This article describes possible side effects of mifepristone oral tablet. To learn more about mifepristone, including the drug’s uses, side effects, ways to save on cost, and more, talk with your doctor or pharmacist.
Mifepristone oral tablet is a generic version of the brand-name drugs Mifeprex and Korlym.
Boxed warnings
Mifepristone oral tablet has boxed warnings about the risk of serious infections or bleeding and the ending of a pregnancy. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). The warning varies depending on the strength of mifepristone and the reason you’re taking the drug.
For details, see the “Side effects of mifepristone in detail” and “Warnings for mifepristone” sections below.
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More common side effects of mifepristone
Mifepristone oral tablet may cause mild or serious side effects. Below are some of the more common side effects of mifepristone oral tablet that occurred during the drug’s studies. The more common side effects varied based on the condition being treated.
More common side effects reported in people taking mifepristone oral tablet to end a pregnancy include:
- nausea*
- weakness
- fever or chills
More common side effects reported in people taking mifepristone oral tablet for Cushing syndrome include:
* To learn more about this side effect, see the “Side effects of mifepristone in detail” section below.”
Mild side effects of mifepristone
Mifepristone may cause certain mild side effects. Usually, mild side effects are temporary and can be easily managed. Tell your doctor or pharmacist if you have side effects that don’t go away or become bothersome.
Mild side effects of mifepristone oral tablet that occurred in studies include:
* To learn more about this side effect, see the “Side effects of mifepristone in detail” section below.
† An allergic reaction is possible with mifepristone oral tablet. But it’s unclear whether it occurred in the studies for mifepristone 200-mg oral tablet and mifepristone 300-mg oral tablet.
These side effects were reported in studies of mifepristone 200-mg oral tablet and mifepristone 300-mg oral tablet. The drug may cause more mild side effects than those listed above. For details, see the prescribing information for mifepristone 200-mg oral tablet and mifepristone 300-mg oral tablet.
Serious side effects of mifepristone
Mifepristone may cause certain serious side effects. If you have any serious side effects from mifepristone oral tablet, call your doctor right away. But if you think you’re having a medical emergency or your side effects feel life threatening, take immediate action. Call 911 or a local emergency number, or go to the nearest emergency room.
After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Visit MedWatch’s website if you’d like to notify the FDA about a side effect you’ve had with mifepristone.
Serious side effects of mifepristone oral tablet that occurred in studies include:
* To learn more about this side effect, see the “Side effects of mifepristone in detail” section below.
† Mifepristone 200-mg oral tablet and mifepristone 300-mg oral tablet have boxed warnings for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of mifepristone in detail” and “Warnings for mifepristone” sections below.
‡ An allergic reaction is possible with mifepristone oral tablet. But it’s unclear whether it occurred in the studies for mifepristone 200-mg oral tablet and mifepristone 300-mg oral tablet.
These side effects were reported in studies of mifepristone 200-mg oral tablet and mifepristone 300-mg oral tablet.
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Common questions about side effects of mifepristone
Here are answers to some common questions about side effects of mifepristone oral tablet. If you have other questions, talk with your doctor or pharmacist.
Does mifepristone cause long-term side effects?
Long-term side effects aren’t expected with mifepristone oral tablet. In studies of mifepristone 200-mg oral tablet and mifepristone 300-mg oral tablet, specific side effects weren’t seen in people who had taken the drug for a long time. Long-lasting side effects after treatment ended also weren’t reported.
Talk with your doctor if you have more questions about possible long-term side effects with mifepristone.
How long do side effects of mifepristone usually last?
It depends. In most cases, mild side effects of mifepristone are temporary and last a few days or weeks.
But in rare cases, mifepristone 200-mg oral tablet may cause serious side effects that can lead to hospitalization or death if left untreated. This includes serious infections and bleeding.*
Talk with your doctor if you have questions about side effects of mifepristone or if you have side effects that don’t go away or get worse over time.
* Mifepristone oral tablet has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Side effects of mifepristone in detail” section below.
How much vaginal bleeding is normal with mifepristone?
The amount of vaginal bleeding expected with mifepristone can vary depending on the strength of the drug and the reason you’re taking it.
Vaginal bleeding is expected with a medication abortion or the ending of a pregnancy.* (Keep in mind that mifepristone 200-mg oral tablet is taken with misoprostol to complete a medication abortion.) If you aren’t already bleeding after taking mifepristone for this use, you may start bleeding once you take misoprostol.
In studies of mifepristone 200-mg oral tablet, bleeding and spotting occurred for an average of 9 to 16 days. And in some cases, it lasted up to 30 days or more.
The bleeding can be similar to or greater than a usual heavy period. And you may pass blood clots and tissue.
However, prolonged heavy bleeding can be a sign that your pregnancy hasn’t ended and you may need further treatment. Prolonged heavy bleeding is defined as soaking through two thick full-size sanitary pads per hour for 2 hours in a row. If this occurs, get medical help right away.
If you have more questions about vaginal bleeding with mifepristone, talk with your doctor.
* Mifepristone 300-mg oral tablet has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. To learn more, see the “Warnings for mifepristone” section below.
Side effects of mifepristone in detail
Below you’ll find details on some of the side effects of mifepristone oral tablet.
Risk of serious infections or bleeding
Mifepristone 200-mg oral tablet has a boxed warning for the risk of serious infections or bleeding. A boxed warning is the most serious warning from the FDA.
In studies, serious infections or bleeding were rare in people taking mifepristone 200-mg oral tablet. These side effects may be serious.
Serious infections may be severe and lead to sepsis. With serious infections, you may experience symptoms including:
- fever
- severe abdominal pain
- tenderness in the pelvis
- general discomfort
- weakness
- nausea
- vomiting
- diarrhea
Vaginal bleeding is expected with mifepristone treatment. You should expect bleeding that’s similar to or greater than a usual heavy period. But in rare cases, prolonged heavy bleeding may occur. (Prolonged heavy bleeding is defined as soaking through two thick full-size sanitary pads per hour for 2 or more hours in a row.) This can lead to serious complications and requires immediate medical attention, including the need for a blood transfusion.
Ways to manage
Due to these risks, mifepristone 200-mg oral tablet is only available through a risk evaluation and mitigation strategy (REMS) program. The FDA requires REMS programs for certain drugs to help make sure they’re prescribed safely.
If you experience any of the above symptoms of serious infections or bleeding, tell your doctor right away. They’ll likely evaluate you for an infection and provide treatment if needed. If you have prolonged heavy bleeding, this may be a sign that your pregnancy hasn’t ended and needs medical or surgical treatment.
Diarrhea
In studies, diarrhea was common in people taking mifepristone 200-mg oral tablet and mifepristone 300-mg oral tablet. This side effect is usually mild.
With diarrhea, you can experience loose, watery stools. Other symptoms may include an urgent need to pass stools, multiple bowel movements per day, and abdominal cramping.
Diarrhea can also make you lose fluids quickly and increase your risk of dehydration.
Ways to manage
If you experience symptoms of diarrhea, tell your doctor. They can discuss ways to manage your diarrhea. It’s also important to stay hydrated while you’re having diarrhea.
Nausea
In studies, nausea was common in people taking mifepristone 200-mg oral tablet and mifepristone 300-mg oral tablet. This side effect is usually mild.
With nausea, you may experience a feeling of wanting to vomit, or you may have stomach discomfort.
Ways to manage
If you experience nausea, tell your doctor. They’ll likely recommend ways to manage your nausea, or they can prescribe medications to help.
For some people, mifepristone oral tablet can cause an allergic reaction. But it’s not clear whether this side effect occurred in the studies of mifepristone 200-mg oral tablet and mifepristone 300-mg oral tablet.
Symptoms can be mild or serious, and they may include:
- itchiness
- skin rash
- swelling under the skin, usually affecting eyelids, lips, hands, or feet
- swelling of the mouth, tongue, or throat, which can make it hard to breathe
- flushing (temporary warmth, redness, or deepening of skin color)
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to mifepristone oral tablet, your doctor may recommend taking a different medication instead.
Warnings for mifepristone
Below are some factors you may want to discuss with your doctor before taking mifepristone oral tablet.
Boxed warnings: Risk of serious infections or bleeding and risk of ending a pregnancy
Mifepristone oral tablet has boxed warnings for the risk of serious infections or bleeding and the ending of a pregnancy. A boxed warning is the most serious warning from the FDA. The warning varies depending on the strength of mifepristone and the reason you’re taking the drug.
For details, see “Side effects of mifepristone in detail” and “Warnings for mifepristone.”
Other warnings
It may not be safe for you to take mifepristone oral tablet if you have specific health conditions. These are sometimes called drug-condition interactions. Other things may also affect whether mifepristone oral tablet is a safe treatment option for you.
Before taking mifepristone oral tablet, tell your doctor about your health and medications you take. Things to consider include:
Mifepristone and pregnancy
Mifepristone 200-mg oral tablet should not be taken during pregnancy unless it’s being taken as part of a regimen for a medication abortion. It’s not known whether mifepristone can affect the development of an unborn fetus if your abortion fails and your pregnancy continues.
Mifepristone 300-mg oral tablet has a boxed warning for the risk of the ending of a pregnancy. A boxed warning is the most serious warning from the FDA. Doctors prescribe this strength of mifepristone to help manage blood sugar levels in certain people with Cushing syndrome.
Mifepristone 300-mg oral tablet should not be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. They’ll likely give you a pregnancy test before starting the drug or if you haven’t taken it for more than 14 days. Your doctor may suggest birth control options to use during treatment with this drug.
Mifepristone and breastfeeding
It’s not known whether mifepristone oral tablet should be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.
Mifepristone oral tablet is not known to interact with alcohol.
If you drink alcohol, talk with your doctor about whether it’s safe to consume it during your treatment with mifepristone oral tablet.
What to ask your doctor
This article describes common and serious side effects of mifepristone oral tablet. If your doctor prescribes this medication, they can discuss possible side effects with you. Let your doctor know if you have concerns or questions about treatment with this medication.
Here’s a list of some possible questions you may want to ask your doctor:
- Will the side effects of mifepristone go away after the pregnancy is passed?
- How do the side effects of mifepristone compare with other drugs used for my condition?
- Do I have a higher risk of side effects than others?
Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
