FDA-filed SPL labeling · retrieved through openFDA

Alfuzosin

Alfuzosin is an alpha blocker used to treat the signs and symptoms of benign prostatic hyperplasia (BPH, or enlarged prostate) in men.

Brand name Uroxatral
Drug classes ⓘ Adrenergic Alpha-antagonists
Rx Forms 2 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 18 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveDec 5, 2024
Clinical labels in scope ⓘ18
AvailabilityRx
Earliest approval/marketing year ⓘ2003
FDA-listed product records ⓘ55
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Oct 1, 2026
⭐ Alfuzosin at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line

Alfuzosin is a once-daily tablet that eases the urinary symptoms of benign prostatic hyperplasia. Take it with the same meal each day and swallow it whole. Stand up slowly, and check with your pharmacist or doctor before adding other medicines, especially antifungals, blood pressure medicines or erectile dysfunction drugs.

📖 Alfuzosin: Patient Information Guide

A plain-language walkthrough of Alfuzosin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

What Alfuzosin is used for

▾

Alfuzosin is used for one condition across all supported products.

  • Signs and symptoms of benign prostatic hyperplasia (BPH, or enlarged prostate), for Alfuzosin Hydrochloride tablets and extended-release tablets, and Uroxatral.
  • Not for high blood pressure.
  • Not for children.

How Alfuzosin works

▾

Alfuzosin is an alpha-1 blocker. It blocks alpha-1 receptors found in the prostate, bladder base, bladder neck, prostatic capsule and urethra. This lets the smooth muscle in the bladder neck and prostate relax. The result is better urine flow and fewer BPH symptoms.

How Alfuzosin is taken (dosage)

▾

Alfuzosin is taken by mouth once a day. Take it with food, and with the same meal each day, because absorption is about 50% lower when fasting. Swallow tablets whole. Do not chew or crush them.

Follow your prescriber’s directions and your pharmacy label.

Alfuzosin side effects in detail

▾

Most side effects are mild. The most common ones were:

  • Dizziness
  • Upper respiratory tract infection
  • Headache
  • Fatigue
  • Abdominal pain, indigestion, constipation, nausea
  • Impotence

Fainting, allergic reactions, liver problems, a long-lasting erection or chest pain need prompt medical attention.

Alfuzosin warnings and precautions

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  • Low blood pressure and fainting: Stand up slowly. Take extra care if you take blood pressure medicines or nitrates.
  • Liver disease: Alfuzosin must not be used with moderate or severe liver impairment.
  • Strong CYP3A4 inhibitors: These raise alfuzosin levels and must not be combined with it.
  • Severe kidney impairment: Use with caution.
  • Cataract surgery: Intraoperative Floppy Iris Syndrome has been reported.
  • Heart effects: Chest pain and angina in people with coronary artery disease, as well as atrial fibrillation, have been reported after approval.

Alfuzosin interactions: what it interacts with

▾

Some medicines can raise alfuzosin levels or add to its blood pressure effects.

  • Ketoconazole, itraconazole, ritonavir: raise alfuzosin blood levels. Do not combine.
  • Other alpha blockers: interactions are expected, so do not combine.
  • Blood pressure medicines and nitrates: higher risk of low blood pressure and fainting.
  • PDE5 inhibitors: both lower blood pressure, so symptomatic hypotension is possible.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

Before taking Alfuzosin

▾
  • Do not take it with moderate or severe liver impairment.
  • Do not take it if you are allergic to alfuzosin or any of its ingredients.
  • Tell your doctor if you have low blood pressure or severe kidney impairment.
  • It is not indicated for women, including during pregnancy or breastfeeding.
  • It is not indicated for children. It did not work in a trial in patients ages 2 to 16.
  • Older adults (75 and over) had about 35% higher trough levels than those under 65.

Alfuzosin overdose: if you take too much

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Too much alfuzosin can cause low blood pressure. Treatment focuses on supporting the heart and circulation, such as lying flat, and sometimes IV fluids or medicines to raise blood pressure. Dialysis may not help because alfuzosin binds strongly to proteins in the blood.

Pharmacodynamics: what Alfuzosin does in the body

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Alfuzosin is selective for alpha receptors in the lower urinary tract. Blocking them relaxes smooth muscle in the bladder neck and prostate, which improves urine flow. In heart rhythm studies, higher doses showed a larger effect on the QT interval (a heart rhythm measure). Even so, the effect was smaller than the comparison drug, and the clinical impact is unknown.

Pharmacokinetics: how your body processes Alfuzosin

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With food, about 49% of the extended-release tablet is absorbed, and blood levels peak around 8 hours after dosing. Absorption is about 50% lower when fasting. The liver breaks alfuzosin down extensively, mainly through CYP3A4, and the metabolites are not active. It leaves the body mostly in feces, and some in urine, with a half-life of about 10 hours.

How to store Alfuzosin

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Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Dispense in a tight, light-resistant container as described in the USP. Protect from light and moisture.

📄 Written from Alfuzosin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

139

Supplements & herbs that interact with Alfuzosin

139 supplements and herbal products have documented interactions with Alfuzosin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 95
  • Minor · 41
Every supplement checked against Alfuzosin — ranked by severity The full interaction hub: 3 major · 95 moderate · 41 minor · every one linked to its full report. Check Alfuzosin against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Alfuzosin: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Alfuzosin — the kind of thing our pharmacy team would talk through with you at the counter.

What is alfuzosin for?

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It treats the urinary symptoms of an enlarged prostate, called benign prostatic hyperplasia (BPH). It relaxes muscle in the prostate and bladder neck so urine flows more easily. It is not a blood pressure medicine.

How should I take it?

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Take it by mouth once a day, with food, and with the same meal each day. Swallow it whole. Do not chew or crush it. Taking it on an empty stomach cuts absorption by about half.

What side effects should I expect?

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The most common ones are dizziness, headache, tiredness and cold-like symptoms. Some people have stomach upset or erectile problems. Stand up slowly, since it can lower your blood pressure.

When should I call my doctor?

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Call if you faint, or have swelling of the face or throat, hives, yellowing of the skin or eyes, chest pain or a racing heartbeat. An erection that will not go away needs urgent care.

What medicines should I avoid with it?

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Do not take it with strong CYP3A4 inhibitors like ketoconazole, itraconazole or ritonavir. Do not combine it with other alpha blockers. Tell me if you use blood pressure medicines, nitrates or erectile dysfunction drugs, since these can lower your blood pressure further.

I’m having cataract surgery. Does it matter?

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Yes. Tell your eye surgeon you take or have taken alfuzosin. Medicines like it have been linked to a small-pupil problem during surgery called Intraoperative Floppy Iris Syndrome.

Is Alfuzosin available over the counter?

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Alfuzosin is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.

When was Alfuzosin first available?

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Alfuzosin has been available in the United States since at least 2003, based on FDA approval history (Drugs@FDA) and product marketing records.

Who makes Alfuzosin?

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Alfuzosin is supplied by 25 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, Aurobindo Pharma Limited, Apotex Corp..

💬 Answers drafted from Alfuzosin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 More about Alfuzosin on HelloPharmacist

💊 Alfuzosin forms and strengths (how it comes)

Alfuzosin is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Extended-release tablet

By mouth
Brands Uroxatral
How this form is used
What it may be used for
  • Alfuzosin Hydrochloride extended-release tablets are used for signs and symptoms of benign prostatic hyperplasia.
  • Uroxatral is used for signs and symptoms of benign prostatic hyperplasia.
Important instructions
  • Alfuzosin Hydrochloride extended-release tablets are taken once daily with food and with the same meal each day.
  • Uroxatral is taken once daily with food and with the same meal each day.
  • Uroxatral and Alfuzosin Hydrochloride extended-release tablets should not be chewed or crushed.
Available strengths 1 strength
44 FDA-listed product records ⓘ

Tablet

By mouth
How this form is used
What it may be used for
  • Alfuzosin Hydrochloride tablets are used for signs and symptoms of benign prostatic hyperplasia.
Important instructions
  • Alfuzosin Hydrochloride tablets are taken once daily with food and with the same meal each day.
  • Alfuzosin Hydrochloride tablets should not be chewed or crushed.
Available strengths 1 strength
3 FDA-listed product records ⓘ

📊 Alfuzosin on the U.S. market: products, makers and brands

How Alfuzosin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2
Dose forms ⓘ
25
Manufacturers
3
Brand names
55
FDA-listed product records ⓘ
2003
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (8) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack27%
Aurobindo Pharma Limited11%
Apotex Corp.5%
Northwind Pharmaceuticals, LLC5%
Exelan Pharmaceuticals Inc.5%
Northwind Health Company, LLC5%
Other makers40%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Alfuzosin is used (Medicaid data)

A general measure of how commonly Alfuzosin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Alfuzosin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

80,100
Medicaid prescriptions filled (Q1–Q4 2025)
$1.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Alfuzosin prescribed? Of the 1,599 medications we measure, Alfuzosin ranks #547 by Medicaid prescriptions — more than 66% of them.

Where Alfuzosin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Alfuzosin product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

24 HR alfuzosin hydrochloride 10 MG Extended Release Oral Tablet

80,100 Medicaid prescriptions (Q1–Q4 2025) 100% of Alfuzosin prescriptions shown $1.1M gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 6 of 77 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861132

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Alfuzosin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 77 listed Alfuzosin NDCs with Medicaid activity.

🔍 Compare Alfuzosin products

A representative set of FDA-listed product records for Alfuzosin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 55 of 55 products — FDA National Drug Code Directory. See every product, package size and price: browse all 55 Alfuzosin NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Alfuzosin RxCUI 17300 2 dose forms · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 370797 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 2.5 MG RxCUI 1088455

Look up RxCUI 17300 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Alfuzosin brand names

Uroxatral

🏭 Who makes Alfuzosin: manufacturers and labelers

Bryant Ranch Prepack 15 Aurobindo Pharma Limited 6 Apotex Corp. 3 Northwind Pharmaceuticals, LLC 3 Exelan Pharmaceuticals Inc. 3 Northwind Health Company, LLC 3 Sun Pharmaceutical Industries, Inc. 2 Rising Pharma Holdings, Inc. 2 Denton Pharma, Inc. DBA Northwind Pharmaceuticals 2 Wockhardt USA LLC. 1 Advanz Pharma (US) Corp. 1 Unichem Pharmaceuticals (USA), Inc. 1 Unichem Laboratories Limited, India 1 Rising Health, LLC 1 MSN Laboratories Private Limited 1 Hetero Drugs Limited 1 Golden State Medical Supply, Inc. 1 Farmak, a,s 1 DirectRX 1 CZECH-GEN, a.s. 1 Concordia Pharmaceuticals Inc. 1 Cipla USA Inc. 1 Apotex Inc. 1 Aphena Pharma Solutions - Tennessee, LLC 1

…and 1 more on the FDA NDC directory.

Alfuzosin drug class (RxNorm)

Alfuzosin belongs to the alpha-Adrenergic Blocker class.

Pharmacologic class alpha-Adrenergic Blocker
Drug family (ATC) Alpha-adrenoreceptor antagonists
How it works Adrenergic alpha-Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Sources for this Alfuzosin page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 5, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Alfuzosin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Alfuzosin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
18
NDC products indexed
55
Distinct labelers/manufacturers represented
25
Linked representative label ⓘ
Concordia Pharmaceuticals Inc.
Linked label effective
Dec 5, 2024
Composite sections available
22
Linked SPL Set ID
9fc7f119-f36b-44cf-945d-940160f3afe3
Linked SPL Document ID
ffbc758d-7556-4269-8947-baa7ddb88541
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 18 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Concordia Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.