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doxazosin Side Effects

Also known as: Cardura

Analysis of 27,049 adverse event reports submitted to the FDA from 2003 to 2025.

Total Reports

27,049

Death-Related

2,269

8.4% of reports

Hospitalizations

11,467

42.4% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DYSPNOEA
1,479
DIZZINESS
1,295
FATIGUE
1,276
DRUG INEFFECTIVE
1,250
DIARRHOEA
1,237
ACUTE KIDNEY INJURY
1,135
NAUSEA
1,131
HYPOTENSION
988
ASTHENIA
950
HEADACHE
941
HYPERTENSION
853
DRUG INTERACTION
851
VOMITING
835
OFF LABEL USE
781
RENAL FAILURE
773
MALAISE
765
FALL
742
PAIN
708
ARTHRALGIA
703
SYNCOPE
684

Who Reports Side Effects

Gender Distribution

Female 8,688 (35%)
Male 16,206 (65%)
Unknown 51

Age Distribution

0-17 206 (1%)
18-44 1,048 (5%)
45-64 5,427 (26%)
65-74 6,253 (30%)
75+ 7,693 (37%)

Reporting Trend by Year

2003 2025

Reactions in Death Reports

Top reactions reported in 2,269 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 677
RENAL FAILURE 165
DYSPNOEA 163
PNEUMONIA 140
ACUTE KIDNEY INJURY 136
CARDIAC ARREST 100
ASTHENIA 98
CHRONIC KIDNEY DISEASE 97
MYOCARDIAL INFARCTION 95
SEPSIS 93
ANXIETY 91
PULMONARY EMBOLISM 86
COMPLETED SUICIDE 82
FATIGUE 82
HYPOXIA 78
CARDIAC FAILURE CONGESTIVE 77
CONDITION AGGRAVATED 74
ARTERIOSCLEROSIS 73
RESPIRATORY FAILURE 73
END STAGE RENAL DISEASE 70

Reactions in Hospitalization Reports

Top reactions in 11,467 reports where hospitalization was an outcome.

Reaction Reports
DYSPNOEA 825
ACUTE KIDNEY INJURY 806
HYPOTENSION 613
FALL 522
DIARRHOEA 514
PNEUMONIA 505
VOMITING 501
DIZZINESS 473
ANAEMIA 471
DRUG INTERACTION 451
ASTHENIA 444
HYPERTENSION 439
NAUSEA 434
RENAL FAILURE 420
FATIGUE 409
SYNCOPE 407
HYPONATRAEMIA 389
DRUG INEFFECTIVE 359
CONDITION AGGRAVATED 357
ATRIAL FIBRILLATION 345

Nearby — Related Medications

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What the FAERS Data Reveals About doxazosin Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 27,049 voluntary reports linked to doxazosin and its brand equivalents (Cardura), spanning 2003 through 2025. Of those, 2,269 (8.4%) listed death as an outcome and 11,467 (42.4%) 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, 35% were female and 65% male; age distribution skews toward 75+, with 7,693 reports in that bracket. The single most reported reaction is dyspnoea with 1,479 submissions, followed by dizziness and fatigue.

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.