Adverse events associated with budesonide nasal irrigation reported to the US Food and Drug Administration: 2007 to 2022

Abstract

Between 2007 and 2022, the FDA received 119 US-based reports mentioning budesonide nasal irrigation. Most reports were submitted by patients and alerted FDA to off-label usage of budesonide. Notable adverse events reported to the FDA included headache, dyspnea, and blurred vision.

Keywords: FDA; adverse events; budesonide; chronic rhinosinusitis; irrigation; nasal polyposis; safety.