Prescription medication · Alpha-1 Blocker (BPH)

alfuzosin

Also sold as Uroxatral. This medicine treats the symptoms of benign prostatic hyperplasia (BPH), also known as an enlarged prostate.

Data updated 2026-05-15

2,222
FDA reportsRarely reported
5
InteractionsFew interactions
$0.11
Generic price (NADAC)

What the data shows

alfuzosin (Uroxatral) is a prescription Alpha-1 Blocker (BPH), among the least-reported drugs the FDA tracks (2,222 FDA reports), with 5 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

alfuzosin (Uroxatral) is a prescription Alpha-1 Blocker (BPH). This medicine treats the symptoms of benign prostatic hyperplasia (BPH), also known as an enlarged prostate.

Alfuzosin is a medicine that helps men with enlarged prostate glands. It relaxes the muscles in the prostate and bladder, making it easier to urinate.

Drug Pricing (NADAC)

Generic Price

$0.11/unit

Generic Available

Yes (5 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

NADAC price trail: ALFUZOSIN HCL ER 10 MG TABLET

Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -8.2% vs prior release.

Effective NADAC / unit vs prior NDCs
February 21, 2024 $0.1150/EA - 3
December 18, 2024 $0.1056/EA -8.2% 12
Compare with Another Drug → Full Side Effects Report →

What it does

This medicine treats the symptoms of benign prostatic hyperplasia (BPH), also known as an enlarged prostate.

Common side effects

Dizziness, Upper respiratory tract infection, Headache

Key warnings

Alfuzosin can cause your blood pressure to drop suddenly when you stand up, leading to dizziness or fainting.

The sections below are summarized in plain English from alfuzosin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Alfuzosin belongs to a class of drugs called alpha-1 blockers. It works by relaxing the muscles in the prostate and bladder neck. This relaxation allows urine to flow more freely, relieving the symptoms of BPH.

Side Effects (from patient reports)

Based on 2,222 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for alfuzosin, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for alfuzosin each year to the FDA Adverse Event Reporting System (FAERS).

0100200300400500 20042007201020132016201920222025 406

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where alfuzosin sits

alfuzosin has more FDA adverse-event reports than 14% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is alfuzosin; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 2,222 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

2,222

Reports Mentioning Death

212

9.5% of reports — not proof of cause

Hospitalization Reports

1,009

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 66 (3%)
Male 1,919 (97%)

Age Distribution

0–17 23
18–44 32
45–64 295
65–74 590
75+ 736

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
3 DYSPNOEA 89
4 DRUG INTERACTION 87
5 FATIGUE 87
6 ACUTE KIDNEY INJURY 79
7 DIZZINESS 74
8 HYPOTENSION 74
9 DIARRHOEA 71
10 ASTHENIA 68
11 FALL 62
12 CONFUSIONAL STATE 54
13 DEATH 53
14 MALAISE 48
15 NAUSEA 48
16 HEADACHE 47
17 PNEUMONIA 47

Reactions in Death Reports

DEATH 52
GASTROINTESTINAL HAEMORRHAGE 17
MULTIPLE ORGAN DYSFUNCTION SYNDROME 15
TOXIC EPIDERMAL NECROLYSIS 14
FALL 13
BONE MARROW FAILURE 12
CARDIO-RESPIRATORY ARREST 12
ACUTE KIDNEY INJURY 10
DYSPNOEA 10
SEPSIS 10

Reactions in Hospitalization Reports

DYSPNOEA 65
ACUTE KIDNEY INJURY 50
HYPOTENSION 46
FALL 43
PNEUMONIA 42
HYPONATRAEMIA 41
DRUG INTERACTION 40
CONFUSIONAL STATE 34
MALAISE 34
ANAEMIA 30

Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Alfuzosin can cause your blood pressure to drop suddenly when you stand up, leading to dizziness or fainting. Be careful when standing up quickly, especially when you first start taking this medicine. If you have chest pain (angina), tell your doctor immediately. This medicine may also affect your heart rhythm. Tell your doctor if you have a history of heart problems.

Known Drug Interactions

7 DRUG INTERACTIONS Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists, including alfuzosin hydrochloride extended-release tablets, can potentially cause symptomatic hypotension ( 5.4 , 7.4) 7.1 CYP3A4 Inhibitors Alfuzosin hydrochloride extended-release tablets are 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) ].

