Drug · FAERS side-effect profile with label screen

Albuterol and Budesonide side effects: what 1,354 FDA adverse event reports show

Albuterol Sulfate And Budesonide · 47 reaction terms · 2,129 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Albuterol (Albuterol)

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

Who reports

1,354 reports · 20% serious · 18 with death outcome · 70% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Albuterol tablets, USP are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

FDA label, Indications and Usage

What it is

DESCRIPTION Albuterol tablets, USP contain albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta 2 -adrenergic bronchodilator. Albuterol sulfate has the chemica.

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 23 strongest signals

Labeled adverse reaction 1Reporting / coding artifact 16Not in label — unassessed 6

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.
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. 24 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	377	223.4 204.8–243.7ROR 307.5 · χ² 82,130 / p <1e-300	217.7 EB05 199.9 · IC025 +7.2 3/3 methods agree	Reporting / coding artifact	serious n=18 · 93% consumer	no trial data cached
Device use issue	117	103.8 87.3–123.6ROR 113.4 · χ² 11,742 / p <1e-300	101.5 EB05 86.9 · IC025 +5.9 3/3 methods agree	Reporting / coding artifact	serious n=11 · 95% consumer	no trial data cached
Incorrect dose administered by device	114	68.8 57.7–82.1ROR 74.9 · χ² 7,525 / p <1e-300	67.8 EB05 57.9 · IC025 +5.4 3/3 methods agree	Reporting / coding artifact	serious n=8 · 96% consumer	no trial data cached
Device defective	62	58.7 46.0–74.9ROR 61.4 · χ² 3,448 / p <1e-300	57.5 EB05 46.4 · IC025 +4.9 3/3 methods agree	Reporting / coding artifact	serious n=3 · 92% consumer	no trial data cached
Wrong technique in device usage process	150	50.2 43.2–58.4ROR 56.3 · χ² 7,180 / p <1e-300	49.8 EB05 43.4 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious n=11 · 98% consumer	no trial data cached
Device malfunction	147	33.5 28.7–39.0ROR 37.3 · χ² 4,601 / p <1e-300	33.3 EB05 29.0 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 32.8 · 88% consumer	no trial data cached
Asthma	160	21.8 18.9–25.2ROR 24.6 · χ² 3,169 / p <1e-300	21.7 EB05 19.1 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 25.2	no trial data cached
Drug dose omission by device	84	16.8 13.6–20.6ROR 17.8 · χ² 1,232 / p 4e-270	16.7 EB05 13.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=8 · 90% consumer	no trial data cached
Seasonal allergy	14	15.1 9.0–25.5ROR 15.3 · χ² 171 / p 2e-39	14.2 EB05 8.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Insurance issue	14	14.4 8.5–24.2ROR 14.5 · χ² 161 / p 3e-37	13.3 EB05 7.7 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 66.9	no trial data cached
Drug effect less than expected	13	14.1 8.2–24.2ROR 14.2 · χ² 145 / p 1e-33	12.8 EB05 7.2 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Device failure	12	12.1 6.9–21.2ROR 12.2 · χ² 111 / p 3e-26	10.4 EB05 5.7 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 12.8	no trial data cached
Product dose omission issue	220	11.8 10.5–13.3ROR 13.9 · χ² 2,192 / p <1e-300	11.7 EB05 10.5 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 17.4 · 92% consumer	no trial data cached
Wrong technique in product usage process	132	10.0 8.5–11.7ROR 10.9 · χ² 1,067 / p 2e-234	9.8 EB05 8.5 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 11.8 · 100% consumer	no trial data cached
Wheezing	38	9.8 7.2–13.4ROR 10.1 · χ² 292 / p 7e-66	9.3 EB05 6.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 10.2	no trial data cached
Product prescribing issue	12	9.0 5.1–15.8ROR 9.1 · χ² 78 / p 6e-19	7.3 EB05 4.2 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 11.3	no trial data cached
Dysphonia	34	8.9 6.4–12.4ROR 9.1 · χ² 231 / p 2e-52	8.3 EB05 6.1 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.9	no trial data cached
Device issue	42	7.3 5.5–9.9ROR 7.5 · χ² 225 / p 4e-51	6.9 EB05 5.3 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 2.4 · ♀ 46% (drug 70%) · 93% consumer	no trial data cached
