Drug · FAERS side-effect profile with label screen
Budesonide side effects: what 10,306 FDA adverse event reports show
Brand names
Pulmicort Flexhaler
openFDA label
Who reports
10,306 reports · 42% serious · 1,280 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
PULMICORT FLEXHALER is a corticosteroid indicated for: • Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 ) 1.1 Treatment of Asthma PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older.
FDA label, Indications and Usage
What it is
Budesonide, the active component of PULMICORT FLEXHALER, is a corticosteroid designated chemically as (RS)-11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S).
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 20Lab value / disease marker 1Not in label — unassessed 15
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 960 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug delivery system issue | 132 | 152.4 127.8–181.7ROR 154.3 · χ² 18,302 / p <1e-300 | 138.8 EB05 120.0 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=27 · 95% consumer | no trial data cached |
| Device use issue | 1,089 | 135.6 127.9–143.7ROR 151.3 · χ² 136,181 / p <1e-300 | 126.7 EB05 120.5 · IC025 +6.8 3/3 methods agree | Reporting / coding artifact | serious n=226 · 95% consumer | no trial data cached |
| Device delivery system issue | 1,579 | 129.9 123.9–136.1ROR 153.0 · χ² 189,669 / p <1e-300 | 121.8 EB05 116.8 · IC025 +6.8 3/3 methods agree | Reporting / coding artifact | serious n=272 · 95% consumer | no trial data cached |
| Wrong technique in product usage process performed in error | 17 | 121.8 74.7–198.6ROR 122.0 · χ² 1,807 / p <1e-300 | 102.0 EB05 67.4 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Device use confusion | 18 | 75.5 47.2–120.8ROR 75.6 · χ² 1,204 / p 5e-264 | 67.7 EB05 45.3 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Incorrect dose administered by device | 803 | 65.9 61.6–70.5ROR 71.4 · χ² 49,685 / p <1e-300 | 63.7 EB05 60.1 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=137 · 95% consumer | no trial data cached |
| Contraindicated device used | 10 | 64.2 34.2–120.5ROR 64.3 · χ² 543 / p 2e-120 | 56.0 EB05 32.5 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Breath holding | 11 | 63.1 34.6–115.0ROR 63.2 · χ² 593 / p 3e-131 | 55.6 EB05 33.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Intentional device use issue | 25 | 62.3 41.9–92.7ROR 62.5 · χ² 1,404 / p <1e-300 | 57.9 EB05 41.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=6 · 100% consumer | no trial data cached |
| Incorrect dose administered by product | 44 | 60.2 44.6–81.2ROR 60.4 · χ² 2,429 / p <1e-300 | 57.1 EB05 44.3 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=5 · 91% consumer | no trial data cached |
| Intentional device misuse | 123 | 57.2 47.9–68.4ROR 57.9 · χ² 6,554 / p <1e-300 | 55.2 EB05 47.5 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious n=15 · 96% consumer | no trial data cached |
| Wrong technique in device usage process | 1,166 | 52.8 50.0–55.8ROR 59.4 · χ² 57,825 / p <1e-300 | 51.4 EB05 49.0 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious n=209 · 96% consumer | no trial data cached |
| Device ineffective | 26 | 50.2 34.0–74.1ROR 50.3 · χ² 1,176 / p 5e-258 | 47.4 EB05 34.0 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=6 · 100% consumer | no trial data cached |
| Product after taste | 22 | 48.5 31.8–74.0ROR 48.6 · χ² 954 / p 1e-209 | 45.6 EB05 31.8 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=8 · 91% consumer | no trial data cached |
| Product cleaning inadequate | 55 | 42.5 32.6–55.5ROR 42.7 · χ² 2,142 / p <1e-300 | 41.1 EB05 32.8 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=4 · 100% consumer | no trial data cached |
| Product delivery mechanism issue | 92 | 38.9 31.7–47.8ROR 39.3 · χ² 3,297 / p <1e-300 | 37.9 EB05 31.8 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=17 · 92% consumer | no trial data cached |
