PURPOSE: To evaluate reported ocular side effects associated with isotretinoin usage. METHODS: One thousand seven hundred forty-one case reports received from spontaneous reporting systems, data from the Drug Safety Section of Roche Pharmaceuticals, and the world's literature were evaluated using the World Health Organization Causality Assessment Guide of Suspected Adverse Reactions. RESULTS: Thirty-eight different signs or symptoms of ocular abnormalities associated with isotretinoin usage have been classified as 'certain,' 'probable/likely,' 'possible,' 'unlikely,' or 'conditional/unclassifiable.' CONCLUSION: Adverse ocular side effects secondary to isotretinoin that are 'certain' include abnormal meibomian gland secretion, blepharoconjunctivitis, corneal opacities, decreased dark adaptation, decreased tolerance to contact lens, decreased vision, increased tear osmolarity, keratitis, meibomian gland atrophy, myopia, ocular discomfort, ocular sicca, photophobia, and teratogenic ocular abnormalities. Those that are 'probable/likely' are decreased color vision (reversible) and permanent loss of dark adaptation. Those that have a 'possible' association include permanent keratoconjunctivitis sicca. Suggested guidelines for ocular examination for patients on isotretinoin are given.
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