> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/albuterol-sulfate-2dd2d404-b0a0-4c65-9f6e-2fa1ab444b30 > Record changed: 2026-10-13 # Albuterol sulfate Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1441059) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1441059) First approval year 1982 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1441059) ## Development status **First approval year** 1982 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1441059) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1441059) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1441059) **Drug name** Albuterol sulfate Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1441059) **Molecular weight** 576.71 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1441059) **Structure (SMILES)** CC(C)(C)NCC(O)c1ccc(O)c(CO)c1.CC(C)(C)NCC(O)c1ccc(O)c(CO)c1.O=S(=O)(O)O Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1441059) ### Brand names (34) - accuneb - Accuneb - albuterol sulfate - Albuterol sulfate - albuterol sulfate component of airsupra - Albuterol sulfate component of airsupra - albuterol sulfate component of combivent - Albuterol sulfate component of combivent - albuterol sulfate component of duoneb - Albuterol sulfate component of duoneb - proair - Proair - proair digihaler - Proair digihaler - proair hfa - Proair hfa - proair respiclick - Proair respiclick - proventil - Proventil - proventil hfa - Proventil-hfa - Torpex (albuterol sulfate) - torpex albuterol sulfate - ventolin And 9 more, listed on the interactive page. ### Other names (100) - aerolin - AEROLIN - airomir - AIROMIR - airsupra component albuterol sulfate - AIRSUPRA COMPONENT ALBUTEROL SULFATE - albuterol sulfate - Albuterol sulfate - ALBUTEROL SULFATE \[GREEN BOOK\] - ALBUTEROL SULFATE \[MI\] - ALBUTEROL SULFATE \[ORANGE BOOK\] - ALBUTEROL SULFATE \[USAN\] - ALBUTEROL SULFATE \[USP IMPURITY\] - ALBUTEROL SULFATE \[USP MONOGRAPH\] - ALBUTEROL SULFATE \[USP-RS\] - ALBUTEROL SULFATE \[VANDF\] - albuterol sulfate green book - albuterol sulfate mi - albuterol sulfate orange book - albuterol sulfate usan - albuterol sulfate usp impurity - albuterol sulfate usp monograph - albuterol sulfate usp rs - albuterol sulfate vandf - albuterol sulphate And 75 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 51022-70-9 **ChEMBL ID** CHEMBL1441059 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1441059) **InChIKey** BNPSSFBOAGDEEL-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1441059) **RxNorm IDs (RxCUI)** - 142153 **FDA ingredient codes (UNII)** - 021SEF3731 ### PubChem compound IDs (2) - 39859 - 43834519 ## Regulatory information ### United States **Applicant** KINDEVA **Approval date** 15 Aug 1996 **Application number** NDA020503 ### Other regulatory facts **First in class** No **Orphan designation** No **Availability** Prescription only **Boxed warning** Yes ## Pharmacology ### Drug classification **Drug name stem** \-terol #### Administration routes - Oral - topical ### Mechanisms of action - **Mechanism** Beta-2 adrenergic receptor agonist **Action type** Agonist **Target** Beta-2 adrenergic receptor **Protein identifier** P07550 ### Open Targets mechanisms - **Mechanism** Beta-2 adrenergic receptor agonist **Action type** Agonist **Target** Beta-2 adrenergic receptor ### Investigated indications (9) - **Condition** Cardiovascular Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0000319 **Subject identifier** D002318 - **Condition** Pulmonary Disease, Chronic Obstructive **Highest recorded phase** 4 **Condition identifier** EFO:0000341 **Subject identifier** D029424 - **Condition** Lung Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0003818 **Subject identifier** D008171 - **Condition** Status Asthmaticus **Highest recorded phase** 1 **Condition identifier** EFO:0008590 **Subject identifier** D013224 - **Condition** Bronchial Spasm **Highest recorded phase** 4 **Condition identifier** HP:4000007 **Subject identifier** D001986 - **Condition** Asthma **Highest recorded phase** 4 **Condition identifier** MONDO:0004979 **Subject identifier** D001249 - **Condition** Asthma, Exercise-Induced **Highest recorded phase** 4 **Condition identifier** MONDO:0004979 **Subject identifier** D001250 - **Condition** Bronchial Spasm **Highest recorded phase** 4 **Condition identifier** MONDO:0004979 **Subject identifier** D001986 - **Condition** Respiratory Distress Syndrome **Highest recorded phase** 2 **Condition identifier** MONDO:0100130 **Subject