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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

Along with its needed effects, dinoprostone topical 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

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

  • 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]

References

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

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

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

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

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

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.

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