Miudella
Miudella (copper IUD) is a new, hormone-free copper intrauterine device (IUD) FDA approved to prevent pregnancy for up to 3 years. It's a small, flexible device that a healthcare professional inserts into your uterus (womb). Since Miudella (copper IUD) contains less than half the copper of other copper IUDs, it's an option for those looking for a lower copper dose. Common side effects include heavy period bleeding, period cramps, and pelvic discomfort and pain.
What is Miudella (copper IUD)?
What is Miudella (copper IUD) used for?
How Miudella (copper IUD) works
Miudella (copper IUD) is a contraceptive, which means it helps prevent pregnancy. It works by continuously releasing a small amount of copper into the uterus. This interferes with sperm movement, making it harder for sperm to reach and fertilize an egg.
Drug Facts
What are the side effects of Miudella (copper IUD)?
Common Side Effects
- Heavy period bleeding
- Period cramps
- Bleeding between periods
- Pelvic discomfort or pain
- Pain during the procedure
- Vaginal bleeding after the procedure
- Pain during sex
Other Side Effects
- Stomach pain
- Bleeding during or after sex
- Shorter periods
- IUD falling out of place
Serious Side Effects
- Sepsis: feeling confused, trouble speaking, fever, dizziness, chills, clammy skin, fast heart rate, not making much urine
- Serious infection: severe pain, fever, body aches, chills, feeling weak, flu-like symptoms
- Tear in the uterus: excessive pain, vaginal bleeding, can't feel IUD threads
Source: FDA
Pros and cons of Miudella (copper IUD)
Pros
A good option for people looking for a hormone-free birth control
Don't need to take pills every day
Lasts for up to 3 years
Fewer side effects than birth control pills
Cons
Higher risk of miscarriage if you do get pregnant
Must be inserted and removed by a healthcare professional
Might cause heavier or longer periods
Doesn't protect against sexually transmitted infections (STIs)
Pharmacist tips for Miudella (copper IUD)
Miudella (copper IUD) is placed by a healthcare professional in a quick procedure. It's common to feel pain, dizziness, and bleeding during and after placement. Contact your care team if these symptoms get worse or don't improve.
Miudella (copper IUD) doesn't protect you from HIV or other sexually transmitted infections (STIs). Use condoms or other protection to lower your risk.
See your healthcare professional after your first period so they can make sure Miudella (copper IUD) is in the right position.
You can use tampons with Miudella (copper IUD), but avoid using menstrual cups or discs since these can cause your IUD to move or come out.
Do monthly checks to make sure Miudella (copper IUD) is in the right place by washing your hands and feeling for the threads. Your healthcare professional can teach you how to do this. Don't pull on the threads because this could move the IUD out of place.
If you can't feel the Miudella (copper IUD) threads, avoid sex or use a non-hormonal back-up birth control method (e.g., condoms) until your prescriber checks the IUD placement.
Miudella (copper IUD) can cause heavier or longer periods and spotting (bleeding between periods). These changes might improve over time, but tell your healthcare professional if they bother you.
Miudella (copper IUD) shouldn't interfere with sex, but your partner might feel the ends of the IUD strings. If this is uncomfortable or you have pain during sex, talk to your prescriber.
Tell your healthcare professional you have Miudella (copper IUD) before getting any medical procedures that use heat or an MRI.
You can have Miudella (copper IUD) removed by a healthcare professional at any time, but ask about another birth control method if you don't want to get pregnant.
It's safe to use Miudella (copper IUD) while you're breastfeeding. But keep in mind that having it placed while breastfeeding might raise your risk of it damaging your uterus. Let your prescriber know if you feel pain or have bleeding after insertion.
Frequently asked questions about Miudella (copper IUD)
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What are the risks and warnings for Miudella (copper IUD)?
Miudella (copper IUD) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Complications from improper insertion
If Miudella (copper IUD) isn't inserted correctly, it can raise your risk of tears in the uterus, infection, abnormal bleeding, pregnancy loss (if pregnancy occurs with the IUD in place), or the IUD falling out. Because of this risk, Miudella (copper IUD) is only available through the Miudella REMS Program. This Risk Evaluation and Mitigation Strategies (REMS) program helps make sure that healthcare professionals are properly trained on how to insert Miudella (copper IUD) safely.
Risks with becoming pregnant with Miudella (copper IUD) in place
Although rare, it's possible to become pregnant while Miudella (copper IUD) is in place. If you think you might be pregnant, contact your healthcare professional right away because you'll need to get your IUD removed. Keeping Miudella (copper IUD) in place while pregnant can raise your risk for complications like infections, miscarriage, or having the baby too early.
