U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Surveillance: Post Drug-Approval Activities
  5. Questions and Answers on 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 April - June 2014
  1. Questions and Answers on 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 April - June 2014


Product Name: Active Ingredient (Trade) or Product Class
Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of January 27, 2020)
Everolimus (Zortress) Pulmonary hypertension; Pulmonary arterial hypertension

The Warnings and Precautions section of the everolimus labeling was updated November 2015 to include information about pulmonary hypertension and pulmonary arterial hypertension.


Zortress label

Back to Top