Mirena IUD Side Effects

The most commonly reported side effects of Mirena include device expulsion and dislocation, genital hemorrhage, abdominal pain, general pain and uterine perforation, according to the Food and Drug Administration’s Adverse Events Reporting System (FAERs).

As of June 30, 2024, the FDA has recorded over 122,000 adverse reaction reports regarding Mirena. The FDA considered 40% of all reported adverse reactions to be serious, and death reports make up 0.0014% of all reported cases.

Disclaimer: Because of potential under-reporting and limitations caused by potentially inaccurate, incomplete, unverified or untimely information, FAERS data alone cannot represent all safety information on Mirena IUD. Consult a health care professional before stopping or changing medication.

The most commonly reported adverse reaction to the Mirena intrauterine device is device expulsion, occurring in 33.14% of all reported cases. The second and third most reported adverse reactions are device dislocation, at 12.66%, and genital hemorrhage, at 7.32%.

Weight gain is less common, accounting for 2.73% of adverse event reports.

“Mirena contains levonorgestrel, a progestin that may lead to weight gain in some women due to hormone imbalances and fluid retention,” Sazan Sylejmani, owner and pharmacy manager of Westmont Pharmacy in Westmont, Ill., told Drugwatch. “Diet, exercise, and staying hydrated can help minimize weight gain, which seems to level off for most women over time.”

The most common side effects of this birth control include pain, ovarian cysts, menstrual changes and acne.

Some side effects can be serious. If you experience any signs of an allergic reaction or any of the symptoms listed in the serious side effects section, contact your care provider immediately.

Managing Side Effects of Mirena

Over-the-counter pain medicines like ibuprofen, naproxen or aspirin can usually help with IUD cramps. Additionally, period products such as panty liners or pads may help reduce the incidence of bleeding seeping into your clothes.

If you have cramping or bleeding that doesn’t improve within a few months, talk with your doctor, as they may need to check the placement of your IUD.

The more severe side effects that affect Mirena users, such as pregnancy complications, device migration and infection, can be serious and even life-threatening.

There have been several Mirena lawsuits filed against Mirena’s manufacturer for perforation, ectopic pregnancy and PTC, which is increased pressure in the skull.

Ectopic Pregnancy

According to Mirena’s Frequently Asked Questions, roughly one-half of all pregnancies that occur with Mirena are likely to be ectopic. An ectopic pregnancy occurs when a fertilized egg outside of the uterus, typically in the fallopian tubes, begins to develop into a fetus. Without treatment, this condition has a high mortality rate for the pregnant person. However, even with treatment, the fetus is likely to die.

People who have previously experienced an ectopic pregnancy, pelvic infection or tubal surgery have an increased risk of ectopic pregnancy while using Mirena.

Perforation and Migration

Uterine perforation, which is when the device erodes through your uterus, occurs most often during insertion. However, it may go undetected at first. Perforation risk is higher in those who have recently given birth or are breastfeeding.

Delayed removal of Mirena in cases of perforation may result in the device migrating outside of the uterine cavity.

Expulsion

Complete or partial expulsion of Mirena may occur, rendering it ineffective as a contraceptive. Expulsion may cause symptoms of bleeding or pain, but it may also be asymptomatic and go unnoticed.

The cause of expulsion is usually unknown, but people who have never been pregnant or have heavy periods are more likely to experience this side effect.

Sepsis

Sepsis, which is a severe infection, can cause organ damage if left untreated. The Sepsis Alliance guidelines of T.I.M.E. provide guidance on how to detect sepsis. High temperature, symptoms of infection, altered mental state, and extreme illness are potential symptoms of sepsis. Contact your care provider immediately if you experience any symptoms.

Spontaneous Abortion of Intrauterine Pregnancy

Patients who have become pregnant with an IUD in place may experience a septic abortion where septicemia, septic shock and death may occur.

If you become pregnant, contact your provider right away to have Mirena removed promptly. Leaving Mirena in place may increase the risk of spontaneous abortion and preterm labor.

It is essential not to remove Mirena on your own. Aside from the risk of the device getting stuck, probing the uterus by shifting the device and removing Mirena incorrectly may also result in spontaneous abortion. Only allow a professional to remove your device.

Pelvic Infection

Pelvic or lower abdominal pain, foul-smelling vaginal discharge, bleeding, fever and genital sores or lesions are potential signs of infection. Your doctor will likely remove Mirena if the pelvic infection is severe or does not respond to treatment.

Pelvic Inflammatory Disease (PID)

There is an increased risk of PID in IUD users, most likely due to organisms being introduced to the uterus during insertion. In clinical trials, 3.5% of Mirena users reported upper genital infections, which occurred more frequently in the first year.

Pseudotumor Cerebri (PTC)

Hormonal IUDs like Mirena put users at an increased risk for pseudotumor cerebri, meaning false brain tumor. The condition is also called idiopathic intracranial hypertension. PTC occurs when there is increased pressure between the skull and brain that isn’t caused by a mass or lesion. This high pressure in the skull can be due to the buildup or poor absorption of cerebrospinal fluid. PTC can cause vision loss from swelling within the eyes, debilitating headaches and reduced quality of life.

“The risk seems highest during the first few months of use but can happen at any time. Early diagnosis is important to prevent vision loss,” Sylejmani said.

You should report symptoms like headaches, vision issues and ringing in the ears to your doctor immediately.

The most recent FDA warnings about Mirena are in Mirena’s 2008 labeling updates. These warnings cover several of its severe side effects.

Patients must consider these potential risks and their own medical history to evaluate whether the Mirena IUD is the best option for them.

Mirena is only one of five FDA-approved IUDs for birth control. If you experience side effects or are unhappy with Mirena, speak with your care provider about alternative birth control options.

Mirena, Skyla, Kyleena and Liletta are IUDs that, like Mirena, release hormones to prevent pregnancy. Skyla and Liletta last for the same amount of time as Mirena, around eight years, and Kyleena lasts for five.

Paragard is a nonhormonal IUD that contains copper, which impedes the movement of sperm to prevent them from fertilizing an egg. It lasts for about a decade.

Other alternatives include contraceptives such as birth control pills and condoms.

While Mirena can be an effective form of birth control, it carries potential side effects ranging from mild discomfort to severe complications. Patients and healthcare providers should communicate openly to mitigate risks and explore alternatives.

Editor Lindsay Donaldson contributed to this article.