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, vaginal insert, vaginal suppository

Get emergency medical help if you have any of these signs of an allergic reaction while taking dinoprostone topical (the active ingredient contained in Prepidil) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if your contractions slow down or become uneven, or if you have:

• fever;

• sudden vaginal bleeding;

• cough, wheezing, chest tightness, trouble breathing; or

• pale skin, blue colored lips.

After your baby is born, seek emergency medical attention if you have any signs of excessive bleeding, such as:

• weakness or fainting;

• unusual bleeding from your nose, mouth, vagina, or rectum;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• unusual bruising, purple or red pinpoint spots under your skin;

• bleeding from a wound, surgical incision, or vein where an IV was placed;

• any bleeding that will not stop.

Less serious side effects of dinoprostone topical may include:

• nausea, stomach pain;

• back pain; or

• feeling of warmth in the vaginal area.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

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.

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

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

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

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

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

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

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

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.

Respiratory

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

Dermatologic

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

Ocular

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

Hypersensitivity

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

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