What the label lists and what reports show
Copper side effects
Copper's FDA label lists its adverse reactions in its own words. FAERS holds 42,854 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is device expulsion (11,180 reports).
- No generic listed
Check it at the source: the copper FDA label on DailyMed (effective June 9, 2024, CooperSurgical, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Paragard?Paragard can cause serious side effects, including: ectopic pregnancy and intrauterine pregnancy risks: There are risks if you become pregnant while using Paragard (see “What if I become pregnant while using Paragard?”). life-threatening infection: Life-threatening infection can occur within the first few days after Paragard is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after Paragard is placed. pelvic inflammatory disease (PID) or endometritis: Some IUS users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. PID and endometritis are usually sexually transmitted. You have a higher chance of getting PID and endometritis if you or your partner has sex with other partners. PID and endometritis can cause serious problems such as infertility, ectopic pregnancy, and pelvic pain that does not go away. […]
Source: FDA drug label, CooperSurgical, Inc., effective June 9, 2024 (SPL set 3c420b53-c95e-46af-aebd-73741be58391), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following serious adverse reactions are discussed elsewhere in the labeling: Ectopic pregnancy [see Warnings and Precautions ( 5.1 )] Intrauterine pregnancy [see Warnings and Precautions ( 5.2 )] Septic abortion [see Warnings and Precautions ( 5.2 )] Group A Streptococcal Sepsis (GAS) [see Warnings and Precautions ( 5.3 )] Pelvic Inflammatory Disease and Endometritis [see Warnings and Precautions ( 5.4 )] Embedment [see Warnings and Precautions ( 5.5 )] Perforation [see Warnings and Precautions ( 5.6 )] Expulsion [see Warnings and Precautions ( 5.7 )] Bleeding Pattern Alterations [see Warnings and Precautions ( 5.9 ) ] Adverse reactions reported in clinical trials include: anemia, backache, dysmenorrhea, dyspareunia, expulsion (complete or partial), prolonged menstrual flow, menstrual spotting, pain and cramping, and vaginitis. …
Source: FDA drug label, CooperSurgical, Inc., effective June 9, 2024 (SPL set 3c420b53-c95e-46af-aebd-73741be58391), via openFDA; the full label on DailyMed
What do FAERS reports show?
42,854 reports list copper among the medicines taken, each a report of something that happened, not proof the medicine caused it; 56 are coded as a death and 749 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Copper: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions