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Cytotec (misoprostol)
Synthetic prostaglandin E1 analog that protects gastric mucosa by inhibiting acid secretion and stimulating mucus/bicarbonate, also causes uterine contraction.
Misoprostol (Cytotec) is a prostaglandin analog with dual GI protective and uterotonic properties. Essential in obstetrics for labor induction and postpartum hemorrhage. WHO Essential Medicine. Available generically.
At a glance
| Generic name | misoprostol |
|---|---|
| Also known as | Cytotec |
| Sponsor | Generic (originally Searle/Pfizer) |
| Drug class | Prostaglandin E1 analog |
| Target | Prostaglandin E2 receptor EP2 subtype, Prostaglandin E2 receptor EP3 subtype, Prostaglandin E2 receptor EP4 subtype |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1988-12-27 (United States) |
Mechanism of action
Misoprostol was originally developed to prevent NSAID-induced gastric ulcers by replacing the protective prostaglandins that NSAIDs deplete. However, its uterotonic properties have made it one of the most important drugs in obstetrics/gynecology for labor induction, cervical ripening, postpartum hemorrhage management, and medical abortion (in combination with mifepristone).
Approved indications
- Osteoarthritis in Patients at High Ulcer Risk
- Postpartum hemorrhage
- Prevention of CMV Disease After Organ Transplant
- Prevention of NSAID-Induced Gastric Ulcer
- Rheumatoid Arthritis in Patient at High Ulcer Risk
Common side effects
- nausea
- flatulence
- headache
- dyspepsia
- vomiting
- constipation
Key clinical trials
- Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage (PHASE4)
- Simultaneous Mifepristone and Misoprostol Versus Misoprostol Alone for Induction of Labor of Nonviable Second Trimester Pregnancy: a Pilot Randomized Controlled Trial (PHASE4)
- Laminaria Japonicum Followed by Misoprostol Versus Misoprostol Alone for Mid-Trimester Abortion Induction in Scarred Uterus (PHASE4)
- A Real-World Study Comparing the Efficacy of Different Treatment Regimens for Early Missed Abortion (NA)
- Comparison of Outcome of Foley Catheter Versus Misoprostol for Induction of Labor (NA)
- Cooling the Uterus in C-section After Dysfunctional Labor (NA)
- Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention (NA)
- Missed Period Pill Study (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |