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Data updated: Jun 28, 2026

DOXAZOSIN MESYLATE · ACCORD HLTHCARE

Cardiovascular Approved 1990-11-02

Doxazosin mesylate treats high blood pressure and helps patients manage the symptoms of benign prostatic hyperplasia (BPH). By lowering blood pressure, it helps reduce the risk of serious cardiovascular events like strokes and heart attacks. For men with BPH, this medication addresses issues such as frequent nighttime urination, weak urine flow, and incomplete bladder emptying.

How DOXAZOSIN MESYLATE Works

This medication works by selectively blocking alpha 1 adrenergic receptors, which are found in high concentrations in the prostate and blood vessels. In the prostate and bladder neck, this blockade relaxes smooth muscle tone to reduce urethral resistance and improve urine flow. For blood pressure management, the drug decreases systemic vascular resistance to help lower overall pressure.

NDA
Small Molecule
11
Indications
--
Phase 3 Trials
35
Years on Market

DOXAZOSIN MESYLATE Approval History

2001
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Original
New Indication
New Form
Label Update
336 FDA actions from 2000 to 2024
Oct 2024 SUPPL
Label · Labeling
Sep 2024 SUPPL
Label · Labeling
Jun 2024 SUPPL
Label · Labeling

What DOXAZOSIN MESYLATE Treats

2 indications

DOXAZOSIN MESYLATE is approved for 2 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.

Source: FDA Label

DOXAZOSIN MESYLATE 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 DOXAZOSIN MESYLATE

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Shared indications:
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Active Pipeline

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Key Completed Trials

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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.

DOXAZOSIN MESYLATE FDA Label Details

Indications & Usage

FDA Label (PDF)

Doxazosin tablets are an alpha 1 adrenergic antagonist indicated for: Signs and symptoms of Benign Prostatic Hyperplasia (BPH) Treatment of Hypertension 1.1 Benign Prostatic Hyperplasia (BPH) Doxazosin tablets are indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension Doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk offatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a ...

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Data Sources

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