Drug · FAERS side-effect profile with label screen
Budesonide side effects: what 58,545 FDA adverse event reports show
Brand names
Pulmicort Flexhaler
openFDA label
Who reports
58,545 reports · 65% serious · 3,687 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) 5Likely indication confounding 3Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 28
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. 1,195 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 |
|---|---|---|---|---|---|---|
| Congenital hiatus hernia | 129 | 504.9 385.8–660.8ROR 506.0 · χ² 26,455 / p <1e-300 | 201.9 EB05 174.3 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=129 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Vaginal flatulence | 165 | 424.3 338.3–532.1ROR 425.5 · χ² 31,416 / p <1e-300 | 188.8 EB05 165.8 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=165 · ♀ 100% (drug 59%) | not reported in cached trials |
| Spirometry abnormal | 295 | 364.6 309.9–429.0ROR 366.5 · χ² 52,389 / p <1e-300 | 177.6 EB05 161.3 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | serious n=295 · ♀ 0% (drug 59%) | not reported in cached trials |
| Mite allergy | 300 | 320.2 274.0–374.4ROR 321.9 · χ² 49,845 / p <1e-300 | 166.5 EB05 151.2 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=300 · ♀ 0% (drug 59%) | not reported in cached trials |
| Acquired factor v deficiency | 47 | 262.8 180.1–383.4ROR 263.0 · χ² 6,871 / p <1e-300 | 142.3 EB05 111.3 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=47 · ♀ 0% (drug 59%) · 100% consumer | not reported in cached trials |
| Pulmonary vasculitis | 201 | 220.6 185.0–263.1ROR 221.3 · χ² 26,884 / p <1e-300 | 134.3 EB05 119.4 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious n=201 · ♀ 0% (drug 59%) | not reported in cached trials |
| Total lung capacity abnormal | 140 | 209.0 169.6–257.5ROR 209.5 · χ² 18,058 / p <1e-300 | 129.3 EB05 112.3 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=138 · ♀ 0% (drug 59%) | not reported in cached trials |
| Eosinophilic bronchitis | 74 | 206.9 155.3–275.7ROR 207.2 · χ² 9,423 / p <1e-300 | 126.5 EB05 104.1 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=74 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Mycotic allergy | 303 | 201.8 175.2–232.3ROR 202.8 · χ² 38,362 / p <1e-300 | 127.6 EB05 116.0 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=302 · ♀ 0% (drug 59%) | not reported in cached trials |
| Coagulation factor deficiency | 55 | 184.5 133.2–255.7ROR 184.7 · χ² 6,468 / p <1e-300 | 116.6 EB05 93.0 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 0% (drug 59%) | not reported in cached trials |
| Dust allergy | 318 | 176.7 154.5–202.1ROR 177.7 · χ² 36,882 / p <1e-300 | 117.2 EB05 106.8 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=315 · ♀ 0% (drug 59%) | not reported in cached trials |
| Malignant melanoma stage 0 | 55 | 156.3 113.8–214.6ROR 156.4 · χ² 5,770 / p <1e-300 | 104.7 EB05 83.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 269 | 149.0 129.2–171.8ROR 149.7 · χ² 27,687 / p <1e-300 | 104.2 EB05 94.2 · IC025 +6.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=269 | not reported in cached trials |
| Steroid dependence | 211 | 118.4 101.3–138.3ROR 118.8 · χ² 18,291 / p <1e-300 | 88.2 EB05 78.6 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=209 · ♀ 23% (drug 59%) | not reported in cached trials |
| Capillaritis | 63 | 109.9 82.8–145.8ROR 110.0 · χ² 5,098 / p <1e-300 | 82.0 EB05 66.3 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=63 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Conjunctivitis allergic | 301 | 92.8 81.7–105.3ROR 93.2 · χ² 21,558 / p <1e-300 | 73.3 EB05 66.6 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious n=298 · ♀ 0% (drug 59%) | not reported in cached trials |
| Growth failure | 68 | 87.4 67.0–114.0ROR 87.5 · χ² 4,585 / p <1e-300 | 68.9 EB05 56.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=68 · 100% clinician | not reported in cached trials |
| Catarrh | 165 | 81.5 68.8–96.5ROR 81.7 · χ² 10,592 / p <1e-300 | 65.9 EB05 57.9 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=165 · ♀ 25% (drug 59%) · 90% clinician | not reported in cached trials |
| Ejection fraction | 108 | 81.1 65.8–100.0ROR 81.3 · χ² 6,882 / p <1e-300 | 65.4 EB05 55.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=108 · ♀ 100% (drug 59%) | not reported in cached trials |
