Drug · FAERS side-effect profile with label screen
Alfuzosin Hydrochloride side effects: what 2,378 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Alfuzosin Hydrochloride (Alfuzosin Hydrochloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,378 reports · 81% serious · 218 with death outcome · 3% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablets are an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
FDA label, Indications and Usage
What it is
Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C.
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 2Labeled (related wording) 4Reporting / coding artifact 5Lab value / disease marker 1Not 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. 55 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hepatic cytolysis | 42 | 30.4 22.5–41.0ROR 30.9 · χ² 1,160 / p 2e-254 | 29.9 EB05 23.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 21.5 · 95% clinician | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 18 | 15.6 9.8–24.7ROR 15.7 · χ² 231 / p 2e-52 | 14.9 EB05 9.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Cholestasis (bile flow blockage) | 32 | 14.8 10.5–20.8ROR 15.0 · χ² 397 / p 1e-88 | 14.5 EB05 10.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · 97% clinician | no trial data cached |
| Product administration error | 30 | 13.2 9.3–18.9ROR 13.4 · χ² 327 / p 2e-73 | 12.8 EB05 9.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 19.1 | no trial data cached |
| Pancreatitis acute | 30 | 11.9 8.3–16.9ROR 12.0 · χ² 287 / p 1e-64 | 11.3 EB05 8.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 100% clinician | no trial data cached |
| Poisoning deliberate | 12 | 11.4 6.5–20.0ROR 11.4 · χ² 103 / p 1e-24 | 9.6 EB05 5.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Toxic skin eruption | 13 | 11.3 6.6–19.5ROR 11.4 · χ² 112 / p 2e-26 | 9.8 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Hyperkalaemia (high potassium) | 41 | 10.4 7.6–14.0ROR 10.5 · χ² 337 / p 1e-75 | 9.9 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 93% clinician | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 20 | 9.5 6.2–14.8ROR 9.6 · χ² 144 / p 2e-33 | 8.5 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 100% clinician | no trial data cached |
| Micturition urgency | 12 | 9.3 5.3–16.4ROR 9.4 · χ² 81 / p 1e-19 | 7.6 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Product dispensing error | 23 | 9.3 6.2–14.0ROR 9.4 · χ² 163 / p 2e-37 | 8.4 EB05 5.7 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious n=23 · 91% clinician | no trial data cached |
| Dizziness postural | 10 | 9.2 4.9–17.0ROR 9.2 · χ² 65 / p 4e-16 | 7.2 EB05 3.9 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 14 | 8.2 4.8–13.8ROR 8.2 · χ² 81 / p 1e-19 | 6.8 EB05 4.2 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Hyponatraemia (low sodium) | 46 | 7.2 5.4–9.6ROR 7.3 · χ² 240 / p 2e-54 | 6.8 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 96% clinician | no trial data cached |
| Coma | 36 | 6.7 4.8–9.2ROR 6.7 · χ² 168 / p 1e-38 | 6.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 94% clinician | no trial data cached |
| Urinary retention | 25 | 6.6 4.5–9.8ROR 6.7 · χ² 114 / p 7e-27 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Altered state of consciousness | 16 | 6.5 4.0–10.7ROR 6.6 · χ² 70 / p 4e-17 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Erectile dysfunction | 19 | 6.5 4.2–10.2ROR 6.5 · χ² 83 / p 4e-20 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Hepatocellular injury | 10 | 6.2 3.3–11.5ROR 6.2 · χ² 39 / p 3e-10 | 5.0 EB05 2.9 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 12 | 6.1 3.4–10.7ROR 6.1 · χ² 46 / p 7e-12 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Pneumonia aspiration | 17 | 6.0 3.7–9.6ROR 6.0 · χ² 66 / p 2e-16 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Rash maculo-papular | 15 | 6.0 3.6–9.9ROR 6.0 · χ² 57 / p 2e-14 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 11 | 5.9 3.3–10.6ROR 5.9 · χ² 40 / p 1e-10 | 4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Therapy non-responder | 29 | 5.7 4.0–8.2ROR 5.8 · χ² 109 / p 9e-26 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 | no trial data cached |
| Drug interaction | 102 | 5.7 4.7–6.8ROR 5.9 · χ² 390 / p 5e-87 | 5.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 | no trial data cached |
| Bone marrow failure | 13 | 5.6 3.3–9.6ROR 5.6 · χ² 45 / p 1e-11 | 4.7 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Expired product administered | 21 | 5.6 3.6–8.5ROR 5.6 · χ² 74 / p 3e-18 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious n=20 · 90% clinician | no trial data cached |
| Lower respiratory tract infection | 27 | 5.2 3.6–7.6ROR 5.3 · χ² 89 / p 2e-21 | 4.8 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 | no trial data cached |
