Alfuzosin hydrochloride: adverse event reports filed with FDA

646

reports as suspect product

0% of all reports · about 29 a year

56

reports, 12 months to June 2026

81 in the 12 months before

85.8%

marked serious by the reporter

76.2% across the class

8.5%

record death among outcomes, as reported

55 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Alfuzosin hydrochloride reports recording the termmedian drug in alpha-adrenergic blocker

1. Hypotensionlow blood pressure7.1%46
2. Drug ineffectivethe medicine did not work as expected5.7%37
3. Drug interactionan interaction between medicines5%32
4. Off label useused for a purpose or in a way not on the label5%32
5. Malaisegeneral feeling of being unwell4.5%29
6. Wrong product administered3.9%25
7. Growth hormone deficiency3.7%24
8. Pituitary tumour benign3.7%24
9. Product administration errora mistake in giving the product3.7%24
10. Falla fall3.6%23
11. Drug dispensed to wrong patient3.4%22
12. Product dispensing error3.4%22
13. Product storage errorthe product was stored wrongly3.4%22
14. Wrong patient received product3.4%22
15. Dizzinesslight-headedness or unsteadiness2.9%19
16. Expired product administeredthe product was used past its expiry date2.9%19
17. Lower respiratory tract infectiona chest infection2.9%19
18. Therapy non-responderthe treatment did not work2.9%19
19. Antimicrobial susceptibility test resistant2.8%18
20. Cholestasis2.8%18
21. Drug ineffective for unapproved indication2.8%18
22. Hepatic cytolysis2.8%18
23. Therapeutic response delayed2.8%18
24. Intentional product misusedeliberate use not as intended2.6%17
25. Dyspnoeashortness of breath2.5%16
26. Acute kidney injurysudden loss of kidney function2.3%15
27. Electrocardiogram QT prolongeda QT prolongation on the ECG2.3%15
28. Minimum inhibitory concentration2.3%15
29. Pancreatitis acute2.3%15
30. Vertigoa spinning sensation2.3%15

Top 30 of 212 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 12 drugs in the alpha-adrenergic blocker class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 38,454 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 21.2% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 646 reports.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the alpha-adrenergic blocker class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Alfuzosin hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (1,829) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.