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Quick facts
- Drug class
- Copper-containing Intrauterine Device [EPC]
- How it is given
- intrauterine
- Type
- human prescription drug
- Brand names
- ParaGard T 380A
- RxNorm ID
- 2267305
We do not publish dosing. How much of this medicine to take, how often, and for how long depends on your age, weight, kidney and liver function, other conditions and other medicines. That is a decision for the person who prescribes or dispenses it. Follow the directions on your own pack and ask your pharmacist if anything is unclear.
What it is used to treat
Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. Paragard is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. ( 1 )
About this medicine
Figure 10 Figure 11 11.1 Paragard IUS Paragard (intrauterine copper contraceptive) is a T-shaped intrauterine system (IUS), measuring 32 mm horizontally and 36 mm vertically, with a 3 mm diameter bulb at the tip of the vertical stem. (See Figure 10) [see Dosage and Administration (2.3)]. A monofilament polyethylene thread is tied through the tip, resulting in two white threads, each approximately 36.5 cm in length, to aid in detection and removal of the intrauterine system. The T-frame is made of polyethylene with barium sulfate to aid in detecting the intrauterine system under x-ray. Paragard also contains copper (approximately 176 mg of wire wrapped around the vertical stem and an approximately 68.7 mg collar placed on each side of the horizontal arm). The total exposed copper surface area is 380 ± 23 mm². One Paragard weighs less than one (1) gram. Figure 10 – Paragard IUS Paragard, its components, and the packaging are not made with natural rubber latex. 11.2 Inserter Paragard is packaged with a sterile pre-assembled inserter as a single-use, disposable device in a tray and in a Tyvek ® polyethylene pouch. A moveable blue flange on the insertion tube aids in gauging the depth of insertion through the cervical canal and into the uterine cavity (See Figure 11) [see Dosage and Administration ( 2.3 )]. Figure 11 – Paragard with Inserter
How it works
12.1 Mechanism of Action Copper continuously released into the uterine cavity contributes to the contraceptive effectiveness of Paragard. Mechanism(s) by which copper enhances contraceptive efficacy include interference with sperm transport and fertilization of an egg, and possibly prevention of implantation.
Who should not take it
The use of Paragard is contraindicated when one or more of the following conditions exist: Pregnancy or suspicion of pregnancy [see Warnings and Precautions ( 5.1 , 5.2 ) and Use in Specific Populations ( 8.1 )] Abnormalities of the uterus resulting in distortion of the uterine cavity Acute pelvic inflammatory disease (PID) [see Warnings and Precautions ( 5.4 )] Postpartum endometritis or postabortal endometritis in the past 3 months [see Warnings and Precautions ( 5.4 )] Known or suspected uterine or cervical malignancy Uterine bleeding of unknown etiology Untreated acute cervicitis or vaginitis or other lower genital tract infection Conditions associated with increased susceptibility to pelvic infections [see Warnings and Precautions ( 5.4 )] Wilson’s disease [see Warnings and Precautions ( 5.8 )] A previously placed IUD or IUS that has not been removed Hypersensitivity to any component of Paragard including to copper or any of the trace elements present in the copper component of Paragard [see Adverse Reactions ( 6.2 ) and Description ( 11 )] Pregnancy or suspicion of pregnancy ( 4 ) Abnormalities of the uterus resulting in distortion of the uterine cavity ( 4 ) Acute pelvic inflammatory disease (PID) ( 4 ) Postpartum endometritis or postabortal endometritis in past 3 months ( 4 ) Known or suspected uterine or cervical malignancy ( 4 ) Uterine bleeding of unknown etiology ( 4 ) Untreated acute cervicitis or vaginitis or other lower genital tract infection ( 4 ) Conditions associated with increased susceptibility to pelvic infections ( 4 ) Wilson’s disease ( 4 ) A previously placed IUD or IUS that has not been removed ( 4 ) Hypersensitivity to any component of Paragard including copper or any trace elements present in the copper components of Paragard ( 4 )
Warnings and cautions
