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Rescula

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Rescula

Rescula Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Rescula (unoprostone isopropyl) Ophthalmic Solution reduces pressure in the eye by increasing the amount of fluid that drains from the eye and is used to treat certain types of glaucoma and other causes of high pressure inside the eye. Common side effects 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.

The recommended dosage of Rescula is one drop in the affected eye(s) twice daily. Rescula may interact with other drugs. Tell your doctor all medications and supplements you use. Rescula may be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Rescula (unoprostone isopropyl) Ophthalmic Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Rescula FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In clinical studies, the most common ocular adverse reactions with use of Rescula were burning/stinging, burning/stinging upon drug instillation, dry eyes, itching, increased length of eyelashes, and injection. These were reported in approximately 10-25% of patients. Approximately 10-14% of patients were observed to have an increase in the length of eyelashes ( ≥ 1 mm) at 12 months, while 7% of patients were observed to have a decrease in the length of eyelashes.

Ocular adverse reactions occurring in approximately 5-10% of patients were abnormal vision, eyelid disorder, foreign body sensation, and lacrimation disorder.

Ocular adverse reactions occurring in approximately 1-5% of patients were blepharitis, cataract, conjunctivitis, corneal lesion, discharge from the eye, eye hemorrhage, eye pain, keratitis, irritation, photophobia, and vitreous disorder.

Other ocular adverse reactions reported in less than 1% of patients were 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, and visual field defect.

The most frequently reported nonocular adverse reaction associated with the use of Rescula in the clinical trials was flu-like syndrome that was observed in approximately 6% of patients. Nonocular adverse reactions reported in the 1-5% of patients were accidental injury, allergic reaction, back pain, bronchitis, increased cough, diabetes mellitus, dizziness, headache, hypertension, insomnia, pharyngitis, pain, rhinitis, and sinusitis.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Rescula. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Voluntary reports of adverse reactions occurring with the use of Rescula include corneal erosion.

There have been rare spontaneous reports with a different formulation of unoprostone isopropyl (0.12%) of chemosis, dry mouth, nausea, vomiting and palpitations.

Read the entire FDA prescribing information for Rescula (Unoprostone isopropyl) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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