MedPath

Atenolol

Generic Name
Atenolol
Brand Names
Tenoretic, Tenormin
Drug Type
Small Molecule
Chemical Formula
C14H22N2O3
CAS Number
29122-68-7
Unique Ingredient Identifier
50VV3VW0TI

Overview

Atenolol is a cardioselective beta-blocker used in a variety of cardiovascular conditions. Sir James Black, a Scottish pharmacologist, pioneered the use of beta-blockers for the management of angina pectoris in 1958 for which he received the Nobel Prize. Beta-blockers quickly became popular in clinical use and where subsequently investigated for use in myocardial infarction, arrhythmias, and hypertension during the 1960s. Later they continued to be investigated for use in heart failure throughout the 1970-1980s. Atenolol itself was developed early on in this history by Alvogen Malta under the trade name Tenormin and received FDA approval in September, 1981. Despite being one of the most widely prescribed beta blockers, evidence suggests atenolol may not significantly reduce mortality, and only modestly reduce the risk of cardiovascular disease in patients with hypertension. A Cochrane review of patients being treated for primary hypertension shows that atenolol shows a risk ratio of 0.88 for cardiovascular disease risk and a risk ratio of 0.99 for mortality. Similar results have been found in other meta-analyses. A meta-analysis of over 145,000 patients showed the risk of stroke in patients taking atenolol may depend on the age of the patient. The use of atenolol may need to be based on more patient factors than hypertension alone.

Indication

Indicated for: 1) Management of hypertension alone and in combination with other antihypertensives. 2) Management of angina pectoris associated with coronary atherosclerosis. 3) Management of acute myocardial infarction in hemodynamically stable patients with a heart rate greater than 50 beats per minutes and a systolic blood pressure above 100 mmHg. Off-label uses include: 1) Secondary prevention of myocardial infarction. 2) Management of heart failure. 3) Management of atrial fibrillation. 4) Management of supraventricular tachycardia. 5) Management of ventricular arrythmias such as congenital long-QT and arrhythmogenic right ventricular cardiomyopathy. 6) Management of symptomatic thyrotoxicosis in combination with methimazole. 7) Prophylaxis of migraine headaches. 8) Management of alcohol withdrawal.

Associated Conditions

  • Alcohol Withdrawal Syndrome
  • Angina Pectoris
  • Atrial Fibrillation
  • Heart Failure
  • Hypertension
  • Migraine
  • Myocardial Infarction
  • Refractory Hypertension
  • Secondary prevention Myocardial infarction
  • Supra-ventricular Tachyarrhythmias
  • Thyrotoxicosis
  • Ventricular Tachyarrhythmias

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/11/01
Not Applicable
Completed
2024/07/17
Not Applicable
Recruiting
All India Institute of Medical Sciences, Bhubaneswar
2021/11/03
Phase 4
UNKNOWN
Center for Vascular Pathology, Moscow
2021/06/18
Phase 4
Recruiting
Shanghai Jiao Tong University School of Medicine
2021/06/04
Phase 4
Recruiting
Damanhour Teaching Hospital
2021/05/27
Phase 2
Active, not recruiting
Sundeep Khosla, M.D.
2021/02/16
N/A
Recruiting
2020/01/13
Not Applicable
UNKNOWN
Onassis Cardiac Surgery Centre
2018/07/06
Phase 2
Withdrawn
2017/08/10
Phase 4
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Golden State Medical Supply, Inc.
60429-026
ORAL
100 mg in 1 1
8/7/2023
State of Florida DOH Central Pharmacy
53808-0344
ORAL
100 mg in 1 1
5/24/2010
RedPharm Drug, Inc.
67296-1732
ORAL
50 mg in 1 1
1/14/2021
NuCare Pharmaceuticals,Inc.
68071-4527
ORAL
50 mg in 1 1
3/15/2021
direct rx
72189-146
ORAL
25 mg in 1 1
6/28/2023
Central Texas Community Health Centers
76413-140
ORAL
25 mg in 1 1
12/14/2016
State of Florida DOH Central Pharmacy
53808-1012
ORAL
50 mg in 1 1
12/7/2014
Bryant Ranch Prepack
71335-0954
ORAL
50 mg in 1 1
5/26/2023
Aidarex Pharmaceuticals LLC
33261-942
ORAL
50 mg in 1 1
11/22/2013
Blenheim Pharmacal, Inc.
10544-031
ORAL
50 mg in 1 1
3/12/2015

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
ATENOLOL TABLET 50 mg
SIN08753P
TABLET, FILM COATED
50 mg
6/20/1996
PRENOLOL TABLET 100 mg
SIN10278P
TABLET, FILM COATED
100 mg
10/14/1998
TENORMIN TABLET 25 mg
SIN08669P
TABLET, FILM COATED
25 mg
4/19/1996
TENOL-100 TABLET 100mg
SIN07662P
TABLET, FILM COATED
100 mg
3/10/1994
VASCOTEN 50 TABLET 50 mg
SIN07161P
TABLET
50 mg
10/8/1992
NORMATEN TABLET 100 mg
SIN10391P
TABLET, FILM COATED
100 mg
11/6/1998
TENOL TABLET 50 mg
SIN07538P
TABLET
50 mg
11/1/1993
PRENOLOL 50 TABLET 50 mg
SIN10277P
TABLET, FILM COATED
50 mg
10/14/1998
NORMATEN TABLET 50 mg
SIN07584P
TABLET, FILM COATED
50 mg
12/21/1993
ATENOLOL TABLET 100 mg
SIN08755P
TABLET, FILM COATED
100 mg
6/20/1996

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Atenolol Injection
国药准字H20090220
化学药品
注射剂
7/8/2019
Atenolol Injection
国药准字H20183263
化学药品
注射剂
7/6/2023
Atenolol Injection
国药准字H20183389
化学药品
注射剂
8/23/2023
Atenolol Tablets
国药准字H20249783
化学药品
片剂
12/25/2024
Atenolol Tablets
国药准字H20249782
化学药品
片剂
12/25/2024
Atenolol Tablets
国药准字H20063435
化学药品
片剂
5/14/2020
Atenolol Tablets
国药准字H12020259
化学药品
片剂
7/20/2020
Atenolol Tablets
国药准字H44021430
化学药品
片剂
8/27/2024
Atenolol Tablets
国药准字H31020403
化学药品
片剂
12/31/2019
Atenolol Tablets
国药准字H23021130
化学药品
片剂
4/16/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
ATENOLOL 100 STADA TAB 100MG
N/A
N/A
N/A
7/14/1994
TOTAMOL TAB 50MG
N/A
N/A
N/A
3/23/1999
ATENOLOL TABLETS BP 50MG
N/A
N/A
N/A
10/27/2020

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