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Prescribing Information
Paragard | Single Hand InserterPargard
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Safety Considerations

What if…

I've had an abortion?
Yes, women who have had an abortion are still candidates for Paragard®. There is a slightly higher risk of expulsion if Paragard is placed immediately after an abortion. Additionally, placement after second trimester abortion is associated with a higher risk of expulsion than placement after first trimester abortion.
I'm a smoker?
Paragard is not contraindicated for women who smoke.
I'm taking other medications?
You should discuss with your healthcare provider to see if Paragard is the right birth control option for you.
I’ve never had a child?
Paragard can be used regardless of whether you’ve had a child.

If you think you are pregnant, contact your healthcare provider right away. If you are pregnant while using Paragard, you may have an ectopic pregnancy which means the pregnancy is not in your uterus. Unusual vaginal bleeding or abdominal pain may be signs of an ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery; it can cause internal bleeding, infertility and even death.

There are also risks if you get pregnant and Paragard is in your uterus. Severe infection, miscarriage, premature delivery, and even death can occur. Because of this, your healthcare provider may try to remove Paragard, even though removing it may cause a miscarriage.

It is not known if Paragard can cause long-term effects on the fetus if it stays in place during a pregnancy.

What if I become pregnant while using the Paragard® IUD

Woman wondering hat to do if she becomes pregnant while using the Paragard copper IUD

Is it Safe to Breastfeed While Using Paragard®?

You may use Paragard when you are breastfeeding. The risk of Paragard becoming attached to (embedded) or going through the wall of the uterus is increased if Paragard is placed while you are breastfeeding.

You should not use Paragard if you

  • Are or might be pregnant
  • Have a uterus that is abnormally shaped inside
  • Have a pelvic infection called pelvic inflammatory disease (PID) or have current behavior that puts you at high risk of PID
  • Have had an infection in your uterus after a pregnancy or abortion in the past 3 months
  • Get infections easily
  • Have cancer of the uterus or cervix
  • Have unexplained bleeding from your vagina
  • Have an infection in your cervix
  • Have Wilson’s disease
  • Are allergic to anything in Paragard
  • Already have an IUD in your uterus

Before having Paragard placed, tell your healthcare provider if you have any of the conditions listed above, a slow heart beat, dizziness, seizures, recently had a baby or if you are breastfeeding, have AIDS, HIV, or any other sexually transmitted infection.

What are the possible side effects of Paragard®

POSSIBLE SIDE EFFECTS

Paragard can cause serious side effects, including:

ECTOPIC PREGNANCY RISKS

There are risks if you become pregnant while using Paragard (See above)

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)

Some IUS users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. PID and endometritis are usually sexually transmitted; you are at a higher risk if you or your partner has sex with others.

Signs to watch for:

Low abdominal or pelvic pain
Pelvic tenderness
Painful sex
Unusual vaginal discharge
Chills or fever
Long-lasting or heavy bleeding
Genital lesions or sores

Embedment

Paragard may become attached to (embedded) the wall of the uterus. This may make it hard to remove Paragard. Surgery may be needed.

Perforation

Paragard may go through the wall of the uterus. You are not protected from pregnancy if perforation occurs. It may move outside the uterus and cause scarring, infection, damage to other organs, pain, or infertility. The risk of perforation is increased in breastfeeding women.

Expulsion

Paragard may partially or completely fall out of the uterus. Expulsion occurs in about 2 out of 100 women. You are not protected from pregnancy if Paragard is expelled.

Changes in Bleeding

You may have heavier and longer periods with spotting in between. Call your healthcare provider if the bleeding remains heavier or longer and spotting continues.

Reactions After Placement

Some women have had reactions such as dizziness (syncope), slowed heart rate (bradycardia), or seizures, immediately after Paragard was placed or removed.

COMMON SIDE EFFECTS

You may have other side effects with Paragard. For example:

Anemia (low blood count)
Pain during sex
Spotting between periods
Prolonged or painful periods
Vaginal irritation
Vaginal discharge
Backache
Cramping or pain

This is not a complete list of possible side effects. Tell your healthcare provider about any side effect that bothers you or does not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-2088.
See Living with Paragard