Prescription medicine
Dinoprostone Brand names: Prepidil, Cervidil; first approved as Prostin E2
Dinoprostone (Cervidil) is a prescription medicine with an FDA approval on record since 1977. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the dinoprostone FDA label on DailyMed (effective June 2, 2023, Ferring Pharmaceuticals Inc.); the NDA 17810 record on Drugs@FDA; every dinoprostone label on DailyMed.
Highlights of the record
FDA label of June 2, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCERVIDIL is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor.
Forms and strengths
- 0.5 mg/3g
- 10 mg/241
Gel; insert.
On the market
- Earliest approval on file
- August 23, 1977 Prostin E2, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 799 through July 30, 2026
What is dinoprostone used for?
From the label: indications and usageCERVIDIL is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor. CERVIDIL is a prostaglandin analog indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor.
FDA pharmacologic class: Prostaglandin Analog.
Source: FDA drug label (CERVIDIL), Ferring Pharmaceuticals Inc., effective June 2, 2023 (SPL set f3bc9031-0620-4a50-b440-f661cadfeb1d), via openFDA; the full label on DailyMed
Is there a generic for dinoprostone (Cervidil)?
No generic dinoprostone is approved (Drugs@FDA, October 8, 2026).
- 1977 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the dinoprostone label say about other medicines?
The dinoprostone label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Heparin | warnings and precautions | Therapy consisting of prompt removal of the source of procoagulant material, replacement of depleted clotting factors and, in some cases, anti-coagulation with heparin should be instituted promptly. |
Source: FDA drug label (CERVIDIL), Ferring Pharmaceuticals Inc., effective June 2, 2023 (SPL set f3bc9031-0620-4a50-b440-f661cadfeb1d), via openFDA; the full label on DailyMed
What do FAERS reports show for dinoprostone?
The FDA Adverse Event Reporting System holds 799 reports that list dinoprostone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 50 are coded as a death and 207 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other prostaglandin analogs
- the pharmacologic class, with prices and generics
- Dinoprostone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other