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Cervidil

Last reviewed on RxList: 5/1/2017
Cervidil Side Effects Center

Last reviewed on RxList 02/21/2017

Cervidil Vaginal Insert (dinoprostone) 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. 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).

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 breastfeeding.

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.

Cervidil Consumer Information

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.

After your baby is born, seek emergency medical attention if you have any signs of excessive bleeding, such as:

  • 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)

Cervidil Professional Information

SIDE EFFECTS

Cervidil 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 – Treated Drug-Related Advers e Events

  Controlled Studies*
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 101-801†
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
*Controlled Studies (with and without retrieval system)
†Controlled Study (with retrieval system)

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

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. In a report of a 3 year pediatric follow-up study in 121 infants, 51 of whose mothers evaluation (18).

Post-Marketing Surveillance

Immune System Disorders: Hypersensitivity

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

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

Vascular Disorders: Hypotension

Pregnancy, Puerperium and Perinatal Conditions: Amniotic fluid embolism

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.

Read the entire FDA prescribing information for Cervidil (Dinoprostone)

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Read the Cervidil User Reviews »

© 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.

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