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
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
