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PREPIDIL® (dinoprostone) 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 Reaction PGE2
(N = 884)
Control*
(N = 847)
*
placebo gel or no treatment
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 36 (4.1) 26 (3.1)
  Deceleration
    Late 25 (2.8) 18 (2.1)
    Variable 38 (4.3) 29 (3.4)
    Unspecified 19 (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).

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