Prescription medicine
Alfuzosin Brand names: Uroxatral
Alfuzosin (Uroxatral) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $0.105 per alfuzosin HCl ER 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the alfuzosin FDA label on DailyMed (effective December 5, 2024, Advanz Pharma (US) Corp.); the NDA 21287 record on Drugs@FDA; every alfuzosin label on DailyMed.
Highlights of the record
FDA label of December 5, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageUROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
Forms and strengths
- 10 mg
Extended-release tablet; film-coated extended-release tablet; tablet.
On the market
- Earliest approval on file
- June 12, 2003 Uroxatral, Advanz Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first July 18, 2011; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 11 of which 10 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.105 per tablet Alfuzosin HCl ER 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2017 0 Class I among all firms' recalls; latest January 5, 2017
- FAERS reports
- 5,746 through July 30, 2026
What is alfuzosin used for?
From the label: indications and usageUROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. UROXATRAL is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. ( 1 ) Important Limitations of Use: UROXATRAL is not indicated for treatment of hypertension. ( 1.1 ) UROXATRAL is not indicated for use in the pediatric population. ( 1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use UROXATRAL is not indicated for the treatment of hypertension. UROXATRAL is not indicated for use in the pediatric population.
Conditions named in the indications of alfuzosin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: alpha-Adrenergic Blocker.
Source: FDA drug label (Uroxatral), Advanz Pharma (US) Corp., effective December 5, 2024 (SPL set 9fc7f119-f36b-44cf-945d-940160f3afe3), via openFDA; the full label on DailyMed
What does the patient leaflet for alfuzosin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about UROXATRAL?UROXATRAL can cause serious side effects, including a sudden drop in blood pressure, especially when you start treatment. This may cause you to faint, or to feel dizzy or lightheaded. Your risk of having this problem may be increased if you take UROXATRAL with certain other medicine that lowers blood pressure: medicines for high blood pressure a nitrate medicine for angina Ask your doctor if you are not sure if you are taking one of these medicines. Do not drive, operate machinery, or do any dangerous activities until you know how UROXATRAL affects you. This is especially important if you already have a problem with low blood pressure or take medicines to treat high blood pressure. If you begin to feel dizzy or lightheaded, lie down with your legs and feet up. If your symptoms do not improve call your doctor. See the section "What are the possible side effects of UROXATRAL?" for more information about side effects.
Source: FDA drug label (Uroxatral), Advanz Pharma (US) Corp., effective December 5, 2024 (SPL set 9fc7f119-f36b-44cf-945d-940160f3afe3), via openFDA; the full label on DailyMed
Is there a generic for alfuzosin (Uroxatral)?
The FDA approved the first generic alfuzosin on July 18, 2011. 9 generic applications are approved; 4 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 alfuzosin from 10 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2003 earliest approval on file
- 2011 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 alfuzosin (Uroxatral)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.105 per Alfuzosin HCl ER 10 mg tablet, about the same as a year earlier. 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.
- Alfuzosin HCl ER 10 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Alfuzosin HCl ER 10 mg tablet | Generic | $0.105 per tablet | $3.15 | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has alfuzosin been recalled?
The FDA's Enforcement Report lists 1 recall naming alfuzosin since 2017: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 5, 2017 | Class II | Sun Pharmaceutical Industries, Inc. | Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the alfuzosin label say about other medicines?
The alfuzosin label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 16 other medicines name alfuzosin. 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 |
|---|---|---|
| Itraconazole | contraindications | … Populations (8.7) and Clinical Pharmacology (12.3) ]. with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. … |
| Ketoconazole | contraindications | … Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ]. with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. … |
| Ritonavir | contraindications | … and Clinical Pharmacology (12.3) ]. with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. … |
Other labels that name alfuzosin
Source: FDA drug label (Uroxatral), Advanz Pharma (US) Corp., effective December 5, 2024 (SPL set 9fc7f119-f36b-44cf-945d-940160f3afe3), via openFDA; the full label on DailyMed
What do FAERS reports show for alfuzosin?
The FDA Adverse Event Reporting System holds 5,746 reports that list alfuzosin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 457 are coded as a death and 2,082 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 alfuzosin?
6 other medicines are given the same way (oral) and in the same FDA class as alfuzosin 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. 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 |
|---|---|---|---|---|
| Doxazosin | Enlarged prostate (BPH) | 29 labelers | $0.0752 per tablet 1 mg tablet | No current entry |
| Terazosin | 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 |
| Finasteride | Enlarged prostate (BPH) | 30 labelers | $0.0688 per tablet 5 mg tablet | No current entry |
| Dutasteride | Enlarged prostate (BPH) | 13 labelers | $0.157 per capsule 0.5 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does alfuzosin compare with medicines for the same use?
7 side-by-side pages set alfuzosin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to alfuzosin
- 6 medicines for the same use
- Other alpha blockers
- the pharmacologic class, with prices and generics
- Alfuzosin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other