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ParaGard

Last reviewed on RxList: 4/27/2021
ParaGard Side Effects Center

What Is ParaGard?

ParaGard T 380A (intrauterine copper contraceptive) is indicated for intrauterine contraception for up to 10 years.

What Are Side Effects of ParaGard?

Common side effects of ParaGard include:

  • 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:

Dosage for ParaGard

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.

What Drugs, Substances, or Supplements Interact with ParaGard?

ParaGard is not expected to interact with other drugs. Tell your doctor all medications and supplements you use.

ParaGard During Pregnancy or Breastfeeding

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.

Additional Information

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.

SLIDESHOW

Choosing Your Birth Control Method See Slideshow
ParaGard Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

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

  Year
1 2 3 4 5 6 7 8 9 10
Number of Women at Start of Year 4,932 3,149 2,018 1,121 872 621 563 483 423 325
Expulsion 5.7 2.5 1.6 1.2 0.3 0.0 0.6 1.7 0.2 0.4
Bleeding/Pain 11.9 9.8 7.0 3.5 3.7 2.7 3.0 2.5 2.2 3.7
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.

Postmarketing Experience

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)

QUESTION

Which of the following are methods for contraception? See Answer
Related Resources for ParaGard

© ParaGard Patient Information is supplied by Cerner Multum, Inc. and ParaGard Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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