Illness	47	7.1 5.4–9.5ROR 7.4 · χ² 243 / p 4e-55	6.7 EB05 5.2 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 16.7 · 77% consumer	no trial data cached
Product use issue	79	6.5 5.2–8.0ROR 6.8 · χ² 362 / p 7e-81	6.2 EB05 5.2 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 6.3 · 94% consumer	no trial data cached
Incorrect dose administered	88	6.0 4.9–7.3ROR 6.3 · χ² 363 / p 3e-81	5.8 EB05 4.9 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.4 · 92% consumer	no trial data cached
Device breakage	11	4.3 2.4–7.7ROR 4.3 · χ² 24 / p 4e-7	3.7 EB05 2.2 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 2.3	no trial data cached
Injection site swelling	12	2.4 1.4–4.2ROR 2.4 · χ² 9 / p 0.002	2.3 EB05 1.4 · IC025 +0.2	Not in label — unassessed	serious PRR 14.9	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	377	223.4 204.8–243.7ROR 307.5 · χ² 82,130 / p <1e-300	217.7 EB05 199.9 · IC025 +7.2 3/3 methods agree	Reporting / coding artifact	serious n=18 · 93% consumer	no trial data cached
Product dose omission issue	220	11.8 10.5–13.3ROR 13.9 · χ² 2,192 / p <1e-300	11.7 EB05 10.5 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 17.4 · 92% consumer	no trial data cached
Asthma	160	21.8 18.9–25.2ROR 24.6 · χ² 3,169 / p <1e-300	21.7 EB05 19.1 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 25.2	no trial data cached
Wrong technique in device usage process	150	50.2 43.2–58.4ROR 56.3 · χ² 7,180 / p <1e-300	49.8 EB05 43.4 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious n=11 · 98% consumer	no trial data cached
Device malfunction	147	33.5 28.7–39.0ROR 37.3 · χ² 4,601 / p <1e-300	33.3 EB05 29.0 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 32.8 · 88% consumer	no trial data cached
Wrong technique in product usage process	132	10.0 8.5–11.7ROR 10.9 · χ² 1,067 / p 2e-234	9.8 EB05 8.5 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 11.8 · 100% consumer	no trial data cached
Device use issue	117	103.8 87.3–123.6ROR 113.4 · χ² 11,742 / p <1e-300	101.5 EB05 86.9 · IC025 +5.9 3/3 methods agree	Reporting / coding artifact	serious n=11 · 95% consumer	no trial data cached
Incorrect dose administered by device	114	68.8 57.7–82.1ROR 74.9 · χ² 7,525 / p <1e-300	67.8 EB05 57.9 · IC025 +5.4 3/3 methods agree	Reporting / coding artifact	serious n=8 · 96% consumer	no trial data cached
Incorrect dose administered	88	6.0 4.9–7.3ROR 6.3 · χ² 363 / p 3e-81	5.8 EB05 4.9 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.4 · 92% consumer	no trial data cached
Drug dose omission by device	84	16.8 13.6–20.6ROR 17.8 · χ² 1,232 / p 4e-270	16.7 EB05 13.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=8 · 90% consumer	no trial data cached
Product use issue	79	6.5 5.2–8.0ROR 6.8 · χ² 362 / p 7e-81	6.2 EB05 5.2 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 6.3 · 94% consumer	no trial data cached
Device defective	62	58.7 46.0–74.9ROR 61.4 · χ² 3,448 / p <1e-300	57.5 EB05 46.4 · IC025 +4.9 3/3 methods agree	Reporting / coding artifact	serious n=3 · 92% consumer	no trial data cached
Illness	47	7.1 5.4–9.5ROR 7.4 · χ² 243 / p 4e-55	6.7 EB05 5.2 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 16.7 · 77% consumer	no trial data cached
Device issue	42	7.3 5.5–9.9ROR 7.5 · χ² 225 / p 4e-51	6.9 EB05 5.3 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 2.4 · ♀ 46% (drug 70%) · 93% consumer	no trial data cached
Wheezing	38	9.8 7.2–13.4ROR 10.1 · χ² 292 / p 7e-66	9.3 EB05 6.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 10.2	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=84, PRR 16.8
Wheezing — n=38, PRR 9.8
Dysphonia — n=34, PRR 8.9

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 Albuterol and Budesonide?

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

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

Do FAERS signals prove that Albuterol and 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 230d66fc-f62c-42a6-adb3-0a0f879c8ad4, effective 20260414; matched on openfda.generic_name.exact:"ALBUTEROL")
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, 47 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.