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Dinoprostone topical Side Effects

In Summary

More frequently reported side effects include: hypertonic uterine contractions. See below for a comprehensive list of adverse effects.

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. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

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

Minor Side Effects

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


Uncommon (0.1% to 1%): Nausea, vomiting, diarrhea, abdominal pain[Ref]


Very common (10% or more): Any fetal heart rate abnormality
Frequency not reported: Hearing impairment, neonatal distress, neonatal death, stillbirths, low Apgar score[Ref]


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]


Rare (0.01% to 0.1%): Postpartum disseminated intravascular coagulation
Frequency not reported: Elevated WBC[Ref]


Frequency not reported: Dehydration[Ref]


Frequency not reported: Back pain, joint inflammation or pain new or exacerbated, muscle cramp or pain, nocturnal leg cramps[Ref]


Frequency not reported: Dyspnea, coughing, pharyngitis, laryngitis, wheezing, tightness in chest, pharyngitis, laryngitis[Ref]


Frequency not reported: Rash, diaphoresis, skin discoloration[Ref]


Frequency not reported: Blurred vision, eye pain[Ref]


Frequency not reported: Anaphylactic reactions (including anaphylactic shock)[Ref]


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]


Frequency not reported: Tension[Ref]


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

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

3. Cerner Multum, Inc. "Australian Product Information." O 0

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

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.