Rescula
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Rescula
Rescula Side Effects Center
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 Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Rescula in Detail - Patient Information: Side Effects
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 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.
Read the entire detailed patient monograph for Rescula (Unoprostone isopropyl) »
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) »
Additional Rescula Information
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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