This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.
Albuterol Sulfate Hfa is the brand name for albuterol sulfate. According to the FDA-approved label, 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. FAERS contains 287,348 submissions naming this drug from 1995 through 2026; the top three reactions cited are dyspnoea, asthma, and drug ineffective.
Most-Reported Reactions
Counts of the reactions most often cited in FAERS submissions that named Albuterol Sulfate Hfa. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.
Patient Demographics
Patient sex and age across the FAERS submissions that named Albuterol Sulfate Hfa. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.
By Sex
Severity Outcomes
Severity flags recorded across the 287,348 FAERS submissions that named Albuterol Sulfate Hfa. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.
Submissions Per Quarter
Quarterly count of FAERS submissions that named Albuterol Sulfate Hfa. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.
From the FDA-Approved Label
Excerpts from the official FDA-approved prescribing information for Albuterol Sulfate Hfa. This is the authoritative source on indications, warnings, and known adverse reactions.
Indications
1 INDICATIONS AND USAGE 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.
Adverse Reactions (from label)
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Paradoxical bronchospasm [see Warnings and Precautions ( 5.1 )] Cardiovascular effects [see Warnings and Precautions ( 5.4 )] Hypersensitivity reactions, including anaphylaxis [see Warnings and Precautions ( 5.6 )] Hypokalemia [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence ≥3%) are throat irritation, viral respiratory infections, upper respiratory inflammation, cough, and musculoskeletal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflects exposure to albuterol sulfate HFA in 248 subjects treated with albuterol sulfate HFA in 3 placebo-controlled clinical trials of 2 to 12 weeks’ duration. (continues in label)
AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.