| Laryngeal stenosis | 101 | 75.9 61.2–94.0ROR 76.0 · χ² 6,078 / p <1e-300 | 61.9 EB05 52.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=101 · ♀ 100% (drug 59%) · 71% consumer | not reported in cached trials |
| Total lung capacity increased | 47 | 74.2 54.2–101.7ROR 74.3 · χ² 2,745 / p <1e-300 | 60.1 EB05 47.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=47 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Antineutrophil cytoplasmic antibody positive | 125 | 74.1 61.1–89.9ROR 74.3 · χ² 7,390 / p <1e-300 | 60.9 EB05 52.4 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=125 · ♀ 0% (drug 59%) | not reported in cached trials |
| Sensitisation | 127 | 71.1 58.8–86.1ROR 71.3 · χ² 7,248 / p <1e-300 | 58.8 EB05 50.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=126 · ♀ 100% (drug 59%) | not reported in cached trials |
| Reversible airways obstruction | 85 | 70.8 56.1–89.3ROR 70.9 · χ² 4,812 / p <1e-300 | 58.4 EB05 48.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=85 | not reported in cached trials |
| Vocal cord dysfunction | 82 | 70.3 55.5–89.1ROR 70.4 · χ² 4,611 / p <1e-300 | 58.0 EB05 48.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=79 · ♀ 100% (drug 59%) | not reported in cached trials |
| Encephalitis cytomegalovirus | 70 | 69.1 53.5–89.2ROR 69.2 · χ² 3,870 / p <1e-300 | 57.1 EB05 46.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=70 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Eosinophilic granulomatosis with polyangiitis | 277 | 56.9 50.1–64.5ROR 57.1 · χ² 13,043 / p <1e-300 | 48.9 EB05 44.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=277 · ♀ 13% (drug 59%) | not reported in cached trials |
| Neuritis | 204 | 54.6 47.2–63.3ROR 54.8 · χ² 9,255 / p <1e-300 | 47.2 EB05 42.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=203 · ♀ 0% (drug 59%) | not reported in cached trials |
| Factor v leiden mutation | 51 | 52.5 39.1–70.5ROR 52.6 · χ² 2,199 / p <1e-300 | 45.1 EB05 35.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 0% (drug 59%) · 100% consumer | not reported in cached trials |
| Granuloma skin | 101 | 49.6 40.3–61.1ROR 49.7 · χ² 4,175 / p <1e-300 | 43.3 EB05 36.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=101 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Female genital tract fistula | 200 | 47.0 40.6–54.5ROR 47.2 · χ² 7,905 / p <1e-300 | 41.4 EB05 36.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=200 · ♀ 100% (drug 59%) | not reported in cached trials |
| Chronic sinusitis | 424 | 45.6 41.2–50.5ROR 45.9 · χ² 16,346 / p <1e-300 | 40.4 EB05 37.3 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious n=409 · ♀ 91% (drug 59%) | NCT01444430: 1/5,847 (0.0%) on Budesonide (serious AE) |
| Vital capacity decreased | 50 | 44.6 33.2–59.8ROR 44.6 · χ² 1,853 / p <1e-300 | 39.1 EB05 30.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Respiratory symptom | 298 | 42.6 37.7–48.0ROR 42.8 · χ² 10,753 / p <1e-300 | 38.0 EB05 34.5 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=295 · ♀ 23% (drug 59%) | not reported in cached trials |
| Full blood count abnormal | 1,120 | 42.5 40.0–45.2ROR 43.3 · χ² 40,473 / p <1e-300 | 38.0 EB05 36.2 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious PRR 44.9 | not reported in cached trials |
| Bronchial secretion retention | 132 | 41.7 34.8–49.9ROR 41.8 · χ² 4,649 / p <1e-300 | 37.2 EB05 32.2 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=128 · ♀ 85% (drug 59%) | not reported in cached trials |
| Pulmonary function test abnormal | 157 | 39.9 33.9–47.1ROR 40.0 · χ² 5,318 / p <1e-300 | 35.8 EB05 31.4 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=148 · ♀ 100% (drug 59%) | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 52 | 39.6 29.8–52.8ROR 39.7 · χ² 1,726 / p <1e-300 | 35.3 EB05 28.0 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=51 · ♀ 100% (drug 59%) · 100% clinician | not reported in cached trials |
| Normochromic normocytic anaemia | 296 | 39.1 34.7–44.1ROR 39.3 · χ² 9,858 / p <1e-300 | 35.2 EB05 32.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=296 · ♀ 0% (drug 59%) | not reported in cached trials |
| Hypertensive urgency | 48 | 36.8 27.3–49.5ROR 36.8 · χ² 1,480 / p <1e-300 | 33.0 EB05 25.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 0% (drug 59%) · 100% consumer | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Budesonide as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).
