Product name as reported

Etonogestrel Implant- Unknown: adverse event reports filed with FDA

417 reports list it as a suspect or interacting product, 2013–2020.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

417
reports as suspect product: 0% of all reports · about 31 a year; 0
reports, 12 months to June 2026: 0 in the 12 months before; 52.3%
marked serious by the reporter: 57.4% across all reports; 0.5%
record death among outcomes, as reported: 2 reports · not verified by FDA

Between April 2013 and October 2020, 417 adverse event reports received by FDA list the product name "Etonogestrel Implant- Unknown" as reporters wrote it as a suspect or interacting product. Reports that mention it only as a concomitant medication (7) are left out of every figure here.

In the 12 months to June 2026, 0 reports listed it, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 31 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.

The MedDRA terms listed most often are complication associated with device (19.7%), pregnancy with implant contraceptive (14.9%) and unintended pregnancy (14.9%). A report can list several reactions, so shares add to more than 100%; 92 different terms appear across these reports. Complication associated with device is recorded in 19.7% of these reports, against 0.1% of all reports in the database.

52.3% of the reports are marked serious by the reporter; 0.5% record death among the outcomes and 3.1% record hospitalisation, as reported. 41.2% of the reports came from consumers, and the largest patient age group is 18 to 44 (25.7%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

No report listing Etonogestrel Implant- Unknown was received in the five years to June 2026; the latest was received in October 2020.

By year received

Reactions recorded in the reports

share of Etonogestrel Implant- Unknown reports recording the termall reports in the database

Complication associated with device19.7%82
Pregnancy with implant contraceptive14.9%62
Unintended pregnancy14.9%62
Incorrect drug administration duration11.8%49
Device deployment issuethe device did not deploy properly9.8%41
Device difficult to usethe device was hard to use7.2%30
Complication of device removal5.8%24
Medical device complicationa complication with the device5.5%23
Device breakagethe device broke5%21
Device dislocationthe device moved out of position5%21
No adverse eventno adverse event was reported5%21
Incorrect product administration duration4.6%19
Adverse eventan unwanted medical event, type not specified3.4%14
Device embolisation3.1%13
Overdosea dose above the recommended amount3.1%13
Vaginal haemorrhagevaginal bleeding3.1%13
Migration of implanted drug2.9%12
Menstruation irregularirregular periods2.6%11
Weight increasedweight gain2.6%11
Abortion induced2.4%10
Maternal exposure during pregnancythe mother took the medicine during pregnancy2.2%9
Implant site painpain at an implant1.9%8
Device kink1.7%7
Difficulty removing drug implant1.7%7
Menorrhagiaheavy periods1.7%7
Pain in extremitypain in an arm or leg1.7%7
Abortion1.2%5
Haemorrhagebleeding1.2%5
Mood swingsmood swings1.2%5
Pregnancy on contraceptive1.2%5

Top 30 of 92 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the share of all reports in the database; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Death0.5%2

Life-threatening1%4

Hospitalisation (initial or prolonged)3.1%13

Disability3.1%13

Congenital anomaly0.2%1

Other serious49.6%207

Not serious47.7%199

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Patient age

Under 20.2%1

2 to 110%0

12 to 175.8%24

18 to 4425.7%107

45 to 640.5%2

65 to 740%0

75 and over0%0

Age not given67.9%283

Patient sex

Female91.4%381

Male0%0

Not given8.6%36

Who reported

Physician23.3%97

Pharmacist1.2%5

Other health professional34.3%143

Lawyer0%0

Consumer or non-health professional41.2%172

Not given0%0

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 56.4% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)	Reports	Share
Contraception	121	29%

The indication field is filled in by the reporter and is often blank; shares are of all 417 reports.

In context

Measure	Etonogestrel Implant- Unknown	All reports
Reports as suspect product	417	20,646,523
Share of that pool	—	0%
Reports, latest 12 months	0	1,332,454
Marked serious	52.3%	57.4%
Death recorded among outcomes, per 1,000 reports	5	91
Hospitalisation recorded, per 1,000 reports	31	213
Consumer-filed share	41.2%	45.8%
Top term, share of reports	Complication associated with device 19.7%	0.1%

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Questions about Etonogestrel Implant- Unknown reports

How many adverse event reports has FDA received for Etonogestrel Implant- Unknown?

417 reports list Etonogestrel Implant- Unknown as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 7 list it only as a concomitant medication.

What reactions are recorded in Etonogestrel Implant- Unknown reports?

complication associated with device (19.7%), pregnancy with implant contraceptive (14.9%), unintended pregnancy (14.9%), incorrect drug administration duration (11.8%) and device deployment issue (9.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Etonogestrel Implant- Unknown was responsible.

How serious are the reports?

52.3% are marked serious by the reporter. Among the outcomes recorded, 0.5% of reports include death and 3.1% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

consumer or non-health professional (41.2%), other health professional (34.3%) and physician (23.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Etonogestrel Implant- Unknown rising?

0 reports in the 12 months to June 2026, and none in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Etonogestrel Implant- Unknown was responsible for these reactions?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Etonogestrel Implant- Unknown?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Etonogestrel Implant- Unknown as a suspect or interacting product; reports listing it only as a concomitant medication (7) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.