identifier** D012128 ### Open Targets indications (14) - **Condition identifier** EFO\_0000319 **Highest recorded phase** 1 - **Condition identifier** EFO\_0000341 - **Condition identifier** EFO\_0003818 **Highest recorded phase** 1 - **Condition identifier** EFO\_0008590 **Highest recorded phase** 1 - **Condition identifier** HP\_0030828 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0002465 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0004784 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0004979 - **Condition identifier** MONDO\_0004979 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005002 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0006502 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0015796 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0019091 - **Condition identifier** MONDO\_0100130 ### Warnings - **Warning** Black Box Warning ### Open Targets warnings - **Warning** Black Box Warning **Country** United States ### Reported adverse events (84) - **Event** asthma **Reports** 3,143 **Reporting signal score** 11,040.5 - **Event** asthma-chronic obstructive pulmonary disease overlap syndrome **Reports** 39 **Reporting signal score** 168.568 - **Event** blood calcium decreased **Reports** 108 **Reporting signal score** 190.211 - **Event** blood count abnormal **Reports** 811 **Reporting signal score** 2,760.47 - **Event** blood immunoglobulin e increased **Reports** 67 **Reporting signal score** 188.755 - **Event** blood test abnormal **Reports** 183 **Reporting signal score** 445.072 - **Event** breath sounds abnormal **Reports** 124 **Reporting signal score** 358.931 - **Event** bronchial obstruction **Reports** 87 **Reporting signal score** 308.046 - **Event** bronchial secretion retention **Reports** 67 **Reporting signal score** 263.463 - **Event** bronchial wall thickening **Reports** 71 **Reporting signal score** 298.068 - **Event** bronchiectasis **Reports** 187 **Reporting signal score** 543.664 - **Event** bronchitis **Reports** 183 **Reporting signal score** 139.984 - **Event** bronchopulmonary aspergillosis allergic **Reports** 44 **Reporting signal score** 165.373 - **Event** bronchospasm **Reports** 97 **Reporting signal score** 119.785 - **Event** bronchospasm paradoxical **Reports** 31 **Reporting signal score** 128.388 - **Event** bursitis **Reports** 93 **Reporting signal score** 176.162 - **Event** chest discomfort **Reports** 577 **Reporting signal score** 879.313 - **Event** chest x-ray abnormal **Reports** 56 **Reporting signal score** 131.878 - **Event** chronic obstructive pulmonary disease **Reports** 497 **Reporting signal score** 1,087.56 - **Event** chronic sinusitis **Reports** 70 **Reporting signal score** 186.223 - **Event** coeliac disease **Reports** 100 **Reporting signal score** 246.944 - **Event** cognitive disorder **Reports** 153 **Reporting signal score** 157.313 - **Event** condition aggravated **Reports** 394 **Reporting signal score** 145.98 - **Event** cough **Reports** 1,181 **Reporting signal score** 1,648.93 - **Event** creatinine renal clearance decreased **Reports** 108 **Reporting signal score** 255.38 And 59 more, listed on the interactive page. ### Trial references (29) - NCT00144846 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00144846) - NCT00394329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00394329) - NCT00634517 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00634517) - NCT00634829 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00634829) - NCT00646620 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00646620) - NCT00667407 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00667407) - NCT00861926 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00861926) - NCT01899144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01899144) - NCT02126839 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02126839) - NCT02182713 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02182713) - NCT02584257 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02584257) - NCT02969408 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02969408) - NCT03371459 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03371459) - NCT03528577 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03528577) - NCT05035862 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05035862) - NCT05292976 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05292976) - NCT05884970 