Pharmacologic class (EPC) · 2 drug pages

Copper-containing intrauterine device: adverse event reports filed with FDA

43,223 reports list a drug in this class as a suspect or interacting product, 2005–2026.

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.

43,223
reports across the class: 0.2% of all reports; 5,605
reports, 12 months to June 2026: 3,155 in the 12 months before; 46.6%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Copper-containing intrauterine device is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 43,223 adverse event reports received by FDA, 0.2% of the database, from August 2005 to June 2026.

5,605 reports arrived in the 12 months to June 2026, up 78% from 3,155 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 46.6% of the class's reports are marked serious, 1.4% record death among the outcomes and 3.4% record hospitalisation, as reported.

Across the class the reactions recorded most often are device expulsion (25.9%), device breakage (25.8%) and complication of device removal (23.1%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
ParaGard T 380ACopper	brand	41,934	5,356	45%	Device expulsion
Nicotinamide	generic	1,289	249	99%	Off label use

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Device expulsionthe device came out25.9%11,175
Device breakagethe device broke25.8%11,138
Complication of device removal23.1%9,998
Foreign body in reproductive tract20.1%8,693
Complication of device insertion19.3%8,348
Device dislocationthe device moved out of position16.8%7,242
Painpain, site not specified14.4%6,219
Embedded device10.7%4,641
Reproductive complication associated with device8%3,447
Off label useused for a purpose or in a way not on the label7.5%3,261
Anxietyanxiety6.8%2,957
Emotional distressemotional distress6.7%2,886
Muscle spasmsmuscle cramps6.3%2,741
Procedural painpain from a procedure6.2%2,674
Injury associated with device6.1%2,634
Pelvic pain6%2,588
Abnormal uterine bleeding4.4%1,911
Drug ineffectivethe medicine did not work as expected4.1%1,793
Discomfortdiscomfort3.9%1,679
Vaginal haemorrhagevaginal bleeding3.7%1,598
Device use issue3.6%1,568
Abdominal painstomach or belly pain3.5%1,511
Pregnancy with contraceptive device3.4%1,480
Heavy menstrual bleeding3.4%1,470
Dysmenorrhoea3.2%1,380

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death1.4%591

Life-threatening1.6%692

Hospitalisation (initial or prolonged)3.4%1,449

Disability1.7%724

Congenital anomaly1.3%564

Other serious45.4%19,643

Not serious53.4%23,071

Patient age

Under 20.1%24

2 to 110%2

12 to 171.1%494

18 to 4456.1%24,233

45 to 645%2,168

65 to 740.5%205

75 and over0.2%97

Age not given37%16,000

Who reported

Physician17.6%7,593

Pharmacist0.3%134

Other health professional38.9%16,825

Lawyer8.1%3,515

Consumer or non-health professional34.2%14,770

Not given0.9%386

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Copper-containing intrauterine device reports

Which drugs are in the Copper-containing intrauterine device class on this site?

ParaGard T 380A and Nicotinamide. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

43,223 reports through June 2026, 5,605 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

device expulsion (25.9%), device breakage (25.8%), complication of device removal (23.1%), foreign body in reproductive tract (20.1%) and complication of device insertion (19.3%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.