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Bepreve (bepotastine besilate) 1.5% ophthalmic solution
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2012
- Bepreve is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients.
- Hypersensitivity reactions have been reported rarely during the post-marketing use of Bepreve. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The hypersensitivity reactions may include itching, body rash, and swelling of lips, tongue and/or throat.