Misoprostol
Active ingredient · 2 therapeutic classes
Sold as ARTHROTEC 50 · ARTHROTEC 75
- Drug class
- Prostaglandins
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 24
- FDA reports (12 mo)
- 257
Overview
Plain-language summary, compiled from the cited regulatory records
Misoprostol is a medication belonging to the prostaglandin drug class [1]. It is approved for the treatment of signs and symptoms associated with osteoarthritis or rheumatoid arthritis in adult patients who are at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications [1]. Factors that may increase this risk are detailed in the product labeling [1].
In the past 12 months, there have been 257 adverse event reports associated with this active ingredient [2]. The most frequently reported adverse events include off-label use, drug ineffectiveness, fetal exposure during pregnancy, maternal exposure during pregnancy, and nausea [2].
This active ingredient is available under several brand names [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 12 | May 22, 2026 |
| CA Canada | Health Canada | 9 | March 22, 2025 |
| US United States | FDA | 3 | March 24, 2026 |
GBUnited Kingdom· MHRA
12 products
Uses
2). Cervix uteri preparation prior to surgical termination of pregnancy during the first trimester. Misoprostol is indicated in adults.
How to take
CACanada· Health Canada
9 products
Uses
pms-DICLOFENAC-MISOPROSTOL (Diclofenac Sodium and Misoprostol Delayed-Release Tablets) is indicated for: • Acute and chronic use in the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Throughout this document, the term NSAIDs refers to both non-selective NSAIDs and selective COX-2 inhibitor NSAIDs, unless otherwise indicated.
Diclofenac, particularly at higher doses, is associated with an increased risk of serious cardiovascular related adverse events that is comparable to COX-2 inhibitors and high dose ibuprofen. For patients with pre-existing risk factors for cardiovascular disease (including ischemic heart disease, cerebrovascular disease and/or congestive heart failure NYHA II-IV) other management strategies that do not include NSAlDs, particularly COX-2 inhibitors, ibuprofen and diclofenac, should be considered first (see
USUnited States· FDA
3 products
Uses
1 INDICATIONS AND USAGE Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.
3 )] . Diclofenac sodium and misoprostol delayed-release tablets are a combination of diclofenac sodium, a non-steroidal anti-inflammatory drug, and misoprostol, a prostaglandin-1 (PGE1) analog, indicated for the treatment of signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.
( 1 )
How to take
Drug interactions
Known interactions involving Misoprostol. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL161520007 · revised May 22, 2026
- [2]Health Canada (DPD) · 02413469 · revised March 22, 2025
- [3]FDA DailyMed · 0d6509a1-7af8-47… · revised March 24, 2026 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.