Tamsulosin hydrochloride: adverse event reports filed with FDA

5,444

reports as suspect product

0% of all reports · about 242 a year

539

reports, 12 months to June 2026

618 in the 12 months before

85%

marked serious by the reporter

76.2% across the class

13.9%

record death among outcomes, as reported

759 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 Tamsulosin hydrochloride reports recording the termmedian drug in alpha-adrenergic blocker

1. Dizzinesslight-headedness or unsteadiness12.7%689
2. Dyspnoeashortness of breath12.4%676
3. Fatiguetiredness7.3%399
4. Syncopefainting7.1%386
5. Falla fall7%380
6. Headachehead pain6.6%360
7. Coughcough6.4%351
8. Wheezingwheezing6.2%336
9. Astheniaweakness or lack of energy5.8%314
10. Obstructive airways disorder5.8%314
11. Off label useused for a purpose or in a way not on the label5.7%312
12. Drug ineffectivethe medicine did not work as expected5.7%311
13. Diarrhoealoose or frequent stools5.7%310
14. Asthmaasthma5.6%307
15. Drug interactionan interaction between medicines5.6%307
16. Insomniadifficulty sleeping5.5%302
17. Malaisegeneral feeling of being unwell5.4%296
18. Nauseafeeling sick5.3%287
19. Pruritusitching5.1%277
20. Haemorrhagic stroke5.1%276
21. Hypotensionlow blood pressure4.9%269
22. Cardio-respiratory arrestthe heart and breathing stopped4.9%267
23. Presyncope4.8%264
24. Sepsisa severe body-wide response to infection4.8%264
25. Somnolencedrowsiness4.8%263
26. Altered state of consciousness4.8%261
27. Arthralgiajoint pain4.8%261
28. Tachycardiafast heart rate4.7%256
29. Therapeutic product effect incomplete4.6%253
30. Myalgiamuscle pain4.6%249

Top 30 of 1,004 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. 21.6% 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 5,444 reports.

Drugs most often listed in the same reports

Other products listed in reports where Tamsulosin hydrochloride is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

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 Tamsulosin hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (23,972) 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.