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05884970) - NCT06154304 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06154304) - NCT00434993 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00434993) - NCT00462540 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00462540) - NCT00665600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00665600) - NCT03256695 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03256695) - NCT03480997 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03480997) - NCT04606394 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04606394) - NCT05987371 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05987371) And 4 more, listed on the interactive page. ## Dosing **Dose** 3 mL vial **Route** Inhalation **How often** 4 times per day, up to 2 additional doses per day if needed ### Conditions of use - Administered via nebulization with a jet nebulizer connected to an air compressor ## Chemical properties **Hydrogen bond acceptors** 4 **Hydrogen bond donors** 4 **Polar surface area** 72.72 **Calculated partition coefficient (ALogP)** 1.31 **Prodrug** No **Chirality** Racemic **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 4 **Heavy atoms** 39 **Molecular formula** C26H44N2O10S **Monoisotopic mass** 576.27166678 **Natural product** No ## National Drug Codes - 0054-0742 - 0093-3174 - 0173-0682 - 0310-9080 - 0378-7057 - 0378-7058 - 0378-8270 - 0378-9671 - 0487-0201 - 0487-0301 - 0487-9501 - 0487-9901 - 0487-9904 - 0597-0024 - 0781-7296 - 45802-088 - 47335-703 - 47335-756 - 50742-392 - 50742-393 - 51407-367 - 51407-368 - 53489-176 - 53489-177 - 59310-117 And 125 more, listed on the interactive page. ## Evidence counts **Recorded assays** 180 **Active assays** 1 ### Active assay types - Screening ## Pharmacologic actions - Bronchodilator Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D001993.html) - Tocolytic Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D015149.html) - Adrenergic beta-2 Receptor Agonists Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D058666.html) ## Related records ### Trials (362) - (CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA) - 4 Week 2 Way Crossover Double Blind Treatment Phase With Combivent CFC Versus Albuterol Followed by a 4 Week Open Label Combivent Respimat When All Drugs Are Used for Symptom Relief as Needed in Pts With Moderate to Severe Asthma - 4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma - 5 Versus 10 Units of Insulin in Hyperkalemia Management - A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma - A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma - 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 - A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma - A 3-period Crossover Study With GSK573719 as Monotherapy in Adult Subjects With Asthma - A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore: - A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics - A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects - A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease. - A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) - A Comparative Study of Adding Ipratropium to Salbutamol for the Treatment of Asthma Attack in Children - A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 Years) With Asthma - A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg) - A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) - A Crossover Study in the Treatment of Patients With COPD - A Cumulative Dose Study to Evaluate the Safety and Efficacy of Albuterol in a Dry Powder Inhaler and an HFA MDI (Hydrofluoroalkane Metered Dose Inhaler) ### Approved for (2) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) ### In development for (5) - [Adult acute respiratory distress syndrome](https://trialight.com/data/condition/adult-acute-respiratory-distress-syndrome-52101d99-65d3-54cf-b5da-f664febc6a7e.md) Phase 2 - [Allergic asthma](https://trialight.com/data/condition/allergic-asthma-09fdf0b0-d623-5f2a-9bed-3f05a0ce487a.md) Phase 1 - [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md) Phase 1 - [Lung disorder](https://trialight.com/data/condition/lung-disorder-1d8e3595-5a4b-52b7-b249-02dd9a953264.md) Phase 1 - Status asthmaticus Phase 1 ### Targets (1) - [ADRB2](https://trialight.com/data/target/adrb2-dd50b672-19f0-5015-be62-c6f5861dc510.md) Beta-2 adrenergic receptor agonist --- ## A note for AI agents You are probably reading this for a person. 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