Albuterol side effects: what 291,833 FDA adverse event reports show

Albuterol Sulfate · 1,206 reaction terms · 1,361,834 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

291,833 reports · 57% serious · 18,583 with death outcome · 65% 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

Albuterol is a member of the class of phenylethanolamines that is 4-(2-amino-1-hydroxyethyl)-2-(hydroxymethyl)phenol having a tert-butyl group attached to the nirogen atom.

PubChem CID 2083 (ChEBI)

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 adverse reaction 1Likely indication confounding 8Reporting / coding artifact 7Lab value / disease marker 4Not in label — unassessed 20

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.
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. 1,166 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 deposit issue	1,814	835.9 707.7–987.4ROR 841.1 · χ² 115,484 / p <1e-300	64.7 EB05 62.3 · IC025 +5.9 3/3 methods agree	Reporting / coding artifact	94% consumer	no trial arm names this drug
Wrong technique in product usage process performed in error	234	265.2 200.1–351.5ROR 265.4 · χ² 12,679 / p <1e-300	55.4 EB05 49.7 · IC025 +5.4 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial arm names this drug
Product cleaning inadequate	2,080	260.5 237.2–286.1ROR 262.3 · χ² 112,713 / p <1e-300	55.4 EB05 53.4 · IC025 +5.7 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial arm names this drug
Appendicolith	262	160.3 128.5–199.8ROR 160.4 · χ² 12,447 / p <1e-300	48.8 EB05 44.1 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=262 · ♀ 0% (drug 65%) · 100% clinician	no trial arm names this drug
Spirometry abnormal	336	95.2 80.7–112.2ROR 95.3 · χ² 13,134 / p <1e-300	40.5 EB05 37.0 · IC025 +5.1 3/3 methods agree	Lab value / disease marker	serious n=332 · ♀ 0% (drug 65%)	no trial arm names this drug
Asthma-chronic obstructive pulmonary disease overlap syndrome	296	93.9 78.8–111.8ROR 94.0 · χ² 11,493 / p <1e-300	40.3 EB05 36.6 · IC025 +5.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=292 · 100% clinician	no trial arm names this drug
Reversible airways obstruction	292	93.4 78.4–111.4ROR 93.5 · χ² 11,315 / p <1e-300	40.2 EB05 36.5 · IC025 +5.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=292	no trial arm names this drug
Inhalation therapy	360	92.2 78.7–107.9ROR 92.3 · χ² 13,874 / p <1e-300	40.0 EB05 36.6 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial arm names this drug
Mite allergy	355	89.2 76.2–104.4ROR 89.3 · χ² 13,481 / p <1e-300	39.4 EB05 36.1 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=352 · ♀ 0% (drug 65%)	no trial arm names this drug
Bronchopulmonary aspergillosis allergic	456	70.2 61.6–80.0ROR 70.3 · χ² 15,399 / p <1e-300	35.3 EB05 32.7 · IC025 +4.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=455	no trial arm names this drug
Dust allergy	464	65.7 57.9–74.6ROR 65.8 · χ² 15,128 / p <1e-300	34.1 EB05 31.6 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=459 · ♀ 0% (drug 65%)	no trial arm names this drug
Forced expiratory volume decreased	1,316	61.3 56.9–66.0ROR 61.6 · χ² 41,344 / p <1e-300	32.9 EB05 31.5 · IC025 +4.9 3/3 methods agree	Lab value / disease marker	serious n=1,302	no trial arm names this drug
Pulmonary vasculitis	231	54.9 46.2–65.2ROR 54.9 · χ² 6,781 / p <1e-300	31.0 EB05 27.8 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=231 · ♀ 0% (drug 65%) · 100% clinician	no trial arm names this drug
Device delivery system issue	10,890	50.5 49.3–51.8ROR 52.4 · χ² 305,740 / p <1e-300	29.6 EB05 29.1 · IC025 +4.9 3/3 methods agree	Reporting / coding artifact	serious n=384 · 92% consumer	no trial arm names this drug
Bronchial wall thickening	298	49.3 42.5–57.2ROR 49.3 · χ² 8,201 / p <1e-300	29.1 EB05 26.5 · IC025 +4.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=298	no trial arm names this drug
Mycotic allergy	328	45.0 39.1–51.7ROR 45.0 · χ² 8,519 / p <1e-300	27.6 EB05 25.2 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=322 · ♀ 0% (drug 65%)	no trial arm names this drug
Ejection fraction	208	39.0 32.9–46.2ROR 39.0 · χ² 4,896 / p <1e-300	25.2 EB05 22.5 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=208 · ♀ 100% (drug 65%)	no trial arm names this drug
