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
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]
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 | 
TGA Drug Approvals
| Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date | 
|---|---|---|---|---|---|
| ARX-METOPROLOL 50 Metoprolol tartrate 50mg tablet blister pack | 75835 | Medicine | A | 8/28/2000 | |
| METOPROLOL-WGR metoprolol tartrate 50mg tablet blister pack | 234003 | Medicine | A | 9/23/2015 | |
| NOUMED METOPROLOL metoprolol tartrate 50mg tablet blister pack | 298212 | Medicine | A | 2/26/2018 | |
| METROL 100 metoprolol tartrate 100 mg tablet blister pack | 234002 | Medicine | A | 9/23/2015 | |
| ETOCAR metoprolol tartrate 50 mg film-coated tablet blister pack | 222125 | Medicine | A | 3/25/2015 | |
| MYOTAR metoprolol tartrate 100 mg film-coated tablet blister pack | 222122 | Medicine | A | 3/25/2015 | |
| TOPRELOC-XL metoprolol succinate 23.75 mg modified release tablet blister pack | 356239 | Medicine | A | 3/4/2022 | |
| Metoprolol tartrate 100 mg tablet bulk | 371588 | Medicine | A | 7/23/2021 | |
| Metoprolol tartrate 50 mg tablet bulk | 371587 | Medicine | A | 7/23/2021 | |
| IPCA-METOPROLOL metoprolol tartrate 50mg tablet blister pack | 192780 | Medicine | A | 1/8/2013 | 
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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