Cervidil Side Effects
Please note - some side effects for Cervidil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Cervidil Side Effects - for the Professional
Cervidil
Cervidil 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.
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1Controlled Studies (with and without retrieval system) |
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2Controlled Study (with retrieval system) |
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| 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 |
In Postmarketing Experience Reports, uterine rupture has been reported in association with the use of Cervidil.
Drug related fever, nausea, vomiting, diarrhea, and abdominal pain were noted in less than 1% of patients who received Cervidil.
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. In a report of a 3 year pediatric follow-up study in 121 infants, 51 of whose mothers received Cervidil, there were no deleterious effects on physical examination or psychomotor evaluation (18).
TopSide Effects by Body System
Genitourinary
Genitourinary side effects including uterine stimulation with or without fetal distress has been reported.
Gastrointestinal
Gastrointestinal side effects including nausea, vomiting, diarrhea, and abdominal pain have been reported in less than 1% of patients.
Other
Other side effects including drug related fever have been reported in less than 1% of patients.
TopMore resources:
Cervidil Cervical/Vaginal - Includes detailed dosage instructions.
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