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Salbutamol

Generic Name
Salbutamol
Brand Names
Airomir, Airsupra, Combivent, Proair, Proventil, Ventolin
Drug Type
Small Molecule
Chemical Formula
C13H21NO3
CAS Number
18559-94-9
Unique Ingredient Identifier
QF8SVZ843E

Overview

Salbutamol is a short-acting, selective beta2-adrenergic receptor agonist used in the treatment of asthma and COPD. It is 29 times more selective for beta2 receptors than beta1 receptors giving it higher specificity for pulmonary beta receptors versus beta1-adrenergic receptors located in the heart. Salbutamol is formulated as a racemic mixture of the R- and S-isomers. The R-isomer has 150 times greater affinity for the beta2-receptor than the S-isomer and the S-isomer has been associated with toxicity. This lead to the development of levalbuterol, the single R-isomer of salbutamol. However, the high cost of levalbuterol compared to salbutamol has deterred wide-spread use of this enantiomerically pure version of the drug. Salbutamol is generally used for acute episodes of bronchospasm caused by bronchial asthma, chronic bronchitis and other chronic bronchopulmonary disorders such as chronic obstructive pulmonary disorder (COPD). It is also used prophylactically for exercise-induced asthma.

Indication

Salbutamol is indicated for (i) the symptomatic relief and prevention of bronchospasm due to bronchial asthma, chronic bronchitis, reversible obstructive airway disease, and other chronic bronchopulmonary disorders in which bronchospasm is a complicating factor, and/or (ii) the acute prophylaxis against exercise-induced bronchospasm and other stimuli known to induce bronchospasm.

Associated Conditions

  • Asthma
  • Asthmatic Bronchitis
  • Bronchial Asthma
  • Bronchoconstriction
  • Bronchospasm
  • Chronic Asthma
  • Chronic Bronchitis
  • Cough
  • Emphysema
  • Exacerbation of asthma
  • Exercise-Induced Bronchospasm
  • Hyperkalemia
  • Wheezing
  • Excess mucus or phlegm

Research Report

Published: Jul 15, 2025

Salbutamol (Albuterol): A Comprehensive Pharmacological and Clinical Monograph

Introduction

Salbutamol, known as albuterol in the United States, stands as a cornerstone in the management of respiratory diseases characterized by reversible airway obstruction. For over half a century, this short-acting β2-adrenergic receptor agonist (SABA) has been a first-line rescue medication, providing rapid and effective relief from the distressing symptoms of bronchospasm.[1] Discovered in 1966 by a team at Allen and Hanburys in the UK and launched in 1969 as Ventolin, its profound impact on patient care is underscored by its inclusion on the World Health Organization's List of Essential Medicines and its immense global utilization; in 2022, it was the seventh most commonly prescribed medication in the United States, with over 59 million prescriptions filled.[1]

The enduring success of salbutamol lies in its targeted and potent pharmacological action, which provides immediate bronchodilation and symptom relief, making it an indispensable tool for patients with asthma and chronic obstructive pulmonary disease (COPD).[1] However, the very efficacy that cemented its status as a life-saving medication has also revealed a critical paradox in its long-term use. The reliance on salbutamol for symptom relief can mask underlying chronic airway inflammation, the true driver of disease progression in asthma. This has led to a phenomenon of SABA over-reliance, which is now recognized as a marker of poor disease control and is associated with an increased risk of severe exacerbations and mortality.[2]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/25
Not Applicable
Not yet recruiting
2025/05/20
Phase 3
Not yet recruiting
2025/04/27
Phase 3
Recruiting
2025/04/10
Phase 1
Completed
2025/04/09
Phase 4
Completed
Children's Hospital and Institute of Child Health, Multan
2024/10/24
Phase 2
Completed
2024/10/01
Phase 3
Not yet recruiting
2024/07/01
Phase 2
Active, not recruiting
Università degli Studi di Ferrara
2024/05/30
Phase 1
Recruiting
2024/05/30
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Lupin Pharmaceuticals, Inc.
68180-963
RESPIRATORY (INHALATION)
90 ug in 1 1
12/1/2022
A-S Medication Solutions
50090-0516
RESPIRATORY (INHALATION)
2.5 mg in 3 mL
12/19/2022
American Health Packaging
68084-952
ORAL
4 mg in 1 1
10/4/2022
Prasco Laboratories
66993-019
RESPIRATORY (INHALATION)
90 ug in 1 1
12/19/2014
Proficient Rx LP
63187-026
RESPIRATORY (INHALATION)
90 ug in 1 1
10/1/2023
A-S Medication Solutions
50090-6288
RESPIRATORY (INHALATION)
2.5 mg in 3 mL
12/9/2021
Sun Pharmaceutical Industries, Inc.
53489-177
ORAL
4 mg in 1 1
1/30/2019
Sun Pharmaceutical Industries, Inc.
47335-703
RESPIRATORY (INHALATION)
0.83 mg in 1 mL
12/6/2023
Direct_Rx
72189-002
INTRABRONCHIAL
2.5 mg in 3 mL
7/30/2019
H.J. Harkins Company, Inc.
76519-1175
RESPIRATORY (INHALATION)
90 ug in 1 g
4/26/2019

