OpenClaim

Budesonide Side Effects

The most commonly reported side effects of budesonide include dyspnoea, asthma, and off label use, based on 185,334 FDA adverse event reports from 2004 to 2025. 7.5% of reports found the drug to be ineffective.

Budesonide side effects

Percentages show how often each reaction appears relative to total reports for budesonide.

1
Dyspnoea13.4%24,845
2
Asthma9.4%17,501
3
Off Label Use7.6%14,086
4
Drug Ineffective7.5%13,893
5
Cough6.5%12,065
6
Fatigue5.3%9,832
7
Pneumonia4.9%8,994
8
Wheezing4.7%8,653
9
Headache4.4%8,221
10
Nausea4.0%7,330
11
Malaise3.9%7,182
12
Diarrhoea3.7%6,846
13
Death3.3%6,158
14
Pain3.2%5,915
15
Condition Aggravated3.2%5,844

These are voluntary reports and do not establish that budesonide caused these reactions.

Report severity

62.4%Serious115,725 reports
29.7%Hospitalizations55,063 reports
6.9%Fatal12,745 reports

Seriousness is determined by the reporter, not by OpenClaim.

Budesonide drug interactions

Other drugs that appear in adverse event reports alongside budesonide. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Formoterol25.8%47,878
2
Albuterol6.4%11,894
3
Tiotropium-bromide4.8%8,855
4
Prednisone4.6%8,514
5
Adalimumab4.4%8,079
6
Glycopyrrolate4.0%7,432
7
Omalizumab3.9%7,194
8
Dupilumab3.8%7,059
9
Mepolizumab3.5%6,424
10
Montelukast-sodium3.3%6,116
11
Fluticasone3.1%5,762
12
Infliximab2.8%5,137
13
Vedolizumab2.7%5,032
14
Ipratropium-bromide1.8%3,347
15
Pantoprazole-sodium1.7%3,234

Taken alongside

1
Formoterol33.5%62,093
2
Albuterol27.7%51,388
3
Montelukast-sodium11.9%22,076
4
Acetaminophen10.7%19,754
5
Prednisone10.5%19,404
6
Ergocalciferol9.9%18,412
7
Fluticasone9.4%17,486
8
Tiotropium-bromide9.2%17,085
9
Aspirin8.8%16,276
10
Omeprazole8.5%15,766
11
Levothyroxine-sodium7.9%14,654
12
Furosemide7.8%14,448
13
Atorvastatin-calcium7.1%13,132
14
Pantoprazole-sodium6.2%11,518
15
Amlodipine6.1%11,320

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports budesonide side effects

56.9% of budesonide adverse event reports involve female patients and 34.3% involve male patients. The largest age group is adult at 52%. These figures reflect who reports side effects, not underlying risk.

Sex

Female56.9%
Male34.3%
Unknown8.7%

Age group

< 21.0%
2–113.2%
12–172.3%
18–6451.9%
65+41.6%

What is budesonide used for

Conditions and purposes for which patients were taking budesonide when the adverse event was reported.

Abdominal DiscomfortAbdominal PainAbdominal Pain UpperAccidental Exposure To ProductActinomycotic Pulmonary InfectionAcute Graft Versus Host DiseaseAcute Graft Versus Host Disease In IntestineAcute Graft Versus Host Disease In LiverAcute Graft Versus Host Disease In SkinAcute Graft Versus Host Disease OralAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAcute Pulmonary OedemaAcute Respiratory Distress SyndromeAcute Respiratory Failure

Showing 15 of 1,547 indications

Budesonide brand names and reporting trend

Budesonide is sold under the brand name Symbicort Aerosphere.

Brand names

Symbicort Aerosphere51,223

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking budesonide with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.