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

Author:

Rathi Vinay K.1,Sawicki Nicholas W.2,Schlosser Rodney J.13,Soler Zachary M.1,Scangas George A.45,Workman Alan D.45,Gray Stacey T.45

Affiliation:

1. Division of Rhinology and Sinus Surgery Department of Otolaryngology – Head and Neck Surgery Medical University of South Carolina Charleston South Carolina USA

2. Brown University Providence Rhode Island USA

3. Department of Surgery Ralph H. Johnson VA Medical Center Charleston South Carolina USA

4. Department of Otolaryngology Harvard Medical School Boston Massachusetts USA

5. Department of Otolaryngology – Head and Neck Surgery Massachusetts Eye & Ear Infirmary Boston Massachusetts USA

Abstract

KEYPOINTS 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.

Funder

National Institute on Deafness and Other Communication Disorders

National Institutes of Health

Publisher

Wiley

Subject

Otorhinolaryngology,Immunology and Allergy

Reference15 articles.

1. U.S. Food and Drug Administration.Highlights of Prescribing Information: Pulmicort Respules. Published September 6 2019. Accessed May 7 2023.https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020929s052lbl.pdf

2. Safety of budesonide in saline sinonasal irrigations in the management of chronic rhinosinusitis with polyposis: lack of significant adrenal suppression;Bhalla RK;J Otolaryngol ‐ Head Neck Surg J Oto‐Rhino‐Laryngol Chir Cervico‐Faciale,2008

3. Distribution of topical agents to the paranasal sinuses: an evidence-based review with recommendations

4. Is topical high-volume budesonide sinus irrigation safe?

5. Safety of long-term high-volume sinonasal budesonide irrigations for chronic rhinosinusitis

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