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Cervidil

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Cervidil

Cervidil Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cervidil Vaginal Insert (dinoprostone) is 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. It is a prostaglandin, a hormone-like substance that is naturally produced by the body. Side effects are uncommon and usually mild and include fever, nausea, vomiting, diarrhea or abdominal pain.

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. Other drugs may interact with Cervidil. Tell your doctor all prescription and over-the-counter medications and supplements you use. Cervidil should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cervidil in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these 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:

  • fever;
  • sudden vaginal bleeding;
  • cough, wheezing, chest tightness, trouble breathing; or
  • pale skin, blue colored lips.
  • weakness or fainting;
  • unusual bleeding from your nose, mouth, vagina, or rectum;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • unusual bruising, purple or red pinpoint spots under your skin;
  • bleeding from a wound, surgical incision, or vein where an IV was placed;
  • any bleeding that will not stop.

Less serious side effects may include:

  • nausea, stomach pain;
  • back pain; or
  • feeling of warmth in the vaginal area.

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.

Read the entire detailed patient monograph for Cervidil (Dinoprostone) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Cervidil Overview - Patient Information: Side Effects

SIDE EFFECTS: Side effects such as fever, nausea, vomiting, diarrhea or abdominal pain are uncommon and usually mild. If these persist or worsen, notify your doctor or midwife immediately.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this uncommon but serious side effect occurs: strong contractions that are very close together (uterine overstimulation).

This drug has rarely caused injury to the womb (uterine rupture), which may require emergency surgery. Symptoms include severe pain in your womb and an abnormal heart rate in your baby. Your doctor or midwife will be monitoring for this and for signs of uterine overstimulation.

A very serious allergic reaction to this drug is unlikely, but immediate medical attention is required if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Cervidil (Dinoprostone)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cervidil FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Cervidil (dinoprostone) is well tolerated. In placebo-controlled trials in which 658 women were entered and 320 received active therapy (218 without retrieval system, 102 with retrieval system), the following events were reported.

Table 1 : Total Cervidil (dinoprostone) - Treated Drug Related Adverse Events

  Controlled Studies1
Active Placebo
Uterine hyperstimulation with fetal distress 2.8% 0.3%
Uterine hyperstimulation without fetal distress 4.7% 0%
Fetal Distress without uterine hyperstimulation 3.8% 1.2%
N 320 338
  STUDY 101-8012
  Active Placebo
Uterine hyperstimulation with fetal distress 2.9% 0%
Uterine hyperstimulation without fetal distress 2.0% 0%
Fetal Distress without uterine hyperstimulation 2.9% 1.0%
N 102 104
1Controlled Studies (with and without retrieval system)
2Controlled Study (with retrieval system)

Drug related fever, nausea, vomiting, diarrhea, and abdominal pain were noted in less than 1% of patients who received Cervidil (dinoprostone) .

In study 101-801 (with the retrieval system) cases of hyperstimulation reversed within 2 to 13 minutes of removal of the product. Tocolytics were required in one of the five cases.

In cases of fetal distress, when product removal was thought advisable there was a return to normal rhythm and no neonatal sequelae.

Five minute Apgar scores were 7 or above in 98.2% (646/658) of studied neonates whose mothers received Cervidil (dinoprostone) . In a report of a 3 year pediatric follow-up study in 121 infants, 51 of whose mothers received Cervidil (dinoprostone) , there were no deleterious effects on physical examination or psychomotor evaluation (18).

Post-marketing surveillance

Immune System Disorders: Hypersensitivity

Blood and lymphatic system disorders: Disseminated Intravascular Coagulation (See WARNINGS Section)

Reproductive system: Reports of uterine rupture have been reported in association with use of Cervidil (dinoprostone) some required a hysterectomy and some resulted in subsequent fetal or neonatal death.

Vascular Disorders: Hypotension

Pregnancy, Puerperium and Perinatal Conditions: Amniotic fluid embolism

Drug Abuse And Dependence

No drug abuse or dependence has been seen with the use of Cervidil (dinoprostone) .

Read the entire FDA prescribing information for Cervidil (Dinoprostone) »

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Cervidil - User Reviews

Cervidil User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Cervidil sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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