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Prepidil

"Many pregnant women take prescription medicines for health problems like diabetes, asthma, seizures, heartburn, and morning sickness. Other women take medicines before they realize they are pregnant.

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Prepidil

Prepidil

Prepidil Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Prepidil (dinoprostone) Cervical Gel 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. Common side effects include nausea, stomach pain, back pain, or feeling of warmth in the vaginal area.

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.

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.

Prepidil 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 Prepidil (Dinoprostone Cervical Gel) »

What is Prescribing information?

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

Prepidil FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

PREPIDIL (dinoprostone cervical gel) 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 extra-amniotic intrauterine administration of PGE2. Uterine rupture has been reported in association with the use of PREPIDIL (dinoprostone cervical gel) Gel intracervically. Additional events reported in the literature, associated by the authors with the use of PREPIDIL (dinoprostone cervical gel) 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 section WARNINGS). The frequency of this adverse event, however, appears to be rare ( < 1 per 1,000 labors).

Drug Abuse And Dependence

No drug abuse or drug dependence has been seen with the use of PREPIDIL (dinoprostone cervical gel) Gel.

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

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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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