| Device defective | 269 | 34.1 30.3–38.4ROR 35.0 · χ² 8,475 / p <1e-300 | 33.5 EB05 30.3 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=47 · 90% consumer | no trial data cached |
| Device malfunction | 822 | 25.0 23.4–26.7ROR 27.1 · χ² 18,736 / p <1e-300 | 24.7 EB05 23.3 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 32.4 · 93% consumer | no trial data cached |
| Chronic obstructive pulmonary disease | 634 | 24.8 23.0–26.8ROR 26.4 · χ² 14,342 / p <1e-300 | 24.5 EB05 23.0 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.3 · 75% consumer | no trial data cached |
| Oxygen therapy | 18 | 22.5 14.2–35.9ROR 22.6 · χ² 345 / p 2e-77 | 21.8 EB05 14.5 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Obstructive sleep apnoea syndrome | 15 | 21.9 13.2–36.4ROR 21.9 · χ² 276 / p 3e-62 | 21.1 EB05 13.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Device dispensing error | 12 | 20.7 11.7–36.6ROR 20.7 · χ² 204 / p 2e-46 | 19.6 EB05 11.4 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Emphysema | 102 | 20.5 16.9–24.9ROR 20.7 · χ² 1,858 / p <1e-300 | 20.3 EB05 17.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 19.8 · 75% consumer | no trial data cached |
| Oxygen saturation abnormal | 27 | 19.6 13.4–28.7ROR 19.7 · χ² 455 / p 3e-101 | 19.2 EB05 13.8 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=18 · 73% consumer | no trial data cached |
| Chronic respiratory failure | 11 | 18.8 10.4–34.1ROR 18.8 · χ² 167 / p 2e-38 | 17.6 EB05 9.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Total lung capacity decreased | 14 | 17.8 10.5–30.1ROR 17.8 · χ² 204 / p 2e-46 | 16.9 EB05 10.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Respiration abnormal | 55 | 16.4 12.6–21.3ROR 16.5 · χ² 773 / p 3e-170 | 16.1 EB05 12.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=18 · 87% consumer | no trial data cached |
| Candida infection (yeast infection) | 128 | 15.6 13.1–18.5ROR 15.8 · χ² 1,722 / p <1e-300 | 15.4 EB05 13.3 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.6 · 84% consumer | no trial data cached |
| Device deposit issue | 15 | 15.3 9.2–25.5ROR 15.3 · χ² 185 / p 2e-42 | 14.4 EB05 8.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Infusion site discharge | 12 | 14.3 8.1–25.1ROR 14.3 · χ² 134 / p 3e-31 | 12.8 EB05 6.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Drug dose omission by device | 516 | 13.7 12.6–14.9ROR 14.3 · χ² 6,036 / p <1e-300 | 13.6 EB05 12.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=100 · 94% consumer | no trial data cached |
| Oropharyngeal discomfort | 57 | 13.0 10.0–16.8ROR 13.0 · χ² 613 / p 1e-135 | 12.7 EB05 10.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=20 · 84% consumer | no trial data cached |
| Sputum increased | 13 | 12.5 7.2–21.5ROR 12.5 · χ² 125 / p 2e-29 | 11.0 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Product label issue | 41 | 12.4 9.1–16.9ROR 12.5 · χ² 417 / p 7e-93 | 12.0 EB05 9.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=7 · 100% consumer | no trial data cached |
| Aphonia | 82 | 11.9 9.6–14.8ROR 12.0 · χ² 806 / p 1e-177 | 11.7 EB05 9.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · 78% consumer | no trial data cached |
| Dysphonia | 337 | 11.7 10.5–13.0ROR 12.1 · χ² 3,280 / p <1e-300 | 11.6 EB05 10.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 82% consumer | no trial data cached |
| Drug delivery system malfunction | 29 | 11.6 8.1–16.8ROR 11.7 · χ² 270 / p 6e-61 | 11.0 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=6 · 96% consumer | no trial data cached |
| Pulmonary pain | 15 | 10.6 6.4–17.6ROR 10.6 · χ² 120 / p 3e-28 | 9.2 EB05 5.5 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Asthma | 577 | 10.4 9.6–11.3ROR 11.0 · χ² 4,917 / p <1e-300 | 10.4 EB05 9.7 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.2 | no trial data cached |
