Medical Editor: John P. Cunha, DO, FACOEP
- heavier, longer periods and spotting between periods;
- most of these side effects diminish after 2-3 months
Uncommon but serious side effects of ParaGard include:
- pelvic inflammatory disease (PID),
- difficult removals,
- perforation of the uterine wall, and
- expulsion of the device
A single ParaGard should be placed at the fundus of the uterine cavity by a physician. ParaGard should be removed on or before 10 years from the date of insertion. ParaGard is not expected to interact with other drugs. Tell your doctor all medications and supplements you use. ParaGard is not recommended for use during pregnancy or suspected pregnancy. No difference has been detected in concentration of copper in breast milk before and after insertion of copper IUDs such as ParaGard. Breastfeeding is acceptable while ParaGard is inserted.
Our ParaGard T 380A (intrauterine copper contraceptive) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are discussed elsewhere in the labeling:
- Ectopic pregnancy [see WARNINGS AND PRECAUTIONS]
- Intrauterine pregnancy [see WARNINGS AND PRECAUTIONS]
- Septic abortion [see WARNINGS AND PRECAUTIONS]
- Group A Streptococcal Sepsis (GAS) [see WARNINGS AND PRECAUTIONS]
- Pelvic Inflammatory Disease and Endometritis [see WARNINGS AND PRECAUTIONS]
- Embedment [see WARNINGS AND PRECAUTIONS]
- Perforation [see WARNINGS AND PRECAUTIONS]
- Expulsion [see WARNINGS AND PRECAUTIONS]
- Bleeding Pattern Alterations [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure in two trials [see Clinical Studies].
- The WHO Study 79914 was a randomized, multicenter, multinational study of copper T IUSs, including Paragard in 1,396 women outside the US. In the WHO Study, 100% were parous and the mean age at enrollment was 29 years old.
- The US Composite Study was a meta-analysis that evaluated randomized, double-blind, comparative studies of copper T IUSs, including Paragard in 3,536 women in the US. In the US Composite Study, 64% were nulliparous, 49% were nulligravida, 68% were under age 25 at the time of enrollment (median age 23 years old).
Table 2 shows discontinuation rates from the two clinical studies by adverse reaction and year.
Table 2: Summary of Rates* (No. per 100 Subjects) by Year for Adverse Reactions Causing Discontinuation
|Number of Women at Start of Year||4,932||3,149||2,018||1,121||872||621||563||483||423||325|
|Other Medical Event||2.5||2.1||1.6||1.7||0.1||0.3||1.0||0.4||0.7||0.3|
|*Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the US Composite Study (3536 subjects) and the World Health Organization (1396 subjects) trials.|
The following adverse reactions have also been observed: anemia, backache, dysmenorrhea, dyspareunia, complete or partial expulsion, prolonged menstrual flow, menstrual spotting, pain and cramping, and vaginitis.
The following adverse reactions have been identified during post-approval use of Paragard. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: abdominal distension, nausea
General Disorders and Administration Site Conditions: device breakage, pyrexia
Immune System Disorders: allergy to metals, hypersensitivity
Infections and Infestations: endometritis/uterine infection
Musculoskeletal and Connective Tissue Disorders: muscle spasms
Nervous System Disorders: dizziness
Reproductive System and Breast Disorders: amenorrhea
Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome
Read the entire FDA prescribing information for ParaGard (Intrauterine Copper Contraceptive)