Cytotec
Misoprostol
Misoprostol (mye soe PROST ole) is a generic medication prescribed to reduce the risk of stomach ulcers caused by certain drugs. Misoprostol belongs to a group of drugs called prostaglandin analogs.
Misoprostol (mye soe PROST ole) is a generic medication prescribed to reduce the risk of stomach ulcers caused by certain drugs. Misoprostol belongs to a group of drugs called prostaglandin analogs.
- Generic
- • Tablet
- • 200mcg
- • 2 Tablets
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Intro
Introduction
Written by Julz Richterman, PharmD, MBA, BCGP
Medically reviewed by Patricia Weiser, PharmD
Updated on November 22, 2023
Misoprostol (mye soe PROST ole) is a generic medication prescribed to reduce the risk of gastric (stomach) ulcers caused by certain drugs. Misoprostol belongs to a group of drugs called prostaglandin analogs.
Boxed warning: Risk of harm if taken during pregnancy
Misoprostol tablets have a boxed warning about the risk of harm if taken during pregnancy. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).
For details, see the “Interactions and warnings for misoprostol” section.
Side effects
Side effects of misoprostol
Misoprostol may cause mild or serious side effects. More common mild side effects of misoprostol and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.
To learn more about misoprostol’s side effects, see this article or ask your doctor or pharmacist. You can also refer to the prescribing information for misoprostol listed in the “Resources” section.
Mild side effects
More common mild side effects reported with misoprostol are listed below.
This article doesn’t include all possible mild side effects of the drug. To learn more about misoprostol’s side effects, refer to the prescribing information for misoprostol listed in the “Resources” section.
With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.
Misoprostol oral tablet’s mild side effects include:
- diarrhea and abdominal pain
- nausea
- changes in your period (spotting, cramps, and increased bleeding or pain)
- postmenopausal vaginal bleeding
- mild allergic reaction*
* For details about this side effect, see the “Interactions and warnings for misoprostol” section.
Serious side effects
Serious side effects of misoprostol are listed below.
This article doesn’t include all possible serious side effects of the drug. To learn more about misoprostol’s side effects, refer to the prescribing information for misoprostol listed in the “Resources” section.
With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.
In general, misoprostol’s serious side effects include:
- severe diarrhea leading to dehydration (low fluid level)
- boxed warning: risk of harm if used during pregnancy*
- severe allergic reaction*
* For details about this side effect, see the “Interactions and warnings for misoprostol” section.
Uses
Uses of misoprostol
The Food and Drug Administration (FDA) approves prescription drugs such as misoprostol for certain conditions. Approved uses for misoprostol are described below.
Use for lowering risk of stomach ulcers caused by certain drugs
Doctors may prescribe misoprostol tablets for reducing the risk of stomach ulcers* while taking certain drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). A stomach ulcer is a painful sore in your stomach lining. It’s used for this purpose in adults. It’s usually prescribed for as long as you’re taking an NSAID.
NSAIDs are a type of medication used to reduce pain and inflammation (swelling). They do this by blocking a specific type of enzyme that produces natural compounds called prostaglandins. (An enzyme is a protein that helps chemical reactions happen in the body.)
Some prostaglandins help maintain the stomach lining and protect it from stomach acid. And there are others that help injured parts of your body heal. But this also leads to increased swelling and pain. When NSAIDs block these enzymes, they help reduce pain and inflammation. But without prostaglandins for protection, your stomach lining can become thinner than usual. This can lead to a painful sore called an ulcer.
FAQ
Common questions about misoprostol
Below you’ll find answers to a few commonly asked questions about misoprostol.
How does misoprostol work? And how long does it take to start working?
Misoprostol is prescribed to reduce the risk of stomach ulcers while taking certain drugs called nonsteroidal anti-inflammatory drugs (NSAIDs).
NSAIDs are a type of medication used to reduce pain and inflammation (swelling). They do this by blocking a specific type of enzyme that produces natural compounds called prostaglandins. (An enzyme is a protein that helps chemical reactions happen in the body.) The prostaglandins maintain your stomach lining. When this enzyme is blocked, less prostaglandins are made. Without prostaglandins for protection, your stomach lining can become thinner than usual. This can lead to a painful sore called an ulcer.
