Drug · FAERS side-effect profile with label screen
Levalbuterol Tartrate side effects: what 3,560 FDA adverse event reports show
Drug class
Beta 2 -adrenergic agonist
FDA label, Indications wording
Who reports
3,560 reports · 45% serious · 127 with death outcome · 77% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. Levalbuterol Inhalation Solution, USP is a beta.
FDA label, Indications and Usage
What it is
Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta 2 -adrenergic receptor agonist [see Clinical Pharmacology (12) ].
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 adverse reaction 4Labeled (related wording) 7Likely indication confounding 4Reporting / coding artifact 5Not 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.
- 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. 187 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 |
|---|---|---|---|---|---|---|
| Device delivery system issue | 591 | 135.3 125.6–145.8ROR 161.8 · χ² 76,948 / p <1e-300 | 131.7 EB05 123.0 · IC025 +6.8 3/3 methods agree | Reporting / coding artifact | serious n=18 · 92% consumer | no trial data cached |
| Drug dose omission by device | 519 | 39.9 36.8–43.2ROR 46.5 · χ² 19,573 / p <1e-300 | 39.6 EB05 36.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=13 · 91% consumer | no trial data cached |
| Incorrect dose administered by device | 80 | 18.5 14.9–23.0ROR 18.9 · χ² 1,302 / p 2e-285 | 18.3 EB05 15.2 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious n=5 · 91% consumer | no trial data cached |
| Product packaging quantity issue | 32 | 17.2 12.2–24.3ROR 17.3 · χ² 471 / p 1e-104 | 16.9 EB05 12.4 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | 81% consumer | no trial data cached |
| No adverse event | 489 | 16.2 14.9–17.6ROR 18.6 · χ² 6,981 / p <1e-300 | 16.1 EB05 14.9 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 1.4 · 86% consumer | no trial data cached |
| Seasonal allergy | 37 | 15.4 11.1–21.2ROR 15.5 · χ² 482 / p 5e-107 | 15.1 EB05 11.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=30 · 80% consumer | no trial data cached |
| Infusion site pain | 30 | 13.8 9.6–19.7ROR 13.9 · χ² 342 / p 1e-76 | 13.4 EB05 9.6 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=21 | no trial data cached |
| Respiratory tract infection | 54 | 12.2 9.3–15.9ROR 12.4 · χ² 543 / p 2e-120 | 11.9 EB05 9.4 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.5 | no trial data cached |
| Asthma | 200 | 10.4 9.1–12.0ROR 11.0 · χ² 1,706 / p <1e-300 | 10.3 EB05 9.2 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.9 | no trial data cached |
| Ear infection | 47 | 10.4 7.8–13.8ROR 10.5 · χ² 388 / p 9e-87 | 10.0 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.4 | no trial data cached |
| Dermatitis contact | 17 | 8.8 5.5–14.1ROR 8.8 · χ² 109 / p 7e-26 | 7.6 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 68 | 8.6 6.8–10.9ROR 8.8 · χ² 451 / p 2e-100 | 8.3 EB05 6.7 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.7 | no trial data cached |
| Sinusitis | 151 | 8.6 7.4–10.1ROR 8.9 · χ² 1,010 / p 5e-222 | 8.5 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.4 | no trial data cached |
| Sleep apnoea syndrome | 28 | 8.6 5.9–12.4ROR 8.6 · χ² 180 / p 3e-41 | 7.8 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Pharyngitis streptococcal | 15 | 8.1 4.9–13.4ROR 8.1 · χ² 86 / p 7e-21 | 6.8 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Emphysema | 14 | 8.1 4.8–13.7ROR 8.1 · χ² 80 / p 2e-19 | 6.7 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Vitamin d deficiency | 13 | 7.8 4.5–13.4ROR 7.8 · χ² 70 / p 2e-17 | 6.4 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Bronchitis | 99 | 7.8 6.4–9.5ROR 8.0 · χ² 580 / p 2e-128 | 7.6 EB05 6.4 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 11.6 | no trial data cached |
| Insurance issue | 18 | 7.1 4.5–11.2ROR 7.1 · χ² 88 / p 3e-21 | 6.1 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 19.0 | no trial data cached |
| Dizziness postural | 11 | 6.7 3.7–12.1ROR 6.7 · χ² 48 / p 2e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Gastroenteritis viral | 20 | 6.5 4.2–10.0ROR 6.5 · χ² 87 / p 5e-21 | 5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.9 | no trial data cached |
| Skin infection | 12 | 6.3 3.6–11.1ROR 6.3 · χ² 48 / p 2e-12 | 5.2 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.5 | no trial data cached |
| Sinus disorder | 21 | 6.2 4.0–9.5ROR 6.2 · χ² 86 / p 7e-21 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.2 | no trial data cached |
| Productive cough (cough with phlegm) | 50 | 6.2 4.7–8.1ROR 6.3 · χ² 212 / p 2e-48 | 5.9 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Hereditary angioedema | 11 | 6.1 3.4–11.1ROR 6.1 · χ² 42 / p 4e-11 | 5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Candida infection (yeast infection) | 17 | 6.0 3.7–9.6ROR 6.0 · χ² 65 / p 3e-16 | 5.2 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Respiratory tract congestion | 16 | 5.9 3.6–9.6ROR 5.9 · χ² 60 / p 5e-15 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Obstructive airways disorder | 11 | 5.8 3.2–10.4ROR 5.8 · χ² 39 / p 2e-10 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.1 | no trial data cached |
