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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Limited Use [what does this mean?]
Generic drug name: misoprostol (mice o PROST all)
Brand name(s): CYTOTEC
GENERIC: available FAMILY: Prostaglandins
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Breast-Feeding Warning

No information is available from either human or animal studies. However, it is likely that this drug, like many others, is excreted in human milk, and because of the potential for adverse effects in nursing infants, including serious diarrhea, you should not take this drug while nursing.

Pregnancy Warning

There are literature reports of skull defects, cranial nerve palsies, facial malformations and limb defects in women who took misoprostol during the first trimester of pregnancy. Because of the possibility of inducing an abortion, misoprostol should not be used by women who are pregnant. Patients must be advised of these properties and warned not to give the drug to others.

Safety Warnings For This Drug [top]

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 TO 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.

MISOPROSTOL TABLETS SHOULD NOT BE TAKEN IN PREGNANT WOMEN REDUCE THE RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs).

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 NSAIDs 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 using misoprostol only on the second or third day of the next normal menstrual period.

Facts About This Drug [top]

Misoprostol is used to prevent stomach ulcers caused by aspirin, ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) that are commonly used to treat pain and arthritis. NSAIDs can cause serious harm, even fatalities, from bleeding in the stomach or intestines. Misoprostol is a synthetic prostaglandin drug that may protect the lining of the stomach and modestly decreases the secretion of stomach acid.  

People at high risk of ulcers from NSAIDs include the elderly, people with...

Misoprostol is used to prevent stomach ulcers caused by aspirin, ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) that are commonly used to treat pain and arthritis. NSAIDs can cause serious harm, even fatalities, from bleeding in the stomach or intestines. Misoprostol is a synthetic prostaglandin drug that may protect the lining of the stomach and modestly decreases the secretion of stomach acid.  

People at high risk of ulcers from NSAIDs include the elderly, people with other debilitating diseases, and those who have had an ulcer previously. Misoprostol should be used only by those with severe arthritis who have had an ulcer previously. 

Because too many people receive NSAIDs for too long, approach taking misoprostol to treat the adverse effects of NSAIDs with great caution. Many patients have conditions that can be treated with more conservative measures or with generic acetaminophen (which does not induce stomach ulcers). Of patients chronically taking NSAIDs, 2 to 4 percent will develop a serious complication of an ulcer.[1] However, there is no evidence that misoprostol prevents the serious, life-threatening gastrointestinal complications associated with NSAIDs. It has only been shown to reduce the number of stomach ulcers visible through an endoscope. It has not been shown to have an effect on duodenal (part of the small intestine, not the stomach) ulcers or abdominal pain. 

Before deciding to take misoprostol along with an NSAID, ask your doctor why misoprostol was prescribed and how long you should expect to take it. Ask if a different arthritis drug with a lower rate of adverse effects can be used. If you develop a duodenal (not a stomach) ulcer, one of the histamine2-blockers should be tried first.[2] 

Diarrhea is a common adverse effect of misoprostol, ranging from minor to severe enough to be life-threatening.[3],[4] In clinical trials, the incidence of loose stools ranged from 14 percent to 40 percent. In older people, loss of fluids and minerals from diarrhea can cause heart, kidney and mental problems.

In 2015, an article published in Prescrire International reported that misoprostol rarely has been  associated with heart attacks and other serious cardiovascular events, in some cases after only a single dose of the drug.[5]

Before You Use This Drug [top]

Do not use if you have or have had:

  •   pregnancy or are breast-feeding

Tell your doctor if you have or have had:

  •   allergies to prostaglandins or similar drugs
  •   cerebral vascular disease, stroke, or transient ischemic attack
  •   coronary artery disease
  •   epilepsy heart problems
  •   inflammatory bowel disease

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • Call your doctor immediately if you have black, tarry stools or if you vomit material that looks like coffee grounds. These are signs of a bleeding ulcer.
  • Call your doctor if you have trouble swallowing or persistent abdominal pain.
  • Check with your doctor if your symptoms do not improve or get worse.
  • Do not drink alcohol or smoke.
  • Avoid any food or drink that aggravates your ulcer.
  • Stop medication immediately and check with your doctor if you suspect that you are pregnant.
  • Consult your doctor if diarrhea lasts more than a week.
  • Use antacids and laxatives that do not contain magnesium.
  • Drink liquids to replace fluids lost by diarrhea.

How to Use This Drug [top]

  • If you miss a dose, take it as soon as you remember, but skip it if it is almost time for the next dose. Do not take double doses.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day.
  • Take with or after meals or at bedtime. Take with food or milk.
  • Swallow tablets whole or break in half. Take with or after meals to lessen chance of diarrhea.
  • Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children.

Interactions with Other Drugs [top]

Evaluations of Drug Interactions 2003 lists no drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods as causing “highly clinically significant” or “clinically significant” interactions when used together with the drugs in this section. We also found no interactions in the drugs’ FDA-approved professional package inserts. However, as the number of new drugs approved for marketing increases and as more experience is gained with these drugs over time, new interactions may be discovered.

Adverse Effects [top]

Call your doctor if these symptoms continue:

  •   abdominal or stomach cramps, or pain in lower abdomen or stomach
  •   confusion[6]
  •   constipation
  •   diarrhea
  •   gas
  •   headache
  •   heartburn, indigestion, or acid stomach
  •   nausea and/or vomiting
  •   urinary incontinence[7]
  •   vaginal bleeding

Signs of overdose:

  •   abdominal pain
  •   blood pressure decrease
  •   breathing difficulty
  •   diarrhea
  •   drowsiness
  •   fever
  •   heartbeat fast or pounding
  •   heartbeat slow
  •   seizures
  •   tremor

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.

last reviewed March 31, 2021