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Unoprostone ophthalmic Side Effects

In Summary

Commonly reported side effects of unoprostone ophthalmic include: burning sensation of eyes, conjunctival injection, eye pruritus, stinging of eyes, xerophthalmia, and increased eyelash length. Other side effects include: eyelid disease, visual disturbance, abnormal lacrimation, decreased eyelash length, and foreign body sensation. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to unoprostone ophthalmic: ophthalmic solution

Along with its needed effects, unoprostone ophthalmic 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 as soon as possible if any of the following side effects occur while taking unoprostone ophthalmic:

Less common
  • Blood in the whites of the eyes
  • blurred vision or eye pain
  • eye irritation or redness
Rare
  • Blindness
  • color blindness
  • decreased vision or other changes in vision

Some side effects of unoprostone ophthalmic 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
  • Abnormal tearing of eyes
  • burning or stinging of eyes
  • chills
  • cough
  • diarrhea
  • double vision
  • dry eyes
  • fever
  • general feeling of discomfort or illness
  • headache
  • itching of eyes
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • runny nose
  • shivering
  • sore throat
  • sweating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
Less common or rare
  • Discharge from eye
  • inflammation of the eye
  • redness, pain, swelling of eye, eyelid, or inner lining of eyelid
  • sensitivity to light

Some side effects of unoprostone ophthalmic 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
  • Feeling of having something in the eye
  • increased or decreased length of eyelashes
Less common or rare
  • Change in the color of the iris or eyelid
  • increase in number of eyelashes
  • difficulty seeing at night
  • increased sensitivity of eyes to sunlight

For Healthcare Professionals

Applies to unoprostone ophthalmic: ophthalmic solution

Ocular

Unoprostone ophthalmic may change the eye color. This is caused by a gradual increase of the brown pigment in the iris. The change in iris color is slow and may not be noticeable for months.

When administered to animals for 12 months, one of ten animals exhibited increased pigmentation of the iris.

The manufacturer reports after 12 months of therapy an increased length in eyelashes (>= 1 mm) in approximately 10% to 14% of patients and a decreased length in eyelashes in 7% of patients.[Ref]

Very common (10% or more): Burning/stinging, dry eyes, itching, increased length of eyelashes
Common (1% to 10%): Abnormal vision, eyelid disorder, foreign body sensation, lacrimation disorder, blepharitis, cataract, conjunctivitis, corneal lesion, discharge from the eye, eye hemorrhage, eye pain, keratitis, irritation, photophobia, vitreous disorder
Uncommon (0.1% to 1%): Acute elevated intraocular pressure, color blindness, corneal deposits, corneal edema, corneal opacity, diplopia, hyperpigmentation of the eyelid, increased number of eyelashes, iris hyperpigmentation, iritis, optic atrophy, ptosis, retinal hemorrhage, visual field defect, decrease in the length of eyelashes
Postmarketing reports: Corneal erosion, chemosis[Ref]

Respiratory

Common (1% to 10%): Bronchitis, increased cough, pharyngitis, rhinitis, sinusitis[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Metabolic

Common (1% to 10%): Diabetes mellitus[Ref]

Cardiovascular

Common (1% to 10%): Hypertension
Postmarketing reports: Palpitations[Ref]

Gastrointestinal

Postmarketing reports: Dry mouth, nausea, vomiting[Ref]

Other

Common (1% to 10%): Accidental injury, pain[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction[Ref]

General

The most commonly reported side effects were burning/stinging, dry eyes, itching, and increased length of eyelashes.[Ref]

Immunologic

Common (1% to 10%): Flu-like syndrome[Ref]

Psychiatric

Common (1% to 10%): Insomnia[Ref]

References

1. "Product Information. Rescula (unoprostone ophthalmic)" Ciba Vision Ophthalmics, Duluth, GA.

Some side effects of unoprostone ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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