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.