Drug · FAERS side-effect profile with label screen

Alfuzosin side effects: what 3,371 FDA adverse event reports show

Alfuzosin Hcl · 181 reaction terms · 2,587 drug–reaction co-reports · data 2026-09-14

Drug class

Alpha adrenergic antagonist

FDA label, Indications wording of the closest related product

Label matched

Alfuzosin Hcl (Uroxatral)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

3,371 reports · 58% serious · 242 with death outcome · 4% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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. ( 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.

FDA label, Indications and Usage

What it is

Each UROXATRAL extended-release tablet contains 10 mg alfuzosin hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 5Labeled (related wording) 2Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 28

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 141 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Nocturia (night-time urination)	28	14.4 10.0–20.9ROR 14.5 · χ² 336 / p 3e-75	14.0 EB05 9.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.1 · 74% consumer	no trial data cached
Urinary retention	61	11.4 8.9–14.7ROR 11.6 · χ² 570 / p 3e-126	11.2 EB05 8.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Erectile dysfunction	47	11.4 8.6–15.1ROR 11.5 · χ² 434 / p 9e-97	11.0 EB05 8.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.3 · 70% consumer	no trial data cached
Prostatic specific antigen increased	24	10.8 7.2–16.1ROR 10.9 · χ² 203 / p 2e-46	10.0 EB05 6.8 · IC025 +2.5 3/3 methods agree	Lab value / disease marker	serious PRR 8.8	no trial data cached
Dysuria (painful urination)	54	9.1 7.0–11.9ROR 9.3 · χ² 383 / p 1e-85	8.7 EB05 6.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Orthostatic hypotension (dizziness on standing)	25	8.9 6.0–13.2ROR 9.0 · χ² 168 / p 1e-38	8.1 EB05 5.6 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.1	no trial data cached
Libido decreased (lower sex drive)	17	8.5 5.3–13.7ROR 8.6 · χ² 106 / p 4e-25	7.4 EB05 4.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.4	no trial data cached
Pollakiuria (frequent urination)	55	8.2 6.3–10.7ROR 8.4 · χ² 342 / p 1e-76	7.8 EB05 6.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.9 · 75% consumer	no trial data cached
Micturition urgency	13	7.1 4.2–12.3ROR 7.2 · χ² 63 / p 1e-15	5.9 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.5	no trial data cached
Cold sweat	19	6.7 4.3–10.5ROR 6.7 · χ² 87 / p 7e-21	5.9 EB05 3.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Syncope (fainting)	97	6.0 5.0–7.3ROR 6.2 · χ² 404 / p 4e-90	5.9 EB05 5.0 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.2	no trial data cached
Hiatus hernia	12	5.8 3.3–10.1ROR 5.8 · χ² 43 / p 3e-11	4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
End stage renal disease	17	5.7 3.6–9.2ROR 5.8 · χ² 62 / p 2e-15	5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Hyperlipidaemia	11	5.7 3.2–10.3ROR 5.7 · χ² 38 / p 3e-10	4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Economic problem	14	5.7 3.4–9.5ROR 5.7 · χ² 49 / p 1e-12	4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 6.1	no trial data cached
Blood pressure decreased	56	5.3 4.1–6.8ROR 5.3 · χ² 189 / p 2e-43	5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.3	no trial data cached
International normalised ratio increased	23	5.0 3.3–7.5ROR 5.0 · χ² 69 / p 5e-17	4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree	Lab value / disease marker	serious PRR 4.8	no trial data cached
Coagulopathy	13	4.9 2.8–8.4ROR 4.9 · χ² 36 / p 9e-10	4.2 EB05 2.6 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.1	no trial data cached
Agranulocytosis (severe loss of white cells)	14	4.7 2.8–8.0ROR 4.7 · χ² 37 / p 5e-10	4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 4.7	no trial data cached
Atrial fibrillation	71	4.5 3.6–5.7ROR 4.6 · χ² 193 / p 4e-44	4.4 EB05 3.6 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.4	no trial data cached
Tendonitis	11	4.4 2.4–7.9ROR 4.4 · χ² 26 / p 2e-7	3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.1	no trial data cached
Renal failure acute	30	4.3 3.0–6.2ROR 4.4 · χ² 74 / p 4e-18	4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.4	no trial data cached
Subdural haematoma	10	4.3 2.3–8.1ROR 4.3 · χ² 22 / p 1e-6	3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.3	no trial data cached
Cholestasis (bile flow blockage)	13	4.2 2.5–7.3ROR 4.3 · χ² 29 / p 4e-8	3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.6	no trial data cached
Urinary incontinence	20	4.2 2.7–6.5ROR 4.2 · χ² 46 / p 7e-12	3.9 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.1	no trial data cached
Oedema peripheral (swelling of legs/feet)	82	4.2 3.4–5.2ROR 4.3 · χ² 196 / p 9e-45	4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.6	no trial data cached
Blood urea increased	11	4.1 2.3–7.3ROR 4.1 · χ² 22 / p 1e-6	3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree	Lab value / disease marker	serious PRR 4.5	no trial data cached
Circulatory collapse	11	4.0 2.2–7.2ROR 4.0 · χ² 22 / p 1e-6	3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 3.3	no trial data cached
