Safety

Synarel (nafarelin acetate) Nasal Solution 2mg/mL

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

August 2015

Summary View

ADVERSE REACTIONS

Post-marketing
  • Reproductive system adverse events: Cases of ovarian hyperstimulation syndrome have been reported with Synarel monotherapy when used for Assisted Reproductive Technology which is not an approved indication.

 

January 2012

Summary View

ADVERSE REACTIONS [Labeling for endometriosis]

Post-marketing 

Central/peripheral nervous adverse events: 

  • Convulsion

Hepatic adverse events: 

  • Rarely reported serious liver injury

ADVERSE REACTIONS [Labeling for central precocious puberty]

Post-marketing

Central/peripheral nervous adverse events: 

  • Convulsion  

 

January 2011 

Summary View 

ADVERSE REACTIONS

Postmarketing
  • Cardiovascular adverse events: Cases of serious venous and arterial thromboembolism have been reported, including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, and transient ischemic attack. Although a temporal relationship was reported in some cases, most cases were confounded by risk factors or concomitant medication use. It is unknown if there is a causal association between the use of GnRH analogs and these events. 

Page Last Updated: 09/10/2015
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