Albuterol Side Effects: Common, Serious & FDA Warnings
Based on 291,000+ FDA adverse event reports, the most-reported albuterol reactions include dyspnoea, asthma, and cough. No active recalls are on record. The FDA-approved label does not carry a boxed warning.
Common Side Effects of Albuterol
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for albuterol. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Dyspnoea | 42,195 | 14.5% |
| Asthma | 24,491 | 8.4% |
| Cough | 19,881 | 6.8% |
| Wrong Technique In Product Usage Process | 18,712 | 6.4% |
| Fatigue | 16,466 | 5.6% |
| Pneumonia | 16,375 | 5.6% |
| Headache | 15,249 | 5.2% |
| Nausea | 14,340 | 4.9% |
| Wheezing | 13,604 | 4.7% |
| Pain | 12,757 | 4.4% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
From the FDA-approved label, Section 5.1: Paradoxical Bronchospasm Albuterol Sulfate
HFA can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with Albuterol Sulfate HFA, it should be discontinued immediately and alternative therapy should be instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.
From the FDA-approved label, Section 5.4: Cardiovascular Effects Albuterol Sulfate
HFA, like all other beta 2 -adrenergic agonists, can produce clinically significant cardiovascular effects in some patients such as changes in pulse rate or blood pressure. If such effects occur, Albuterol Sulfate HFA may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical relevance of these findings is unknown. Therefore, Albuterol Sulfate HFA, like all other sympathomimetic amines, should be used with caution in patients with underlying cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Albuterol Recalls
FDA enforcement actions matched to albuterol via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →).
No recalls are on record for this drug in the FDA enforcement database.
Albuterol Shortages
FDA-listed shortages of albuterol products. Strength and dosage-form level detail.
Is Albuterol Safe?
Albuterol is FDA-approved and the label does not carry a boxed warning. The label's Warnings and Precautions section covers paradoxical bronchospasm albuterol sulfate (Section 5.1), deterioration of asthma (Section 5.2), use of anti-inflammatory (Section 5.3), cardiovascular effects albuterol sulfate (Section 5.4), do not exceed recommended dose (Section 5.5), hypersensitivity reactions, including anaphylaxis (Section 5.6), coexisting conditions albuterol sulfate (Section 5.7), hypokalemia (Section 5.8).
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Albuterol is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
Albuterol Sulfate HFA is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. ( 1.2 ) 1.1 Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm Albuterol Sulfate HFA is indicated for the prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older.
Frequently Asked Questions
What are the most-reported side effects of albuterol?
Is albuterol the same as Proair Hfa?
Has albuterol been recalled?
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.