Dinoprostone
Dinoprostone is a prostaglandin medication used to ripen the cervix and help prepare the body for labor induction in pregnant women at or near term.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Dinoprostone (Cervidil insert, Prepidil gel) is a hospital-only medicine that delivers prostaglandin E2, a hormone-like substance the body makes before labor, to soften and open the cervix before labor is induced at or near term; on the U.S. market since the late 1970s, it is one of the standard cervical ripening options on labor units. Most women tolerate it well, and the effects people notice are cramping or belly pain, sometimes with nausea, vomiting, diarrhea or fever. The main thing the team watches for is contractions coming too often or lasting too long (tachysystole), which can stress the baby, so your contractions and the baby's heart rate are monitored continuously.
Clinical pearls
- IV oxytocin (Pitocin) is never run alongside it; after Cervidil is removed, at least 30 minutes must pass before oxytocin starts.
- A previous C-section or other uterine surgery rules out Cervidil, so make sure the labor team knows your full surgical history.
- Cervidil can be pulled out quickly if contractions get too strong, and contractions usually settle within minutes of removal.
- Tell the team if you have glaucoma, since prostaglandins can raise eye pressure and a non-prostaglandin method may suit you better.
Patient information guide A plain-language walkthrough of Dinoprostone, written from its FDA label.
What Dinoprostone is used for
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Dinoprostone is a prostaglandin medication used in hospital settings to ripen the cervix before labor induction in pregnant women at or near term.
- Cervidil (vaginal insert): indicated for initiating or continuing cervical ripening in pregnant women at or near term who have a medical or obstetrical reason for labor induction
- Prepidil (vaginal gel): indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction
How Dinoprostone works
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Dinoprostone is a prostaglandin — a hormone-like chemical naturally produced by the fetal membranes and placenta during pregnancy. When given as a medication, it works locally on the cervix to promote softening, effacement (thinning), and dilation (opening), which are necessary steps before labor can begin. It also stimulates prostaglandin F2α, which sensitizes the uterus to oxytocin, making uterine contractions more likely. Evidence suggests that at doses used for cervical ripening, it primarily acts on the cervix rather than directly triggering strong contractions.
Dinoprostone dosage
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Both forms of dinoprostone are administered vaginally in a hospital by trained obstetrical personnel — this is never a take-home medication. Cervidil is given as a single vaginal insert worn for up to 12 hours, then removed. Prepidil gel is placed into the cervical canal via syringe; repeat doses may be given at 6-hour intervals if there is no adequate response, up to a maximum daily limit.
- Cervidil: removed at 12 hours, at the start of active labor, or sooner if complications arise — at least 30 minutes before any IV oxytocin is started
- Prepidil: after a clinical response, a 6–12 hour gap is recommended before IV oxytocin is started
Dosing details from the FDA-approved label
From the Dinoprostone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Cervidil vaginal insert (cervical ripening)
- One CERVIDIL insert (10 mg) intravaginally for use up to 12 hours (approximately 0.3 mg of dinoprostone is released per hour)
- Prepidil gel (cervical ripening) - repeat dosing
- If there is no cervical/uterine response to the initial dose, repeat dosing may be given
- The recommended repeat dose is 0.5 mg dinoprostone with a dosing interval of 6 hours
- Maximum: The maximum recommended cumulative dose for a 24-hour period is 1.5 mg of dinoprostone (7.5 mL PREPIDIL Gel)
- Use the 20 mm endocervical catheter if no effacement is present and the 10 mm catheter if the cervix is 50% effaced
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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 personnel in a hospital setting with appropriate obstetrical care facilities. Preparation and Administration Instructions Keep CERVIDIL frozen until ready for use. Do not warm CERVIDIL prior to vaginal insertion. Tear open the individually-wrapped foil package containing CERVIDIL along the tear mark. Never open the package using scissors or other sharp objects because this may damage the knitted polyester retrieval system. Do not cut the retrieval system and do not use CERVIDIL unless its retrieval system is intact. Immediately after opening the package, insert CERVIDIL transversely, in the posterior fornix of the vagina (see Figure 1 ). If necessary, use a minimal amount of water-miscible lubricant to assist vaginal insertion. Do not permit excess contact or coating with the lubricant, as this could prevent release of dinoprostone from the vaginal insert. Insertion does not require sterile conditions.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Dinoprostone side effects
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The most commonly reported side effects of dinoprostone involve uterine and fetal responses during treatment.
