Paragard Side Effects
Common Paragard intrauterine device (IUD) side effects are anemia, back pain, prolonged heavy periods and pain during sex. Serious Paragard side effects include ectopic pregnancy, embedment and uterus perforation. Most mild side effects resolve in a few days; speak to your doctor if they persist or are severe.
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- Common Side Effects
- Anemia, back pain, cramping, heavy or painful periods, expulsion, pain during sex, prolonged periods, spotting, vaginal discharge and irritation
- Serious Side Effects
- Ectopic or intrauterine pregnancy, embedment in the uterine wall, endometritis, expulsion, infection, pelvic inflammatory disease and perforation
Latest Paragard Side Effects Information
Paragard may produce pain, heavy periods, spotting and anemia. Bleeding and pain were the most commonly reported side effects, according to the Food and Drug Administration’s Adverse Event Reporting System (FAERS). In rare cases, ectopic pregnancy, uterus perforation, infection and device expulsion or uterine wall embedment may occur. These can lead to a serious medical emergency or death.
As of June 31, 2024, device expulsion or dislocation was the most common Paragard side effect reported to the FDA. Device breakage and complications with insertion were also commonly reported. Of the over 53,000 reported adverse effects, about 43% were serious.
FDA Adverse Event Reports for Paragard Side Effects | |
---|---|
Total cases reported | 53,025 |
Serious cases (including deaths) | 22,681 |
Deaths | 19 |
Disclaimer: Reports sent to the FDA don’t necessarily mean the drug caused an adverse event. Consult a health care professional before stopping or changing medication.
A 2023 study conducted by researchers at the Center for Global Infectious Disease Research at Seattle Children’s Research Institute showed that copper IUDs such as Paragard disrupted normal vaginal bacterial balance. The same study also uncovered significant increases in inflammatory markers in vaginal tissue with IUDs compared to other hormonal contraceptives.
Common Paragard Side Effects
Pain and heavy and frequent periods are among the most common Paragard side effects. These contribute to a significant number of patients requesting IUD removal. Device expulsion is also relatively common, especially if it’s inserted within the first six weeks following childbirth.
“The copper in Paragard can cause inflammation, leading to expulsion in up to 5% of women. This risk is highest in the first year,” Sazan Sylejmani, owner and pharmacy manager of Westmont Pharmacy in Westmont, Ill., told Drugwatch.
- Expulsion
- Frequent bleeding
- Increased menstrual pain and cramps
Most side effects are mild and do not affect contraceptive performance. Additionally, while most common Paragard symptoms resolve on their own soon after insertion, some may persist.
Serious and Rare Paragard Side Effects
Ectopic pregnancies, device expulsion, infection and uterus perforation are all possible with a Paragard IUD. These serious side effects can cause severe health risks and possibly death, but they are rare.
Research shows that the risk of both the risk of perforation, which is when the device pierces through the uterus, and the risk of expulsion, is very low. Within the first five years of using Parargard, the risk of expulsion is nearly 5%, and the risk of perforation is 0.6%, according to a 2023 study published in the journal of Obstetrics and Gynecology.
- Ectopic pregnancy
- Embedment, perforation and expulsion
- Infections, including sepsis
“Perforation from an IUD like Paragard is rare but can damage organs if undetected,” Sylejmani said. “Patients should be informed of risks like infection and organ damage.”
There is also a small risk of the IUD breaking during removal. Paragard lawsuits seek compensation for patients who were not adequately warned about this possibility. As of November 2024, there were 2,824 cases pending in a multidistrict litigation against the device’s manufacturers. If you experienced side effects after your IUD broke upon removal, you may be able to join the ongoing MDL. Speak with an attorney to get a case evaluation.
Ectopic Pregnancies
Ectopic pregnancy in the Paragard clinical trials (which did not include women with a prior history of ectopic pregnancy) was around 0.06%. Those who conceive while using an inserted Paragard are more likely to develop an ectopic pregnancy.
