ParaGard T 380Acopper

Name: PARAGARD T 380A (copper) — FDA Adverse Event Reports
Creator: PillSignal
License: https://open.fda.gov/license/

According to the FDA label: Use: For temporary relief of spasms, cramps. Calming effect. May also be use for standard homeopathic indications or as directed by your physician.

42,708 adverse event reports submitted to the FDA (2004–2026)

This data reflects voluntary reports submitted to the FDA's Adverse Event Monitoring System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS). A report does not mean the medication caused the event. Data may be incomplete or contain errors. Learn more about AEMS. New to this data? Read our guide on how to interpret FDA adverse event reports →

New to FDA adverse event data? Here's how to read these reports →

Top Reported Adverse Events

The most frequently reported events in association with ParaGard T 380A in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.

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Device Expulsion 11,095 reports
Device Breakage 11,052 reports
Complication Of Device Removal 9,905 reports
Foreign Body In Reproductive Tract 8,683 reports
Complication Of Device Insertion 8,342 reports
Device Dislocation 7,187 reports
Pain 5,735 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →
Embedded Device 4,417 reports
Reproductive Complication Associated With Device 3,595 reports
Anxiety 2,860 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →
Injury Associated With Device 2,747 reports
Off Label Use 2,719 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →
Emotional Distress 2,695 reports
A report of emotional suffering such as upset, worry, or anguish. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →
Pelvic Pain 2,461 reports
Procedural Pain 2,449 reports

Browse the full glossary →

Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.

Who Is Reporting

Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.

By Sex

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ParaGard T 380A adverse event reports by reporter sex
Sex	Reports
Female	38,150
Male	378
Unknown	3

By Age Group

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ParaGard T 380A adverse event reports by reporter age group
Age group	Reports
0-17	543
18-34	17,476
35-49	7,678
50-64	768
65-74	142
75+	93

This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.

Reported Outcomes

Outcomes recorded in FAERS reports that included ParaGard T 380A. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.

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ParaGard T 380A adverse event reports by reported outcome
Outcome	Reports
Non-Serious	23,376
Other Serious	18,797
Hospitalization	733
Disability	233
Life-Threatening	142
Death	55

Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.

Report Volume Over Time

Number of FAERS reports received per quarter for ParaGard T 380A. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.

View report trend as a table

ParaGard T 380A adverse event reports by year
Year	Reports
2004	1
2005	4
2006	3
2007	11
2008	110
2009	58
2010	139
2011	187
2012	65
2013	40
2014	243
2015	3,156
2016	3,078
2017	3,429
2018	1,080
2019	7,055
2020	3,507
2021	3,297
2022	2,204
2023	4,300
2024	3,086
2025	3,245
2026 (partial)	4,410

The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.

Medications commonly reported with ParaGard T 380A

In FDA adverse event reports that mention ParaGard T 380A, these medications appeared most often in the same report.

Ergocalciferol (748 reports)
Cupric (703 reports)
Escitalopram (569 reports)
Sertraline (518 reports)
Levothyroxine (512 reports)

This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.

Other medications with similar adverse event profiles in FDA FAERS reports.

Data Source

This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.

View this data on the FDA website →

Data last updated: June 2026