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Prostin E2 Side Effects

Generic name: dinoprostone topical

Medically reviewed by Drugs.com. Last updated on Oct 2, 2023.

Note: This document contains side effect information about dinoprostone topical. Some dosage forms listed on this page may not apply to the brand name Prostin E2.

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 Prostin E2

Along with its needed effects, dinoprostone topical (the active ingredient contained in Prostin E2) 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

Other side effects of Prostin E2

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

Less common or rare

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:

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]

References

1. Product Information. Prostin E2 (dinoprostone topical). Apothecon Inc. 2022.

2. Product Information. Prepidil (dinoprostone topical). Pharmacia and Upjohn. 2001;PROD.

3. Product Information. Cervidil (dinoprostone topical). Forest Pharmaceuticals. 2002.

4. Cerner Multum, Inc. UK Summary of Product Characteristics.

5. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.