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U.S. Department of Health and Human Services

Safety

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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

 

Summary View

 

CONTRAINDICATIONS
  • Bepreve is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients.
 
ADVERSE REACTIONS
Post-Marketing Experience
  • 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.