Haematuria (blood in urine)	22	4.0 2.6–6.1ROR 4.0 · χ² 46 / p 5e-12	3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.8	no trial data cached
Sleep apnoea syndrome	12	3.9 2.2–6.9ROR 3.9 · χ² 23 / p 8e-7	3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.2	no trial data cached
Coronary artery disease	19	3.9 2.5–6.1ROR 3.9 · χ² 38 / p 4e-10	3.6 EB05 2.4 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.9	no trial data cached
Haematocrit decreased	12	3.7 2.1–6.6ROR 3.8 · χ² 21 / p 2e-6	3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree	Lab value / disease marker	serious PRR 4.2	no trial data cached
Rib fracture	12	3.6 2.1–6.4ROR 3.6 · χ² 20 / p 3e-6	3.3 EB05 2.0 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 4.0	no trial data cached
Chromaturia	13	3.6 2.1–6.2ROR 3.6 · χ² 22 / p 2e-6	3.2 EB05 2.0 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 3.0	no trial data cached
Dementia	16	3.6 2.2–5.8ROR 3.6 · χ² 27 / p 9e-8	3.3 EB05 2.2 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Heart rate irregular	13	3.6 2.1–6.1ROR 3.6 · χ² 21 / p 2e-6	3.2 EB05 2.0 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 3.6	no trial data cached
Diabetes mellitus inadequate control	10	3.5 1.9–6.5ROR 3.5 · χ² 16 / p 4e-5	3.1 EB05 1.8 · IC025 +0.6	Not in label — unassessed	serious PRR 3.3	no trial data cached
Abasia	14	3.5 2.1–5.9ROR 3.5 · χ² 22 / p 1e-6	3.2 EB05 2.0 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 3.6	no trial data cached
Angina pectoris	16	3.5 2.1–5.6ROR 3.5 · χ² 26 / p 2e-7	3.2 EB05 2.1 · IC025 +0.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.9	no trial data cached
Osteomyelitis	10	3.4 1.9–6.4ROR 3.4 · χ² 15 / p 5e-5	3.1 EB05 1.8 · IC025 +0.5	Not in label — unassessed	serious PRR 3.5	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Dizziness	252	3.2 2.8–3.5ROR 3.3 · χ² 377 / p 3e-84	3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.8	no trial data cached
Syncope (fainting)	97	6.0 5.0–7.3ROR 6.2 · χ² 404 / p 4e-90	5.9 EB05 5.0 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.2	no trial data cached
Oedema peripheral (swelling of legs/feet)	82	4.2 3.4–5.2ROR 4.3 · χ² 196 / p 9e-45	4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.6	no trial data cached
Atrial fibrillation	71	4.5 3.6–5.7ROR 4.6 · χ² 193 / p 4e-44	4.4 EB05 3.6 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.4	no trial data cached
Urinary retention	61	11.4 8.9–14.7ROR 11.6 · χ² 570 / p 3e-126	11.2 EB05 8.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Loss of consciousness	59	2.9 2.2–3.7ROR 2.9 · χ² 70 / p 3e-17	2.8 EB05 2.3 · IC025 +1.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.9	no trial data cached
Blood pressure decreased	56	5.3 4.1–6.8ROR 5.3 · χ² 189 / p 2e-43	5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.3	no trial data cached
Pollakiuria (frequent urination)	55	8.2 6.3–10.7ROR 8.4 · χ² 342 / p 1e-76	7.8 EB05 6.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.9 · 75% consumer	no trial data cached
Dysuria (painful urination)	54	9.1 7.0–11.9ROR 9.3 · χ² 383 / p 1e-85	8.7 EB05 6.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Blood glucose increased	50	1.6 1.2–2.2ROR 1.7 · χ² 12 / p 2e-4	1.6 EB05 1.3 · IC025 +0.2	Lab value / disease marker	serious PRR 2.1	no trial data cached
Erectile dysfunction	47	11.4 8.6–15.1ROR 11.5 · χ² 434 / p 9e-97	11.0 EB05 8.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.3 · 70% consumer	no trial data cached
Gastrointestinal haemorrhage	37	2.7 2.0–3.8ROR 2.8 · χ² 39 / p 2e-10	2.7 EB05 2.0 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.8	no trial data cached
Flushing	36	2.2 1.6–3.0ROR 2.2 · χ² 22 / p 1e-6	2.2 EB05 1.6 · IC025 +0.6	Labeled adverse reaction exact term	serious PRR 1.0 · 77% consumer	no trial data cached
Chronic kidney disease	36	2.9 2.1–4.0ROR 2.9 · χ² 44 / p 2e-11	2.8 EB05 2.2 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.0	no trial data cached
Epistaxis (nosebleed)	35	2.9 2.1–4.0ROR 2.9 · χ² 42 / p 4e-11	2.8 EB05 2.1 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 3.4	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Nocturia — n=28, PRR 14.4
Urinary retention — n=61, PRR 11.4
Erectile dysfunction — n=47, PRR 11.4
Dysuria — n=54, PRR 9.1
Pollakiuria — n=55, PRR 8.2
Renal failure acute — n=30, PRR 4.3
Urinary incontinence — n=20, PRR 4.2
Haematuria — n=22, PRR 4.0

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Alfuzosin?

In FDA FAERS, the most frequently co-reported reaction terms for Alfuzosin are dizziness, syncope, oedema peripheral, atrial fibrillation, urinary retention, loss of consciousness. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Alfuzosin have an FDA boxed warning?

No. The FDA label retrieved for Alfuzosin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Alfuzosin causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 9fc7f119-f36b-44cf-945d-940160f3afe3, effective 20241205; matched on openfda.generic_name.exact:"ALFUZOSIN HCL")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 181 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.