Misoprostol: Side Effects, Uses & Monitoring
Carefully consider the potential benefits and risks of diclofenac sodium/misoprostol tablets and other treatment options before deciding to use diclofenac sodium/misoprostol tablets.
- Data source
- FDA labeling via NIH DailyMed (label 253ee985…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Abdominal pain | 21% |
| Diarrhea | 19% |
| Dyspepsia | 14% |
| Nausea | 11% |
| Flatulence | 9% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
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.
Conditions associated with Misoprostol in labeling
Frequently Asked Questions
What is Misoprostol used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Misoprostol?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Misoprostol. Individual risk varies.
Does Misoprostol require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Misoprostol.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.