This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.

Budesonide

corticosteroid

Last updated: June 17, 2026

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Budesonide is a medication, a corticosteroid. According to the FDA-approved label, s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • itchy nose • sneezing. FAERS contains 57,446 submissions naming this drug from 2002 through 2026; the top three reactions cited are dyspnoea, drug ineffective, and off label use.

Most-Reported Reactions

Counts of the reactions most often cited in FAERS submissions that named Budesonide. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.

Patient Demographics

Patient sex and age across the FAERS submissions that named Budesonide. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.

By Sex

By Age Group

Severity Outcomes

Severity flags recorded across the 57,446 FAERS submissions that named Budesonide. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.

Submissions Per Quarter

Quarterly count of FAERS submissions that named Budesonide. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.

From the FDA-Approved Label

Excerpts from the official FDA-approved prescribing information for Budesonide. This is the authoritative source on indications, warnings, and known adverse reactions.

Indications

s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • itchy nose • sneezing

Warnings

Do not use in children under 6 years of age if you have ever had an allergic reaction to any of the ingredients Ask a doctor before use if you have had recent nose ulcers or nose surgery have had a nose injury that has not healed are using a steroid medicine for asthma, allergies or skin rash have an eye infection have or had glaucoma or cataracts When using this product the growth rate of some children may be slower some symptoms may get better on the first day of treatment. It may take up to two weeks of daily use to feel the most symptom relief. do not share this bottle with anyone else as this may spread germs remember to tell your doctor about all the medicines you take, including this one Stop use and ask a doctor if you have, or come into contact with someone who has, chickenpox, measles or tuberculosis you have or develop symptoms of an infection such as persistent fever you have any change in vision you have severe or frequent nosebleeds If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

FDA label effective date: 2026-02-27

Disclaimer

AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.