Misoprostol reduces stomach acid and replaces protective substances in the stomach that are
inhibited by nonsteroidal anti-inflammatory drugs (NSAIDs) and aspirin.
Misoprostol is used to prevent the formation of ulcers in the stomach during treatment with
aspirin or an NSAID such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Orudis
KT, Oruvail), naproxen (Naprosyn, Aleve, Anaprox, Naprelan), oxaprozin (Daypro), indomethacin
(Indocin), diclofenac (Voltaren, Cataflam), etodolac (Lodine), piroxicam (Feldene), meloxicam
(Mobic), tolmetin (Tolectin), nabumetone (Relafen), and fenoprofen (Nalfon). NSAIDs and aspirin are
used to treat pain, fever, arthritis, and inflammatory conditions.
Misoprostol may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before taking misoprostol?
Before taking misoprostol, tell your doctor if you have inflammatory bowel disease, irritable
bowel syndrome, or other intestinal problems. You may need a dosage adjustment or special
monitoring during treatment with misoprostol.
Do not
take misoprostol for the prevention of stomach ulcers if you are
pregnant or if you might become pregnant during treatment. If you do become pregnant during
treatment with misoprostol, stop taking the medication and contact your doctor immediately.
Misoprostol is in the FDA pregnancy category X. This means that misoprostol is known to be harmful
to an unborn baby. Misoprostol can cause miscarriage or spontaneous abortion (sometimes incomplete
which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or
birth defects. Misoprostol has also been reported to cause uterine rupture (tearing) when given after the
eighth week of pregnancy, which can result in severe bleeding, hysterectomy, and/or maternal or fetal
death. A pregnancy test with negative results will be required within 2 weeks of starting treatment with
misoprostol, and treatment will begin only on the second or third day of a regular menstrual cycle. Also,
appropriate contraception will be needed to prevent pregnancy during treatment and for one menstrual
cycle following treatment. In some cases, misoprostol may be used under the supervision of a doctor
for the induction of labor and delivery or abortion.
It is not known whether misoprostol passes into breast milk. Do not take misoprostol
without first talking to your doctor if you are breast-feeding a baby.
How should I take misoprostol?
Take misoprostol exactly as directed by your doctor. If you do not understand these directions,
ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water.
Misoprostol is usually taken four times a day, with meals and at bedtime. Follow your
doctor's instructions.
Misoprostol may cause mild to moderate diarrhea, stomach cramps, and/or nausea. These
problems usually occur during the first few weeks of treatment and stop after about a week. The
occurrence of diarrhea may be minimized by taking misoprostol with food. Contact your doctor if these
symptoms persist for longer than 8 days or if they are severe.
Take misoprostol for the full amount of time prescribed by your doctor. Treatment usually
continues for as long as aspirin or an NSAID is taken.
Do not share this medication with anyone else. Misoprostol has been prescribed for your
specific condition, may not be the correct treatment for another person, and would be dangerous if the
other person were pregnant.
Store misoprostol at room temperature away from moisture and heat.
What happens if I miss a dose of misoprostol?
Take the missed dose as soon as you remember. However, if it is almost time for the next dose,
skip the missed dose and take only the next regularly scheduled dose.
Do not
take a
double dose of this medication.
Where can I get more information about misoprostol?
Your pharmacist has information about misoprostol written for health professionals that you may read.
What are the possible side effects of misoprostol?
Stop taking misoprostol and seek emergency medical attention if you experience an allergic
reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).
Misoprostol may cause mild to moderate diarrhea, stomach cramps, and/or nausea. These
problems usually occur during the first few weeks of treatment and stop after about a week. The
occurrence of diarrhea may be minimized by taking misoprostol with food. Contact your doctor if these
symptoms persist for longer than 8 days or if they are severe.
Other, less serious side effects may also occur. Continue to take misoprostol and talk to your
doctor if you experience
vomiting;
flatulence;
constipation;
headache; or
menstrual cramps, spotting, or increased or irregular
menstruation.
Side effects other than those listed here may also occur. Talk to your doctor
about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about misoprostol?
Do not
take misoprostol for the prevention of stomach ulcers if you are
pregnant or if you might become pregnant during treatment. If you do become pregnant during
treatment with misoprostol, stop taking the medication and contact your doctor immediately.
Misoprostol is in the FDA pregnancy category X. This means that misoprostol is known to be harmful
to an unborn baby. Misoprostol can cause miscarriage or spontaneous abortion (sometimes incomplete
which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or
birth defects. Misoprostol has also been reported to cause uterine rupture (tearing) when given after the
eighth week of pregnancy, which can result in severe bleeding, hysterectomy, and/or maternal or fetal
death. A pregnancy test with negative results will be required within 2 weeks of starting treatment with
misoprostol, and treatment will begin only on the second or third day of a regular menstrual cycle. Also,
appropriate contraception will be needed to prevent pregnancy during treatment and for one menstrual
cycle following treatment. In some cases, misoprostol may be used under the supervision of a doctor
for the induction of labor and delivery or abortion.
Do not share this medication with anyone else. Misoprostol has been prescribed for your
specific condition, may not be the correct treatment for another person, and would be dangerous if the
other person were pregnant.
What should I avoid while taking misoprostol?
Do not share this medication with anyone else. Misoprostol has been prescribed for your
specific condition, may not be the correct treatment for another person, and would be dangerous if the
other person were pregnant.
The incidence of diarrhea may be reduced by avoiding antacids that contain magnesium. If an
antacid is needed, one that contains aluminum or calcium may be a more appropriate choice.
There are no restrictions on food, beverages, or activities during treatment with misoprostol
unless otherwise directed by your doctor.
What other drugs will affect misoprostol?
The incidence of diarrhea may be reduced by avoiding antacids that contain magnesium. If an
antacid is needed, one that contains aluminum or calcium may be a more appropriate choice.
Drugs other than those listed here may also interact with misoprostol. Talk to your doctor and
pharmacist before taking any prescription or over-the-counter medicines, including herbal products.
What happens if I have an overdose of misoprostol?
Remember, keep this and all other medicines out of the reach of children, never share
your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate,
up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum
information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not
warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does
not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist
licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not
a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or
drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any
given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information
Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug
interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse
or pharmacist.
Content provided by Multum - Last Updated 11/10/2009