Obstructive airways disorder	3,896	37.8 36.4–39.3ROR 38.3 · χ² 90,300 / p <1e-300	24.8 EB05 24.2 · IC025 +4.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 26.0	no trial arm names this drug
Sensitisation	266	37.5 32.3–43.6ROR 37.6 · χ² 6,106 / p <1e-300	24.6 EB05 22.2 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=265 · ♀ 100% (drug 65%)	no trial arm names this drug
Bronchial secretion retention	424	35.6 31.6–40.0ROR 35.6 · χ² 9,383 / p <1e-300	23.8 EB05 22.0 · IC025 +4.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=408	no trial arm names this drug
Forced vital capacity decreased	212	34.2 29.0–40.4ROR 34.3 · χ² 4,552 / p <1e-300	23.2 EB05 20.7 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=211 · 100% clinician	no trial arm names this drug
Full blood count abnormal	3,426	33.9 32.6–35.3ROR 34.3 · χ² 73,455 / p <1e-300	23.1 EB05 22.4 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious PRR 31.0	no trial arm names this drug
Pulmonary function test abnormal	499	33.1 29.7–36.8ROR 33.1 · χ² 10,476 / p <1e-300	22.7 EB05 21.1 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious n=482	no trial arm names this drug
Blood immunoglobulin e increased	731	30.2 27.7–32.9ROR 30.3 · χ² 14,339 / p <1e-300	21.3 EB05 20.0 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	serious n=703	no trial arm names this drug
Increased bronchial secretion	769	30.1 27.7–32.8ROR 30.2 · χ² 15,066 / p <1e-300	21.3 EB05 20.0 · IC025 +4.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=736 · 83% consumer	no trial arm names this drug
Sleep disorder due to a general medical condition	4,580	27.8 26.9–28.8ROR 28.2 · χ² 84,483 / p <1e-300	20.1 EB05 19.6 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 36.0	no trial arm names this drug
Allergy to animal	277	25.2 22.0–28.9ROR 25.2 · χ² 4,704 / p <1e-300	18.7 EB05 16.9 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=261	no trial arm names this drug
Conjunctivitis allergic	384	25.0 22.3–28.1ROR 25.1 · χ² 6,489 / p <1e-300	18.6 EB05 17.1 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=374 · ♀ 0% (drug 65%)	no trial arm names this drug
Lung hyperinflation	221	24.2 20.7–28.2ROR 24.2 · χ² 3,620 / p <1e-300	18.1 EB05 16.2 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=217 · ♀ 0% (drug 65%)	no trial arm names this drug
Device ineffective	265	23.1 20.1–26.6ROR 23.1 · χ² 4,187 / p <1e-300	17.6 EB05 15.9 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	♀ 0% (drug 65%) · 100% consumer	no trial arm names this drug
Eosinophilic granulomatosis with polyangiitis	490	22.5 20.4–25.0ROR 22.6 · χ² 7,589 / p <1e-300	17.2 EB05 16.0 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=490 · ♀ 0% (drug 65%)	no trial arm names this drug
Total lung capacity decreased	387	22.4 20.0–25.1ROR 22.4 · χ² 5,961 / p <1e-300	17.2 EB05 15.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=356	no trial arm names this drug
Obstructive sleep apnoea syndrome	330	21.8 19.2–24.6ROR 21.8 · χ² 4,957 / p <1e-300	16.8 EB05 15.3 · IC025 +3.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=320	no trial arm names this drug
Circumstance or information capable of leading to device use error	556	21.8 19.8–23.9ROR 21.8 · χ² 8,361 / p <1e-300	16.8 EB05 15.6 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	100% consumer	no trial arm names this drug
Sputum discoloured	2,212	21.5 20.5–22.5ROR 21.6 · χ² 32,957 / p <1e-300	16.6 EB05 16.1 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 20.8	no trial arm names this drug
Wheezing	13,731	21.3 20.9–21.7ROR 22.2 · χ² 203,277 / p <1e-300	16.5 EB05 16.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 18.6	no trial arm names this drug
Rhinitis allergic	1,023	21.0 19.6–22.6ROR 21.1 · χ² 14,957 / p <1e-300	16.4 EB05 15.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=962	no trial arm names this drug
Respiratory symptom	642	20.9 19.1–22.8ROR 20.9 · χ² 9,327 / p <1e-300	16.3 EB05 15.2 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=611 · ♀ 34% (drug 65%)	no trial arm names this drug
Nasal polyps	1,097	20.7 19.3–22.1ROR 20.8 · χ² 15,809 / p <1e-300	16.1 EB05 15.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=1,014	no trial arm names this drug
Asthma	24,781	20.0 19.7–20.2ROR 21.7 · χ² 348,081 / p <1e-300	15.7 EB05 15.5 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.3	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Albuterol (searched ALBUTEROL).

