Cervidil
SIDE EFFECTS
Cervidil (dinoprostone) is well tolerated. In placebo-controlled trials in which 658 women were entered and 320 received active therapy (218 without retrieval system, 102 with retrieval system), the following events were reported.
Table 1 : Total Cervidil (dinoprostone) - Treated Drug Related Adverse Events
| Controlled Studies1 | ||
| Active | Placebo | |
| Uterine hyperstimulation with fetal distress | 2.8% | 0.3% |
| Uterine hyperstimulation without fetal distress | 4.7% | 0% |
| Fetal Distress without uterine hyperstimulation | 3.8% | 1.2% |
| N | 320 | 338 |
| STUDY 101-8012 | ||
| Active | Placebo | |
| Uterine hyperstimulation with fetal distress | 2.9% | 0% |
| Uterine hyperstimulation without fetal distress | 2.0% | 0% |
| Fetal Distress without uterine hyperstimulation | 2.9% | 1.0% |
| N | 102 | 104 |
| 1Controlled Studies (with and
without retrieval system) 2Controlled Study (with retrieval system) |
||
Drug related fever, nausea, vomiting, diarrhea, and abdominal pain were noted in less than 1% of patients who received Cervidil (dinoprostone) .
In study 101-801 (with the retrieval system) cases of hyperstimulation reversed within 2 to 13 minutes of removal of the product. Tocolytics were required in one of the five cases.
In cases of fetal distress, when product removal was thought advisable there was a return to normal rhythm and no neonatal sequelae.
Five minute Apgar scores were 7 or above in 98.2% (646/658) of studied neonates whose mothers received Cervidil (dinoprostone) . In a report of a 3 year pediatric follow-up study in 121 infants, 51 of whose mothers received Cervidil (dinoprostone) , there were no deleterious effects on physical examination or psychomotor evaluation (18).
Post-marketing surveillance
Immune System Disorders: Hypersensitivity
Blood and lymphatic system disorders: Disseminated Intravascular Coagulation (See WARNINGS Section)
Reproductive system: Reports of uterine rupture have been reported in association with use of Cervidil (dinoprostone) some required a hysterectomy and some resulted in subsequent fetal or neonatal death.
Vascular Disorders: Hypotension
Pregnancy, Puerperium and Perinatal Conditions: Amniotic fluid embolism
Drug Abuse And Dependence
No drug abuse or dependence has been seen with the use of Cervidil (dinoprostone) .
Read the Cervidil (dinoprostone) Side Effects Center for a complete guide to possible side effects »
DRUG INTERACTIONS
Cervidil (dinoprostone) may augment the activity of oxytocic agents and their concomitant use is not recommended. A dosing interval of at least 30 minutes is recommended for the sequential use of oxytocin following the removal of the dinoprostone vaginal insert. No other drug interactions have been identified.
Last reviewed on RxList: 6/17/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Cervidil Information
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