Budesonide
Active ingredient · 4 therapeutic classes
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- Drug class
- Corticosteroids Acting Locally
- Availability
- Prescription and OTC
- Routes
- Inhalation, Nasal, Oral, Rectal, Respiratory (Inhalation)
- Markets covered
- 4
- Products on record
- 400
- FDA reports (12 mo)
- 11,852
Overview
Plain-language summary, compiled from the cited regulatory records
Budesonide is a medication classified as a locally acting corticosteroid [1]. It is approved for the temporary relief of nasal congestion, runny nose, itchy nose, and sneezing associated with hay fever and other upper respiratory allergies [1].
This active ingredient is available under various brand names, including PULMICORT FLEXHALER [1]. In the past 12 months, there have been 11,852 adverse event reports associated with budesonide [2]. The most frequently reported issues in these reports include dyspnoea, product dose omission, issues with the device delivery system, off-label use, and the drug being perceived as ineffective [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 365 | May 29, 2026 |
| CA Canada | Health Canada | 25 | May 4, 2026 |
| US United States | FDA | 5 | February 27, 2026 |
| EU European Union | EMA | 5 | April 23, 2026 |
GBUnited Kingdom· MHRA
365 products
Uses
Regular treatment of persistent asthma. Note: budesonide is not intended to be used as a reliever of acute asthma.
How to take
CACanada· Health Canada
25 products
Uses
ENTOCORT ENEMA (budesonide dispersible tablets) is indicated for: • the management of distal ulcerative colitis (rectum, sigmoid and descending colon). 3 Pediatrics). 2 Geriatrics Geriatrics (≥65 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
How to take
USUnited States· FDA
5 products
Uses
Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • itchy nose • sneezing
How to take
EUEuropean Union· EMA
5 products
Uses
8 g/g).
How to take
Drug interactions
Known interactions involving Budesonide. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL463020185 · revised March 27, 2026
- [2]Health Canada (DPD) · 02052431 · revised July 15, 2025
- [3]FDA DailyMed · 04eb9e98-1323-35… · revised February 27, 2026 [PDF]
- [4]European Medicines Agency · EMEA/H/C/005653 · revised April 23, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.