Focus on misoprostol: review of worldwide safety data.

Gastrointestinal symptoms have been the most frequently reported adverse experiences in the misoprostol (Cytotec) studies of both patients with peptic ulcer disease, and healthy subjects. There have been relatively few cardiovascular, genito-urinary, or other adverse effects. This is similar to the results of animal studies in which misoprostol had little, if any, effects on cardiovascular, central nervous, and endocrine systems. The predominant activity of misoprostol in the gastrointestinal tract, essential to its ulcer-healing activity, may also account in part for the association of misoprostol with gastrointestinal adverse experiences. Abnormal bowel movements were the most common complaint (9-13%) of patients in pivotal controlled studies. In patients taking misoprostol 200 micrograms four times daily, 7.1% had diarrhea, with less than 1% stopping therapy because of diarrhea. Abdominal pain in these patients was reported in an incidence of 12.8%, was mild, and only rarely resulted in stopping therapy. Other adverse reactions reported in these patients were nausea, headache, and dizziness. In pregnant women, undergoing a legal termination of pregnancy, it has been shown that misoprostol has a greater incidence of uterine bleeding, and partial or complete expulsion of uterine contents, than placebo. Misoprostol (Cytotec) has received government approval for marketing in 12 countries, since the first gave its approval in June, 1984. It has been launched in 6 of those markets to date, with an estimated 100,000 patients having taken the drug. No serious adverse experiences attributed to misoprostol have been reported, but mild adverse experiences have occurred. Those most frequently reported were gastrointestinal in nature, and included diarrhea, abdominal pain, and nausea.(ABSTRACT TRUNCATED AT 250 WORDS)