Prescription medicine
Doxazosin Brand names: Cardura
Doxazosin (Cardura) is a prescription medicine with an FDA approval on record since 1990. FDA's NDC Directory lists it from 29 generic labelers, and pharmacies paid $0.0752 per doxazosin mesylate 1 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the doxazosin FDA label on DailyMed (effective October 15, 2023, Viatris Specialty LLC); the NDA 19668 record on Drugs@FDA; every doxazosin label on DailyMed.
Highlights of the record
FDA label of October 15, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCARDURA is an alpha 1 adrenergic antagonist indicated for:
Signs and symptoms of Benign Prostatic Hyperplasia (BPH) ( 1.1 )
Treatment of Hypertension ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) CARDURA is indicated for the treatment of the signs and symptoms of BPH.
Forms and strengths
- 1 mg
- 2 mg
- 4 mg
- 8 mg
Tablet; film-coated extended-release tablet.
On the market
- Earliest approval on file
- November 2, 1990 Cardura, Viatris; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first October 18, 2000; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 32 of which 29 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0752 per tablet Doxazosin mesylate 1 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 11 since 2012 0 Class I among all firms' recalls; latest January 21, 2026; 2 more by firms not listed as its makers
- FAERS reports
- 35,891 through July 30, 2026
What is doxazosin used for?
From the label: indications and usageCARDURA is an alpha 1 adrenergic antagonist indicated for:
Signs and symptoms of Benign Prostatic Hyperplasia (BPH) ( 1.1 )
Treatment of Hypertension ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) CARDURA is indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension CARDURA is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. […]
Conditions named in the indications of doxazosin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: alpha-Adrenergic Blocker.
Source: FDA drug label (Cardura), Viatris Specialty LLC, effective October 15, 2023 (SPL set 5e1f5e49-2da1-43ab-9795-228a8bcc5a82), via openFDA; the full label on DailyMed
What does the patient leaflet for doxazosin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking CARDURA?Do not drive or perform any hazardous task until at least 24 hours after you have taken CARDURA if you are taking: • your first dose of CARDURA • CARDURA for the first time after your healthcare provider has increased your dose of CARDURA • CARDURA for the first time after any breaks (interruptions) in your treatment with CARDURA
Source: FDA drug label (Cardura), Viatris Specialty LLC, effective October 15, 2023 (SPL set 5e1f5e49-2da1-43ab-9795-228a8bcc5a82), via openFDA; the full label on DailyMed
Is there a generic for doxazosin (Cardura)?
The FDA approved the first generic doxazosin on October 18, 2000. 19 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists doxazosin from 29 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1990 earliest approval on file
- 2000 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for doxazosin (Cardura)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0752 per Doxazosin mesylate 1 mg tablet, down 10% from $0.0839 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Doxazosin mesylate 2 mg tablet (generic)
- Cardura xl 4 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Doxazosin mesylate 1 mg tablet | Generic | $0.0752 per tablet | $2.26 | -10% |
| Doxazosin mesylate 2 mg tablet | Generic | $0.0635 per tablet | $1.91 | -7% |
| Doxazosin mesylate 4 mg tablet | Generic | $0.0834 per tablet | $2.50 | -9% |
| Doxazosin mesylate 8 mg tablet | Generic | $0.0976 per tablet | $2.93 | +1% |
| Cardura xl 4 mg tablet | Brand | $6.99 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $209.67 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has doxazosin been recalled?
The FDA's Enforcement Report lists 13 recalls naming doxazosin since 2012: 0 Class I (the most serious), 12 Class II, 1 Class III; 4 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of doxazosin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 21, 2026 | Class III | Unichem Pharmaceuticals USA Inc. | Tablets/Capsules Imprinted with Wrong ID |
| December 23, 2024 | Class II | Viatris Inc not a listed maker | Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing. |
| March 23, 2023 | Class II | Preferred Pharmaceuticals, Inc. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| March 20, 2023 | Class II | RemedyRepack Inc. | cGMP Deviations |
| March 16, 2023 | Class II | Northwind Pharmaceuticals LLC | CGMP Deviations |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: DOXAZOSIN MESYLATE, Tablet, 1 mg may have potentially been mislabeled as the following drug: PYRIDOXINE HCL, Tablet, 100 mg, NDC … |
| August 7, 2012 | Class II | Mylan Pharmaceuticals Inc. | Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the doxazosin label say about other medicines?
