Prepidil Side Effects
Generic Name: dinoprostone topical
Note: This document contains side effect information about dinoprostone topical. Some of the dosage forms listed on this page may not apply to the brand name Prepidil.
Some side effects of Prepidil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to dinoprostone topical: vaginal gel/jelly, vaginal insert extended release, vaginal suppository, vaginal tampon
Along with its needed effects, dinoprostone topical (the active ingredient contained in Prepidil) 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
- 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
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
- Chills or shivering
- 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
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.
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.
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.
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.
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.
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.
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.
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.
Postpartum disseminated intravascular coagulation has been reported rarely (less than 1 per 1000 labors).
Metabolic side effects associated with dinoprostone vaginal suppository have included dehydration.
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.
Respiratory side effects associated with dinoprostone vaginal suppository have included dyspnea, coughing, pharyngitis, laryngitis, and wheezing.
Dermatologic side effects associated with dinoprostone vaginal suppository have included rash, diaphoresis, and skin discoloration.
Ocular side effects associated with dinoprostone vaginal suppository have included blurred vision and eye pain.
Hypersensitivity side effects associated with dinoprostone vaginal insert have included hypersensitivity during postmarketing experience.
More about Prepidil (dinoprostone topical)
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