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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.