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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)
(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)|
|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).
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 Prepidil (dinoprostone cervical gel) Side Effects Center for a complete guide to possible side effects
PREPIDIL (dinoprostone cervical gel) Gel may augment the activity of other oxytocic agents and their concomitant use is not recommended. For the sequential use of oxytocin following PREPIDIL (dinoprostone cervical gel) Gel administration, a dosing interval of 6–12 hours is recommended.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/26/2010
Additional Prepidil Information
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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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