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Medication Guide — Misoprostol 0 2 Mg

Patient-friendly FDA guidance and safety information.

Last updated · May 19, 2026Source: DailyMed ↗
Boxed Warning

MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH OR UTERINE RUPTURE.


UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION. THE RISK OF UTERINE RUPTURE INCREASES WITH ADVANCING GESTATIONAL AGES AND WITH PRIOR UTERINE SURGERY, INCLUDING CESAREAN DELIVERY (See also PRECAUTIONSand LABOR AND DELIVERY).


MISOPROSTOL SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs) (See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).


PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS.


Misoprostol should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with use of the NSAID, or is at high risk of developing gastric ulceration. In such patients, misoprostol may be prescribed if the patient

  • has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
  • is capable of complying with effective contraceptive measures.
  • has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
  • will begin misoprostol only on the second or third day of the next normal menstrual period.

Poison Help

If you suspect an overdose or accidental ingestion, call Poison Control: 1-800-222-1222 (free, 24/7, U.S.). For life-threatening symptoms, call 911.

SPL PATIENT PACKAGE INSERT

PATIENT INFORMATION

Read this leaflet before taking misoprostol and each time your prescription is renewed, because the leaflet may be changed.


Misoprostol is being prescribed by your doctor to decrease the chance of getting stomach ulcers related to the arthritis/pain medication that you take.


Do not take misoprostol to reduce the risk of NSAID-induced ulcers if you are pregnant. (See boxed WARNINGS.) Misoprostol can cause abortion (sometimes incomplete which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or birth defects. It is also important to avoid pregnancy while taking this medication and for at least one month or through one menstrual cycle after you stop taking it. Misoprostol may cause the uterus to tear (uterine rupture) during pregnancy. The risk of uterine rupture increases as your pregnancy advances and if you have had surgery on the uterus, such as a Cesarean delivery. Rupture (tearing) of the uterus can result in severe bleeding, hysterectomy, and/or maternal or fetal death.


If you become pregnant during misoprostol therapy, stop taking misoprostol and contact your physician immediately. Remember that even if you are on a means of birth control it is still possible to become pregnant. Should this occur, stop taking misoprostol and contact your physician immediately.


Misoprostol may cause diarrhea, abdominal cramping, and/or nausea in some people. In most cases these problems develop during the first few weeks of therapy and stop after about a week. You can minimize possible diarrhea by making sure you take misoprostol with food.


Because these side effects are usually mild to moderate and usually go away in a matter of days, most patients can continue to take misoprostol. If you have prolonged difficulty (more than 8 days), or if you have severe diarrhea, cramping and/or nausea, call your doctor.


Take misoprostol only according to the directions given by your physician.


Do not give misoprostol to anyone else. It 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.


This information sheet does not cover all possible side effects of misoprostol. This patient information leaflet does not address the side effects of your arthritis/pain medication. See your doctor if you have questions.


Keep out of reach of children.


All trademarks are the property of their respective owners.


Distributed by:

ANI Pharmaceuticals, Inc.

Baudette, MN 56623


Issued:04/2025

LB4429-03

Sources

RxCUI: 317128

NDC: [{'@sourceNdc9': '43386-0161', 'ndc9': ['33261-0076', '43393-0203', '64205-0161', '68084-0041', '69189-0161', '43063-0707']}]

Last fetched: May 19, 2026

Source: DailyMed ↗

⚠️ Disclaimer

This information is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.