Quick answers
- What is Alfuzosin hydrochloride used for?
- The FDA-approved label (Uroxatral, Advanz Pharma (US) Corp., December 5, 2024) says: “UROXATRAL 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. Important Limitations of Use: UROXATRAL is not indicated for treatment of hypertension. UROXATRAL is not indicated for use in the pediatric population. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Alfuzosin hydrochloride?
- The “Adverse Reactions” section of the FDA label (Uroxatral, Advanz Pharma (US) Corp., December 5, 2024) begins: “Most common adverse reactions in clinical studies (incidence ≥2% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Alfuzosin hydrochloride?
- The “Drug Interactions” section of the FDA label (Uroxatral, Advanz Pharma (US) Corp., December 5, 2024) begins: “Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists, including UROXATRAL, can potentially cause symptomatic hypotension (5.4, 7.4) 7.1 CYP3A4 Inhibitors UROXATRAL is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir, since alfuzosin blood levels are increased [see Contraindications (4), Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)]. 7.2 Alpha Adrenergic Antagonists The pharmacokinetic and pharmacodynamic interactions between UROXATRAL and other alpha adrenergic antagonists have not been determined.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Alfuzosin hydrochloride have a boxed warning?
- No. None of the 16 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Alfuzosin hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Alfuzosin hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started January 5, 2017 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Alfuzosin hydrochloride?
- 11 companies list prescription products of Alfuzosin hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Northwind Health Company, LLC and Rising Pharma Holdings, Inc.
What Alfuzosin hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
UROXATRAL 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. Important Limitations of Use: UROXATRAL is not indicated for treatment of hypertension. UROXATRAL is not indicated for use in the pediatric population. …
— FDA label: Uroxatral, Advanz Pharma (US) Corp., effective December 5, 2024. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, extended release, oral), Uroxatral, Advanz Pharma (US) Corp.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 16 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 16 FDA labels for this medicine have a boxed warning.
Alfuzosin hydrochloride side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Most common adverse reactions in clinical studies (incidence ≥2% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue.
Read more of this section
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Advanz Pharma (US) Corp. at 1-877-370-1142 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 clinical practice. The incidence of adverse reactions has been ascertained from 3 placebo-controlled clinical trials involving 1,608 men where daily doses of 10 and 15 mg alfuzosin were evaluated. In these 3 trials, 473 men received UROXATRAL (alfuzosin HCl) 10 mg extended-release tablets. In these trials, 4% of patients taking UROXATRAL (alfuzosin HCl) 10 mg extended-release tablets withdrew from the trial due to adverse reactions, compared with 3% in the placebo group. Table 1 summarizes adverse reactions that occurred in ≥2% of patients receiving UROXATRAL, and at a higher incidence than that of the placebo group. In general, the adverse reactions seen in long-term use were similar in type and frequency to the events described below for the 3-month trials. Table 1 — Adverse Reactions Occurring in ≥2% of UROXATRAL-Treated Patients and More Frequently than with Placebo in 3-Month Placebo-Controlled Clinical Trials Adverse Reaction Placebo (n=678) UROXATRAL (n=473) Dizziness 19 (2.8%) 27 (5.7%) Upper respiratory tract infection 4 (0.6%) 14 (3.0%) Headache 12 (1.8%) 14 (3.0%) Fatigue 12 (1.8%) 13 (2.7%) The following adverse reactions, reported by between 1% and 2% of patients receiving UROXATRAL and occurring more frequently than with placebo, are listed alphabetically by body system and by decreasing frequency within body system: Body as a whole: pain Gastrointestinal system: abdominal pain, dyspepsia, constipation, nausea Reproductive system: impotence Respiratory system: bronchitis, sinusitis, pharyngitis Signs and Symptoms of Orthostasis in Clinical Trials: The adverse reactions related to orthostasis that occurred in the double-blind phase 3 trials with alfuzosin 10 mg are summarized in Table 2. Approximately 20% to 30% of patients in these trials were taking antihypertensive medication. Table 2— Number (%) of Patients with Symptoms Possibly Associated with Orthostasis in 3-Month Placebo-Controlled Clinical Trials Symptoms Placebo (n=678) UROXATRAL (n=473) Dizziness 19 (2.8%) 27 (5.7%) Hypotension or postural hypotension 0 2 (0.4%) Syncope 0 1 (0.2%) Testing for blood pressure changes or orthostatic hypotension was conducted in three controlled studies.
Table from the label
| Adverse Reaction | Placebo (n=678) | UROXATRAL (n=473) |
|---|---|---|
| Dizziness | 19 (2.8%) | 27 (5.7%) |
| Upper respiratory tract infection | 4 (0.6%) | 14 (3.0%) |
| Headache | 12 (1.8%) | 14 (3.0%) |
| Fatigue | 12 (1.8%) | 13 (2.7%) |
— FDA label: Uroxatral, Advanz Pharma (US) Corp., effective December 5, 2024. This is part of the section. Read the full label on DailyMed →
Alfuzosin hydrochloride drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists, including UROXATRAL, can potentially cause symptomatic hypotension (5.4, 7.4) 7.1 CYP3A4 Inhibitors UROXATRAL is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir, since alfuzosin blood levels are increased [see Contraindications (4), Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)]. 7.2 Alpha Adrenergic Antagonists The pharmacokinetic and pharmacodynamic interactions between UROXATRAL and other alpha adrenergic antagonists have not been determined.
