U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Surveillance: Post Drug-Approval Activities
  5. FDA's Adverse Event Reporting System (FAERS)
  6. Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between July - September 2014
  1. FDA's Adverse Event Reporting System (FAERS)

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between July - September 2014


Product Name: Active Ingredient (Trade) or Product Class
Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of October 1, 2014)
Xenazine (Tetrabenazine) Death FDA decided that no action is necessary at this time based on available information.
Regadenoson (Lexiscan) Seizures, worsening or recurrence of seizures after use of aminophylline, cerebrovascular accident, and atrial fibrillation/atrial flutter The Warnings and Precautions section of the labeling for Lexiscan was updated in September 2014 to include:
  • seizure
  • warning not to use aminophylline in patients who have seizures after receiving regadenoson
  • cerebrovascular accident
  • atrial fibrillation/atrial flutter
Back to Top