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ProAir (albuterol)
Short-acting beta-2 adrenergic agonist (SABA) that relaxes bronchial smooth muscle, providing rapid relief of bronchospasm.
Albuterol (Ventolin/salbutamol) is the world\
At a glance
| Generic name | albuterol |
|---|---|
| Also known as | ProAir, Ventolin, Proventil, Salbutamol |
| Sponsor | Generic (originally Allen & Hanburys/GSK) |
| Drug class | SABA (Short-acting beta-2 agonist) |
| Target | Beta-1 adrenergic receptor, Beta-2 adrenergic receptor, Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 1982-05-05 (United States) |
Mechanism of action
Albuterol (salbutamol outside the US) selectively stimulates beta-2 adrenergic receptors on bronchial smooth muscle, causing rapid bronchodilation within 5 minutes. It is the world\
Approved indications
- Acute exacerbation of asthma
- Bronchospasm
- Bronchospasm Prevention
- Chronic Obstructive Pulmonary Disease with Bronchospasms
- Exercise-Induced Bronchospasm Prevention
Common side effects
- Lung Disease
- Pharyngitis
- Bronchitis
- Chest Pain
- Urinary Tract Infection
- Diarrhea
- Leg Cramps
- Nausea
- Pain
- Dyspepsia
- Pneumonia
- Constipation
Serious adverse events
- Allergic-type Reactions (skin rash, pruritus, urticaria)
- Narrow-angle Glaucoma
- Paradoxical Bronchospasm
- Metabolic Acidosis
Key clinical trials
- A Prospective, Open-Label Assessment of the Albuterol Spiromax® DPI Integrated Dose Counter (Phase 3)
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuat (Phase 3)
- Inspiratory Capacity and HRCT Comparison of Nebulized Arformoterol (Brovana) vs. Dry-powder Inhaler Salmeterol (Serevent) (Phase 4)
- A 26-Week Open-Label Study to Assess the Long-Term Safety of Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients 12 Years (Phase 3)
- An Exploratory Study to Evaluate the Response of Salmeterol Plus Fluticasone vs Fluticasone Alone to Experimental Nasal Inoculation With Rhinovirus (Phase 4)
- Dynamic Clinical Decision Support Algorithms to Manage Sick Children in Primary Health Care Settings in Tanzania (NA)
- An Open-Label, Crossover Study to Determine the Pharmacokinetic Profile and Tolerability of Single Doses of High Strength Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate (Phase 1)
- An Open-Label, Randomized, Cross-Over Study to Evaluate the Dose Response of SYN006 HFA MDI in Asthma Patients (Phase 2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ProAir CI brief — competitive landscape report
- ProAir updates RSS · CI watch RSS
- Generic (originally Allen & Hanburys/GSK) portfolio CI