Label Changes for:

Razadyne ER (galantamine HBr) Extended-Release Capsules 

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

 

 

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
Hide
(web1)