Side effects and contraindications

The most commonly reported adverse effect of taking a misoprostol 200 µg tablet by mouth four times a day to reduce the risk of NSAID-induced gastric ulcers is diarrhea. In clinical trials, an average 13% of patients reported diarrhea, which was dose-related and usually developed early in the course of therapy (after 13 days) and was usually self-limiting (often resolving within 8 days), but sometimes (in 2% of patients) required discontinuation of misoprostol.

The next most commonly reported adverse effects of taking a misoprostol 200 µg tablet by mouth four times a day to reduce the risk of NSAID-induced gastric ulcers are: abdominal pain, nausea, flatulence, headache, dyspepsia, vomiting, and constipation, but none of these adverse effects occurred significantly more often than when taking placebos.

Misoprostol should not be taken by pregnant women to reduce the risk of NSAID-induced gastric ulcers because it increases uterine tone and contractions in pregnancy which may cause partial or complete abortions, and because its use in pregnancy has been associated with birth defects.

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Obstetric and gynecological

Labor induction

Misoprostol is commonly prescribed off-label to cause labor induction by promoting uterine contractions and the ripening (effacement or thinning) of the cervix. Misoprostol is considered to be more effective than oxytocin and dinoprostone, the FDA-approved drugs for medically necessary labor induction. It is also less expensive than either of these two drugs.

Concern has been expressed about the overuse or misuse of misoprostol for labor induction. High doses can cause uterine rupture (especially in women who have previously had a caesarean section), fetal death and severe fetal brain damage. All induction agents cause uterine contractions – this can affect the blood supply to the fetus, especially if contractions become very frequent. Induction agents therefore need to be used with great care and with close fetal monitoring. One of the problems with induction using prostaglandins (such as dinoprostone or misoprostol) is that once given, the process is difficult to reverse. In contrast, oxytocin has a half-life of about 10 minutes and is administered via intravenous drip, which can be stopped immediately in the event of adverse reaction.

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