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Label Changes for:

Razadyne (galantamine hydrobromide) Tablets, Oral Solution

March 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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




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