Drug · FAERS side-effect profile with label screen

Budesonide and Formoterol side effects: what 1,241 FDA adverse event reports show

Budesonide And Formoterol Fumarate · 40 reaction terms · 1,454 drug–reaction co-reports · data 2026-09-14

Drug class

Corticosteroid

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Budesonide (Pulmicort Flexhaler)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,241 reports · 32% serious · 19 with death outcome · 64% 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 20 strongest signals

Labeled adverse reaction 1Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 15Not in label — unassessed 2

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
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.
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. 20 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Device delivery system issue	262	169.7 152.3–189.2ROR 214.4 · χ² 43,392 / p <1e-300	166.0 EB05 149.8 · IC025 +6.8 3/3 methods agree	Reporting / coding artifact	serious n=7 · 92% consumer	no trial data cached
Device mechanical issue	43	56.0 41.7–75.2ROR 58.0 · χ² 2,263 / p <1e-300	54.6 EB05 42.2 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious n=1 · 88% consumer	no trial data cached
Device malfunction	174	43.5 37.9–50.0ROR 50.4 · χ² 7,189 / p <1e-300	43.2 EB05 38.1 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 4.6 · 93% consumer	no trial data cached
Wrong technique in device usage process	91	33.4 27.4–40.7ROR 36.0 · χ² 2,830 / p <1e-300	33.1 EB05 27.8 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious n=1 · 92% consumer	no trial data cached
Product substitution issue	97	28.3 23.4–34.3ROR 30.6 · χ² 2,530 / p <1e-300	28.1 EB05 23.7 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 18.1 · ♀ 31% (drug 64%) · 80% consumer	no trial data cached
Device issue	121	23.3 19.6–27.6ROR 25.7 · χ² 2,564 / p <1e-300	23.2 EB05 19.9 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 5.0 · 89% consumer	no trial data cached
Product packaging quantity issue	15	23.1 13.9–38.2ROR 23.3 · χ² 295 / p 2e-66	22.4 EB05 14.2 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device defective	22	22.8 15.1–34.5ROR 23.2 · χ² 437 / p 2e-97	22.4 EB05 15.5 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial data cached
Incorrect dose administered by device	32	21.1 15.0–29.8ROR 21.7 · χ² 594 / p 2e-131	20.9 EB05 15.5 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious n=4 · 100% consumer	no trial data cached
Wrong technique in product usage process	183	15.2 13.3–17.4ROR 17.6 · χ² 2,435 / p <1e-300	15.2 EB05 13.4 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 1.8 · 90% consumer	no trial data cached
Asthma	74	11.1 8.9–13.8ROR 11.7 · χ² 671 / p 3e-148	10.8 EB05 8.8 · IC025 +3.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 14.6	no trial data cached
Throat irritation	25	9.4 6.4–13.8ROR 9.5 · χ² 179 / p 4e-41	8.5 EB05 5.9 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.8 · 76% consumer	no trial data cached
Product prescribing issue	11	9.1 5.0–16.3ROR 9.1 · χ² 71 / p 2e-17	7.2 EB05 4.1 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product quality issue	72	9.0 7.2–11.2ROR 9.4 · χ² 504 / p 7e-112	8.7 EB05 7.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.6 · ♀ 37% (drug 64%) · 94% consumer	no trial data cached
Circumstance or information capable of leading to medication error	15	7.5 4.5–12.4ROR 7.6 · χ² 78 / p 5e-19	6.3 EB05 4.0 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious n=1	no trial data cached
Device breakage	17	7.3 4.5–11.6ROR 7.3 · χ² 86 / p 1e-20	6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Therapeutic response decreased	25	7.0 4.7–10.2ROR 7.1 · χ² 122 / p 1e-28	6.3 EB05 4.4 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.9 · 72% consumer	no trial data cached