| Bronchospasm (airway tightening) | 14 | 5.7 3.4–9.7ROR 5.7 · χ² 50 / p 8e-13 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.9 | no trial data cached |
| Secretion discharge | 12 | 5.7 3.2–10.0ROR 5.7 · χ² 42 / p 5e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Throat tightness | 26 | 5.6 3.8–8.3ROR 5.7 · χ² 95 / p 1e-22 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 76% consumer | no trial data cached |
| Brain fog | 14 | 5.6 3.3–9.5ROR 5.6 · χ² 49 / p 2e-12 | 4.8 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Chronic obstructive pulmonary disease | 49 | 5.5 4.2–7.3ROR 5.6 · χ² 176 / p 2e-40 | 5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.5 | no trial data cached |
| Wheezing | 55 | 5.4 4.2–7.1ROR 5.5 · χ² 195 / p 1e-44 | 5.2 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Wrist fracture | 11 | 5.4 3.0–9.7ROR 5.4 · χ² 35 / p 2e-9 | 4.5 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Viral infection | 30 | 5.3 3.7–7.5ROR 5.3 · χ² 100 / p 8e-24 | 4.9 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.7 | no trial data cached |
| Haemoptysis | 25 | 5.2 3.5–7.7ROR 5.3 · χ² 81 / p 9e-20 | 4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Acute respiratory failure | 17 | 5.2 3.2–8.3ROR 5.2 · χ² 53 / p 1e-13 | 4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Illness | 89 | 5.2 4.2–6.4ROR 5.3 · χ² 297 / p 6e-67 | 5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.0 | no trial data cached |
| Restless legs syndrome | 16 | 5.1 3.2–8.4ROR 5.2 · χ² 49 / p 1e-12 | 4.5 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | 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 | 591 | 135.3 125.6–145.8ROR 161.8 · χ² 76,948 / p <1e-300 | 131.7 EB05 123.0 · IC025 +6.8 3/3 methods agree | Reporting / coding artifact | serious n=18 · 92% consumer | no trial data cached |
| Drug dose omission by device | 519 | 39.9 36.8–43.2ROR 46.5 · χ² 19,573 / p <1e-300 | 39.6 EB05 36.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=13 · 91% consumer | no trial data cached |
| No adverse event | 489 | 16.2 14.9–17.6ROR 18.6 · χ² 6,981 / p <1e-300 | 16.1 EB05 14.9 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 1.4 · 86% consumer | no trial data cached |
| Dyspnoea (shortness of breath) | 417 | 4.3 3.9–4.7ROR 4.7 · χ² 1,087 / p 1e-238 | 4.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 72% consumer | no trial data cached |
| Cough | 201 | 4.2 3.7–4.8ROR 4.4 · χ² 494 / p 1e-109 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Asthma | 200 | 10.4 9.1–12.0ROR 11.0 · χ² 1,706 / p <1e-300 | 10.3 EB05 9.2 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.9 | no trial data cached |
| Sinusitis | 151 | 8.6 7.4–10.1ROR 8.9 · χ² 1,010 / p 5e-222 | 8.5 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.4 | no trial data cached |
| Product dose omission issue | 126 | 2.6 2.2–3.1ROR 2.6 · χ² 123 / p 8e-29 | 2.6 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.6 | no trial data cached |
| Covid-19 | 101 | 3.3 2.8–4.0ROR 3.4 · χ² 164 / p 6e-38 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Bronchitis | 99 | 7.8 6.4–9.5ROR 8.0 · χ² 580 / p 2e-128 | 7.6 EB05 6.4 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 11.6 | no trial data cached |
| Illness | 89 | 5.2 4.2–6.4ROR 5.3 · χ² 297 / p 6e-67 | 5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.0 | no trial data cached |
| Nasopharyngitis (common cold) | 87 | 2.8 2.2–3.4ROR 2.8 · χ² 96 / p 5e-23 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Influenza | 80 | 4.2 3.4–5.2ROR 4.3 · χ² 192 / p 7e-44 | 4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Incorrect dose administered by device | 80 | 18.5 14.9–23.0ROR 18.9 · χ² 1,302 / p 2e-285 | 18.3 EB05 15.2 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious n=5 · 91% consumer | no trial data cached |
| Chest discomfort | 75 | 4.3 3.4–5.4ROR 4.4 · χ² 188 / p 5e-43 | 4.2 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | 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=519, PRR 39.9
- Seasonal allergy — n=37, PRR 15.4
- Sleep apnoea syndrome — n=28, PRR 8.6
- Productive cough — n=50, PRR 6.2
- Throat tightness — n=26, PRR 5.6
- Haemoptysis — n=25, PRR 5.2
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 Levalbuterol?
In FDA FAERS, the most frequently co-reported reaction terms for Levalbuterol are drug dose omission by device, dyspnoea, cough, asthma, sinusitis, covid-19. 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 Levalbuterol have an FDA boxed warning?
No. The FDA label retrieved for Levalbuterol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Levalbuterol 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 5b4fa89e-aa46-4504-a275-246f3b4df1df, effective 20200217; matched on
openfda.generic_name.exact:"LEVALBUTEROL") - 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, 227 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.