What the label lists and what reports show
Alfuzosin side effects
Alfuzosin's FDA label: “Most common adverse reactions in clinical studies (incidence ≥2% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue.” FAERS holds 5,746 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dizziness (330 reports).
- Generic listed
Check it at the source: the alfuzosin FDA label on DailyMed (effective December 5, 2024, Advanz Pharma (US) Corp.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of UROXATRAL?UROXATRAL can cause serious side effects, including: See "What is the most important information I should know about UROXATRAL?" A painful erection that will not go away. UROXATRAL can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, you may not be able to get an erection in the future. The most common side effects with UROXATRAL are: dizziness headache tiredness Call your doctor if you get any side effect that bothers you. These are not all the side effects of UROXATRAL. For more information ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How do I store UROXATRAL? Store UROXATRAL between 59°F and 86°F (15°C and 30°C). Protect from light and moisture. […]
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost common adverse reactions in clinical studies (incidence ≥2% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue.
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%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common adverse reactions in clinical studies (incidence ≥2% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue. ( 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.
Source: FDA drug label, 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?
5,746 reports list alfuzosin among the medicines taken, 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. Of the 21 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Alfuzosin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions