55/100 · Moderate
Manufactured by Organon LLC
Etonogestrel Safety Profile: Device-Related Issues Predominate
110,074 FDA adverse event reports analyzed
Last updated: 2026-05-12
ETONOGESTREL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Organon LLC. Based on analysis of 110,074 FDA adverse event reports, ETONOGESTREL has a safety score of 55 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for ETONOGESTREL include NO ADVERSE EVENT, PRODUCT QUALITY ISSUE, COMPLICATION ASSOCIATED WITH DEVICE, DEVICE DIFFICULT TO USE, DEVICE BREAKAGE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ETONOGESTREL.
Etonogestrel has a safety concern score of 55 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 110,074 adverse event reports for this medication, which is primarily manufactured by Organon Llc.
The most commonly reported adverse events include No Adverse Event, Product Quality Issue, Complication Associated With Device. Of classified reports, 27.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are device-related, with complications during insertion, removal, and deployment being common.
Weight changes and mood alterations are also frequently reported, indicating potential hormonal side effects. Serious adverse events account for 27.9% of all reports, highlighting the need for careful monitoring.
Patients taking Etonogestrel should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other hormonal contraceptives are not well-documented, and patients should be advised to avoid use in conjunction with certain medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Etonogestrel received a safety concern score of 55/100 (elevated concern). This is based on a 27.9% serious event ratio across 46,934 classified reports. The score accounts for 110,074 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 44,403, Unknown: 696, Male: 82. The most frequently reported age groups are age 21 (1,544 reports), age 18 (1,533 reports), age 20 (1,495 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 46,934 classified reports for ETONOGESTREL:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Interactions with other hormonal contraceptives are not well-documented, and patients should be advised to avoid use in conjunction with certain medications.
If you are taking Etonogestrel, here are important things to know. The most commonly reported side effects include no adverse event, product quality issue, complication associated with device, device difficult to use, device breakage. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be informed about the potential for device-related complications and should seek medical attention if issues arise. Regular follow-up appointments are recommended to ensure proper device placement and to address any adverse events promptly. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of Etonogestrel, and updates will be provided based on ongoing reviews.
The FDA has received approximately 110,074 adverse event reports associated with Etonogestrel. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Etonogestrel include No Adverse Event, Product Quality Issue, Complication Associated With Device, Device Difficult To Use, Device Breakage. By volume, the top reported reactions are: No Adverse Event (9,909 reports), Product Quality Issue (5,554 reports), Complication Associated With Device (5,228 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Etonogestrel.
Out of 46,934 classified reports, 13,111 (27.9%) were classified as serious and 33,823 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Etonogestrel break down by patient sex as follows: Female: 44,403, Unknown: 696, Male: 82. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Etonogestrel adverse events are: age 21: 1,544 reports, age 18: 1,533 reports, age 20: 1,495 reports, age 19: 1,476 reports, age 22: 1,395 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Etonogestrel adverse event reports is Organon Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Etonogestrel include: Incorrect Product Administration Duration, Unintended Pregnancy, Device Deployment Issue, Complication Of Device Removal, Complication Of Device Insertion. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Etonogestrel to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Etonogestrel has a safety concern score of 55 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The majority of adverse events are device-related, with complications during insertion, removal, and deployment being common.
Key safety signals identified in Etonogestrel's adverse event data include: Device breakage and difficulty in use are significant issues, affecting patient satisfaction and adherence.. Complications during device insertion and removal are frequent, suggesting potential procedural risks.. Weight changes and mood alterations are common, indicating hormonal side effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other hormonal contraceptives are not well-documented, and patients should be advised to avoid use in conjunction with certain medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Etonogestrel.
Patients should be informed about the potential for device-related complications and should seek medical attention if issues arise. Regular follow-up appointments are recommended to ensure proper device placement and to address any adverse events promptly.
Etonogestrel has 110,074 adverse event reports on file with the FDA. Weight changes and mood alterations are also frequently reported, indicating potential hormonal side effects. The volume of reports for Etonogestrel reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Etonogestrel, and updates will be provided based on ongoing reviews. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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