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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using unoprostone ophthalmic and call your doctor at once if you have any of these serious side effects:

• redness, swelling, itching, or pain in or around your eye;

• oozing or discharge from your eye;

• increased sensitivity to light; or

• vision changes.

Less serious side effects of unoprostone ophthalmic may include:

• cold or flu symptoms such as fever, chills, runny nose, sore throat, cough, diarrhea, and body aches;

• headache, dizziness;

• mild eye discomfort;

• blurred vision;

• feeling like something is in your eye;

• dry or watery eyes; or

• stinging or burning of the eyes after using the drops.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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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