Nexplanon: adverse event reports filed with FDA

43,751

reports as suspect product

0.2% of all reports · about 2,824 a year

836

reports, 12 months to June 2026

1,241 in the 12 months before

24.8%

marked serious by the reporter

41.9% across the class

0.1%

record death among outcomes, as reported

65 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Nexplanon reports recording the termmedian drug in progestin

1. No adverse eventno adverse event was reported22.6%9,871
2. Product quality issuea problem with the product itself12.6%5,509
3. Complication associated with device11.6%5,056
4. Device difficult to usethe device was hard to use10.4%4,554
5. Device breakagethe device broke10.2%4,474
6. Incorrect product administration duration8%3,509
7. Device deployment issuethe device did not deploy properly7.6%3,333
8. Complication of device insertion7.3%3,192
9. Complication of device removal7.2%3,133
10. Unintended pregnancy7%3,049
11. Pregnancy with implant contraceptive6.2%2,733
12. Implant site painpain at an implant5.8%2,541
13. Device dislocationthe device moved out of position5.8%2,523
14. Menorrhagiaheavy periods5.6%2,431
15. Vaginal haemorrhagevaginal bleeding4.9%2,131
16. Device expulsionthe device came out4.6%2,007
17. Device kink4.5%1,989
18. Menstruation irregularirregular periods4.5%1,967
19. Weight increasedweight gain4.3%1,874
20. Amenorrhoeaperiods stopped3.6%1,580
21. Headachehead pain3.4%1,495
22. Pain in extremitypain in an arm or leg3.2%1,391
23. Metrorrhagia2.7%1,191
24. Device issuea problem with the device2.7%1,169
25. Incorrect drug administration duration2.4%1,042
26. Nauseafeeling sick2.3%1,010
27. Adverse eventan unwanted medical event, type not specified2%895
28. Heavy menstrual bleeding2%889
29. Mood swingsmood swings1.9%810
30. Depressionlow mood1.8%808

Top 30 of 1,036 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 median share across the 17 drugs in the progestin class; 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

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 293,492 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 93% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 43,751 reports.

Drugs most often listed in the same reports

Other products listed in reports where Nexplanon is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

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."

Other drugs in the progestin class

Ordered by report count for navigation only. 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." A brand and its generic are separate rows because reporters name them separately.

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 Nexplanon as a suspect or interacting product; reports listing it only as a concomitant medication (1,490) 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.