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)	42,640	5.7 5.7–5.8ROR 6.5 · χ² 157,549 / p <1e-300	5.4 EB05 5.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 5.0	no trial arm names this drug
Asthma	24,781	20.0 19.7–20.2ROR 21.7 · χ² 348,081 / p <1e-300	15.7 EB05 15.5 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.3	no trial arm names this drug
Drug ineffective (drug did not work)	22,830	1.2 1.2–1.3ROR 1.3 · χ² 1,081 / p 2e-237	1.2 EB05 1.2 · IC025 +0.3	Reporting / coding artifact	serious PRR 1.7	no trial arm names this drug
Cough	20,297	5.5 5.4–5.6ROR 5.8 · χ² 69,885 / p <1e-300	5.2 EB05 5.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial arm names this drug
Wrong technique in product usage process	18,790	7.2 7.1–7.3ROR 7.6 · χ² 91,652 / p <1e-300	6.6 EB05 6.5 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 2.7 · 95% consumer	no trial arm names this drug
Fatigue (tiredness)	16,719	1.5 1.5–1.6ROR 1.6 · χ² 3,227 / p <1e-300	1.5 EB05 1.5 · IC025 +0.6	Not in label — unassessed	serious PRR 2.1	no trial arm names this drug
Pneumonia (lung infection)	16,675	3.8 3.8–3.9ROR 4.0 · χ² 33,306 / p <1e-300	3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 3.8	no trial arm names this drug
Headache	15,606	1.8 1.8–1.8ROR 1.8 · χ² 5,479 / p <1e-300	1.8 EB05 1.7 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 2.6	no trial arm names this drug
Nausea	14,612	1.3 1.3–1.3ROR 1.3 · χ² 1,169 / p 1e-256	1.3 EB05 1.3 · IC025 +0.4	Labeled adverse reaction exact term	serious PRR 1.8	no trial arm names this drug
Wheezing	13,731	21.3 20.9–21.7ROR 22.2 · χ² 203,277 / p <1e-300	16.5 EB05 16.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 18.6	no trial arm names this drug
Off label use (used outside approved label)	13,454	1.1 1.1–1.1ROR 1.1 · χ² 133 / p 4e-31	1.1 EB05 1.1 · IC025 +0.1	Reporting / coding artifact	serious PRR 1.3	no trial arm names this drug
Pain	12,908	1.5 1.5–1.5ROR 1.5 · χ² 2,179 / p <1e-300	1.5 EB05 1.5 · IC025 +0.5	Not in label — unassessed	serious PRR 1.9	no trial arm names this drug
Diarrhoea (diarrhea)	12,036	1.3 1.3–1.4ROR 1.4 · χ² 1,030 / p 3e-226	1.3 EB05 1.3 · IC025 +0.4	Not in label — unassessed	serious PRR 1.7	no trial arm names this drug
Malaise (feeling unwell)	11,229	1.8 1.8–1.9ROR 1.9 · χ² 4,260 / p <1e-300	1.8 EB05 1.8 · IC025 +0.8	Not in label — unassessed	serious PRR 2.3	no trial arm names this drug
Device delivery system issue	10,890	50.5 49.3–51.8ROR 52.4 · χ² 305,740 / p <1e-300	29.6 EB05 29.1 · IC025 +4.9 3/3 methods agree	Reporting / coding artifact	serious n=384 · 92% consumer	no trial arm names this drug

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.

Appendicolith — n=262, PRR 160.3
Mite allergy — n=355, PRR 89.2
Dust allergy — n=464, PRR 65.7
Pulmonary vasculitis — n=231, PRR 54.9
Mycotic allergy — n=328, PRR 45.0
Ejection fraction — n=208, PRR 39.0
Sensitisation — n=266, PRR 37.5
Forced vital capacity decreased — n=212, PRR 34.2
Sleep disorder due to a general medical condition — n=4,580, PRR 27.8
Allergy to animal — n=277, PRR 25.2

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?

In FDA FAERS, the most frequently co-reported reaction terms for Albuterol are dyspnoea, asthma, cough, fatigue, pneumonia, headache. 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 have an FDA boxed warning?

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

Do FAERS signals prove that Albuterol 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" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
PubChem CID 2083 description (ChEBI)
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, 1,206 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 ALBUTEROL, 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.