Safety

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)  

February 2015

Summary View

WARNINGS AND PRECAUTIONS

Serious Skin Reactions
  • Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving Razadyne  ER and Razadyne. Inform patients and caregivers that the use of Razadyne ER or Razadyne should be discontinued at the first appearance of a skin rash, unless the rash is clearly not drug-related. If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed and alternative therapy should be considered.

 

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

 

Page Last Updated: 03/11/2015
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