This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Albuterol Sulfate HFA Inhalation Aerosol is a beta 2 -adrenergic agonist indicated for: • Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1 ) • Prevention of exercise-induced bronchospasm in patients 4 years of age and older. ( 1.2 ) 1.1 Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
Albuterol Sulfate HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other Albuterol Sulfate HFA Inhalation Aerosol components. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see Warnings and Precautions (5.6) ] . Hypersensitivity to albuterol and any other Albuterol Sulfate HFA Inhalation Aerosol Components. ( 4 )
• Life-threatening paradoxical bronchospasm may occur. Discontinue Albuterol Sulfate HFA immediately and treat with alternative therapy. ( 5.1 ) • Need for more doses of Albuterol Sulfate HFA than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. ( 5.2 ) • Albuterol Sulfate HFA is not a substitute for corticosteroids. ( 5.3 ) • Cardiovascular effects may occur. Use with caution in patients sensitive to sympathomimetic drugs and patients with cardiovascular or convulsive disorders. ( 5.4 , 5.7 ) • Excessive use may be fatal. Do not exceed recommended dose. ( 5.5 ) • Immediate hypersensitivity reactions may occur. Discontinue Albuterol Sulfate HFA immediately. ( 5.6 ) • Hypokalemia and changes in blood glucose may occur. ( 5.7 , 5.8 ) 5.1 Paradoxical Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, Albuterol Sulfate HFA Inhalation Aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use ...
Use of Albuterol Sulfate HFA may be associated with the following: • Paradoxical bronchospasm [see Warnings and Precautions (5.1) ] • Cardiovascular Effects [see Warnings and Precautions (5.4) ] • Immediate hypersensitivity reactions [see Warnings and Precautions (5.6) ] • Hypokalemia [see Warnings and Precautions (5.8) ] Most common adverse reactions (≥3.0% and >placebo) are headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Respiratory, LLC at 1-888-482-9522 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience A total of 1090 subjects were treated with Albuterol Sulfate HFA Inhalation Aerosol, or with the same formulation of albuterol as in Albuterol Sulfate HFA Inhalation Aerosol, during the worldwide clinical development program. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult and Adolescents 12 Years of Age and Older: The adverse reaction information presen...
Source: FDA SPL label for Albuterol Sulfate HFA (Proficient Rx LP), effective 20231001. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 33,095 | 35,082 | 31,456 | 25,028 | 26,777 | 29,608 | 30,008 | 14,220 |
3,469 reports blaming this drug for every million Medicare prescriptions filled, which is 1.3× the typical drug on this site. (73,641 reports in 2024–2026, against 21,226,306 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 07/2025 | Class III | Cipla USA, Inc. | Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point. |
| 06/2023 | Class I | Cipla USA, Inc. | Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket). |
| 04/2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| 04/2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| 01/2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| 01/2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| 09/2020 | Class II | Perrigo Company PLC | Defective Delivery System: Sustained trend of failure to dispense complaints. |
| 05/2017 | Class II | GlaxoSmithKline, LLC | Defective Delivery System: Elevated number of units with out of specification results for leak rate |
| 03/2017 | Class II | GlaxoSmithKline, LLC | Defective Delivery System: Elevated number of units with out of specification results for leak rate. |
| 12/2015 | Class II | GlaxoSmithKline, LLC | Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life. |
| 07/2012 | Class II | GlaxoSmithKline Inc | Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Albuterol Sulfate HFA | 18,591,605 | $30 |
| Ventolin HFA | 2,272,575 | $67 |
| Albuterol Sulfate | 301,760 | $33 |
| Proair Respiclick | 55,802 | $81 |
| Proair Digihaler | 3,914 | $104 |
| Proair HFA | 549 | $77 |
| Proventil HFA | 101 | $71 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.