| Product dose omission issue | 1,464 | 10.4 9.9–10.9ROR 12.0 · χ² 12,579 / p <1e-300 | 10.4 EB05 9.9 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 · 91% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 2,012 | 7.2 6.9–7.5ROR 8.7 · χ² 11,003 / p <1e-300 | 7.2 EB05 6.9 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 · 81% consumer | no trial data cached |
| Device delivery system issue | 1,579 | 129.9 123.9–136.1ROR 153.0 · χ² 189,669 / p <1e-300 | 121.8 EB05 116.8 · IC025 +6.8 3/3 methods agree | Reporting / coding artifact | serious n=272 · 95% consumer | no trial data cached |
| Product dose omission issue | 1,464 | 10.4 9.9–10.9ROR 12.0 · χ² 12,579 / p <1e-300 | 10.4 EB05 9.9 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 · 91% consumer | no trial data cached |
| Wrong technique in device usage process | 1,166 | 52.8 50.0–55.8ROR 59.4 · χ² 57,825 / p <1e-300 | 51.4 EB05 49.0 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious n=209 · 96% consumer | no trial data cached |
| Death | 1,140 | 2.7 2.5–2.8ROR 2.9 · χ² 1,243 / p 1e-272 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.7 | no trial data cached |
| Device use issue | 1,089 | 135.6 127.9–143.7ROR 151.3 · χ² 136,181 / p <1e-300 | 126.7 EB05 120.5 · IC025 +6.8 3/3 methods agree | Reporting / coding artifact | serious n=226 · 95% consumer | no trial data cached |
| Cough | 839 | 6.1 5.7–6.5ROR 6.5 · χ² 3,585 / p <1e-300 | 6.0 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 · 74% consumer | no trial data cached |
| Device malfunction | 822 | 25.0 23.4–26.7ROR 27.1 · χ² 18,736 / p <1e-300 | 24.7 EB05 23.3 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 32.4 · 93% consumer | no trial data cached |
| Incorrect dose administered by device | 803 | 65.9 61.6–70.5ROR 71.4 · χ² 49,685 / p <1e-300 | 63.7 EB05 60.1 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=137 · 95% consumer | no trial data cached |
| Wrong technique in product usage process | 666 | 6.7 6.2–7.2ROR 7.1 · χ² 3,229 / p <1e-300 | 6.6 EB05 6.2 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 11.7 · 95% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 665 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.308 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.4 · 71% consumer | no trial data cached |
| Chronic obstructive pulmonary disease | 634 | 24.8 23.0–26.8ROR 26.4 · χ² 14,342 / p <1e-300 | 24.5 EB05 23.0 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.3 · 75% consumer | no trial data cached |
| Asthma | 577 | 10.4 9.6–11.3ROR 11.0 · χ² 4,917 / p <1e-300 | 10.4 EB05 9.7 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.2 | no trial data cached |
| Product use issue | 528 | 5.7 5.3–6.2ROR 6.0 · χ² 2,062 / p <1e-300 | 5.7 EB05 5.3 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · 93% consumer | no trial data cached |
| Drug dose omission by device | 516 | 13.7 12.6–14.9ROR 14.3 · χ² 6,036 / p <1e-300 | 13.6 EB05 12.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=100 · 94% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Drug delivery system issue — n=132, PRR 152.4
- Intentional device use issue — n=25, PRR 62.3
- Emphysema — n=102, PRR 20.5
- Respiration abnormal — n=55, PRR 16.4
- Drug dose omission by device — n=516, PRR 13.7
- Oropharyngeal discomfort — n=57, PRR 13.0
- Aphonia — n=82, PRR 11.9
- Dysphonia — n=337, PRR 11.7
- Drug delivery system malfunction — n=29, PRR 11.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Budesonide?
In FDA FAERS, the most frequently co-reported reaction terms for Budesonide are dyspnoea, cough, chronic obstructive pulmonary disease, asthma, drug dose omission by device. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Budesonide have an FDA boxed warning?
No. The FDA label retrieved for Budesonide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Budesonide causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 10ea5d87-6ed0-4fa5-a37b-2043c8560bc0, effective 20231107; matched on
openfda.generic_name.exact:"BUDESONIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,000 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.