Reported Reactions

Reactions

MedDRA preferred term

Foreign body in reproductive tract: adverse event reports recording this term

8,740 reports to FDA record it, 2013–2026; 0% of the database.

8,740
reports recording the term
0% of all reports
2,167
reports, 12 months to June 2026
1,729 in the 12 months before
98.6%
marked serious by the reporter
57.4% across all reports
0%
record death among outcomes, as reported
9.1% across all reports

"Foreign body in reproductive tract" is a MedDRA preferred term recorded in 8,740 adverse event reports received by FDA, 0% of the database, from July 2013 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

2,167 reports recorded it in the 12 months to June 2026, up 25% from 1,729 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 98.6% are marked serious, 0% include death among the outcomes and 1.3% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are ParaGard T 380A, Mirena and Nexplanon. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. 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

06951,390Jul 2021: 15Aug 2021: 89Sep 2021: 103Oct 2021: 112Nov 2021: 49Dec 2021: 3852022Jan 2022: 133Feb 2022: 79Mar 2022: 84Apr 2022: 104May 2022: 115Jun 2022: 90Jul 2022: 49Aug 2022: 62Sep 2022: 109Oct 2022: 67Nov 2022: 46Dec 2022: 872023Jan 2023: 503Feb 2023: 36Mar 2023: 71Apr 2023: 116May 2023: 118Jun 2023: 79Jul 2023: 24Aug 2023: 45Sep 2023: 37Oct 2023: 52Nov 2023: 49Dec 2023: 712024Jan 2024: 431Feb 2024: 60Mar 2024: 25Apr 2024: 17May 2024: 47Jun 2024: 122Jul 2024: 29Aug 2024: 12Sep 2024: 17Oct 2024: 46Nov 2024: 80Dec 2024: 1272025Jan 2025: 195Feb 2025: 166Mar 2025: 218Apr 2025: 310May 2025: 233Jun 2025: 296Jul 2025: 128Aug 2025: 94Sep 2025: 127Oct 2025: 118Nov 2025: 103Dec 2025: 542026Jan 2026: 1,390Feb 2026: 37Mar 2026: 26Apr 2026: 39May 2026: 33Jun 2026: 18

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

Drugs listed as suspect products in these reports

DrugClassReports with this termShare of the drug's own reports
ParaGard T 380ACopper-containing intrauterine device8,69320.7%
MirenaProgestin210%
NexplanonProgestin80%
CaverjectProstaglandin analog70.6%
Finasteride5-alpha reductase inhibitor60%
Propecia5-alpha reductase inhibitor60.1%
Depo-ProveraProgestin30%
LilettaProgestin30%
KyleenaProgestin20%
NuvaringEstrogen20%
Caverject ImpulseProstaglandin analog10.4%
Miconazole 3 Combination Pack—10.1%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0% across the whole database. 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."

By pharmacologic class

ClassReports with this termShare of class reportsMedian drug in class
Copper-containing intrauterine device8,69320.1%10.4%
Progestin370%0%
5-alpha reductase inhibitor120%0%
Prostaglandin analog70%0%
Estrogen20%0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20%0
2 to 110%0
12 to 170.1%11
18 to 4437.4%3,273
45 to 648.5%746
65 to 740%3
75 and over0%3
Age not given53.8%4,704

Patient sex

Female95.8%8,375
Male0.2%16
Not given4%349

Grey bar: all 20,646,523 reports in the database. 99.7% of these reports give the United States as the country.

Questions about "Foreign body in reproductive tract"

What does "Foreign body in reproductive tract" mean in an adverse event report?

It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record foreign body in reproductive tract?

8,740 reports through June 2026 (0% of all reports), 2,167 of them in the latest 12 months.

Which drugs appear most often in these reports?

ParaGard T 380A (8,693), Mirena (21), Nexplanon (8), Caverject (7) and Finasteride (6). Drugs with many reports overall lead almost every term's list. 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."

Does a drug appearing here mean it was responsible for this reaction?

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."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

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. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. 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.