Read more of this section
However, interactions may be expected, and UROXATRAL should not be used in combination with other alpha adrenergic antagonists [see Warnings and Precautions (5.4)]. 7.3 Antihypertensive Medication and Nitrates There may be an increased risk of hypotension/postural hypotension and syncope when taking UROXATRAL concomitantly with anti-hypertensive medication and nitrates [see Warnings and Precautions (5.1)]. 7.4 PDE5 Inhibitors Caution is advised when alpha adrenergic antagonists, including UROXATRAL, are co-administered with PDE5 inhibitors. Alpha adrenergic antagonists and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension [see Warnings and Precautions (5.4)].
— FDA label: Uroxatral, Advanz Pharma (US) Corp., effective December 5, 2024. Read the full label on DailyMed →
Alfuzosin hydrochloride dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
The recommended dosage is one 10 mg UROXATRAL (alfuzosin HCl) extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, Uroxatral should be taken with food and with the same meal each day. The tablets should not be chewed or crushed. 10 mg once daily with food and with the same meal each day. (2) Tablets should not be chewed or crushed (2, 12.3)
— FDA label: Uroxatral, Advanz Pharma (US) Corp., effective December 5, 2024. Read the full label on DailyMed →
Alfuzosin hydrochloride in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary Uroxatral is not indicated for use in women. There are no adequate data on the developmental risk associated with use of UROXATRAL in pregnant women. Based on findings from animal studies, alfuzosin administered during the period of organogenesis was not teratogenic, embryotoxic or fetotoxic at upto 1200 times the MRHD of 10 mg via AUC in rats and 3 times in rabbit, via body surface area.
Read more of this section
In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. Data Animal data Alfuzosin was not teratogenic, embryotoxic or fetotoxic in rats at plasma exposure levels (based on AUC of unbound drug) up to 1200 times (maternal oral dose of 250 mg/kg/day) the maximum recommended human dose (MRHD) of 10 mg. In rabbits administered up to 3 times the MRHD (based on body surface area) (maternal oral dose of 100 mg/kg/day) no embryofetal toxicity or teratogenicity was observed. Gestation was slightly prolonged in rats at exposure levels (based on AUC of unbound drug) approximately 12 times (greater than 5 mg/kg/day oral maternal dose) the MRHD, but difficulties with parturition were not observed.
— FDA label: Uroxatral, Advanz Pharma (US) Corp., effective December 5, 2024. Read the full label on DailyMed →
When Alfuzosin hydrochloride should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
UROXATRAL is contraindicated for use: in patients with moderate or severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin blood levels are increased in these patients [see 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)]. in patients with known hypersensitivity, such as urticaria and angioedema, to alfuzosin hydrochloride or any component of UROXATRAL tablets [see Adverse Reactions (6.2)] Moderate or severe hepatic impairment (4, 8.7, 12.3) Co-administration with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) (4, 5.4, 7.1, 12.3) Known hypersensitivity (e.g., urticaria or angioedema) to alfuzosin or any of the ingredients (4, 6.2)
— FDA label: Uroxatral, Advanz Pharma (US) Corp., effective December 5, 2024. Read the full label on DailyMed →
Alfuzosin hydrochloride overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Should overdose of UROXATRAL lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, then the administration of intravenous fluids should be considered. If necessary, vasopressors should then be used, and the renal function should be monitored and supported as needed.
Read more of this section
Alfuzosin is 82% to 90% protein bound; therefore, dialysis may not be of benefit.
— FDA label: Uroxatral, Advanz Pharma (US) Corp., effective December 5, 2024. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet, extended release · Tablet, film coated, extended release · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 16 in the FDA NDC Directory |
| Brand names | Uroxatral |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| alfuzosin hydrochloride 10 mg tablet, extended release | Generic | $0.1047 per tablet |
| alfuzosin hydrochloride 10 mg tablet, film coated, extended release | Generic | $0.1047 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack4 products
- Northwind Health Company, LLC3 products
- Rising Pharma Holdings, Inc.1 product
- Exelan Pharmaceuticals Inc.1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Unichem Pharmaceuticals (USA), Inc.1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- Aurobindo Pharma Limited1 product
- Advanz Pharma (US) Corp.1 product
- Cipla USA Inc.1 product
- Apotex Corp.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021287 UROXATRAL | Advanz Pharma | June 12, 2003 | 14, latest May 22, 2020 2020: Labeling · 2018: Labeling · 2016: Manufacturing (CMC) |
Generic approvals (5)
- ANDA079013Apotex Inc · July 18, 2011
- ANDA079057Sun Pharm · July 18, 2011
- ANDA090284Invagen Pharms · January 17, 2012
- ANDA079060Aurobindo Pharma Ltd · August 30, 2012
- ANDA203192Unichem · January 28, 2016
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 5, 2017 · Class II · Terminated · D-0502-2017
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Hi — Sun Pharmaceutical Industries, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 861132, 861134 |
|---|---|
| SPL set ID of the quoted label | 9fc7f119-f36b-44cf-945d-940160f3afe3 |
| FDA labels (SPL) | 16 |
| FDA applications | NDA021287, 5 ANDA |
| Active ingredients (FDA) | ALFUZOSIN |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- UroxatralBrand page: products, maker and price
- Bryant Ranch PrepackMaker or distributor
- Northwind Health Company, LLCMaker or distributor
- Rising Pharma Holdings, Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Uroxatral, Advanz Pharma (US) Corp., effective December 5, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →