Medical Editor: John P. Cunha, DO, FACOEP
What Is Cervidil?
Cervidil (dinoprostone) Vaginal Insert is a prostaglandin, a hormone-like substance that is naturally produced by the body, used in a pregnant woman to relax the muscles of the cervix (opening of the uterus) in preparation for inducing labor at the end of a pregnancy.
What Are Side Effects of Cervidil?
Side effects of Cervidil Vaginal Insert are uncommon and usually mild and include:
- fever,
- nausea,
- vomiting,
- diarrhea,
- abdominal or stomach pain,
- back pain, or
- a feeling of warmth in the vaginal area.
Tell your doctor if you have an uncommon but serious side effect of Cervidil Vaginal Insert: strong contractions that are very close together (uterine overstimulation).
Dosage for Cervidil
The dosage of dinoprostone in the vaginal insert is 10 mg designed to be released at approximately 0.3 mg/hour over a 12-hour period. Cervidil should be removed upon onset of active labor or 12 hours after insertion.
What Drugs, Substances, or Supplements Interact with Cervidil?
Other drugs may interact with Cervidil. Tell your doctor all prescription and over-the-counter medications and supplements you use.
Cervidil During Pregnancy and Breastfeeding
Cervidil should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Cervidil Vaginal Insert (dinoprostone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
Conception: The Amazing Journey from Egg to Embryo See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if your contractions slow down or become uneven, or if you have:
- a light-headed feeling, like you might pass out;
- weak or shallow breathing;
- intense pain between contractions;
- sudden vaginal bleeding;
- unexpected stomach pain;
- chest pain;
- easy bruising, unusual bleeding;
- bleeding from a wound, surgical incision, or vein where an IV needle was placed; or
- any bleeding that will not stop.
Common side effects may include:
- contractions that are more frequent;
- slow heartbeats in the baby;
- nausea, stomach pain;
- feeling of warmth in the vaginal area;
- back pain; or
- fever.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SIDE EFFECTS
The following adverse reactions are described, or described in greater detail, in other sections:
- Disseminated Intravascular Coagulation [see WARNINGS AND PRECAUTIONS]
- Amniotic Fluid Embolism [see WARNINGS AND PRECAUTIONS]
- Uterine Tachysytole and Uterine Hypersystole/Hypertonicity [see WARNINGS AND PRECAUTIONS]
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].
Table 1: Common Adverse Reactions (≥2%) in Pregnant Patients Near Term Gestation in Trial 11, Trial 21, and Trial 32
| Trials 11 and 21 | ||
| CERVIDIL (N=320) | Placebo (N=338) | |
| Uterine tachysystole with fetal distress | 2.8% | 0.3% |
| Uterine tachysystole without fetal distress | 4.7% | 0% |
| Fetal distress without uterine tachysystole - | 3.8% | 1.2% |
| Trial 32 | ||
| CERVIDIL (N=102) | Placebo (N=104) | |
| Uterine tachysystole with fetal distress | 2.9% | 0% |
| Uterine tachysystole -without fetal distress | 2% | 0% |
| Fetal distress without uterine tachysystole | 2.9% | 1% |
| 1Trial 1 (101-103)and Trial 2 (101-003)evaluated the dinoprostoneinsertonly, without the useofaretrieval system 2Trial 3 (101-801) evaluated the dinoprostoneinsert with the retrieval system. | ||
Drug related fever, nausea, vomiting, diarrhea, and abdominal pain occurred in less than 1% of CERVIDIL-treated patients.
In Trial 3 (with the retrieval system) cases of tachysystole uterine hyperstimulation reversed within 2 to 13 minutes of removal of CERVIDIL. Tocolytics were required in one of the five cases.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of CERVIDIL or other dinoprostone products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system disorders: Disseminated Intravascular Coagulation
Cardiovascular disorders: Myocardial Infarction in women with a history of myocardial infarction
Immune system disorders: Hypersensitivity
Nervous system disorders: Headache
Pregnancy, puerperium and perinatal conditions: Amniotic fluid embolism
Reproductive system: reports of uterine rupture have been reported in association with use of CERVIDIL. Some required a hysterectomy and others resulted in subsequent fetal or neonatal death. Uterine hypertonus
Vascular disorders: Hypotension
Read the entire FDA prescribing information for Cervidil (Dinoprostone)
© Cervidil Patient Information is supplied by Cerner Multum, Inc. and Cervidil Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
Health Solutions From Our Sponsors