Mirena: adverse event reports filed with FDA

129,479

reports as suspect product

0.6% of all reports · about 5,756 a year

3,433

reports, 12 months to June 2026

4,152 in the 12 months before

40.6%

marked serious by the reporter

41.9% across the class

0.1%

record death among outcomes, as reported

164 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 Mirena reports recording the termmedian drug in progestin

1. Device expulsionthe device came out28.4%36,793
2. Device dislocationthe device moved out of position13.2%17,112
3. Genital haemorrhage7.6%9,819
4. Abdominal pain lower5.8%7,502
5. Uterine perforationa hole in the wall of the womb5.2%6,674
6. Vaginal haemorrhagevaginal bleeding5.1%6,604
7. Painpain, site not specified5%6,530
8. Abdominal painstomach or belly pain5%6,465
9. Procedural painpain from a procedure4.6%5,989
10. Intra-uterine contraceptive device expelled4.3%5,572
11. Pregnancy with contraceptive device3.7%4,847
12. Complication of device insertion3.6%4,725
13. Injurya physical injury3.5%4,551
14. Amenorrhoeaperiods stopped3.4%4,379
15. Depressionlow mood3.3%4,330
16. Anxietyanxiety3.2%4,154
17. Pelvic pain3.1%4,012
18. Device difficult to usethe device was hard to use3.1%3,962
19. Headachehead pain2.7%3,530
20. Drug ineffectivethe medicine did not work as expected2.7%3,522
21. Weight increasedweight gain2.6%3,391
22. Embedded device2.5%3,298
23. Menorrhagiaheavy periods2.5%3,271
24. Device breakagethe device broke2.3%3,038
25. Device issuea problem with the device2.3%3,026
26. Emotional distressemotional distress2.2%2,864
27. Nauseafeeling sick2.2%2,863
28. Fatiguetiredness2.1%2,668
29. Back painback pain2%2,540
30. Complication of device removal1.9%2,444

Top 30 of 1,927 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. 89.9% 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 129,479 reports.

Drugs most often listed in the same reports

Other products listed in reports where Mirena 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 Mirena as a suspect or interacting product; reports listing it only as a concomitant medication (3,968) 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.