Mechanism: Ketoconazole blocks the enzyme that breaks down alfuzosin, which causes the amount of alfuzosin in your blood to rise to unsafe levels.

Other Agents Alpha 1-adrenoreceptor antagonist: alfuzosin ↑ alfuzosin Co-administration is contraindicated due to potential for serious and/or life-threatening reactions such as hypotension.

Mechanism: Darunavir prevents your body from getting rid of alfuzosin, which can cause the drug to reach high levels and lead to dangerously low blood pressure.

Table 2: Established and Other Potentially Significant Drug Interactions Drug Class Drugs within Class Effect on Concentration Clinical Comments Alpha 1- adrenoreceptor antagonist alfuzosin ↑ alfuzosin Co-administration contraindicated due to potential hypotension [see Contraindications (4) ] .

Mechanism: Nirmatrelvir/ritonavir causes alfuzosin to build up in your body by slowing its removal. This can lead to a dangerous drop in your blood pressure.

Table 1:Drug Interactions with Itraconazole that Affect Concomitant Drug Concentrations Examples of Concomitant Drugs Within Class Prevention or Management Drug Interactions with Itraconazole that Increase Concomitant Drug Concentrations and May Increase Risk of Adverse Reactions Associated with the Concomitant Drug Alpha Blockers Alfuzosin Silodosin Tamsulosin Not recommended during and 2 weeks after itraconazole treatment.

Mechanism: Itraconazole slows down the breakdown of alfuzosin in your body, which can lead to an unsafe buildup of the medication. This increases your risk of having a bad reaction to the alfuzosin.

Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, tamsulosin or alfuzosin.

Mechanism: Both of these medicines can relax your blood vessels, which may lead to a further drop in blood pressure when taken together.

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I take alfuzosin if I have liver problems?
You should not take alfuzosin if you have moderate or severe liver problems.
Can I take alfuzosin with other medications?
Alfuzosin can interact with other medications. Tell your doctor about all the medicines you take, especially antifungal medicines like ketoconazole or itraconazole.
What should I do if I feel dizzy after taking alfuzosin?
Be careful when standing up quickly. If you feel dizzy, sit or lie down until the dizziness passes.
Can alfuzosin cure my enlarged prostate?
Alfuzosin does not cure an enlarged prostate, but it can help manage the symptoms.
How long does it take for alfuzosin to start working?
It may take a few days or weeks for you to notice the full effects of alfuzosin.
Can I drink alcohol while taking alfuzosin?
Drinking alcohol while taking alfuzosin may increase the risk of dizziness or lightheadedness.
What if I am having cataract surgery?
Tell your doctor if you are planning to have cataract surgery, as alfuzosin can affect the eye during surgery.
Can I take alfuzosin if I have kidney problems?
Use caution when taking alfuzosin if you have severe kidney problems.
Is alfuzosin safe for children?
No, alfuzosin is not for use in children.
What does alfuzosin look like?
Alfuzosin 10 mg tablets are yellow, round tablets with "APO" on one side and "ALF" over "10" on the other side.
What are the common side effects of alfuzosin?
The registry lists Dizziness, Upper respiratory tract infection, Headache, Fatigue among the most-reported FAERS reaction terms for alfuzosin. The compiled record contains 2,222 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does alfuzosin interact with other medications?
The registry has 5 documented interaction rows for alfuzosin. Notable source-record pairings include ketoconazole, darunavir, nirmatrelvir/ritonavir. These rows are not a complete medication review.
What drug class is alfuzosin?
alfuzosin belongs to the Alpha-1 Blocker (BPH) drug class. It requires a prescription (Rx). This medicine treats the symptoms of benign prostatic hyperplasia (BPH), also known as an enlarged prostate.
What pregnancy or breastfeeding source fields are listed for alfuzosin?
The FDA label for alfuzosin contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

Other drugs grouped near alfuzosin - same-class peers and common alternatives.

Compare alfuzosin vs bethanechol side-by-side →

Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for alfuzosin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.

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What the FDA Data Shows for alfuzosin

The FDA label for alfuzosin (sold under brand names such as Uroxatral) classifies it as a prescription-only medication in the Alpha-1 Blocker (BPH) class. This medicine treats the symptoms of benign prostatic hyperplasia (BPH), also known as an enlarged prostate. Official labeling lists 4 commonly reported side effects, including Dizziness, Upper respiratory tract infection, Headache.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 2,222 voluntary reports. The database also lists 5 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.11.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: April 2, 2025

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page