BUDESONIDE

Generic: BUDESONIDE

WalgreensManufacturer
NASALRoute
BUDESONIDEActive Substance
2014-05-12Original Approval

BUDESONIDE is FDA application ANDA078949, sponsored by APOTEX. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2024-01-08
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort

Failed Dissolution Specifications

Class II2026-05-29
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pou

Presence of Foreign Substance:This recall has been initiated in response to a product quality compla

Class II2025-06-30
Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

Class II2022-09-15
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules pe

Lack of Assurance of Sterility

Class II2021-03-15
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Top Reported Reactions

1
DRUG INEFFECTIVE
4,783 reports
2
DYSPNOEA
4,491 reports
3
OFF LABEL USE
4,349 reports
4
ASTHMA
3,572 reports
5
FATIGUE
2,543 reports
6
CONDITION AGGRAVATED
2,428 reports
7
HEADACHE
2,386 reports
8
DIARRHOEA
2,316 reports
9
COUGH
2,197 reports
10
PNEUMONIA
2,193 reports