Note: This document contains side effect information about dinoprostone topical. Some dosage forms listed on this page may not apply to the brand name Cervidil.
Summary
More frequent side effects include: hypertonic uterine contractions. Continue reading for a comprehensive list of adverse effects.
Applies to dinoprostone topical: vaginal gel/jelly, vaginal insert extended release.
Warning
Vaginal route (Suppository)
Dinoprostone should be used with strict adherence to recommended dosages and only by medically trained personnel in a hospital setting that can provide immediate intensive care and acute surgical facilities.
Serious side effects of Cervidil
Along with its needed effects, dinoprostone topical (the active ingredient contained in Cervidil) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking dinoprostone topical:
Less common or rare
- Fast or slow heartbeat
- hives
- increased pain of the uterus
- pale, cool, blotchy skin on arms or legs
- pressing or painful feeling in chest
- shortness of breath
- swelling of face, inside the nose, and eyelids
- tightness in chest
- trouble in breathing
- weak or absent pulse in arms or legs
- wheezing
Other side effects of Cervidil
Some side effects of dinoprostone topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Abdominal or stomach cramps
- diarrhea
- fever
- nausea
- vomiting
Less common or rare
- Chills or shivering
- constipation
- flushing
- headache
- swelling of the genital area (vulva)
- tender or mildly bloated abdomen or stomach
This procedure may still result in some effects, which occur after the procedure is completed, that need medical attention. Check with your doctor if any of the following side effects occur while taking dinoprostone topical:
- Chills or shivering (continuing)
- fever (continuing)
- foul-smelling vaginal discharge
- pain in lower abdomen
- unusual increase in bleeding of the uterus
For Healthcare Professionals
Applies to dinoprostone topical: vaginal gel, vaginal insert, vaginal suppository.
Gastrointestinal
Uncommon (0.1% to 1%): Nausea, vomiting, diarrhea, abdominal pain[Ref]
Other
Very common (10% or more): Any fetal heart rate abnormality
Frequency not reported: Hearing impairment, neonatal distress, neonatal death, stillbirths, low Apgar score[Ref]
Cardiovascular
Common (1% to 10%): Hypotension, bradycardia
Frequency not reported: Flushing or hot flashes, chest pain, cardiac arrhythmia[Ref]
Nervous system
Uncommon (0.1% to 1%): Fever
Frequency not reported: Headache, dizziness, weakness, tremor, paresthesia[Ref]
Hematologic
Rare (0.01% to 0.1%): Postpartum disseminated intravascular coagulation
Frequency not reported: Elevated WBC[Ref]
Metabolic
Frequency not reported: Dehydration[Ref]
Musculoskeletal
Frequency not reported: Back pain, joint inflammation or pain new or exacerbated, muscle cramp or pain, nocturnal leg cramps[Ref]
Respiratory
Frequency not reported: Dyspnea, coughing, pharyngitis, laryngitis, wheezing, tightness in chest, pharyngitis, laryngitis[Ref]
Dermatologic
Frequency not reported: Rash, diaphoresis, skin discoloration[Ref]
Ocular
Frequency not reported: Blurred vision, eye pain[Ref]
Hypersensitivity
Frequency not reported: Anaphylactic reactions (including anaphylactic shock)[Ref]
Genitourinary
Common (1% to 10%): Uterine hyperstimulation (with or without fetal distress), fetal distress without uterine hyperstimulation, warm feeling in vagina
Frequency not reported: Uterine hypertonus, uterine rupture, placenta abruptio, rapid cervical dilatation, vaginal pain, vaginal irritation, vaginitis or vulvitis, breast tenderness, vaginismus, genital edema, transient vasovagal symptoms (flushing, shivering, headache, dizziness)[Ref]
Psychiatric
Frequency not reported: Tension[Ref]
