PREPIDIL SIDE EFFECTS
- Generic Name: dinoprostone cervical gel
- Brand Name: Prepidil
- Drug Class: Abortifacient, Vaginal Preparations, Other
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. 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).
SRC: NLM .