PREPIDIL® Adverse Reactions

(dinoprostone)

ADVERSE REACTIONS

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 ReactionPGE2
(N = 884)
Control*
(N = 847)
*
placebo gel or no treatment
MaternalN (%)N (%)
  Uterine contractile abnormality58 (6.6)34 (4.0)
  Any gastrointestinal effect50 (5.7)22 (2.6)
  Back pain27 (3.1)0 (0)
  Warm feeling in vagina13 (1.5)0 (0)
  Fever12 (1.4)10 (1.2)
Fetal
  Any fetal heart rate abnormality150 (17.0)123 (14.5)
  Bradycardia36 (4.1)26 (3.1)
  Deceleration
    Late25 (2.8)18 (2.1)
    Variable38 (4.3)29 (3.4)
    Unspecified19 (2.1)19 (2.2)

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 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 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 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).

Find PREPIDIL® medical information:

Find PREPIDIL® medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

PREPIDIL® Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Adverse Reactions

ADVERSE REACTIONS

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 ReactionPGE2
(N = 884)
Control*
(N = 847)
*
placebo gel or no treatment
MaternalN (%)N (%)
  Uterine contractile abnormality58 (6.6)34 (4.0)
  Any gastrointestinal effect50 (5.7)22 (2.6)
  Back pain27 (3.1)0 (0)
  Warm feeling in vagina13 (1.5)0 (0)
  Fever12 (1.4)10 (1.2)
Fetal
  Any fetal heart rate abnormality150 (17.0)123 (14.5)
  Bradycardia36 (4.1)26 (3.1)
  Deceleration
    Late25 (2.8)18 (2.1)
    Variable38 (4.3)29 (3.4)
    Unspecified19 (2.1)19 (2.2)

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 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 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 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).

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5Pm ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.