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Terbutaline

Generic Name
Terbutaline
Brand Names
Bricanyl
Drug Type
Small Molecule
Chemical Formula
C12H19NO3
CAS Number
23031-25-6
Unique Ingredient Identifier
N8ONU3L3PG

Overview

Terbutaline was first synthesized in 1966 and described in the literature in the late 1960s and early 1970s. It is a selective beta-2 adrenergic agonist used as a bronchodilator in asthmatic patients. Terbutaline was granted FDA approval on 25 March 1974.

Indication

Terbutaline is indicated for prevention and reversal of bronchospasm in patients at least 12 years old, with asthma and reversible bronchospasm associated with bronchitis and emphysema.

Associated Conditions

  • Asthma
  • Bronchospasm
  • Chronic Cough (CC)
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Cough
  • Premature Labour
  • Productive cough

Research Report

Published: Aug 20, 2025

A Comprehensive Monograph on Terbutaline (DB00871)

1. Terbutaline: An Overview and Summary of Key Properties

1.1. Introduction

Terbutaline is a synthetic sympathomimetic amine belonging to the phenylethanolamine chemical class.[1] Pharmacologically, it is classified as a selective, short-acting beta-2 (

β2​) adrenergic receptor agonist (SABA).[2] Its primary and approved therapeutic function is as a bronchodilator for the prevention and reversal of bronchospasm in patients with reversible obstructive airway diseases, including asthma, chronic bronchitis, and emphysema.[5] By selectively targeting

β2​ receptors in the bronchial smooth muscle, terbutaline provides rapid relief from symptoms such as wheezing, shortness of breath, and chest tightness, making it a cornerstone of "reliever" or "rescue" therapy in respiratory medicine.[3]

1.2. Executive Summary

This report provides an exhaustive analysis of terbutaline, synthesizing its chemical, pharmacological, clinical, and safety profiles. The clinical narrative of terbutaline is defined by a profound duality. On one hand, it is a well-established, effective, and widely used bronchodilator for a common set of respiratory conditions.[5] On the other hand, its off-label use as a tocolytic agent to manage preterm labor has been associated with significant risks, leading to severe regulatory actions.

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/10/04
Phase 3
Completed
Muhammad Aamir Latif
2022/08/09
Phase 2
UNKNOWN
2022/04/13
Not Applicable
Completed
2022/01/18
Not Applicable
Recruiting
2021/07/22
Phase 2
Suspended
Kanecia Obie Zimmerman
2021/01/12
Phase 3
Terminated
2020/07/22
Phase 2
UNKNOWN
2020/07/13
N/A
Completed
2018/06/21
Not Applicable
UNKNOWN
Morten Hostrup, PhD
2017/04/10
Phase 4
Terminated

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Marlex Pharmaceuticals Inc
10135-580
ORAL
5 mg in 1 1
1/6/2020
Lannett Company, Inc.
0527-1318
ORAL
2.5 mg in 1 1
7/27/2022
Rebel Distributors Corp
21695-121
ORAL
5 mg in 1 1
3/21/2008
Medical Purchasing Solutions. LLC
71872-7080
SUBCUTANEOUS
1 mg in 1 mL
5/23/2023
Lannett Company, Inc.
0527-1311
ORAL
5 mg in 1 1
7/27/2022
UBI Pharma Inc.
72843-101
SUBCUTANEOUS
1 mg in 1 mL
2/15/2019
Amneal Pharmaceuticals of New York LLC
0115-2622
ORAL
5 mg in 1 1
1/25/2020
Henry Schein, Inc.
0404-9962
SUBCUTANEOUS
1 mg in 1 mL
1/12/2022
ANI Pharmaceuticals, Inc.
62559-722
ORAL
5 mg in 1 1
10/16/2018
Chartwell RX, LLC.
62135-525
ORAL
5 mg in 1 1
3/2/2023

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
BUTYLIN SYRUP 1.5 mg/5 ml
SIN08075P
SYRUP
1.5 mg/5 ml
3/18/1995
ASMALIN TABLET 2.5 mg
SIN06420P
TABLET
2.5 mg
7/8/1991
ASMALIN SYRUP 1.5 mg/5 ml
SIN07055P
SYRUP
1.5 mg/5 ml
6/12/1992

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
BUCANIN SYRUP 1.5MG/5ML
N/A
synco (h.k.) limited
N/A
N/A
9/1/1995
BUCANIN SYRUP 3MG/5ML
N/A
N/A
N/A
9/1/1995

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Bricanyl 0.5mg/1mL injection ampoule
12068
Medicine
A
8/13/1991
BRICANYL TURBUHALER terbutaline sulfate 400 microgram powder for inhalation dry powder inhaler
315075
Medicine
A
4/9/2020

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
BRICANYL TAB 5 MG
astrazeneca canada inc
00335363
Tablet - Oral
5 MG
12/31/1975
BRICANYL TAB 2.5 MG
astrazeneca canada inc
00335355
Tablet - Oral
2.5 MG
12/31/1978
BRICANYL TURBUHALER
astrazeneca canada inc
00786616
Powder - Inhalation
0.5 MG / DOSE
12/31/1990

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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