Overview

Carvedilol is a racemic mixture where the S(-) enantiomer is both a beta and alpha-1 adrenoceptor blocker, and the R(+) enantiomer is an alpha-1 adrenoceptor blocker. It is currently used to treat heart failure, left ventricular dysfunction, and hypertension. The dual action of carvedilol is advantageous in combination therapies as moderate doses of 2 drugs have a decreased incidence of adverse effects compared to high dose monotherapy in the treatment of moderate hypertension. Carvedilol was granted FDA approval on 14 September 1995.

Indication

Carvedilol is indicated to treat mild to severe heart failure, left ventricular dysfunction after myocardial infarction with ventricular ejection fraction ≤40%, or hypertension.

Associated Conditions

Atrial Fibrillation
Chronic Stable Angina Pectoris
Hypertension
LVEF ≤40% Left ventricular dysfunction
NYHA Class I or II heart failure
Chronic heart failure with reduced ejection fraction (NYHA Class III)
Chronic heart failure with reduced ejection fraction (NYHA Class IV)

Research Report

Published: Jul 25, 2025

Carvedilol: A Comprehensive Scientific and Clinical Monograph

Executive Summary: Carvedilol - A Comprehensive Monograph

Carvedilol is a third-generation cardiovascular agent that has established a pivotal role in the management of major cardiac conditions. It is distinguished within its therapeutic class by a unique, multifaceted pharmacological profile, functioning as a non-selective beta-adrenergic antagonist with concomitant, competitive alpha-1-adrenergic blocking properties. This dual mechanism of action confers significant hemodynamic advantages over traditional beta-blockers. Administered as a racemic mixture, its stereoisomers possess distinct activities: the S(–) enantiomer is responsible for both beta- and alpha-1 blockade, while the R(+) enantiomer contributes exclusively to alpha-1 blockade.

The cornerstone indications for carvedilol, supported by robust evidence from landmark clinical trials, include the management of mild-to-severe chronic heart failure with reduced ejection fraction (HFrEF), the reduction of cardiovascular mortality in clinically stable patients with left ventricular dysfunction following a myocardial infarction (MI), and the treatment of essential hypertension. In the context of HFrEF, carvedilol has demonstrated a profound ability to improve survival and reduce hospitalizations, making it a first-line therapy in guideline-directed medical treatment.

Continue reading the full research report

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Doppler Ultrasound Hepatic Vein Waveform as a Non-invasive Tool in the Assessment of Severity of Portal Hypertension	2016/11/29	NCT02975323	Phase 3	UNKNOWN	Aga Khan University
Effect of Carvedilol on Exercise Performance in Fontan Patients	2016/10/27	NCT02946892	Phase 4	Completed	University of Texas Southwestern Medical Center
Beta Adrenergic Receptor Blockade as a Novel Therapy for Patients With Adenocarcinoma of the Prostate	2016/10/25	NCT02944201	Phase 2	UNKNOWN	Montefiore Medical Center
Early Precise Diagnosis and Intervention of CPT Based on a Noninvasive 3D-vHPS	2016/10/06	NCT02925975	Phase 4	UNKNOWN	Changqing Yang
Spironolactone on Fibrosis Progrssion-Portal Hypertension(FP-PH)in Cirrhosis	2016/09/20	NCT02907749	Phase 4	Completed	Changqing Yang
Oral Carvedilol in Escalating Doses in the Acute Treatment of Atrial Fibrillation	2016/07/14	NCT02832089	Phase 3	Completed	Andhra Medical College
Effects of Beta-blockade on Platelet Aggregation in Acute Coronary Syndrome	2016/06/22	NCT02809820	Phase 4	Completed	Federico II University
Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors	2016/03/23	NCT02717507	Phase 2	Completed	Children's Oncology Group
The Effect of Carvedilol VS Endoscopic Therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding	2016/03/01	NCT02695732	Phase 4	UNKNOWN	Shanghai Zhongshan Hospital
The Effect of Hepatic Vein Pressure Gradient(HVPG)-Guided Therapy in Cirrhotic Patients With Esophagogastric Varices	2015/12/23	NCT02638415	Phase 4	UNKNOWN	Shanghai Zhongshan Hospital

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Carvedilol	Zydus Lifesciences Limited	65841-616	ORAL	3.125 mg in 1 1	10/31/2022
Carvedilol	Preferred Pharmaceuticals, Inc	68788-0999	ORAL	3.125 mg in 1 1	12/25/2009
Carvedilol	A-S Medication Solutions	50090-4898	ORAL	25 mg in 1 1	9/30/2019
Carvedilol	Blenheim Pharmacal, Inc.	10544-187	ORAL	6.25 mg in 1 1	2/17/2015
Carvedilol	Legacy Pharmaceutical Packaging, LLC	68645-351	ORAL	12.5 mg in 1 1	10/27/2023
Carvedilol	Aidarex Pharmaceuticals LLC	33261-537	ORAL	25 mg in 1 1	9/12/2012
Carvedilol	American Health Packaging	68084-854	ORAL	6.25 mg in 1 1	10/4/2022
COREGCR CR	Physicians Total Care, Inc.	54868-5869	ORAL	40 mg in 1 1	10/19/2010
Carvedilol	Bryant Ranch Prepack	71335-1545	ORAL	12.5 mg in 1 1	11/12/2019
Carvedilol	A-S Medication Solutions	50090-2079	ORAL	12.5 mg in 1 1	8/23/2023

EMA Drug Approvals

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

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
DICARZ carvedilol 3.125 mg tablet bottle	101741	Alphapharm Pty Ltd	Medicine	A	7/15/2005
APO-CARVEDILOL carvedilol 25 mg tablet bottle	123841	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/15/2006

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CARVEDILOL	PRO DOC LIMITEE	02324512	Tablet - Oral	6.25 MG	6/12/2009
CARVEDILOL	PRO DOC LIMITEE	02324504	Tablet - Oral	3.125 MG	6/12/2009
CARVEDILOL	sanis health inc	02364913	Tablet - Oral	3.125 MG	6/10/2011
CARVEDILOL	sivem pharmaceuticals ulc	02248755	Tablet - Oral	25 MG	4/6/2004
ZYM-CARVEDILOL	zymcan pharmaceuticals inc	02338114	Tablet - Oral	25 MG	12/29/2009
NTP-CARVEDILOL	teva canada limited	02362082	Tablet - Oral	6.25 MG	N/A
NU-CARVEDILOL	nu-pharm inc	02248718	Tablet - Oral	25 MG	N/A
RAN-CARVEDILOL	ranbaxy pharmaceuticals canada inc.	02268035	Tablet - Oral	6.25 MG	7/22/2005
JAMP-CARVEDILOL	Jamp Pharma Corporation	02368919	Tablet - Oral	12.5 MG	6/17/2011
PMS-CARVEDILOL	Pharmascience Inc	02245915	Tablet - Oral	6.25 MG	8/4/2003

CIMA AEMPS Drug Approvals

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

Saudi SFDA Drug Approvals

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

Malaysia NPRA Drug Approvals

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Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
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