Drug dose omission by device	28	6.1 4.2–8.8ROR 6.2 · χ² 115 / p 3e-27	5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=1 · 93% consumer	no trial data cached
Device difficult to use	24	6.1 4.1–9.1ROR 6.2 · χ² 97 / p 3e-23	5.5 EB05 3.9 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7 · 92% consumer	no trial data cached
Injection site swelling	11	2.4 1.4–4.4ROR 2.4 · χ² 8 / p 0.002	2.3 EB05 1.4 · IC025 +0.2	Not in label — unassessed	serious PRR 7.8	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
Device delivery system issue	262	169.7 152.3–189.2ROR 214.4 · χ² 43,392 / p <1e-300	166.0 EB05 149.8 · IC025 +6.8 3/3 methods agree	Reporting / coding artifact	serious n=7 · 92% consumer	no trial data cached
Wrong technique in product usage process	183	15.2 13.3–17.4ROR 17.6 · χ² 2,435 / p <1e-300	15.2 EB05 13.4 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 1.8 · 90% consumer	no trial data cached
Device malfunction	174	43.5 37.9–50.0ROR 50.4 · χ² 7,189 / p <1e-300	43.2 EB05 38.1 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 4.6 · 93% consumer	no trial data cached
Device issue	121	23.3 19.6–27.6ROR 25.7 · χ² 2,564 / p <1e-300	23.2 EB05 19.9 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 5.0 · 89% consumer	no trial data cached
Product substitution issue	97	28.3 23.4–34.3ROR 30.6 · χ² 2,530 / p <1e-300	28.1 EB05 23.7 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 18.1 · ♀ 31% (drug 64%) · 80% consumer	no trial data cached
Wrong technique in device usage process	91	33.4 27.4–40.7ROR 36.0 · χ² 2,830 / p <1e-300	33.1 EB05 27.8 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious n=1 · 92% consumer	no trial data cached
Asthma	74	11.1 8.9–13.8ROR 11.7 · χ² 671 / p 3e-148	10.8 EB05 8.8 · IC025 +3.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 14.6	no trial data cached
Product quality issue	72	9.0 7.2–11.2ROR 9.4 · χ² 504 / p 7e-112	8.7 EB05 7.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.6 · ♀ 37% (drug 64%) · 94% consumer	no trial data cached
Device mechanical issue	43	56.0 41.7–75.2ROR 58.0 · χ² 2,263 / p <1e-300	54.6 EB05 42.2 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious n=1 · 88% consumer	no trial data cached
Incorrect dose administered by device	32	21.1 15.0–29.8ROR 21.7 · χ² 594 / p 2e-131	20.9 EB05 15.5 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious n=4 · 100% consumer	no trial data cached
Drug dose omission by device	28	6.1 4.2–8.8ROR 6.2 · χ² 115 / p 3e-27	5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=1 · 93% consumer	no trial data cached
Therapeutic response decreased	25	7.0 4.7–10.2ROR 7.1 · χ² 122 / p 1e-28	6.3 EB05 4.4 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.9 · 72% consumer	no trial data cached
Throat irritation	25	9.4 6.4–13.8ROR 9.5 · χ² 179 / p 4e-41	8.5 EB05 5.9 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.8 · 76% consumer	no trial data cached
Device difficult to use	24	6.1 4.1–9.1ROR 6.2 · χ² 97 / p 3e-23	5.5 EB05 3.9 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7 · 92% consumer	no trial data cached
Device defective	22	22.8 15.1–34.5ROR 23.2 · χ² 437 / p 2e-97	22.4 EB05 15.5 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	100% 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 dose omission by device — n=28, PRR 6.1

✓ 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 and Formoterol?

In FDA FAERS, the most frequently co-reported reaction terms for Budesonide and Formoterol are asthma, drug dose omission by device, throat irritation. 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 and Formoterol have an FDA boxed warning?

No. The FDA label retrieved for Budesonide and Formoterol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Budesonide and Formoterol 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, field patient.drug.openfda.generic_name.exact, 40 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.