- NCT01444430 — A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescent (N=12460, PHASE3; 170 AE terms posted; arms: Symbicort; Budesonide)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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) | 6,567 | 4.2 4.1–4.3ROR 4.6 · χ² 16,222 / p <1e-300 | 4.2 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | NCT01444430: 2/5,847 (0.0%) on Budesonide (serious AE) |
| Drug ineffective (drug did not work) | 6,283 | 1.7 1.7–1.8ROR 1.8 · χ² 1,974 / p <1e-300 | 1.7 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.0 | not reported in cached trials |
| Off label use (used outside approved label) | 6,095 | 2.5 2.5–2.6ROR 2.7 · χ² 5,814 / p <1e-300 | 2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | not reported in cached trials |
| Asthma | 4,818 | 16.0 15.6–16.5ROR 17.4 · χ² 65,328 / p <1e-300 | 15.4 EB05 15.0 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.4 | NCT01444430: 36/5,847 (0.6%) on Budesonide (serious AE) |
| Fatigue (tiredness) | 3,620 | 1.7 1.6–1.7ROR 1.7 · χ² 1,008 / p 1e-221 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.9 | not reported in cached trials |
| Cough | 3,312 | 4.3 4.1–4.4ROR 4.5 · χ² 8,324 / p <1e-300 | 4.2 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | NCT01444430: 1/5,846 (0.0%) on Budesonide (serious AE) |
| Headache | 3,220 | 1.8 1.8–1.9ROR 1.9 · χ² 1,278 / p 3e-280 | 1.8 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.3 | not reported in cached trials |
| Diarrhoea (diarrhea) | 2,864 | 1.6 1.5–1.7ROR 1.6 · χ² 655 / p 8e-145 | 1.6 EB05 1.5 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.9 | NCT01444430: 1/5,847 (0.0%) on Budesonide (serious AE) |
| Condition aggravated | 2,824 | 3.4 3.3–3.5ROR 3.5 · χ² 4,729 / p <1e-300 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | not reported in cached trials |
| Nausea | 2,774 | 1.3 1.2–1.3ROR 1.3 · χ² 153 / p 1e-35 | 1.3 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.6 | not reported in cached trials |
| Pneumonia (lung infection) | 2,702 | 3.0 2.9–3.1ROR 3.1 · χ² 3,649 / p <1e-300 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | NCT01444430: 6/5,847 (0.1%) on Budesonide (serious AE) |
| Wheezing | 2,477 | 15.6 15.0–16.2ROR 16.3 · χ² 32,507 / p <1e-300 | 15.0 EB05 14.5 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.4 | not reported in cached trials |
| Malaise (feeling unwell) | 2,285 | 1.9 1.8–1.9ROR 1.9 · χ² 931 / p 7e-205 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.9 | not reported in cached trials |
| Pain | 2,216 | 1.3 1.2–1.3ROR 1.3 · χ² 148 / p 2e-34 | 1.3 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.5 | NCT01444430: 2/5,847 (0.0%) on Budesonide (serious AE) |
| Pyrexia (fever) | 2,212 | 2.3 2.2–2.4ROR 2.3 · χ² 1,633 / p <1e-300 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.3 | not reported in cached trials |
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.
- Congenital hiatus hernia — n=129, PRR 504.9
- Vaginal flatulence — n=165, PRR 424.3
- Mite allergy — n=300, PRR 320.2
- Acquired factor v deficiency — n=47, PRR 262.8
- Total lung capacity abnormal — n=140, PRR 209.0
- Mycotic allergy — n=303, PRR 201.8
- Coagulation factor deficiency — n=55, PRR 184.5
- Dust allergy — n=318, PRR 176.7
- Malignant melanoma stage 0 — n=55, PRR 156.3
- Steroid dependence — n=211, PRR 118.4
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, asthma, fatigue, cough, headache, diarrhoea. 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, 1,235 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 - ClinicalTrials.gov API v2 (query
BUDESONIDE, results-bearing studies sorted by enrollment)
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.