Common side effects
- Uterine tachysystole (too-frequent contractions) without fetal distress
- Uterine tachysystole with fetal distress
- Fetal distress without uterine tachysystole
- Nausea
- Vomiting
- Diarrhea
- Fever
- Abdominal pain
- Headache (reported post-marketing)
When to get medical help
- Signs of uterine hyperstimulation (very frequent, prolonged, or painful contractions) — medical staff will monitor and may remove the insert
- Signs of fetal distress — abnormal fetal heart rate patterns require prompt evaluation
- Signs of amniotic fluid embolism: sudden low blood pressure, difficulty breathing, seizures, or loss of consciousness
- Signs of disseminated intravascular coagulation (DIC) — a serious blood-clotting disorder — especially in the period right after delivery
- Severe allergic reaction (with Prepidil gel): swelling, hives, or trouble breathing occurring within hours of use
- Signs of uterine rupture: severe abdominal pain or a sudden change in uterine shape
Serious reactions — including uterine rupture, amniotic fluid embolism, and disseminated intravascular coagulation — are rare but potentially life-threatening and require immediate medical attention.
Dinoprostone warnings and precautions
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- Uterine tachysystole and hyperstimulation: Too-frequent or too-strong contractions can reduce oxygen to the baby. Staff monitor uterine activity throughout; with Cervidil, removing the insert typically reverses hyperstimulation within minutes.
- Amniotic fluid embolism: A rare, often fatal condition where amniotic fluid enters the bloodstream, causing low blood pressure, breathing failure, seizures, or coma. Immediate supportive care is needed.
- Disseminated intravascular coagulation (DIC): A dangerous blood-clotting disorder that can develop after delivery, especially in women over 30, those with pregnancy complications, or those past 40 weeks. Close post-delivery monitoring is essential.
- Uterine rupture: Reported in association with Cervidil use, particularly in women with a history of uterine surgery or cesarean section, sometimes requiring hysterectomy or resulting in fetal or neonatal death.
- Serious allergic reactions: Reported post-marketing with Prepidil, including anaphylaxis and severe swelling, occurring within minutes to hours of administration.
- Glaucoma: Prostaglandins can raise eye pressure; non-prostaglandin alternatives should be considered in patients with glaucoma.
- Dinoprostone must be used only in a hospital with immediate intensive obstetric and surgical care available.
Dinoprostone interactions
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Dinoprostone has one key drug interaction to be aware of.
- Oxytocic agents (e.g., IV oxytocin): Dinoprostone can significantly amplify the uterus-stimulating effect of these drugs, increasing the risk of dangerously strong or prolonged contractions. Concurrent use of IV oxytocin with Cervidil is contraindicated; at least 30 minutes must pass after removing Cervidil before an oxytocic agent is started. With Prepidil, a 6–12 hour interval is recommended after a clinical response before giving IV oxytocin.
Interactions listed in the FDA-approved label
From the Dinoprostone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Oxytocic agents (intravenous oxytocic agents): CERVIDIL may augment the activity of oxytocic agents, and it is contraindicated in patients receiving intravenous oxytocic agents. Remove CERVIDIL at least 30 minutes before administering an oxytocic agent; a dosing interval of at least 30 minutes is recommended for sequential use following removal.
Read the label’s full interactions text
7 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.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Dinoprostone
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- Known allergy to prostaglandins — dinoprostone must not be used
- Evidence or suspicion of fetal distress where delivery is not imminent — do not use
- Unexplained vaginal bleeding in the current pregnancy — do not use
- Suspected marked cephalopelvic disproportion (the baby's head is too large to fit through the pelvis) — do not use
- Any condition in which labor induction or oxytocic drugs are contraindicated — do not use
- History of cesarean section or other uterine surgery (e.g., myomectomy) — Cervidil is contraindicated due to risk of uterine rupture
- Conditions where prolonged uterine contractions could be dangerous to the baby — do not use
- Six or more previous full-term pregnancies — Cervidil is contraindicated
- History of glaucoma — discuss with your doctor; prostaglandins can raise eye pressure
- Women over 30, those with pregnancy complications, or those past 40 weeks — higher risk of DIC after delivery; use with caution and close monitoring
- Safety and effectiveness of Cervidil have not been established in pregnant girls
- Cervidil is not indicated in breastfeeding women; effects on breast milk or the breastfed infant are unknown
Dinoprostone overdose
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Too much dinoprostone can cause the uterus to contract too frequently or too forcefully (uterine hyperstimulation). In most cases, this resolves with conservative management — such as changing the mother's position and giving supplemental oxygen. Beta-adrenergic drugs may be used to reduce uterine activity if needed.
What Dinoprostone does in the body
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When applied to the cervix, dinoprostone promotes the tissue changes — softening, effacement (thinning), and dilation (opening) — that normally occur as pregnancy progresses toward term. At the doses used for cervical ripening, it primarily acts locally on the cervix without directly causing strong uterine contractions, though some women do experience systemic effects such as uterine tachysystole. Dinoprostone can also stimulate gastrointestinal smooth muscle, which may explain occasional nausea, vomiting, or diarrhea.
How your body processes Dinoprostone
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Cervidil releases dinoprostone slowly into the vagina at approximately 0.3 mg per hour over 12 hours. Dinoprostone is broken down very rapidly in local tissues, with a half-life of just 2.5 to 5 minutes. Any that escapes local breakdown is cleared almost entirely (about 95%) on its first pass through the lungs, with further metabolism occurring in the liver and kidneys. With Prepidil gel, the drug is absorbed relatively quickly after endocervical placement, with peak levels in the bloodstream occurring within about 30–45 minutes.
