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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

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Title
Posted
Study ID
Phase
Status
Sponsor
2008/07/29
Phase 3
Completed
2008/06/02
Phase 4
Completed
2008/04/30
Phase 4
Completed
2008/04/21
Phase 4
Completed
2008/04/02
Phase 2
UNKNOWN
2008/02/28
Not Applicable
Terminated
2008/01/15
Phase 2
Completed
2007/12/28
Phase 3
Terminated
2007/09/27
Phase 4
Completed
2007/09/14
Phase 4
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
PD-Rx Pharmaceuticals, Inc.
55289-993
ORAL
50 mg in 1 1
9/22/2023
State of Florida DOH Central Pharmacy
53808-0345
ORAL
100 mg in 1 1
5/24/2010
Major Pharmaceuticals
0904-7187
ORAL
25 mg in 1 1
11/8/2021
St. Mary's Medical Park Pharmacy
60760-256
ORAL
25 mg in 1 1
1/2/2020
Northwind Pharmaceuticals
51655-736
ORAL
100 mg in 1 1
1/1/2023
A-S Medication Solutions
50090-3411
ORAL
25 mg in 1 1
9/30/2015
NuCare Pharmaceuticals,Inc.
68071-3830
ORAL
50 mg in 1 1
4/18/2025
Apotheca Inc.
12634-605
ORAL
100 mg in 1 1
7/6/2016
Golden State Medical Supply, Inc.
60429-025
ORAL
50 mg in 1 1
8/7/2023
Northwind Pharmaceuticals, LLC
51655-491
ORAL
25 mg in 1 1
1/25/2023

EMA Drug Approvals

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

HSA Drug Approvals

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Approval Number
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Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Company
Approval Number
Drug Type
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Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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

Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ATENOLOL TABLETS, BP
fc pharma inc.
02239750
Tablet - Oral
100 MG
6/15/1999
ATENOLOL
PRO DOC LIMITEE
00828807
Tablet - Oral
50 MG
12/31/1989
ATENOLOL
sivem pharmaceuticals ulc
02541564
Tablet - Oral
25 MG
1/5/2024
ATENOLOL
sivem pharmaceuticals ulc
02238318
Tablet - Oral
100 MG
3/9/1999
ATENOLOL
ivax pharmaceuticals incorporated
02255626
Tablet - Oral
50 MG
N/A
NTP-ATENOL
teva canada limited
02343819
Tablet - Oral
100 MG
N/A
PMS-ATENOLOL
02237601
Tablet - Oral
100 MG
3/31/1998
NU-ATENOL TAB 100MG
nu-pharm inc
00886122
Tablet - Oral
100 MG
12/31/1990
PMS-ATENOLOL
02237600
Tablet - Oral
50 MG
3/31/1998
APO-ATENOL TAB 50MG
00773689
Tablet - Oral
50 MG
12/31/1988

CIMA AEMPS Drug Approvals

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

Philippines FDA Drug Approvals

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

Saudi SFDA Drug Approvals

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

Malaysia NPRA Drug Approvals

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Registration Number
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Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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MA Holder
MA Number
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Active Ingredient
Authorization Date
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