Drug Safety Information for FLOMAX (Tamsulosin hydrochloride)

Safety-related Labeling Changes for FLOMAX (TAMSULOSIN HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for FLOMAX* (Tamsulosin hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with FLOMAX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective2071
2Dizziness*1880
3Dyspnoea1583
4Fatigue*1580
5Asthenia1287
6Diarrhoea1281
7Nausea1273
8Fall1073
9Pneumonia1038
10Pain*923
11Headache*875
12Hypotension863
13Death850
14Pyrexia794
15Anaemia788
16Vomiting773
17Weight decreased736
18Oedema peripheral698
19Chest pain696
20Back pain694

* This side effect also appears in "Top 10 Side Effects of FLOMAX " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking FLOMAX
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication16738
2Benign prostatic hyperplasia*11861
3Prostatomegaly*3004
4Prostatic disorder2701
5Dysuria1163
6Urinary retention*966
7Bladder disorder778
8Urinary tract disorder776
9Pollakiuria*627
10Prostate cancer*608

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for FLOMAX

Total Reports Filed with FDA: 133949


Number of FDA Adverse Event Reports by Patient Age for FLOMAX

Total Reports Filed with FDA: 133949*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Tamsulosin hydrochloride (Tamsulosin , Tamsulosin, Flomax)

Charts are based on 133949 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and FLOMAX Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.