Unoprostone Side Effects
Please note - some side effects for Unoprostone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects by Body System - for Healthcare Professionals
Applies to: 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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