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
AZMASOL HFA INHALATION AEROSOL 100MCG
SIN13980P
AEROSOL, METERED
100mcg/actuation
6/24/2011
VENTOLIN RESPIRATOR SOLUTION 0.5% w/v
SIN02988P
SOLUTION
0.5% w/v
5/26/1989
VENDEROL TABLET 2 mg
SIN02687P
TABLET
2 mg
4/28/1989
ZENMOLIN SYRUP 2 mg/5 ml
SIN00022P
SYRUP
2 mg/5 ml
2/2/1988
BUVENTOL EASYHALER 100 mcg/inhalation dose
SIN08676P
POWDER, METERED
100 mcg/dose
4/24/1996
SALBUAIR CFC-FREE INHALER 100 mcg/dose
SIN12458P
AEROSOL, SPRAY
100 mcg/dose
10/30/2003
COMBIVENT UNIT DOSE VIAL FOR INHALATION
SIN09558P
SOLUTION
2.500 mg/2.5 ml
11/28/1997
ASMOL SYRUP 2 mg/5 ml
SIN02461P
SYRUP
2 mg/5 ml
2/27/1989
ASMOL TABLET 4 mg
SIN02913P
TABLET
4 mg
5/22/1989
SALBUTAMOL SYRUP 2 mg/5 ml
SIN10339P
SYRUP
2mg/5ml
11/4/1998

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
VENTOLIN IM INJ 0.5MG/ML
glaxo canada inc
00894249
Liquid - Intramuscular
.5 MG / ML
12/31/1992
COMBIVENT INHALATION AEROSOL
boehringer ingelheim (canada) ltd ltee
02163721
Metered-Dose Aerosol - Inhalation ,  Oral
120 MCG / ACT
12/31/1995
VENTOLIN TAB 4MG
glaxo canada inc
01932691
Tablet - Oral
4 MG / TAB
12/31/1993
SABULIN INHALER 100MCG/METERED DOSE AEROSOL
genpharm ulc
00812463
Metered-Dose Aerosol - Inhalation
100 MCG / ACT
12/31/1989
NOVO-SALMOL INHALER 100MCG/AEM
novopharm limited
00874086
Metered-Dose Aerosol - Oral
100 MCG / ACT
12/31/1991
APO-SALVENT AEM 100MCG
00790419
Metered-Dose Aerosol - Inhalation
100 MCG / ACT
12/31/1989
RATIO-SALBUTAMOL
ratiopharm inc division of teva canada limited
00851841
Metered-Dose Aerosol - Inhalation
100 MCG / ACT
12/31/1989
VENTOLIN INHALER 100MCG/AEM
glaxo canada inc
00867179
Metered-Dose Aerosol - Inhalation
100 MCG / ACT
12/31/1972
VENTOLIN INHALER
02213478
Metered-Dose Aerosol - Inhalation
100 MCG / ACT
9/30/1997

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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