Misoprostol acts similar to these prostaglandins. It helps increase the production of mucus and other protective substances in your stomach. It also helps reduce the amount of stomach acid that’s made. These combined effects reduce your risk of forming a stomach ulcer while you’re taking an NSAID.
Misoprostol begins working within 30 minutes of taking it.
If you’d like to know more about misoprostol’s mechanism of action (how it works), talk with your doctor or pharmacist.
Can misoprostol be used to induce labor?
Misoprostol isn’t approved by the Food and Drug Administration (FDA) for inducing labor. This is an off-label use. With off-label use, doctors prescribe a drug for a purpose other than what it’s approved for. It should only be used in this way in a hospital setting where you can be closely monitored by healthcare professionals.
Keep in mind that misoprostol also has a boxed warning about risk of harm if taken during pregnancy. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more details, see the “Pregnancy or breastfeeding and misoprostol” section.
Ask your doctor if you have any questions about taking misoprostol to induce labor.
Interactions and warnings
Interactions and warnings for misoprostol
Below, you’ll find information about misoprostol’s possible interactions and warnings.
Interactions of misoprostol
Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.
Before you take misoprostol, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:
- prescription or over-the-counter drugs
- vitamins, herbs, or supplements
To learn about drug-condition interactions, see the “Warnings for misoprostol” section below.
Warnings for misoprostol
Some people should not take misoprostol, and others should take it cautiously.
Boxed warning: Risk of harm if taken during pregnancy
Misoprostol has a boxed warning about the risk of harm if taken during pregnancy. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA). To learn more about this risk, see the “Pregnancy or breastfeeding and misoprostol” section below.
Other warnings
Misoprostol could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether misoprostol is a safe option for you.
Ask your doctor about specific warnings for misoprostol, and be sure to tell your doctor about your:
- current health, including any allergies to medications
- past health conditions or surgeries
Allergic reaction
Misoprostol can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.
If you’ve had an allergic reaction to misoprostol or any of its ingredients, your doctor will likely not prescribe misoprostol. They can tell you about medications that are safer options for you.
A mild allergic reaction may cause the following symptoms:
A severe allergic reaction may cause the following symptoms:
- swelling under your skin, usually in your hands, feet, eyelids, or lips
- swelling of your mouth, throat, or tongue, which can cause difficulty breathing
If you have an allergic reaction to misoprostol, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.
Overdose of misoprostol
If you take misoprostol by mouth, you should not take more misoprostol than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.
If you think you’ve taken too much misoprostol, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.
Pregnancy or breastfeeding and misoprostol
Information about misoprostol and pregnancy and breastfeeding is described below.
Misoprostol and pregnancy
Misoprostol should not be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. Your doctor may suggest birth control options to use during treatment with misoprostol.
Boxed warning: Risk of harm if taken during pregnancy
Misoprostol has a boxed warning about the risk of harm if taken during pregnancy. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).
Taking misoprostol during pregnancy can cause significant harm to your baby. This includes developmental issues for a fetus (commonly known as birth defects), premature (early) birth, or pregnancy loss.
Also, uterine rupture (a tear in the uterus) has been reported in people who took misoprostol to induce labor or to induce abortion. (These are both off-label* uses of the drug.) This risk may be higher in certain people, such as those who’ve had uterine surgery in the past, such as a cesarean delivery, commonly referred to as a C-section.
Due to these risks, you should not take misoprostol to help prevent stomach ulcers if you’re pregnant or could become pregnant. If you’re able to become pregnant, your doctor can recommend birth control options to use during treatment with misoprostol.
To learn more, talk with your doctor or pharmacist.
* With off-label use, doctors prescribe a drug for a purpose other than what it’s approved for.
Misoprostol and breastfeeding
Misoprostol should be taken cautiously while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other ways to feed your child during treatment with misoprostol.
Ask your doctor
What to ask your doctor
Let your doctor know whether you have questions about misoprostol or would like more details about it.
Here’s a list of some possible questions you may want to ask your doctor:
- What should I do if I forget to take a dose of misoprostol?
- What can I do to decrease my side effects from misoprostol?
- When should I expect my side effects from misoprostol to go away?
Resources
Resources
- Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
- Misoprostol tablet. (2/2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/51b0bac5-19e3-4547-ba1f-01494fda7687/spl-doc
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.
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