Cervidil Side Effects

Generic Name: dinoprostone topical

Note: This page contains information about the side effects of dinoprostone topical. Some of the dosage forms included on this document may not apply to the brand name Cervidil.

Not all side effects for Cervidil may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to dinoprostone topical: vaginal gel/jelly, vaginal insert extended release, vaginal suppository, vaginal tampon

In addition to its needed effects, some unwanted effects may be caused by dinoprostone topical (the active ingredient contained in Cervidil). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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

Some of the side effects that can occur with dinoprostone topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

General

Dinoprostone cervical gel and vaginal insert are generally well tolerated. The most frequent side effects reported with the use of dinoprostone vaginal suppository for abortion are related to its contractile effect on smooth muscle.[Ref]

Genitourinary

In one study, cases of hyperstimulation reversed within 2 to 13 minutes of removal of dinoprostone vaginal insert.

In cases of fetal distress, when removal of dinoprostone vaginal insert was thought advisable there was a return to normal rhythm and no neonatal sequelae.[Ref]

Genitourinary side effects associated with dinoprostone cervical gel have included uterine contractile abnormality (6.6%), warm feeling in vagina (1.5%), amnionitis, intrauterine fetal sepsis, uterine rupture, and premature rupture of membranes. Uterine hyperstimulation with fetal distress (up to 2.9%), uterine hyperstimulation without fetal distress (up to 4.7%), and fetal distress without uterine hyperstimulation (up to 3.8%) have been reported with dinoprostone vaginal insert. Cases of uterine rupture (some requiring hysterectomy and some resulting in subsequent fetal or neonatal death) associated with dinoprostone vaginal insert have been reported during postmarketing experience. Vaginal pain, endometritis, vaginitis or vulvitis, uterine rupture, breast tenderness, urine retention, and vaginismus have been reported with dinoprostone vaginal suppository.[Ref]

Gastrointestinal

Gastrointestinal side effects associated with dinoprostone cervical gel have included unspecified gastrointestinal effect (5.7%). Nausea, vomiting, diarrhea, and abdominal pain have been reported with dinoprostone vaginal insert in less than 1% of patients. Vomiting (about 67%), diarrhea (about 40%), and nausea (about 33%) have been reported with dinoprostone vaginal suppository.[Ref]

Other

Other side effects associated with dinoprostone cervical gel have included back pain (3.1%) and fever (1.4%). Drug related fever has been reported with dinoprostone vaginal insert in less than 1% of patients. Temperature elevations/fever (about 50%), shivering and/or chills (about 10%), backache, flushing or hot flashes, chest pain, tightness in chest, stiff neck, and tension have been reported with dinoprostone vaginal suppository.[Ref]

Cardiovascular

Cardiovascular side effects associated with dinoprostone vaginal insert have included hypotension and amniotic fluid embolism during postmarketing experience. Transient diastolic blood pressure decreases (about 10%) and cardiac arrhythmias have been reported with dinoprostone vaginal suppository. At least 2 cases of myocardial infarction following the use of dinoprostone vaginal suppository have been reported in patients with a history of cardiovascular disease.[Ref]

Nervous system

Nervous system side effects associated with dinoprostone vaginal suppository have included headache (about 10%), dizziness, syncope or fainting sensation, nocturnal leg cramps, tremor, paresthesia, and hearing impairment.[Ref]

Hematologic

Postpartum disseminated intravascular coagulation has been reported rarely (less than 1 per 1000 labors).[Ref]

Hematologic side effects reported during postmarketing experience have included an increased risk of postpartum disseminated intravascular coagulation in patients whose labor was induced by pharmacological means, either with dinoprostone or oxytocin.[Ref]

Metabolic

Metabolic side effects associated with dinoprostone vaginal suppository have included dehydration.[Ref]

Musculoskeletal

Musculoskeletal side effects associated with dinoprostone vaginal suppository have included new or exacerbated joint inflammation or pain, arthralgia, weakness, muscular cramp or pain, and myalgia.[Ref]

Respiratory

Respiratory side effects associated with dinoprostone vaginal suppository have included dyspnea, coughing, pharyngitis, laryngitis, and wheezing.[Ref]

Dermatologic

Dermatologic side effects associated with dinoprostone vaginal suppository have included rash, diaphoresis, and skin discoloration.[Ref]

Ocular

Ocular side effects associated with dinoprostone vaginal suppository have included blurred vision and eye pain.[Ref]

Hypersensitivity

Hypersensitivity side effects associated with dinoprostone vaginal insert have included hypersensitivity during postmarketing experience.[Ref]

References

1. "Product Information. Prepidil (dinoprostone topical)" Pharmacia and Upjohn, Kalamazoo, MI.

2. "Product Information. Prostin E2 Suppository (dinoprostone topical)." Pharmacia and Upjohn, Kalamazoo, MI.

3. "Product Information. Cervidil (dinoprostone topical)." Forest Pharmaceuticals, St. Louis, MO.

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