FDA label 8550ca6e-db0b-463a-a2fe-1cd0360cf734

WARNINGS Not for injection or oral ingestion. FOR TOPICAL OPHTHALMIC USE ONLY.

ADVERSE REACTIONS In clinical studies the overall discontinuation rate related to apraclonidine ophthalmic solution was 15%. The most commonly reported events leading to discontinuation included (in decreasing order of frequency) hyperemia, pruritus, tearing, discomfort, lid edema, dry mouth, and foreign body sensation. The following adverse reactions (incidences) were reported in clinical studies of apraclonidine ophthalmic solution as being possibly, probably, or definitely related to therapy: Ocular The following adverse reactions were reported in 5 to 15% of the patients: discomfort, hyperemia, and pruritus. The following adverse reactions were reported in 1 to 5% of the patients: blanching, blurred vision, conjunctivitis, discharge, dry eye, foreign body sensation, lid edema, and tearing. The following adverse reactions were reported in less than 1% of the patients: abnormal vision, blepharitis, blepharoconjunctivitis, conjunctival edema, conjunctival follicles, corneal erosion, corneal infiltrate, corneal staining, edema, irritation, keratitis, keratopathy, lid disorder, lid erythema, lid margin crusting, lid retraction, lid scales, pain, photophobia. Nonocular Dry mouth occurred in approximately 10% of the patients. The following adverse reactions were reported in less than 3% of the patients: abnormal coordination, asthenia, arrhythmia, asthma, chest pain, constipation, contact dermatitis, depression, dermatitis, dizziness, dry nose, dyspnea, facial edema, headache, insomnia, malaise, myalgia, nausea, nervousness, paresthesia, parosmia, peripheral edema, pharyngitis, rhinitis, somnolence, and taste perversion. Clinical practice The following events have been identified during post-marketing use of apraclonidine ophthalmic solution in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to apraclonidine ophthalmic solution, or a combination of these factors, include: bradycardia and hypersensitivity.