ParaGard T 380A: adverse event reports filed with FDA

41,934

reports as suspect product

0.2% of all reports · about 2,133 a year

5,356

reports, 12 months to June 2026

2,750 in the 12 months before

45%

marked serious by the reporter

46.6% across the class

0%

record death among outcomes, as reported

15 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 ParaGard T 380A reports recording the termmedian drug in copper-containing intrauterine device

1. Device expulsionthe device came out26.6%11,175
2. Device breakagethe device broke26.6%11,138
3. Complication of device removal23.8%9,998
4. Foreign body in reproductive tract20.7%8,693
5. Complication of device insertion19.9%8,348
6. Device dislocationthe device moved out of position17.3%7,242
7. Painpain, site not specified13.7%5,752
8. Embedded device11.1%4,641
9. Reproductive complication associated with device8.2%3,447
10. Anxietyanxiety6.9%2,894
11. Emotional distressemotional distress6.9%2,886
12. Off label useused for a purpose or in a way not on the label6.4%2,695
13. Injury associated with device6.3%2,634
14. Pelvic pain6.2%2,588
15. Procedural painpain from a procedure6.1%2,547
16. Muscle spasmsmuscle cramps5.9%2,494
17. Abnormal uterine bleeding4.6%1,911
18. Discomfortdiscomfort3.9%1,638
19. Vaginal haemorrhagevaginal bleeding3.8%1,598
20. Device use issue3.7%1,568
21. Pregnancy with contraceptive device3.5%1,480
22. Heavy menstrual bleeding3.5%1,470
23. Dysmenorrhoea3.3%1,380
24. Drug ineffectivethe medicine did not work as expected3.2%1,342
25. Deformity3.2%1,339
26. Abdominal painstomach or belly pain3.2%1,335
27. Device placement issue3.1%1,300
28. Complication associated with device3%1,262
29. Sensation of foreign body2.8%1,181
30. Menstruation irregularirregular periods2.7%1,147

Top 30 of 769 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 2 drugs in the copper-containing intrauterine device 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 43,223 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. 99.9% 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 41,934 reports.

Drugs most often listed in the same reports

Other products listed in reports where ParaGard T 380A 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 copper-containing intrauterine device 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 ParaGard T 380A as a suspect or interacting product; reports listing it only as a concomitant medication (196) 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.