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Albuterol-HFA-MDI
Albuterol is a beta-2 adrenergic agonist that binds to beta-2 receptors on airway smooth muscle, causing relaxation and bronchodilation.
Albuterol is a beta-2 adrenergic agonist that binds to beta-2 receptors on airway smooth muscle, causing relaxation and bronchodilation. Used for Acute bronchospasm relief in asthma, Chronic obstructive pulmonary disease (COPD) maintenance and acute symptom relief, Exercise-induced bronchoconstriction prevention.
At a glance
| Generic name | Albuterol-HFA-MDI |
|---|---|
| Also known as | Albuterol, ProAir |
| Sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
| Drug class | Beta-2 adrenergic agonist (short-acting) |
| Target | Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
Mechanism of action
Albuterol activates beta-2 adrenergic receptors on bronchial smooth muscle cells, triggering a cascade that increases intracellular cAMP levels. This leads to smooth muscle relaxation and rapid airway dilation, relieving bronchoconstriction. The HFA (hydrofluoroalkane) formulation is a propellant system used in metered-dose inhalers (MDI) for pulmonary delivery.
Approved indications
- Acute bronchospasm relief in asthma
- Chronic obstructive pulmonary disease (COPD) maintenance and acute symptom relief
- Exercise-induced bronchoconstriction prevention
Common side effects
- Tremor
- Headache
- Nervousness/anxiety
- Palpitations
- Muscle cramps
- Throat irritation
Key clinical trials
- Study to Investigate Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization With AIRSUPRA Compared to Albuterol as Needed in Adults With Mild Asthma (PHASE4)
- A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma (PHASE3)
- Functional Studies of Novel Genes Mutated in Primary Ciliary Dyskinesia II: Genotype to Phenotype (EARLY_PHASE1)
- BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma (PHASE3)
- Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma (NA)
- Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol Sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of Albuterol Base/Inh) of Macleods Pharmaceuticals Ltd (PHASE3)
- Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomitant Asthma (P03280) (PHASE4)
- Study to Assess the Pharmacokinetic Bioequivalence of Budesonide and Albuterol With an Alternate Propellant Compared to Current Propellant. (PHASE1)
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 |
|---|---|
| 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:
- Albuterol-HFA-MDI CI brief — competitive landscape report
- Albuterol-HFA-MDI updates RSS · CI watch RSS
- Teva Branded Pharmaceutical Products R&D, Inc. portfolio CI