Doxazosin is an alpha-adrenergic blocker sold in the U.S. under 3 brand and generic names, for hypertension, prostatic hyperplasia and urinary retention. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Cardura (application NDA019668). Other doxazosin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For the treatment of BPH: Initiate therapy at 1 mg once daily. Dose maybe titrated at 1 to 2-week intervals, up to 8 mg once daily. ( 2.2 ) • For the treatment hypertension: Initiate therapy at 1 mg once daily. Dose may be titrated as needed, up to 16 mg once daily. ( 2.3 ) 2.1 Dosing Information Following the initial dose and with each dose increase of Doxazosin, monitor blood pressure for at least 6 hours following administration. If Doxazosin tablet administration is discontinued for several days, therapy should be restarted using the initial dosing regimen. 2.2 Benign Prostatic Hyperplasia The recommended initial dosage of Doxazosin tablet is 1 mg given once daily either in the morning or evening. Depending on the individual patient's urodynamics and BPH symptomatology, the dose may be titrated at 1 to 2 week intervals to 2 mg, and thereafter to 4 mg and 8 mg once daily. The maximum recommended dose for BPH is 8 mg once daily. Routinely monitor blood pressure in these patients. 2.3 Hypertension The initial dosage of Doxazosin tablet is 1 mg given once daily. Daily dosage may be doubled up 16 mg once daily, as needed, to achieve the desired reduction in blood pressure.
The most commonly reported adverse reactions from clinical trials are Fatigue, malaise, hypotension, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Greenstone LLC Professional Information Services at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Benign Prostatic Hyperplasia (BPH) The incidence of adverse events has been ascertained from worldwide clinical trials in 965 BPH patients. The incidence rates presented below (Table 2) are based on combined data from seven placebo-controlled trials involving once-daily administration of Doxazosin tablet in doses of 1 to 16 mg in hypertensives and 0.5 to 8 mg in normotensives. Adverse reactions occurring more than 1% more frequently in BPH patients treated with Doxazosin vs placebo are summarized in Table 1. Table 1. Adverse Reactions Occurring more than 1% More Frequently in BPH Patients Treated with Doxazosin Versus Placebo BODY SYSTEM Doxazosin N=665 Placebo N=300 NERVOUS SYSTEM DISORDERS Dizziness Includes vertigo 15.6% 9.0% Somnolence 3.0% 1.0% CARDIAC DISORDERS Hypotension 1.7% 0% RESPIRATORY,…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 68/100 | Prescription | Tablet | Generic | $3 | View → | |
| 2 | 64/100 | Prescription | Tablet | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| AC;358 | 4 mg | white | round | — |
| 596;TV | 4 mg | white | diamond | — |
| 593;TV | 2 mg | white | oval | — |
| AC;358 | 4 mg | white | round | — |
| Cardura;1;mg | 1 mg | white | oval | — |
| Cardura;2;mg | 2 mg |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Doxazosin Tablets
Tablets/Capsules Imprinted with Wrong ID
Unichem Pharmaceuticals USA Inc. · Jan 21, 2026
Cardura XL (doxazosin) extended release tablets 8 mg
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Viatris Inc · Dec 23, 2024
Cardura XL (doxazosin) extended release tablets 4 mg
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Viatris Inc · Dec 23, 2024
Cardura XL (doxazosin) extended release tablets 4mg
Failed Impurities/Degradation Specifications
Viatris Inc · Apr 30, 2024
Cardura XL (doxazosin) extended release tablets 8mg
Failed Impurities/Degradation Specifications
Viatris Inc · Apr 30, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
The use of Doxazosin tablet is contraindicated in patients with a hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of its components. • Hypersensitivity to doxazosin, other quinazolines, or any other ingredient in Doxazosin. ( 4 )
Strong cytochrome P450 (CYP) 3A inhibitors may increase exposure to doxazosin and increased risk of hypotension. ( 7.1 ) • Concomitant administration of Doxazosin with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. ( 7.2 ) 7.1 CYP 3A Inhibitors In vitro studies suggest that doxazosin is a substrate of CYP 3A4. Strong CYP3A inhibitors may increase exposure to doxazosin. Monitor blood pressure and for symptoms of hypotension when Doxazosin is used concomitantly with strong CYP3A inhibitors [ see Clinical Pharmacology (12.3) ]. 7.2 Phosphodiesterase-5 (PDE-5) inhibitors Concomitant administration of Doxazosin with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. Monitor blood pressure and for symptoms of hypotension [ see Warnings and Precautions (5.1) ].
| $3 |
| View → |
| 3 | Not yet rated | Prescription | Tablet | Generic | $3 | View → |
| yellow |
| oval |
| — |
| Cardura;4;mg | 4 mg | orange | oval | — |
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| Cardura;8;mg | 8 mg | green | oval | — |
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| CN1;Pfizer | 1 mg | white | round | — |
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| CN2;Pfizer | 2 mg | white | oval | — |
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| CN4;Pfizer | 4 mg | white | diamond | — |
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| CN8;Pfizer | 8 mg | white | oval | — |
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