The doxazosin label names 15 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name doxazosin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions | Caution should be exercised when concomitantly administering CARDURA XL with a strong CYP 3A4 inhibitor, such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole [see Clinical Pharmacology (12.3) ]. |
| Cimetidine | drug interactions | In healthy volunteers, the administration of a single 1 mg dose of doxazosin on day 1 of a four-day regimen of oral cimetidine (400 mg twice daily) resulted in a 10% increase in mean AUC of doxazosin, and a slight but not significant increase in mean C max and mean half-life of doxazosin. |
| Clarithromycin | drug interactions | Caution should be exercised when concomitantly administering CARDURA XL with a strong CYP 3A4 inhibitor, such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole [see Clinical Pharmacology (12.3) ]. |
| Digoxin | drug interactions | In vitro data in human plasma indicate that CARDURA has no effect on protein binding of digoxin, warfarin, phenytoin, or indomethacin. |
| Indomethacin | drug interactions | In vitro data in human plasma indicate that CARDURA has no effect on protein binding of digoxin, warfarin, phenytoin, or indomethacin. |
| Itraconazole | drug interactions | Caution should be exercised when concomitantly administering CARDURA XL with a strong CYP 3A4 inhibitor, such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole [see Clinical Pharmacology (12.3) ]. |
| Ketoconazole | drug interactions | Caution should be exercised when concomitantly administering CARDURA XL with a strong CYP 3A4 inhibitor, such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole [see Clinical Pharmacology (12.3) ]. |
| Nefazodone | drug interactions | Caution should be exercised when concomitantly administering CARDURA XL with a strong CYP 3A4 inhibitor, such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole [see Clinical Pharmacology (12.3) ]. |
| Nelfinavir | drug interactions | Caution should be exercised when concomitantly administering CARDURA XL with a strong CYP 3A4 inhibitor, such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole [see Clinical Pharmacology (12.3) ]. |
| Phenytoin | drug interactions | In vitro data in human plasma indicate that CARDURA has no effect on protein binding of digoxin, warfarin, phenytoin, or indomethacin. |
| Prazosin | contraindications | CONTRAINDICATIONS The use of CARDURA is contraindicated in patients with a hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of its components. |
| Ritonavir | drug interactions | Caution should be exercised when concomitantly administering CARDURA XL with a strong CYP 3A4 inhibitor, such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole [see Clinical Pharmacology (12.3) ]. |
| Terazosin | contraindications | CONTRAINDICATIONS The use of CARDURA is contraindicated in patients with a hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of its components. |
| Voriconazole | drug interactions | Caution should be exercised when concomitantly administering CARDURA XL with a strong CYP 3A4 inhibitor, such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole [see Clinical Pharmacology (12.3) ]. |
Every other medicine the doxazosin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Warfarin | drug interactions | In vitro data in human plasma indicate that CARDURA has no effect on protein binding of digoxin, warfarin, phenytoin, or indomethacin. |
Other labels that name doxazosin
Source: FDA drug label (Cardura), Viatris Specialty LLC, effective October 15, 2023 (SPL set 5e1f5e49-2da1-43ab-9795-228a8bcc5a82), via openFDA; the full label on DailyMed
What do FAERS reports show for doxazosin?
The FDA Adverse Event Reporting System holds 35,891 reports that list doxazosin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,117 are coded as a death and 15,209 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as doxazosin?
9 other medicines are given the same way (oral) and in the same FDA class as doxazosin or labeled mainly for the same use (enlarged prostate (bph)), the same class first. Enlarged prostate (BPH) lists all 8 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Carvedilol | High blood pressure | 41 labelers | $0.0179 per tablet 6.25 mg tablet | No current entry |
| Prazosin | High blood pressure | 33 labelers | $0.0842 per capsule 1 mg capsule | A presentation being discontinued |
| Terazosin | High blood pressure, Enlarged prostate (BPH) | 21 labelers | $0.106 per capsule 2 mg capsule | No current entry |
| Tamsulosin | Enlarged prostate (BPH) | 37 labelers | $0.05 per capsule 0.4 mg capsule | No current entry |
| Silodosin | Enlarged prostate (BPH) | 13 labelers | $0.319 per capsule 8 mg capsule | No current entry |
| Alfuzosin | Enlarged prostate (BPH) | 10 labelers | $0.105 per tablet 10 mg tablet | No current entry |
| Phenoxybenzamine | High blood pressure | 5 labelers | n/a | A presentation being discontinued |
| Finasteride | Enlarged prostate (BPH) | 30 labelers | $0.0688 per tablet 5 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does doxazosin compare with medicines for the same use?
10 side-by-side pages set doxazosin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to doxazosin
- 9 medicines for the same use
- Other alpha blockers
- the pharmacologic class, with prices and generics
- Doxazosin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other