Additionally, a pregnancy with Miudella (copper IUD) in place is more likely to be an ectopic pregnancy (pregnancy outside of the womb). But this is very rare. Symptoms of an ectopic pregnancy include low back pain, abnormal vaginal bleeding, and cramping. If you experience any of these symptoms, contact your prescriber right away.
Sepsis (complication from an infection)
In some rare cases, a life-threatening infection can develop within days after getting Miudella (copper IUD) inserted. This can sometimes lead to sepsis, a serious reaction that affects the whole body. Get medical help right away if you have severe pain within hours after insertion, fever, chills, or other signs of an infection, since delaying treatment can be deadly.
Pelvic infections
Risk factors: History of pelvic inflammatory disease | History of inflammation in the uterus | History of or currently have a sexually transmitted infection (STI) | Multiple sex partners | Conditions that weaken the immune system | Intravenous (IV) drug use
Though rare, getting Miudella (copper IUD) can raise your risk of pelvic infections, including pelvic inflammatory disease (PID) and inflammation of your uterine lining. If you already have either condition, you can't use Miudella (copper IUD). And if you develop these conditions while using it, your prescriber will need to remove your IUD. Contact your care team right away if you experience lower stomach or pelvic pain, smelly vaginal discharge, unexplained bleeding, fever, or vaginal sores. If left untreated, PID can cause serious problems like infertility, the need for surgery, infection, or even death.
Tear in the uterus
Risk factors: Recently given birth | Breastfeeding | Certain uterus shapes or positions
Rarely, Miudella (copper IUD) can cause a tear or hole in the cervix or uterus during insertion. This could lead to pregnancy, infections, scar tissue, blockage in the intestines, or damage to nearby organs. One study suggested that the risk might be higher for people who recently gave birth or are breastfeeding. Contact your prescriber right away if you have severe pain or heavy bleeding during or after insertion, or if you can’t feel the IUD threads.
Miudella (copper IUD) can sometimes attach to the uterine wall, making it harder to remove. In some cases, surgery might be needed to take it out. If you have concerns, talk to your prescriber.
Miudella (copper IUD) falling out
Risk factors: Recently given birth
It's possible for Miudella (copper IUD) to partially or completely fall out, which means it won't protect against pregnancy. The risk might be higher if you've recently given birth. Contact your prescriber if you can't feel the threads or if you feel any other part of the IUD. If Miudella (copper IUD) is partially out, your prescriber will remove it — it shouldn't be pushed back in. If it's fully fallen out, a new one can be inserted once your prescriber confirms you're not pregnant.
Worsening of Wilson's disease
If you have Wilson’s disease, a rare genetic condition that affects how your body gets rid of copper, you shouldn't use Miudella (copper IUD). This IUD contains copper, which can make this condition worse. Talk to your healthcare professional about other birth control options that are safer for you.
Changes in bleeding pattern
Miudella (copper IUD) can cause heavier and longer periods with spotting between cycles. If you have heavy bleeding, let your prescriber know right away so that they can check if everything is okay. They might recommend treatment or decide that removing Miudella (copper IUD) is the best option for you.
Tissue damage from certain medical procedures or scans
Before having any medical procedures or scans, always tell your care team that you have Miudella (copper IUD) in place. Some medical equipment that uses high levels of radiofrequency (RF) energy could cause tissue damage in people with Miudella (copper IUD).
Miudella (copper IUD) dosage forms
Typical dosing for Miudella (copper IUD)
The Miudella (copper IUD) is inserted into the uterus by a healthcare professional. It can remain in place for up to 3 years.
Miudella (copper IUD) contraindications
Pregnancy
Abnormal uterus
Pelvic inflammatory disease
Inflammation of the uterine lining (endometritis) in the past 3 months
Uterine or cervical cancer
Use as emergency contraception
Undiagnosed vaginal bleeding
Untreated inflammation of the cervix or vagina
Lower genital tract infection
Conditions that make you more likely to get a pelvic infection
Wilson's disease
A previously placed IUD that hasn't been removed
Allergy to copper, propylene, or nitinol
What are alternatives to Miudella (copper IUD)?
Prevent pregnancy for up to 8 years
Relieve heavy menstrual periods for up to 5 years
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References
Best studies we foundCreinin, M. D., et al. (2025). Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device. Contraception.
Federal Communications Commission. (n.d.). RF safety FAQ.
Sebela Pharmaceuticals. (2025). Miudella® (copper intrauterine system) [package insert]. U.S. Food and Drug Administration.
Sebela Pharmaceuticals. (n.d.). Miudella®.
Taylor, M., et al. (2023). Endometritis. StatPearls.
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