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Proventil (salbutamol)
Proventil (salbutamol) is a small molecule beta2-Adrenergic Agonist developed by SCHERING, targeting the beta-2 adrenergic receptor. It is used to treat various respiratory conditions, including acute asthma exacerbations, bronchospasm, and chronic obstructive pulmonary disease. Proventil was FDA-approved in 1981 and is still owned by SCHERING. Key safety considerations include potential cardiovascular effects and interactions with other medications. Proventil is used to relax airway muscles and improve breathing.
At a glance
| Generic name | salbutamol |
|---|---|
| Also known as | Inhaled Ventoline (Evohaler) 0,1 mg/dos, Salbutrim, bronchodilator, Ventoline, Salbutamol -100µg+300µg |
| Sponsor | Merck & Co. |
| Drug class | beta2-Adrenergic Agonist |
| Target | Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 1981 |
Approved indications
- Acute exacerbation of asthma
- Bronchospasm
- Bronchospasm Prevention
- Chronic Obstructive Pulmonary Disease with Bronchospasms
- Exercise-Induced Bronchospasm Prevention
Common side effects
- Upper Respiratory Tract Infection
- Rhinitis
- Nausea
- Vomiting
- Tremor
- Nervousness
- Tachycardia
- Fever
- Inhalation Site Sensation
- Allergic Reaction/Symptoms
- Respiratory Disorder (unspecified)
- Back Pain
Serious adverse events
- Urticaria
- Angioedema
- Rash
- Bronchospasm
- Oropharyngeal Edema
- Hypertension
- Angina
- Metabolic Acidosis
Key clinical trials
- High Flow Nasal Cannula Rates in Pediatric Asthma (NA)
- A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations (PHASE3)
- Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (PHASE2)
- Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis (PHASE1,PHASE2)
- A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma (PHASE3)
- A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma (PHASE4)
- A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma (PHASE3)
- Effects of Salbutamol in Athletes and Implications for Screening and Sports (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |