Dinoprostone

Mechanism-of-action class: Prostaglandin Receptor Agonists.

• PREPIDIL Gel is indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction.

• Endocervically administered PREPIDIL Gel is not recommended for the following: a. Patients in whom oxytocic drugs are generally contraindicated or where prolonged contractions of the uterus are considered inappropriate, such as: • cases with a history of cesarean section or major uterine surgery • cases in which cephalopelvic disproportion is present • cases in which there is a history of difficult labor and/or traumatic delivery • grand multiparae with six or more previous term pregnancies cases with non-vertex presentation • cases with hyperactive or hypertonic uterine patterns • cases of fetal distress where delivery is not imminent • in obstetric emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention b.contraindicated

NOTE: USE CAUTION IN HANDLING THIS PRODUCT TO PREVENT CONTACT WITH SKIN. WASH HANDS THOROUGHLY WITH SOAP AND WATER AFTER ADMINISTRATION. PREPIDIL Gel should be brought to room temperature (59° to 86°F; 15° to 30°C) just prior to administration. Do not force the warming process by using a water bath or other source of external heat (eg, microwave oven). To prepare the product for use remove the protective end cap (to serve as plunger extension) and insert the protective end cap into the plunger stopper assembly in the barrel of syringe. Choose the appropriate length shielded catheter (10 mm or 20 mm) and aseptically remove the sterile shielded catheter from the package. Careful vaginal examination will reveal the degree of effacement which will regulate the size of the shielded endocervical catheter to be used. That is, the 20 mm endocervical catheter should be used if no effacement is present, and the 10 mm catheter should be used if the cervix is 50% effaced. Firmly attach the catheter hub to the syringe tip as evidenced by a distinct click. Fill the catheter with sterile gel by pushing the plunger assembly to expel air from the catheter prior to administration to the patient. Proper assembly of the dosing apparatus is shown below. To properly administer the product, the patient should be in a dorsal position with the cervix visualized using a speculum. Using sterile technique, introduce the gel with the catheter provided into the cervical canal just below the level of the internal os.

FOR HOSPITAL USE ONLY Dinoprostone, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Dinoprostone should be administered by physicians in a hospital that can provide immediate intensive care and acute surgical facilities. Women aged 30 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have been shown to have an increased risk of post-partum disseminated intravascular coagulation. In addition, these factors may further increase the risk associated with labor induction (see ADVERSE REACTIONS ). Therefore, in these women, use of dinoprostone should be undertaken with caution. Measures should be applied to detect as soon as possible an evolving fibrinolysis in the immediate post-partum phase. The Clinician should be alert that the intracervical placement of dinoprostone gel may result in inadvertent disruption and subsequent embolization of antigenic tissue causing in rare circumstances the development of Anaphylactoid Syndrome of Pregnancy (Amniotic Fluid Embolism). There have been post-marketing reports of serious and life-threatening hypersensitivity reactions including anaphylaxis and angioedema with PREPIDIL Gel (dinoprostone). Onset of these reported reactions occurred within minutes to hours after initiation with PREPIDIL Gel (dinoprostone). If a hypersensitivity reaction is suspected, if possible remove PREPIDIL Gel (dinoprostone). Assess for other potential causes of the event, and institute symptomatic and supportive therapy, as needed.

PREPIDIL Gel is generally well-tolerated. In controlled trials, in which 1731 women were entered, the following events were reported at an occurrence of ≥ 1%: Adverse Reaction PGE 2 (N = 884) Control placebo gel or no treatment (N = 847) Maternal N (%) N (%) Uterine contractile abnormality 58 (6.6) 34 (4.0) Any gastrointestinal effect 50 (5.7) 22 (2.6) Back pain 27 (3.1) 0 (0) Warm feeling in vagina 13 (1.5) 0 (0) Fever 12 (1.4) 10 (1.2) Fetal Any fetal heart rate abnormality 150 (17.0) 123 (14.5) Bradycardia 36 (4.1) 26 (3.1) Deceleration Late 25 (2.8) 18 (2.1) Variable 38 (4.3) 29 (3.4) Unspecified 19 (2.1) 19 (2.2) In addition, in other trials amnionitis and intrauterine fetal sepsis have been associated with extra-amniotic intrauterine administration of PGE 2 . Uterine rupture has been reported in association with the use of PREPIDIL Gel intracervically. Additional events reported in the literature, associated by the authors with the use of PREPIDIL Gel, included premature rupture of membranes, fetal depression (1 min Apgar < 7), and fetal acidosis (umbilical artery pH < 7.15). Post-marketing surveillance Blood and lymphatic system disorders An increased risk of post-partum disseminated intravascular coagulation has been described in patients whose labor was induced by pharmacological means, either with dinoprostone or oxytocin (see WARNINGS ) . The frequency of this adverse event, however, appears to be rare (<1 per 1,000 labors). Immune system disorders Hypersensitivity reactions (e.g., Anaphylactic reaction, Anaphylactic shock, Anaphylactoid reaction).

5. Pregnancy Teratogenic Effects Prostaglandin E2 produced an increase in skeletal anomalies in rats and rabbits. No effect would be expected clinically, when used as indicated, since PREPIDIL Gel is administered after the period of organogenesis. PREPIDIL Gel has been shown to be embryotoxic in rats and rabbits, and any dose that produces sustained increased uterine tone could put the embryo or fetus at risk. See statements under General Precautions .

Overdosage with PREPIDIL Gel may be expressed by uterine hypercontractility and uterine hypertonus. Because of the transient nature of PGE 2 -induced myometrial hyperstimulation, nonspecific, conservative management was found to be effective in the vast majority of the cases; i.e., maternal position change and administration of oxygen to the mother. β-adrenergic drugs may be used as a treatment of hyperstimulation following the administration of PGE 2 for cervical ripening.

• Dec 9, 1992NDANDA019617Pfizer
• Mar 30, 1995NDANDA020411Ferring Pharms Inc

1. 1Foetal Exposure During Pregnancy12015%
2. 2Drug Exposure During Pregnancy759.5%
3. 3Caesarean Section627.9%
4. 4Maternal Exposure During Pregnancy597.5%
5. 5Exposure During Pregnancy536.7%
6. 6Off Label Use465.8%
7. 7Premature Separation Of Placenta445.6%
8. 8Drug Ineffective384.8%
9. 9Uterine Hyperstimulation374.7%
10. 10Premature Baby364.6%
11. 11Haemoglobin Decreased354.4%
12. 12Premature Delivery334.2%
13. 13Uterine Hypertonus324.1%
14. 14Foetal Distress Syndrome303.8%
15. 15White Matter Lesion303.8%

Recent PubMed references pinned to Dinoprostone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Delivery Outcomes in the First 3 Years Following the Clinical Introduction of the Dinoprostone Vaginal Insert in Japan.
  The journal of obstetrics and gynaecology research · 2026 · Nakajima K, Nagamatsu T, Tanaka H, et al.
  PMID 42244119DOI 10.1111/jog.70352
• COX-2-Derived PGE(2) Modulates IL-17 Production by γδ T Cells During Allergic Lung Inflammation.
  FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026 · Feng C, Li H, Menendez D, et al.
  PMID 42223986DOI 10.1096/fj.202600944RR
• Saccharomyces cerevisiae β-Glucan Training Induces a Nonclassical PGE(2)-(High)/NO-(Low) Macrophage Phenotype in Response to Pseudomonas aeruginosa Exopolysaccharide.
  Archivum immunologiae et therapiae experimentalis · 2026 · Ciszek-Lenda M, Majka G, Suski M, et al.
  PMID 42220247DOI 10.2478/aite-2026-0014
• Reprogrammed apoptotic platelets drive rapid hemostasis through phosphatidylserine and prostaglandin E2 signaling in preclinical models.
  Science translational medicine · 2026 · Wang P, Du S, Wu S, et al.
  PMID 42166543DOI 10.1126/scitranslmed.aea0189
• A dual-asymmetric hemostatic Janus hydrogel patch inhibits postoperative recurrence and metastasis of triple-negative breast cancer by suppressing COX-2/PGE(2) axis.
  Biomaterials · 2026 · Mi D, Liu T, Zou L, et al.
  PMID 42139922DOI 10.1016/j.biomaterials.2026.124298
• Stage-dependent changes in prostaglandin E₂ in tick saliva determine its immunosuppressive effects.
  Ticks and tick-borne diseases · 2026 · Nakamura H, Parizi LF, Sajiki Y, et al.
  PMID 42107318DOI 10.1016/j.ttbdis.2026.102654
• Prostaglandin E2 alleviates acetaminophen-induced liver injury through DDIT4-enhanced autophagy regulated by circLima1/miR-486.
  Scientific reports · 2026 · Chen C, Guan J, Wu S, et al.
  PMID 42092122DOI 10.1038/s41598-026-52049-x
• Eosinophil-derived COX-2 protects against experimental colitis through the PGE(2)-IL-22 axis.
  Proceedings of the National Academy of Sciences of the United States of America · 2026 · Yang Y, Atkins CL, Fan Y, et al.
  PMID 42081718DOI 10.1073/pnas.2525334123

