Dinoprostone: uses, dosing, side effects & brands
Dinoprostone is a prostaglandin analog sold in the U.S. under 2 brand and generic names, for fetal death, uterine neoplasms and gestational trophoblastic disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Prostaglandin Analog
- Treats (across its forms)
- Fetal Death, Uterine Neoplasms and Gestational Trophoblastic Disease
- Available as
- Insert · Topical
- Sold as
- 2 products — Cervidil and Prepidil
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How Cervidil is dosed
From the FDA label for Cervidil (application NDA020411). Other dinoprostone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer a single vaginal insert (10 mg) for up to 12 hours of use (approximately 0.3 mg of dinoprostone is released per hour) ( 2.1 ) Remove upon onset of active labor or 12 hours after insertion. ( 2.1 ) Carefully monitor for uterine activity, fetal status and the progression of cervical dilatation and effacement. ( 2.1 ) CERVIDIL should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities ( 2.2 ). See full prescribing information for complete preparation, administration, and removal instructions. ( 2.2 , 2.3 ) 2.1 Dosage Instructions Administer one CERVIDIL insert (10 mg) intravaginally for use up to 12 hours (approximately 0.3 mg of dinoprostone is released per hour) [see Dosage and Administration (2.2) ]. Monitor uterine activity, fetal status, and the progression of cervical dilatation and effacement with the use of CERVIDIL. Remove CERVIDIL 12 hours after insertion with the onset of active labor, prior to an amniotomy, occurrence of uterine tachysystole, uterine hypersystole/hypertonicity, or fetal distress [see Warnings and Precautions (5.4) ] . Remove CERVIDIL at least 30 minutes prior to administering an oxytocic agent [see Warnings and Precautions (5.4) and Drug Interactions (7) ] . 2.2 Preparation and Administration Instructions CERVIDIL should be administered only by trained obstetrical…
Everything below is the FDA label for Cervidil (insert). Dinoprostone is also sold as topical, and those are different medicines to take — follow the label for the one you were prescribed.
Cervidil side effects
The following adverse reactions are described, or described in greater detail, in other sections: Disseminated Intravascular Coagulation [see Warnings and Precautions (5.2) ] Amniotic Fluid Embolism [see Warnings and Precautions (5.3) ] Uterine Tachysytole and Uterine Hypersystole/Hypertonicity [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 2 %) are uterine tachysystole without fetal distress, uterine tachysystole with fetal distress, and fetal distress without uterine tachysystole. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact FERRING PHARMACEUTICALS, INC. at 1 888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In placebo-controlled trials of 658 pregnant women (320 CERVIDIL-treated women and 338 placebo-treated women), the following treatment related adverse reactions (see Table 1 ) occurred at an incidence greater than 2% (and greater than that reported in the placebo group) in the CERVIDIL group [see Clinical Studies (14) ]. Table 1. Common Adverse Reactions (≥ 2%) in Pregnant Patients Near Term Gestation in Trial 1…
Who shouldn’t take Cervidil
CERVIDIL is contraindicated in patients with: Known hypersensitivity to prostaglandins [see Adverse Reactions (6.2) ] Evidence or clinical suspicion of fetal distress where delivery is not imminent Unexplained vaginal bleeding in the current pregnancy Evidence or clinical suspicion of marked cephalopelvic disproportion Conditions for which induction of labor is contraindicated Conditions for which oxytocic drugs are contraindicated Previous cesarean section or other uterine surgery expected to affect uterine integrity (such as myomectomy) Conditions under which prolonged contraction of the uterus may be detrimental to fetal safety Concurrent use with intravenous oxytocic agents [see Warnings and Precautions (5.4) and Drug Interactions (7) ] Six or more previous term pregnancies CERVIDIL is contraindicated for: Known hypersensitivity to prostaglandins ( 4 ) Evidence or clinical suspicion of fetal distress, where delivery is not imminent ( 4 ) Unexplained vaginal bleeding in the current pregnancy ( 4 ) Evidence or clinical suspicion of marked cephalopelvic disproportion ( 4 ) Contraindication to induction of labor ( 4 ) Concurrent use with intravenous oxytocic agents ( 4 ) History of previous cesarean section or other uterine surgery (such as myomectomy) ( 4 ) Conditions under which prolonged contraction of the uterus may be detrimental to fetal safety. ( 4 ) Six or more previous term pregnancies ( 4 )
Cervidil drug interactions
Oxytocic Agents : May augment the activity of oxytocic agents; concomitant use of intravenous oxytocic agents is contraindicated ( 4 , 7.1 ). Remove vaginal insert at least 30 minutes before administering an oxytocic agent. ( 7.1 ) 7.1 Oxytocic Agents CERVIDIL is contraindicated in patients receiving intravenous oxytocic agents because CERVIDIL may augment the activity of oxytocic agents. A dosing interval of at least 30 minutes is recommended for the sequential use of an oxytocic agent following the removal of CERVIDIL.
Every dinoprostone product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Insert | No data | — | View → | |
| 2 | 64/100 | Prescription | Topical | No data | — | View → |
Can you crush or split dinoprostone?
At least one dinoprostoneproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each dinoprostone label says about crushing, splitting and chewingDinoprostone and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for dinoprostone: levels in milk, effects in breastfed infants, and the drugs it would consider insteadDinoprostone (prostaglandin E2) has not been measured in human milk after exogenous administration, but it is a normal component of breastmilk in small amounts where it may help protect the infant's gastrointestinal tract.
National Institute of Child Health and Human Development, record revised November 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about dinoprostone
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 597 reports naming dinoprostone, and the FDA flagged 97% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- foetal exposure during pregnancy103 reports
- drug exposure during pregnancy82 reports
- caesarean section79 reports
- maternal exposure during pregnancy48 reports
- exposure during pregnancy41 reports
- maternal drugs affecting foetus40 reports
- premature baby36 reports
- haemoglobin decreased33 reports
Read these as a signal, not a rate. A report does not mean dinoprostone caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is Cervidil?
CERVIDIL (dinoprostone) vaginal insert contains dinoprostone, a prostaglandin analog. Each vaginal insert contains 10 mg of dinoprostone in 241 mg of a cross-linked polyethylene oxide/urethane polymer (hydrogel polymer) that is semi-opaque, beige colored, flat, rectangular in shape with rounded corners and measuring 29 mm by 9.5 mm by 0.8 mm. The vaginal insert is contained within a pouch of an off-white knitted polyester yarn retrieval system. When placed in a moist environment, the yarn absorbs water, swells, and releases the enclosed dinoprostone. The knitted polyester retrieval system has a long tape-like end that is designed to aid retrieval of CERVIDIL at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled-release formulation that has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg per hour.
What kind of drug is dinoprostone?
The FDA classifies dinoprostone as a prostaglandin analog. Prostaglandin analogs (used as eye drops for glaucoma) activate FP receptors that relax the eye's drainage tissues, helping fluid flow out more easily. This lowers the pressure inside the eye and protects the optic nerve. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take dinoprostone with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run dinoprostone against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is dinoprostone sold under?
We track 2 dinoprostone-containing products in the U.S.: Cervidil and Prepidil. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does dinoprostone come in?
Across the brands we track, dinoprostone is currently marketed as insert and topical, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic dinoprostone?
We do not currently list a generic-labelled dinoprostone product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Dinoprostone: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/dinoprostone
- MLA
- “Dinoprostone: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/dinoprostone.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for dinoprostone on DailyMed (NIH) ↗.