How to store Dinoprostone
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Store in a freezer between -20°C and -10°C (-4°F and 14°F). stored in a freezer for a period of three years.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Dinoprostone
17 supplements and herbal products have documented interactions with Dinoprostone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Dinoprostone: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Dinoprostone — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is dinoprostone, and why do I need it?
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Will I be awake and aware during the process? What will it feel like?
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What side effects should I expect, and what's serious enough to flag right away?
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I've had a C-section before. Can I still receive this medication?
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Can they start me on Pitocin (oxytocin) at the same time as this medication?
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Is this safe for my baby?
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Is Dinoprostone available over the counter?
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When was Dinoprostone first available?
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Who makes Dinoprostone?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Dinoprostone on HelloPharmacist
Dinoprostone forms and strengths (how it comes)
Dinoprostone is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Dinoprostone inactive ingredients by manufacturer.
Vaginal cream or gel
How this form is used
- Prepidil gel is used to ripen an unfavorable cervix in pregnant women at or near term who have a medical or obstetrical need for labor induction
- Prepidil gel is administered into the cervical canal by trained personnel using a syringe with a shielded catheter, with the patient in a dorsal (lying flat on the back) position
- Prepidil gel should be brought to room temperature before use — do not use a water bath or microwave to warm it; hands should be washed thoroughly after administration
- After Prepidil gel administration, the patient should remain lying on her back for at least 15–30 minutes to minimize leakage from the cervical canal
- Repeat doses of Prepidil gel may be given at 6-hour intervals if there is no adequate response; if a response is achieved, a waiting period of 6–12 hours is recommended before starting IV oxytocin
Vaginal insert
How this form is used
- Cervidil is used to initiate or continue cervical ripening in pregnant women at or near term who have a medical or obstetrical reason for labor induction
- Cervidil is administered as a single vaginal insert placed in the posterior vaginal fornix by trained obstetrical personnel in a hospital setting
- Cervidil is left in place for up to 12 hours and is removed at the onset of active labor, at 12 hours, or sooner if uterine tachysystole, fetal distress, or other complications arise
- Cervidil should be kept frozen until use and should not be warmed before insertion; a small amount of water-miscible lubricant may be used if needed
- After Cervidil insertion, the patient should remain lying down for at least 2 hours; the retrieval system must be left partially outside the vagina and visually confirmed to be intact upon removal
Dinoprostone on the U.S. market: products, makers and brands
How Dinoprostone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
2 companies list 2 Dinoprostone product records with the FDA, mostly as vaginal cream or gel, vaginal insert; the earliest marketing or approval year on record is 1977. Brand names on the directory include Cervidil, Prepidil, Prostin E2; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Compare Dinoprostone products
A representative set of FDA-listed product records for Dinoprostone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Vaginal cream or gel | ||||
| 0.5 mg/3 g | Vaginal | Pharmacia & Upjohn Company LLC | NDA | View NDC → |
| 💊Vaginal insert | ||||
| 10 mg/241 mg | Vaginal | Ferring Pharmaceuticals Inc. | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Dinoprostone NDCs →
Dinoprostone side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Dinoprostone — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Dinoprostone are foetal exposure during pregnancy, drug exposure during pregnancy, caesarean section; about 86% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Dinoprostone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Dinoprostone FDA approval history
How Dinoprostone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Dinoprostone was first approved by the FDA in 1977 (Brand: PROSTIN E2 · Pfizer). It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Dinoprostone recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Dinoprostone recalls since July 2021.
✅No Dinoprostone recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 3478 4 dose forms · 7 strengths
-
Dose form (SCDF) Injectable Solution RxCUI 371879No current FDA listingClinical drug / strength (SCD) 1 MG/MLRxCUI 10545910 MG/MLRxCUI 105460 -
Dose form (SCDF) Oral Tablet RxCUI 371880No current FDA listingClinical drug / strength (SCD) 0.5 MGRxCUI 199728 -
Dose form (SCDF) Vaginal Gel RxCUI 377266In current FDA listings -
Dose form (SCDF) Vaginal Insert RxCUI 2109134In current FDA listings
Look up RxCUI 3478 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Dinoprostone supply and shortage status
Whether Dinoprostone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Dinoprostone brand names
Dinoprostone is sold under 3 brand names in the FDA directory — Cervidil, Prepidil, Prostin E2. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Dinoprostone: manufacturers and labelers
2 companies list Dinoprostone products with the FDA. By number of product records, the largest are Ferring Pharmaceuticals Inc., Pharmacia & Upjohn Company LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Dinoprostone drug class (RxNorm)
Dinoprostone belongs to the Prostaglandin Analog class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Dinoprostone page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Pharmacia and Upjohn Company LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →