Budesonide: Side Effects, Uses & Monitoring
1.1 Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.
- Data source
- FDA labeling via NIH DailyMed (label d2178406…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Respiratory infection | 38% |
| Rhinitis | 12% |
| Otitis media | 12% |
| Coughing | 9% |
| Viral infection | 5% |
| Gastroenteritis | 5% |
| Ear infection | 5% |
| Moniliasis | 4% |
| Vomiting | 4% |
| Diarrhea | 4% |
| Epistaxis | 4% |
| Conjunctivitis | 4% |
| Rash | 4% |
| Abdominal pain | 3% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
1.1 Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.
Frequently Asked Questions
What is Budesonide used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Budesonide?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Budesonide. Individual risk varies.
Does Budesonide require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Budesonide.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.