alfuzosin Side Effects
Also known as: Uroxatral
Analysis of 2,222 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
2,222
Death-Related
212
9.5% of reports
Hospitalizations
1,009
45.4% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 212 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | 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 |
| CARDIAC ARREST | 8 |
| HYPONATRAEMIA | 8 |
| LIVER FUNCTION TEST ABNORMAL | 8 |
| MULTI-ORGAN FAILURE | 8 |
| PNEUMONIA | 8 |
| THROMBOCYTOPENIA | 8 |
| ASTHENIA | 7 |
| ATRIAL FIBRILLATION | 7 |
| INTERSTITIAL LUNG DISEASE | 7 |
| PANCREATITIS ACUTE | 7 |
Reactions in Hospitalization Reports
Top reactions in 1,009 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 65 |
| OFF LABEL USE | 56 |
| ACUTE KIDNEY INJURY | 50 |
| HYPOTENSION | 46 |
| FALL | 43 |
| PNEUMONIA | 42 |
| HYPONATRAEMIA | 41 |
| DRUG INTERACTION | 40 |
| CONFUSIONAL STATE | 34 |
| MALAISE | 34 |
| ANAEMIA | 30 |
| PYREXIA | 30 |
| THROMBOCYTOPENIA | 29 |
| DIARRHOEA | 28 |
| HYPERKALAEMIA | 28 |
| ATRIAL FIBRILLATION | 26 |
| DRUG INEFFECTIVE | 26 |
| CHOLESTASIS | 25 |
| PRODUCT ADMINISTRATION ERROR | 25 |
| THERAPY NON-RESPONDER | 25 |
Nearby — Related Medications
What the FAERS Data Reveals About alfuzosin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 2,222 voluntary reports linked to alfuzosin and its brand equivalents (Uroxatral), spanning 2004 through 2025. Of those, 212 (9.5%) listed death as an outcome and 1,009 (45.4%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 3% were female and 97% male; age distribution skews toward 75+, with 736 reports in that bracket. The single most reported reaction is drug ineffective with 112 submissions, followed by off label use and dyspnoea.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.