE 71
ABDOMINAL PAIN 65
DIZZINESS 65
FATIGUE 64
CHEST PAIN 58
SURGERY 58

Nearby — Related Medications

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What the FAERS Data Reveals About etonogestrel Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 46,939 voluntary reports linked to etonogestrel and its brand equivalents (Nexplanon), spanning 2004 through 2025. Of those, 94 (0.2%) listed death as an outcome and 1,645 (3.5%) involved hospitalization. The most common indication reported alongside adverse events was Contraception.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 98% were female and 0% male; age distribution skews toward 18-44, with 21,245 reports in that bracket. The single most reported reaction is no adverse event with 9,909 submissions, followed by product quality issue and complication associated with device.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.