Ectopic Pregnancy : Promptly evaluate women who become pregnant for ectopic pregnancy while using Paragard. ( 5.1 ) Risks with Intrauterine Pregnancy : Increased risk of spontaneous abortion, septic abortion, premature delivery, sepsis, septic shock and death if pregnancy occurs. Remove Paragard if pregnancy occurs with Paragard in place. ( 5.2 ) Sepsis : Group A streptococcal infection has been reported; strict aseptic technique is essential during insertion ( 5.3 ) Pelvic Inflammatory Disease (PID) and Endometritis : Before using Paragard, consider the risks of PID and endometritis. Promptly assess and treat patients with signs and symptoms of PID. ( 5.4 ) Embedment : Surgical removal may be necessary. ( 5.5 ) Perforation : May reduce contraceptive effectiveness and require surgery. Risk is increased if inserted in lactating women and may be increased if inserted in women with fixed, retroverted uteri or noninvoluted uteri. ( 5.6 ) Expulsion : Partial or complete expulsion may occur. Remove a partially expelled Paragard. ( 5.7 ) Bleeding patterns : May be altered and result in heavier and longer bleeding with spotting. ( 5.9 ) MRI Safety Information : Patients using Paragard can be safely scanned with MRI only under certain conditions. ( 5.10 ) MR 5.1 Ectopic Pregnancy Evaluate for possible ectopic pregnancy in any female who becomes pregnant while using Paragard because a pregnancy that occurs with Paragard in place is more likely to be ectopic than a pregnancy in the general population. However, because Paragard prevents most pregnancies, females who use Paragard have a lower risk of an ectopic pregnancy than sexually active females who do not use any contraception. The incidence of ectopic pregnancy in the clinical trials with Paragard (which excluded females with a previous history of ectopic pregnancy) was approximately 0.06%. Ectopic pregnancy may require surgery and may result in loss of fertility. […]
Reported side effects
The 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CooperSurgical, Inc. at 1-877-727-2427 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 ( 14 )]. The WHO Study 79914 was a randomized, multicenter, multinational study of copper T IUSs, including Paragard in 1,396 women outside the U.S. In the WHO Study, 100% were parous and the mean age at enrollment was 29 years old. The U.S. 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 U.S. In the U.S. 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. […]
Interactions with other medicines
No drug-drug interaction or drug-herbal supplement interaction studies have been conducted with Paragard.
Use in specific groups
8.1 Pregnancy Risk Summary Use of Paragard is contraindicated for use in pregnant females because there is no need for pregnancy prevention in a female who is already pregnant and Paragard may cause adverse pregnancy outcomes. If a female becomes pregnant with Paragard in place, there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 , 5.2 ) ] . Advise the female of the potential risks if pregnancy occurs with Paragard in place. Published studies on pregnancy outcomes exposed to copper IUSs report up to 27% miscarriage when the IUS was removed compared to 77% miscarriage when the IUS remained in the uterus. Studies on Paragard and birth defects have not been conducted. 8.2 Lactation Risk Summary No difference has been detected in concentration of copper in human milk before and after insertion of copper IUSs, including Paragard. There is no information on the effect of copper in a breastfed child or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Paragard and any potential adverse effects on the breastfed child from Paragard. 8.4 Pediatric Use The safety and effectiveness of Paragard have been established in females of reproductive potential. Efficacy is expected to be the same for postmenarcheal females regardless of age. Paragard is not indicated in females before menarche. 8.5 Geriatric Use Paragard has not been studied in women over 65 years of age and is not indicated in this population.
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This page is built from the openFDA record of the U.S. Food and Drug Administration's approved labelling for this product, effective 9 June 2024. Label text has been shortened and reformatted for readability; safety wording has not been altered in meaning. FDA labelling describes products approved in the United States — brand names, strengths, formulations and approved uses may differ in your country. Always read the leaflet that comes with your own pack. PocketsInfo is not affiliated with, and is not endorsed by, the FDA. Retrieved 2026-07-30.