Note: This document contains side effect information about dinoprostone topical. Some dosage forms listed on this page may not apply to the brand name Prepidil.

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

Serious side effects of Prepidil

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
• 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 Prepidil

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]