Unoprostone ophthalmic Side Effects

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.

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.

Ocular side effects have included burning and stinging, burning and stinging upon drug instillation, dry eyes, itching of eyes, increased or decreased length of eyelashes, and injection in 10% to 25% of patients. Abnormal vision, eyelid disorder, foreign body sensation, and lacrimation disorder have been reported in 5% to 10% of patients. Blepharitis, cataract, conjunctivitis, corneal lesion, discharge from the eye, eye hemorrhage, eye pain, keratitis, irritation, photophobia, and vitreous disorder have been reported rarely. Acute elevated intraocular pressure, color blindness, corneal deposits, corneal edema, corneal opacity, cystoid macular edema, diplopia, hyperpigmentation of the eyelid, increased number of eyelashes, iris hyperpigmentation, iritis, macular edema, optic atrophy, retinal hemorrhage, and visual field disturbance have also been reported.

Respiratory

Respiratory side effects have included increased cough, pharyngitis, rhinitis, sinusitis, and bronchitis in 1% to 5% of patients.

Nervous system

Nervous system side effects have included headache, dizziness and insomnia in 1% to 5% of patients.

Musculoskeletal

Musculoskeletal side effects have included back pain (1% to 5%).

Metabolic

Metabolic side effects have included diabetes mellitus (1% to 5%).

Cardiovascular

Cardiovascular side effects have included hypertension (1% to 5%).

Gastrointestinal

Gastrointestinal side effects have included nausea.

Other

Other side effects have included flu syndrome (6%), accidental injury (1% to 5%), and pain (1% to 5%).

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (1% to 5%).

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