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Data updated: May 26, 2026

CARDURA (doxazosin mesylate)

Cardiovascular Approved 1990-11-02

Cardura helps patients with high blood pressure and those experiencing the symptoms of an enlarged prostate, also known as benign prostatic hyperplasia. It is used to lower blood pressure, which helps reduce the risk of serious cardiovascular events like strokes and heart attacks. For men with prostate issues, it helps manage urinary difficulties such as frequency, a weak stream, and the feeling of incomplete bladder emptying.

Source: FDA Label • Viatris

How CARDURA Works

This drug works by selectively blocking alpha 1 adrenergic receptors, which are found in high density in the prostate and bladder neck. By blocking these receptors, the medication relaxes smooth muscle tone to decrease urethral resistance and improve urine flow. In the circulatory system, this same blockade lowers blood pressure by decreasing systemic vascular resistance.

1
Indication
--
Phase 3 Trials
35
Years on Market

Details

Status
Prescription
First Approved
1990-11-02
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: DOXAZOSIN MESYLATE

CARDURA Approval History

1991
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Original
New Indication
New Form
Label Update
96 FDA actions from 1990 to 2021
Jun 2021 SUPPL
Label · Labeling
Jun 2016 SUPPL
Label · Labeling
Jul 2014 SUPPL
Mfg · Manufacturing (CMC)

What CARDURA Treats

2 indications

CARDURA is approved for 2 conditions since its original approval in 1990. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Benign Prostatic Hyperplasia
  • Hypertension
Source: FDA Label

CARDURA Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CARDURA

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

DOXAZOSIN MESYLATE
DOXAZOSIN MESYLATE
2 shared
ZYDUS PHARMS
ACEBUTOLOL HYDROCHLORIDE
ACEBUTOLOL HYDROCHLORIDE
1 shared
PHARMOBEDIENT
Shared indications:
ALDACTONE
SPIRONOLACTONE
1 shared
Pfizer
Shared indications:
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CARDURA FDA Label Details

Indications & Usage

FDA Label (PDF)

CARDURA is indicated for the treatment of Benign Prostatic Hyperplasia; Hypertension.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.