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U.S. Department of Health and Human Services

Safety

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Razadyne (galantamine hydrobromide) Tablets, Oral Solution, and Razadyne ER (galantamine HBr) Extended-Release Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2012

 

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • Gastrointestinal System Disorders: upper and lower GI bleeding, stomach discomfort, abdominal discomfort
  • Nervous System Disorders: lethargy, dysgeusia, hypersomnia
  • Eye Disorders: vision blurred
  • Immune System Disorders: Hypersensitivity
  • Hepatobiliary Disorders: elevated liver enzymes, hepatitis
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