In cases of ectopic pregnancy, the fertilized egg implants in areas other than the uterus, such as the fallopian tubes, cervix or ovaries. They have high rates of miscarriage and can cause maternal health complications. Some ectopic pregnancies can cause the fallopian tubes to rupture, which may lead to internal bleeding, infections or death.
Symptoms of an ectopic pregnancy include nausea, vomiting, cramps, pain on one side of your abdomen, pain in your shoulder or neck, dizziness and weakness. Contact your doctor immediately if experience these symptoms while using Paragard, especially if you suspect you’re pregnant.
Pelvic Inflammatory Disease
There is a correlation between patients with IUDs and increased rates of pelvic inflammatory disease (PID). This is most pronounced during the first three weeks after insertion. In clinical trials with Paragard, the incidence of PID that led to the removal of Paragard was approximately 0.1%.
PID is inflammation of the genital tract and is usually contracted through sexual intercourse. However, procedures that can potentially introduce bacteria to the uterus, such as IUD insertions, can also cause PID.
- Fever or chills
- Genital lesions or sores
- Heavy periods
- Pain during sex
- Pelvic and lower abdominal pain
- Unusual or foul-smelling vaginal discharge
Patients with an IUD who develop PID do not always need it removed. However, if treatment is ineffective and symptoms do not decrease, your doctor may decide removal is necessary.
MRI Compatibility
Paragard is MR conditional, meaning it is safe for patients with Paragard inserted to have Magnetic Resonance Imaging (MRI) scans under certain conditions.
To ensure a safe and effective scan, patients should inform their doctors if they are using Paragard or any other copper IUD before receiving an MRI scan. Current data suggest specific test parameters can increase safety and limit image artifacts.
When To Seek Medical Attention
Some Paragard side effects require immediate medical attention. This includes severe pelvic pain, painful sex, unusually heavy periods, fever and foul-smelling vaginal discharge. These could be signs of a serious complication.
- Device dislocation
- Fever
- Pelvic pain that worsens
- Possible exposure to an STI
- Severe abdominal pain or tenderness
- Symptoms of pregnancy
- Unusually heavy vaginal bleeding
- Unusual vaginal discharge
“Early symptom recognition and regular doctor visits are key,” Sylejmani said. “The greatest risk is within the first few months of insertion.”
Because Paragard can perforate the uterus or become embedded in or expelled from it, you should check its placement at least once per month. If you cannot feel the two threads, they change length or you feel any part of the IUD besides the threads, contact your health care provider for a more comprehensive exam.
If the device has dislocated, your doctor will likely try to remove the Paragard device. You and your doctor should discuss the risks and benefits of removal before deciding.
How To Manage Paragard Side Effects
Post-insertion side effects, including cramping, dizziness, and discomfort, tend to last for a few minutes. Tell your doctor if you experience these symptoms for an extended period.
Other side effects tend to be mild, and many subside over the first few months after insertion. Taking NSAIDs can be an effective way to manage back pain, cramping and period discomfort.
- Pain medication such as ibuprofen, naproxen or aspirin may ease mild pain and cramping.
- Vitamin B1 may help reduce spotting and the amount and duration of bleeding.
- Applying a heating pad can reduce cramping, especially right after insertion.
You should report any severe side effects to your doctor immediately. Some could be signs of serious complications that could lead to infection, permanent scarring of the uterus or death.
Paragard Alternatives
Paragard is only one type of birth control available, and alternatives exist if you decide it isn’t the right choice for you. Paragard is one of five FDA-approved IUDs available in the United States.
- Liletta
- Mirena
- Kyleena
- Skyla
Mirena and the other IUDs use progestin hormones to stop egg production, unlike Paragard which is copper-based.
Oral contraceptives, shots, patches, implants and vaginal rings take a similar hormonal approach and are highly effective at preventing pregnancy.
Emergency contraceptives can prevent many pregnancies if taken within 48 hours of unprotected sex. Like other hormonal birth control options, they do not protect against sexually transmitted infections.
Barrier methods such as condoms can reduce your risk of both pregnancy and sexually transmitted infections.
Your doctor can help you determine the best choice of birth control for your needs.
Editor Lindsay Donaldson contributed to this article.
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