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U.S. Department of Health and Human Services


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Elestat (epinastine hydrochloride ophthalmic solution) 0.05%

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011


Summary View



Postmarketing Experience
  • The following reactions have been identified during postmarketing use of Elestat in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Elestat, or a combination of these factors, include: lacrimation increased.