85/100 · Critical
Manufactured by CooperSurgical, Inc.
High Safety Concerns with Copper-Based Contraceptive Devices
116,047 FDA adverse event reports analyzed
Last updated: 2026-05-12
COPPER is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by CooperSurgical, Inc.. Based on analysis of 116,047 FDA adverse event reports, COPPER has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for COPPER include DEVICE EXPULSION, DEVICE BREAKAGE, COMPLICATION OF DEVICE REMOVAL, FOREIGN BODY IN REPRODUCTIVE TRACT, DEVICE DISLOCATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for COPPER.
Copper has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 116,047 adverse event reports for this medication, which is primarily manufactured by Coopersurgical, Inc..
The most commonly reported adverse events include Device Expulsion, Device Breakage, Complication Of Device Removal. Of classified reports, 45.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious and involve device-related complications.
Pain and reproductive complications are the most frequently reported issues. There is a significant risk of uterine perforation and other serious complications.
Patients taking Copper should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Copper-based contraceptive devices can cause serious complications such as uterine perforation and device breakage, which may require surgical intervention. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Copper received a safety concern score of 85/100 (high concern). This is based on a 45.3% serious event ratio across 38,274 classified reports. The score accounts for 116,047 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 33,739, Male: 359, Unknown: 3. The most frequently reported age groups are age 25 (1,062 reports), age 30 (1,054 reports), age 27 (1,043 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 38,274 classified reports for COPPER:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Copper-based contraceptive devices can cause serious complications such as uterine perforation and device breakage, which may require surgical intervention.
If you are taking Copper, here are important things to know. The most commonly reported side effects include device expulsion, device breakage, complication of device removal, foreign body in reproductive tract, device dislocation. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Women using copper-based devices should be closely monitored by healthcare providers. Patients should report any unusual symptoms or complications immediately. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory bodies are closely monitoring these devices and have issued warnings about the potential for serious complications.
The FDA has received approximately 116,047 adverse event reports associated with Copper. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Copper include Device Expulsion, Device Breakage, Complication Of Device Removal, Foreign Body In Reproductive Tract, Device Dislocation. By volume, the top reported reactions are: Device Expulsion (10,636 reports), Device Breakage (9,388 reports), Complication Of Device Removal (8,216 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Copper.
Out of 38,274 classified reports, 17,331 (45.3%) were classified as serious and 20,943 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Copper break down by patient sex as follows: Female: 33,739, Male: 359, Unknown: 3. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Copper adverse events are: age 25: 1,062 reports, age 30: 1,054 reports, age 27: 1,043 reports, age 31: 1,032 reports, age 28: 1,025 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Copper adverse event reports is Coopersurgical, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Copper include: Complication Of Device Insertion, Pain, Reproductive Complication Associated With Device, Embedded Device, Injury Associated With Device. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Copper to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Copper has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The majority of adverse events are serious and involve device-related complications.
Key safety signals identified in Copper's adverse event data include: High frequency of device expulsion and breakage. Significant number of reports of foreign body in reproductive tract. Multiple reports of uterine perforation and pregnancy with contraceptive device. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Copper-based contraceptive devices can cause serious complications such as uterine perforation and device breakage, which may require surgical intervention. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Copper.
Women using copper-based devices should be closely monitored by healthcare providers. Patients should report any unusual symptoms or complications immediately.
Copper has 116,047 adverse event reports on file with the FDA. Pain and reproductive complications are the most frequently reported issues. The volume of reports for Copper reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory bodies are closely monitoring these devices and have issued warnings about the potential for serious complications. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with COPPER:
Drugs related to COPPER based on therapeutic use, drug class, or shared indications: