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Prepidil

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

Last reviewed on RxList 05/01/2017

Prepidil (dinoprostone) Cervical Gel is a prostaglandin, a hormone-like substance, 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. Common side effects of Prepidil Cervical Gel include:

  • nausea,
  • vomiting,
  • stomach or abdominal pain,
  • diarrhea,
  • back pain, or
  • feeling of warmth in the vaginal area.

Side effects of Prepidil Cervical Gel in the fetus include fetal heart rate abnormality, and slow heart rate. Tell your doctor if your contractions slow down or become uneven, or if you have serious side effects of Prepidil Cervical Gel including:

  • fever,
  • sudden vaginal bleeding,
  • cough,
  • wheezing,
  • chest tightness,
  • trouble breathing,
  • pale skin, or
  • blue colored lips.

Prepidil should be used only with strict adherence to recommended dosages and administered by physicians in a hospital that can provide immediate intensive care and acute surgical facilities. Other drugs may interact with Prepidil. Tell your doctor all medications and supplements you use. Prepidil is used in pregnant women. Consult your doctor before breastfeeding.

Our Prepidil Gel (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.

Prepidil 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 Prepidil (Dinoprostone Cervical Gel)

Prepidil Professional Information

SIDE EFFECTS

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 PGE2
(N = 884)
Control*
(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 Deceleration 36 (4.1) 26 (3.1)
    Late 25 (2.8) 18 (2.1)
    Variable 38 (4.3 29 (3.4)
    Unspecified 19 (2.1) 19 (2.2)
*placebo gel or no treatment

In addition, in other trials amnionitis and intrauterine fetal sepsis have been associated with extraamniotic intrauterine administration of PGE2 . 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 Iymphatic 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).

Read the entire FDA prescribing information for Prepidil (Dinoprostone Cervical Gel)

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© Prepidil Patient Information is supplied by Cerner Multum, Inc. and Prepidil Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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