Misoprostol: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Misoprostol. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Abdominal pain21%
Diarrhea19%
Dyspepsia14%
Nausea11%
Flatulence9%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

Carefully consider the potential benefits and risks of diclofenac sodium/misoprostol tablets and other treatment options before deciding to use diclofenac sodium/misoprostol tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diclofenac sodium/misoprostol tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. See WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation for a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications.

Source: FDA labeling via NIH DailyMed (set 253ee985…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.