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Metoprolol

Generic Name
Metoprolol
Brand Names
Kapspargo, Lopressor, Lopressor Hct, Toprol
Drug Type
Small Molecule
Chemical Formula
C15H25NO3
CAS Number
51384-51-1
Unique Ingredient Identifier
GEB06NHM23

Overview

Metoprolol is a selective beta-1 blocker commonly employed as the succinate and tartrate derivatives depending if the formulation is designed to be of immediate release or extended release. The possibility of the generation of these formulations comes from the lower systemic bioavailability of the succinate derivative. To this date, it is one of the preferred beta-blockers in general clinical guidelines and it is widely prescribed in the Netherlands, New Zealand, and the US. Metoprolol was developed since 1969 by US Pharmaceutical Holdings I and FDA approved in 1978.

Indication

Metoprolol is indicated for the treatment of angina, heart failure, myocardial infarction, atrial fibrillation, atrial flutter and hypertension. Some off-label uses of metoprolol include supraventricular tachycardia and thyroid storm. All the indications of metoprolol are part of cardiovascular diseases. These conditions correspond to a number of diseases that involve the function of the heart and blood vessels. The underlying causes of these conditions are variable and can be due to genetic disposition, lifestyle decisions such as smoking, obesity, diet, and lack of exercise, and comorbidity with other conditions such as diabetes. The cardiovascular diseases are the leading cause of death on a global scale.

Associated Conditions

  • Angina Pectoris
  • Atrial Fibrillation
  • Hypertension
  • Migraine
  • Myocardial Infarction
  • Supraventricular Tachycardia (SVT)
  • Thyroid Crisis
  • Chronic heart failure with reduced ejection fraction (NYHA Class II)
  • Chronic heart failure with reduced ejection fraction (NYHA Class III)

Research Report

Published: Jul 24, 2025

Comprehensive Monograph: Metoprolol (DB00264)

Executive Summary

Metoprolol is a cornerstone therapeutic agent in cardiovascular medicine, classified as a beta-1 selective adrenoceptor antagonist.[1] Its primary mechanism of action involves the competitive blockade of beta-1 adrenergic receptors, which are predominantly located in cardiac tissue. This action results in a reduction of heart rate, myocardial contractility, and cardiac output, leading to a decrease in blood pressure and myocardial oxygen demand.[3]

The U.S. Food and Drug Administration (FDA) has approved metoprolol for a range of critical cardiovascular indications, including the management of hypertension, the long-term treatment of angina pectoris, the improvement of survival following an acute myocardial infarction (MI), and as an essential component in the management of stable, symptomatic heart failure.[5] Its clinical utility extends to several off-label uses, such as the control of arrhythmias, migraine prophylaxis, and symptomatic management of thyrotoxicosis.[8]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/20
Not Applicable
Completed
Shiyan City Renmin Hospital
2025/05/13
Not Applicable
Recruiting
2025/05/09
Phase 4
Recruiting
2025/03/07
Phase 4
Recruiting
VZW Cardiovascular Research Center Aalst
2025/02/05
Phase 1
Completed
2024/11/13
Phase 1
Active, not recruiting
2024/09/19
Phase 2
Completed
2024/09/03
Phase 4
Recruiting
2024/08/23
Phase 4
Recruiting
Madeleine Puissant
2024/04/10
Phase 4
Completed
Pachankis, Yang I., M.D.

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
RedPharm Drug, Inc.
67296-1720
ORAL
50 mg in 1 1
1/14/2021
Wockhardt USA LLC.
64679-734
ORAL
25 mg in 1 1
11/26/2019
Aphena Pharma Solutions - Tennessee, LLC
67544-911
ORAL
50 mg in 1 1
4/3/2014
Aralez Pharmaceuticals US Inc.
70347-025
ORAL
25 mg in 1 1
11/30/2022
REMEDYREPACK INC.
70518-3606
ORAL
50 mg in 1 1
3/26/2024
Camber Pharmaceuticals, Inc.
31722-590
ORAL
50 mg in 1 1
3/12/2024
Bryant Ranch Prepack
63629-8865
ORAL
100 mg in 1 1
2/24/2022
Medical Purchasing Solutions, LLC
71872-7225
INTRAVENOUS
5 mg in 5 mL
5/4/2023
Aphena Pharma Solutions - Tennessee, LLC
43353-944
ORAL
100 mg in 1 1
6/18/2014
Northstar Rx LLC
72603-143
ORAL
50 mg in 1 1
6/20/2023

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
APO-METOPROLOL TABLET 100 mg
SIN00440P
TABLET
100 mg
4/27/1988
DENEX TABLET 100 mg
SIN01331P
TABLET
100 mg
5/19/1988
APO-METOPROLOL TABLET 50 mg
SIN00445P
TABLET
50 mg
4/27/1988

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
BETALOC ZOK TAB 25MG
N/A
N/A
N/A
6/10/2002
BETALOC ZOK TAB 200MG
N/A
N/A
N/A
9/6/1988
CZSY-METLOL TABLETS 50MG
N/A
N/A
N/A
1/9/2017

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
LOPRESOR SR 200 MG
novartis pharmaceuticals canada inc
00534560
Tablet (Extended-Release) - Oral
200 MG
12/31/1983
JAMP-METOPROLOL-L
02356821
Tablet - Oral
50 MG
10/21/2010
PENTA-METOPROLOL TABLETS
pentapharm ltd.
02232547
Tablet - Oral
100 MG
N/A
APO-METOPROLOL
00618640
Tablet - Oral
100 MG
12/31/1984
CO METOPROLOL-L TABLETS 100MG
Cobalt Pharmaceuticals Company
02244643
Tablet - Oral
100 MG
N/A
PMS-METOPROLOL-L
02230804
Tablet - Oral
100 MG
4/16/1998
PMS-METOPROLOL-L
02230803
Tablet - Oral
50 MG
4/16/1998
NU-METOPROLOL SR
nu-pharm inc
02337371
Tablet (Extended-Release) - Oral
100 MG
N/A
AG-METOPROLOL-L
angita pharma inc.
02481308
Tablet - Oral
25 MG
12/27/2018
NU-METOPROLOL (TYPE L)
nu-pharm inc
02337363
Tablet - Oral
100 MG
N/A

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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