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  1. FDA Adverse Event Monitoring System (AEMS)

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
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