| Tubulointerstitial nephritis | 11 | 5.2 2.9–9.3ROR 5.2 · χ² 33 / p 5e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Presyncope (near-fainting) | 14 | 5.1 3.0–8.6ROR 5.1 · χ² 42 / p 4e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Multiple organ dysfunction syndrome | 16 | 5.0 3.1–8.2ROR 5.1 · χ² 48 / p 2e-12 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 87 | 5.0 4.1–6.2ROR 5.2 · χ² 279 / p 7e-63 | 4.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 · 94% clinician | no trial data cached |
| Dyspnoea exertional | 21 | 4.9 3.2–7.5ROR 5.0 · χ² 62 / p 2e-15 | 4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Haematuria (blood in urine) | 19 | 4.9 3.1–7.6ROR 4.9 · χ² 55 / p 7e-14 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Vertigo (spinning dizziness) | 33 | 4.8 3.4–6.7ROR 4.8 · χ² 95 / p 1e-22 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Thinking abnormal | 10 | 4.7 2.5–8.7ROR 4.7 · χ² 26 / p 2e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Lactic acidosis | 17 | 4.7 2.9–7.5ROR 4.7 · χ² 45 / p 8e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Hallucination, visual | 11 | 4.6 2.6–8.3ROR 4.6 · χ² 28 / p 7e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Blood creatine phosphokinase increased | 14 | 4.2 2.5–7.1ROR 4.2 · χ² 31 / p 1e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 3.1 | no trial data cached |
| Disorientation | 19 | 4.2 2.7–6.6ROR 4.2 · χ² 43 / p 2e-11 | 3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | 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 |
|---|---|---|---|---|---|---|
| Drug interaction | 102 | 5.7 4.7–6.8ROR 5.9 · χ² 390 / p 5e-87 | 5.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 87 | 5.0 4.1–6.2ROR 5.2 · χ² 279 / p 7e-63 | 4.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 · 94% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 46 | 7.2 5.4–9.6ROR 7.3 · χ² 240 / p 2e-54 | 6.8 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 96% clinician | no trial data cached |
| Hepatic cytolysis | 42 | 30.4 22.5–41.0ROR 30.9 · χ² 1,160 / p 2e-254 | 29.9 EB05 23.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 21.5 · 95% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 41 | 10.4 7.6–14.0ROR 10.5 · χ² 337 / p 1e-75 | 9.9 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 93% clinician | no trial data cached |
| Hot flush (hot flashes) | 36 | 4.2 3.0–5.8ROR 4.3 · χ² 85 / p 1e-20 | 4.0 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.1 · 89% consumer | no trial data cached |
| Coma | 36 | 6.7 4.8–9.2ROR 6.7 · χ² 168 / p 1e-38 | 6.2 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 94% clinician | no trial data cached |
| Hallucination (hallucinations) | 35 | 4.1 3.0–5.7ROR 4.2 · χ² 80 / p 2e-19 | 3.9 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Vertigo (spinning dizziness) | 33 | 4.8 3.4–6.7ROR 4.8 · χ² 95 / p 1e-22 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Cholestasis (bile flow blockage) | 32 | 14.8 10.5–20.8ROR 15.0 · χ² 397 / p 1e-88 | 14.5 EB05 10.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · 97% clinician | no trial data cached |
| Pancreatitis acute | 30 | 11.9 8.3–16.9ROR 12.0 · χ² 287 / p 1e-64 | 11.3 EB05 8.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 100% clinician | no trial data cached |
| Product administration error | 30 | 13.2 9.3–18.9ROR 13.4 · χ² 327 / p 2e-73 | 12.8 EB05 9.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 19.1 | no trial data cached |
| Therapy non-responder | 29 | 5.7 4.0–8.2ROR 5.8 · χ² 109 / p 9e-26 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 | no trial data cached |
| Lower respiratory tract infection | 27 | 5.2 3.6–7.6ROR 5.3 · χ² 89 / p 2e-21 | 4.8 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 | no trial data cached |
| Urinary retention | 25 | 6.6 4.5–9.8ROR 6.7 · χ² 114 / p 7e-27 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | 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.
- Hepatic cytolysis — n=42, PRR 30.4
- Cholestasis — n=32, PRR 14.8
- Pancreatitis acute — n=30, PRR 11.9
- Hyperkalaemia — n=41, PRR 10.4
- Agranulocytosis — n=20, PRR 9.5
- Hyponatraemia — n=46, PRR 7.2
- Coma — n=36, PRR 6.7
- Urinary retention — n=25, PRR 6.6
- Dyspnoea exertional — n=21, PRR 4.9
- Vertigo — n=33, PRR 4.8
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 acute kidney injury, hyponatraemia, hepatic cytolysis, hyperkalaemia, hot flush, coma. 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 43675e9d-a361-4109-9ae1-54d80580fbbd, effective 20260101; matched on
openfda.generic_name.exact:"ALFUZOSIN HYDROCHLORIDE") - 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, fieldpatient.drug.openfda.generic_name.exact, 95 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.