The 10 most recently updated of 187 ClinicalTrials.gov registrations naming Dinoprostone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy and Safety of Oral Misoprostol 25 μg vs. Vaginal Dinoprostone in Induction of Labor at Term
  Completed · Observational · 706 enrolled · Centre Hospitalier Universitaire, Amiens
  NCT04955847updated 2026-06-12
• An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis
  Recruiting · Phase 2 · Interventional · 38 enrolled · National Cancer Institute (NCI)
  NCT06557733updated 2026-05-13
• YS247 (Neoantigen-Pulsed DC Vaccine) for Metastatic Prostate Cancer
  Enrolling by invitation · Phase 1 · Interventional · 18 enrolled · Changhai Hospital
  NCT07583160updated 2026-05-13
• Comparison of Vaginal PGE2 (Dinoprostone) and Vaginal Misoprostol for Induction of Labour in Primigravid Term Pregnancy
  Active not recruiting · Interventional · 240 enrolled · Mayo Hospital Lahore
  NCT07559812updated 2026-04-30
• Membrane Stripping for Cervical Ripening
  Recruiting · Interventional · 400 enrolled · Meir Medical Center
  NCT06591247updated 2026-04-15
• Effect of Nigella Sativa Toothpaste on Salivary Biomarkers in Patients With Gingivitis
  Completed · Interventional · 100 enrolled · Universitas Airlangga
  NCT07447349updated 2026-03-03
• Dexamethasone as ESPB Adjuvant in Lumbar Laminectomy
  Completed · Phase 3 · Interventional · 36 enrolled · Udayana University
  NCT07429708updated 2026-02-24
• PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)
  Recruiting · Interventional · 450 enrolled · National Hospital of Obstetrics and Gynecology
  NCT07366359updated 2026-02-20
• Comparison of Conventional and Cu-NiTi Archwires Regarding Clinical Efficiency and Pain Intensity Using Prostaglandin E2 Biomarker During Alignment and Leveling
  Completed · Interventional · 30 enrolled · Postgraduate Institute of Dental Sciences Rohtak
  NCT06653881updated 2026-02-13
• Evaluation of the Biomechanical Response of Orthodontic Tooth Movement to Clear Aligner vs Fixed Orthodontic Appliance
  Active not recruiting · Interventional · 20 enrolled · Mansoura University
  NCT07399483updated 2026-02-10

Frequently asked questions

How does Dinoprostone work?

Mechanism-of-action class: Prostaglandin Receptor Agonists.

What is Dinoprostone used for?

According to FDA labeling, Dinoprostone carries indications including: PREPIDIL Gel is indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dinoprostone?

Dinoprostone is classified as Prostaglandins, Prostaglandin Analog, Prostaglandin Receptor Agonists, Increased Cervical Dilation, Increased GI Smooth Muscle Tone, Increased Uterine Smooth Muscle Contraction or Tone.

What are the brand names for Dinoprostone?

Dinoprostone is marketed under brand names including Cervidil, Prepidil.

What are the contraindications for Dinoprostone?

Dinoprostone labeling lists contraindications including: Endocervically administered PREPIDIL Gel is not recommended for the following: a. Patients in whom oxytocic drugs are generally contraindicated or where prolonged contractions of the uterus are considered inappropriate, such as: • cases with a history of cesarean section or major uterine surgery • cases in which cephalopelvic disproportion is present • cases in which there is a history of difficult labor and/or traumatic delivery • grand multiparae with six or more previous term pregnancies cases with non-vertex presentation • cases with hyperactive or hypertonic uterine patterns • cases of fetal distress where delivery is not imminent • in obstetric emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention b.. Always consult the full prescribing information and a clinician.